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Dawka S, Yagnik VD, Kaur B, Menon GR, Garg P. Garg scoring system to predict long-term healing in cryptoglandular anal fistulas: a prospective validation study. Ann Coloproctol 2024; 40:490-497. [PMID: 36217811 PMCID: PMC11532377 DOI: 10.3393/ac.2022.00346.0049] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/19/2022] [Revised: 06/24/2022] [Accepted: 06/24/2022] [Indexed: 12/24/2022] Open
Abstract
PURPOSE Complex anal fistulas can recur after clinical healing, even after a long interval which leads to significant anxiety. Also, ascertaining the efficacy of any new treatment procedure becomes difficult and takes several years. We prospectively analyzed the validity of Garg scoring system (GSS) to predict long-term fistula healing. METHODS In patients operated for cryptoglandular anal fistulas, magnetic resonance imaging was performed preoperatively and at 3 months postoperatively to assess fistula healing. Scores as per the GSS were calculated for each patient at 3 months postoperatively and correlated with long-term healing to check the accuracy of the scoring system. RESULTS Fifty-seven patients were enrolled, but 50 were finally included (7 were excluded). These 50 patients (age, 41.2±12.4 years; 46 men) were followed up for 12 to 20 months (median, 17 months). Forty-seven patients (94.0%) had complex fistulas, 28 (56.0%) had recurrent fistulas, 48 (96.0%) had multiple tracts, 20 (40.0%) had horseshoe tracts, 15 (32.0%) had associated abscesses, 5 (10.0%) were suprasphincteric, and 8 (16.0%) were supralevator fistulas. The GSS could accurately predict long-term healing (high positive predictive value, 31 of 31 [100%]) but was not very accurate in predicting nonhealing (negative predictive value, 15 of 19 [78.9%]). The sensitivity in predicting healing was 31 of 35 (88.6%). CONCLUSION GSS accurately predicts long-term fistula with a high positive predictive value (100%) but is less accurate in predicting nonhealing. This scoring system can help allay anxiety in patients and facilitate the early validation of innovative procedures for anal fistulas.
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Affiliation(s)
- Sushil Dawka
- Department of Surgery, SSR Medical College, Belle Rive, Mauritius
| | - Vipul D. Yagnik
- Department of Surgical Gastroenterology, Nishtha Surgical Hospital and Research Center, Patan, India
- Department of Surgery, Banas Medical College and Research Institute, Palanpur, India
| | - Baljit Kaur
- Department of Radiology, SSRD Magnetic Resonance Imaging Institute, Chandigarh, India
| | - Geetha R. Menon
- Department of National Statistics, Indian Council of Medical Research, New Delhi, India
| | - Pankaj Garg
- Department of Colorectal Surgery, Indus Super Specialty Hospital, Mohali, India
- Department of Colorectal Surgery, Garg Fistula Research Institute, Panchkula, India
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Rong XS, Yao C. Computed tomography imaging and clinical significance of bacterium-positive pulmonary tuberculosis complicated with diabetes. World J Clin Cases 2024; 12:4230-4238. [PMID: 39015935 PMCID: PMC11235566 DOI: 10.12998/wjcc.v12.i20.4230] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/25/2024] [Revised: 05/08/2024] [Accepted: 05/27/2024] [Indexed: 06/30/2024] Open
Abstract
BACKGROUND The increasing prevalence of tuberculosis (TB) and diabetes on a global scale poses a significant health challenge, particularly due to their co-occurrence, which amplifies the severity, recurrence and mortality rates associated with both conditions. This highlights the need for further investigation into their inter-relationship. AIM To explore the computed tomography (CT) imaging and clinical significance of bacterium-positive pulmonary TB (PTB) combined with diabetes. METHODS There were 50 patients with bacterium-positive PTB and diabetes, and 50 with only bacterium-positive PTB. The latter were designated as the control group. The CT imaging of the two groups of patients was compared, including lesion range, shape, density and calcification. RESULTS No significant differences were observed in age, gender, smoking and drinking history, high blood pressure, hyperlipidemia and family genetic factors between the groups. However, compared to the patients diagnosed solely with simple bacterium-positive PTB, those with concurrent diabetes showed a wider range of lesions and more complex and diverse morphology on CT images. Among them, intrapulmonary tuberculosis lesions were often accompanied by manifestations of pulmonary infection, such as cavity formation and bronchiectasis. At the same time, diabetes-related signs were often seen on CT images, such as pulmonary infection combined with diabetic pulmonary lesions. Logistic regression analysis identified age and medical history as significant factors influencing the degree of pulmonary infection and CT imaging outcomes in patients with both TB and diabetes. This suggests that older age and specific medical histories may increase the risk or severity of pulmonary damage in these patients. CONCLUSION CT imaging reveals more complex lesions in PTB patients with diabetes, emphasizing the need for careful evaluation and comprehensive analysis to enhance diagnostic accuracy.
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Affiliation(s)
- Xue-Song Rong
- Section 6, Department of Tuberculosis, Anhui Chest Hospital, Hefei 230022, Anhui Province, China
| | - Chao Yao
- Section 6, Department of Tuberculosis, Anhui Chest Hospital, Hefei 230022, Anhui Province, China
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Khamar J, Sachdeva A, McKechnie T, Lee Y, Tessier L, Hong D, Eskicioglu C. Cutting seton for the treatment of cryptoglandular fistula-in-ano: a systematic review and meta-analysis. Tech Coloproctol 2023; 28:12. [PMID: 38091125 DOI: 10.1007/s10151-023-02886-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/27/2023] [Accepted: 10/21/2023] [Indexed: 12/18/2023]
Abstract
BACKGROUND The use of cutting seton (CS) for the management of cryptoglandular fistula-in-ano has remained controversial because of reports of fecal incontinence, postoperative pain, and extended healing time. The aim of this review was to provide the first synthesis of studies investigating the use of CS for the treatment of cryptoglandular fistula-in-ano. METHODS MEDLINE, Embase, and CENTRAL were searched up to October 2022. Randomized controlled trials and observational studies comparing CS with alternative interventions were included, along with single-arm studies evaluating CS alone. The primary outcome was fistula-in-ano recurrence, and secondary outcomes included incontinence, healing time, proportion with complete healing, and postoperative pain. Inverse variance random-effects meta-analyses were used to pool effect estimates. RESULTS After screening 661 citations, 29 studies were included. Overall, 1513 patients undergoing CS (18.8% female, mean age: 43.1 years) were included. Patients with CS had a 6% (95% CI: 3-12%) risk of recurrence and a 16% (95% CI: 5-38%) risk of incontinence at 6 months. CS patients had an average healing time of 14.6 weeks (95% CI: 10-19 weeks) with 73% (95% CI: 48-89%) of patients achieving complete healing at 6 months postoperatively. There was no difference in recurrence between CS and fistulotomy, advancement flap, two-stage seton fistulotomy, or draining seton. CONCLUSIONS Overall, this analysis shows that CS has comparable recurrence and incontinence rates to other modalities. However, this may be at the expense of more postoperative pain and extended healing time. Further comparative studies between CS and other modalities are warranted.
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Affiliation(s)
- J Khamar
- Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada
| | - A Sachdeva
- Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada
| | - T McKechnie
- Division of General Surgery, Department of Surgery, McMaster University, St. Joseph's Healthcare, 50 Charlton Avenue East, Hamilton, ON, L8N 4A6, Canada
- Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada
| | - Y Lee
- Division of General Surgery, Department of Surgery, McMaster University, St. Joseph's Healthcare, 50 Charlton Avenue East, Hamilton, ON, L8N 4A6, Canada
- Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA, USA
| | - L Tessier
- Division of General Surgery, Department of Surgery, McMaster University, St. Joseph's Healthcare, 50 Charlton Avenue East, Hamilton, ON, L8N 4A6, Canada
| | - D Hong
- Division of General Surgery, Department of Surgery, McMaster University, St. Joseph's Healthcare, 50 Charlton Avenue East, Hamilton, ON, L8N 4A6, Canada
- Division of General Surgery, Department of Surgery, St. Joseph's Healthcare, Hamilton, ON, Canada
| | - C Eskicioglu
- Division of General Surgery, Department of Surgery, McMaster University, St. Joseph's Healthcare, 50 Charlton Avenue East, Hamilton, ON, L8N 4A6, Canada.
- Division of General Surgery, Department of Surgery, St. Joseph's Healthcare, Hamilton, ON, Canada.
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4
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Meima - van Praag EM, Becker MA, van Rijn KL, Wasmann KA, Stoker J, D'Haens GR, Ponsioen CY, Gecse KB, Dijkgraaf MG, Spinelli A, Danese S, Bemelman WA, Buskens CJ. Short-term anti-TNF therapy with surgical closure versus anti-TNF therapy alone for Crohn's perianal fistulas (PISA-II): long-term outcomes of an international, multicentre patient preference, randomised controlled trial. EClinicalMedicine 2023; 61:102045. [PMID: 37457118 PMCID: PMC10344824 DOI: 10.1016/j.eclinm.2023.102045] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/06/2023] [Revised: 05/30/2023] [Accepted: 05/30/2023] [Indexed: 07/18/2023] Open
Abstract
Background The PISA-II trial showed that short-term anti-tumour necrosis factor (anti-TNF) therapy followed by surgical closure induces radiological healing of perianal fistulas in patients with Crohn's disease more frequently than anti-TNF therapy alone after 18 months. This study aimed to compare long-term outcomes of both treatment arms. Methods Follow-up data were collected from patients who participated in the PISA-II trial, an international patient preference randomised controlled trial. This multicentre trial was performed in nine hospitals in the Netherlands and one hospital in Italy. Patients with Crohn's disease above the age of 18 years with an active high perianal fistula and a single internal opening were asked to participate. Patients were allocated to anti-TNF therapy (intravenous infliximab, or subcutaneous adalimumab, at the discretion of the gastroenterologist) for one year, or surgical closure combined with 4-months anti-TNF therapy. Patients without a treatment preference were randomised (1:1) using random block randomisation (block sizes of six without stratification), and patients with a treatment preference were treated according to their preferred treatment arm. For the current follow-up study, data were collected until May 2022. Primary outcome was radiological healing on magnetic resonance imaging (MRI), including all participants with a MRI made less than 6 months ago at the time of data collection. Analysis was based on observed data. Findings Between September 14, 2013, and December 7, 2019, 94 patients were enrolled in the trial. Long-term follow-up data were available in 91 patients (36/38 (95%) anti-TNF + surgical closure, 55/56 (98%) anti-TNF). A total of 14/36 (39%) patients in the surgical closure arm were randomly assigned, which was not significantly different in the anti-TNF treatment arm (16/55 (29%) randomly assigned). Median follow-up was 5.7 years (interquartile range (IQR) 5-7). Radiological healing occurred significantly more often after anti-TNF + surgical closure (15/36 = 42% versus 10/55 = 18%; P = 0.014). Clinical closure was comparable (26/36 = 72% versus 34/55 = 62%; P = 0.18) in both groups. However, clinical closure in the surgical group was achieved with less re-interventions 4/26 (= 15%) versus 18/34 (= 53%), including (redo-)surgical closure procedures. Recurrences occurred in 0/25 (0%) patients with radiological healing versus 27/76 (36%) patients with clinical closure, sometime during follow-up. Anti-TNF trough levels were higher in patients with long-term clinical closure in both groups (P = 0.031 and P = 0.014). In 6/11 (55%) patients in the anti-TNF group with available trough levels, recurrences were diagnosed within three months of a drop under 3.5ug/ml. 36 patients stopped anti-TNF, after which 0/14 (0%) patients with radiological healing developed a recurrence and 9/22 (41%) with clinical closure. Self-rated (in)continence was comparable between groups, and 79% (60/76) of patients indicated comparable/improved continence after treatment. Decision-regret analysis showed that all (30/30) anti-TNF + surgical closure patients agreed or strongly agreed that surgery was the right decision versus 78% (36/46) in the anti-TNF arm. All surgical closure patients would go for the same treatment again, whereas this was 89% (41/46) in the anti-TNF arm. Interpretation This study confirmed that surgical closure should be considered in amenable patients with perianal fistulas and Crohn's disease as long-term outcomes were favourable, and that radiological healing should be the aim of treatment as recurrences only occurred in patients without radiological healing. In patients with complete MRI closure, anti-TNF could be safely stopped. Funding None.
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Affiliation(s)
- Elise M. Meima - van Praag
- Department of Surgery, Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
| | - Marte A.J. Becker
- Tytgat Institute for Liver and Intestinal Research and Department of Gastroenterology & Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
| | - Kyra L. van Rijn
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, the Netherlands
| | - Karin A.T.G.M. Wasmann
- Department of Surgery, Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
| | - Jaap Stoker
- Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology, Endocrinology and Metabolism, Meibergdreef 9, Amsterdam, the Netherlands
| | - Geert R.A.M. D'Haens
- Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
| | - Cyriel Y. Ponsioen
- Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
| | - Krisztina B. Gecse
- Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
| | - Marcel G.W. Dijkgraaf
- Department of Epidemiology and Data Science, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health, Meibergdreef 9, Amsterdam, the Netherlands
| | - Antonino Spinelli
- Department of Biomedical Sciences, Humanitas University, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Silvio Danese
- Department of Gastroenterology and Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy
| | - Willem A. Bemelman
- Department of Surgery, Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
- Department of Gastroenterology and Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy
| | - Christianne J. Buskens
- Department of Surgery, Amsterdam Gastroenterology, Endocrinology and Metabolism, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
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García-Olmo D, Gómez-Barrera M, de la Portilla F. Surgical management of complex perianal fistula revisited in a systematic review: a critical view of available scientific evidence. BMC Surg 2023; 23:29. [PMID: 36740680 PMCID: PMC9901165 DOI: 10.1186/s12893-023-01912-z] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/14/2022] [Accepted: 01/10/2023] [Indexed: 02/07/2023] Open
Abstract
BACKGROUND Treating complex perianal fistulas in Crohn's disease patients remains a challenge. Classical surgical treatments for Crohn's disease fistulas have been extrapolated from cryptoglandular fistulas treatment, which have different etiology, and this might interfere with its effectiveness, in addition, they increase fecal incontinence risk. Recently, new surgical techniques with support from biological approaches, like stem cells, have been developed to preserve the function of the sphincter. We have performed a systematic literature review to compare the results of these different techniques in the treatment of Crohn's or Cryptoglandular fistula. METHODS PubMed, EMBASE, Database of Abstracts of Reviews of Effectiveness, Cochrane Central Register of Controlled Trials were searched systematically for relevant articles. We included randomized controlled trials and observational studies that referred to humans, were written in English, included adults 18+ years old, and were published during the 10-year period from 2/01/2010 to 2/29/2020. Evidence level was assigned as designated by the Scottish Intercollegiate Guidelines Network. RESULTS Of the 577 citations screened, a total of 79 were ultimately included in our review. In Crohn's disease patients, classical techniques such as primarily seton, Ligation of Intersphincteric Fistula Tracks, or lay open, healing rates were approximately 50-60%, while in cryptoglandular fistula were around, 70-80% for setons or flaps. In Crohn's disease patients, new surgical techniques using derivatives of adipose tissue reported healing rates exceeding 70%, stem cells-treated patients achieved higher combined remission versus controls (56.3% vs 38.6%, p = 0.010), mesenchymal cells reported a healing rate of 80% at week 12. In patients with cryptoglandular fistulas, a healing rate of 70% using derivatives of adipose tissue or platelets was achieved, and a healing rate of 80% was achieved using laser technology. Fecal incontinence was improved after the use of autologous platelet growth factors and Nitinol Clips. CONCLUSION New surgical techniques showed better healing rates in Crohn's disease patients than classical techniques, which have better results in cryptoglandular fistula than in Crohn's disease. Healing rates for complex cryptoglandular fistulas were similar between the classic and new techniques, being the new techniques less invasive; the incontinence rate improved with the current techniques.
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Affiliation(s)
- D. García-Olmo
- grid.419651.e0000 0000 9538 1950New Therapies Laboratory, Health Research Institute-Fundación Jiménez Díaz University Hospital (IIS-FJD/UAM), Department of Surgery, Fundación Jiménez Díaz University Hospital (UAM), Avda. Reyes Católicos, 2, 28040 Madrid, Spain
| | - M. Gómez-Barrera
- grid.512746.3Pharmacoeconomics & Outcomes Research Iberia (PORIB), Paseo Joaquín Rodrigo, 4 i, 28224 Pozuelo de Alarcón, Madrid Spain
| | - F. de la Portilla
- grid.9224.d0000 0001 2168 1229Coloproctology Unit, Clinical Management Unit of General and Gastrointestinal Surgery, Division Seville, Biomedical Research Institute (IBIS), University Hospital Virgen del Rocio/CSIC University of Seville, Seville, Spain
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Iqbal N, Shah R, Alrubaiy L, Tozer P. Do Patient-Reported Quality-of-Life (QoL) Scales Provide an Adequate Assessment of Patients with Cryptoglandular Anal Fistulae? A Systematic Review of Measurement Instruments and Their Content Validity. Clin Pract 2022; 12:628-639. [PMID: 36005069 PMCID: PMC9406553 DOI: 10.3390/clinpract12040066] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/20/2022] [Revised: 08/01/2022] [Accepted: 08/10/2022] [Indexed: 11/21/2022] Open
Abstract
Background: Cryptoglandular anal fistulae can significantly affect patient quality of life (QoL), making it essential to ensure that any study of fistula treatment assesses the impact on QoL. The aim of this systematic review was to evaluate the content validity of Patient-Reported Outcome Measures (PROMs) that assess QoL in patients with a fistula. Methods: MEDLINE, EMBASE, PsycINFO, and Scopus were searched and studies assessing the content validity of patient-reported QoL measurement instruments, or PROM development studies in patients with cryptoglandular anal fistulae, were included. Data were extracted from eligible studies to determine the instruments’ relevance, comprehensiveness, and comprehensibility, and their quality was assessed according to COnsensus-based Standards for the Selection of health Measurement Instruments (COSMIN). Results: Two PROM development studies were identified, both of which described the development of a disease-specific QoL measurement instrument for patients with cryptoglandular anal fistulae. The overall content validity of these instruments was inconsistent and supported by very low-quality evidence. There were no studies assessing the content validity of established QoL measurement instruments in patients with fistulae. Conclusions: This systematic review could not establish the content validity of the available QoL PROMs for patients with anal fistulae, due either to the absence of designated content validity studies or a lack of comprehensiveness of the available PROMs. This highlights an important gap in the literature that needs to be addressed to ensure high-quality outcome assessment in patients with fistulae.
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7
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Zahra A, Malla J, Selvaraj R, Dhanoa RK, Venugopal S, Shoukrie SI, Selvamani TY, Hamouda RK, Hamid P. A Comparison of Different Surgical Treatments for Complex Anal Fistula: A Systematic Review. Cureus 2022; 14:e28289. [PMID: 36176822 PMCID: PMC9512314 DOI: 10.7759/cureus.28289] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/23/2022] [Accepted: 08/23/2022] [Indexed: 11/05/2022] Open
Abstract
Fistula-in-ano is a common proctological condition that primarily affects younger people and leads to chronic morbidity. An anal fistula is divided into simple and complex fistulas. A complex fistula is a challenging problem due to higher recurrence rates and incontinence associated with surgery. Many new methods have been developed for the closure of complex fistula-in-ano, but there is no single best method. The aim of this study is to identify a superior surgical technique for treating complex/high cryptoglandular perianal fistulas (HCPFs). A literature search was done using PubMed and Google Scholar for the period of 2012-2021. Articles that contain surgical treatment for complex anal fistula in the English language published in the last 10 years were included. The types of studies included were randomized controlled trials (RCTs), meta-analyses, systematic reviews, cohort studies, and traditional reviews. Articles excluded were those done more than 10 years ago, in other languages, and containing simple fistula management only. Nine studies were included in the review; a systematic review and meta-analysis concluded that no single method is effective. The ligation of the intersphincteric fistula tract (LIFT) procedure seems to be a promising and effective technique as it has a low rate of fecal incontinence as compared to other methods. Biological techniques give variable success rates so does fistula plug (FP). Mucosal advancement flap (MAF) and rerouting seton give good results according to one study. Fistula plug gives variable results and is not a preferred method. Ligation of the intersphincteric fistula tract (LIFT) seems to be a promising new technique for complex anal fistulas, but the data available is not enough to determine the best method. More randomized trials are required to compare traditional techniques and emerging new biological methods to see the best technique available.
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Affiliation(s)
- Anam Zahra
- Surgery, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Jyothirmai Malla
- Surgery, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Ramaneshwar Selvaraj
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Ravneet K Dhanoa
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Sathish Venugopal
- Neurology, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Shoukrie I Shoukrie
- Orthopedics and Traumatology, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Tharun Y Selvamani
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Ranim K Hamouda
- Internal Medicine, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
| | - Pousette Hamid
- Neurology, California Institute of Behavioral Neurosciences & Psychology, Fairfield, USA
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8
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Meima-van Praag EM, van Rijn KL, Wasmann KATGM, Snijder HJ, Stoker J, D'Haens GR, Gecse KB, Gerhards MF, Jansen JM, Dijkgraaf MGW, van der Bilt JDW, Mundt MW, Spinelli A, Danese S, Bemelman WA, Buskens CJ. Short-term anti-TNF therapy with surgical closure versus anti-TNF therapy in the treatment of perianal fistulas in Crohn's disease (PISA-II): a patient preference randomised trial. Lancet Gastroenterol Hepatol 2022; 7:617-626. [PMID: 35427495 DOI: 10.1016/s2468-1253(22)00088-7] [Citation(s) in RCA: 39] [Impact Index Per Article: 13.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/21/2022] [Revised: 03/07/2022] [Accepted: 03/08/2022] [Indexed: 06/14/2023]
Abstract
BACKGROUND Guidelines on Crohn's perianal fistulas recommend anti-tumour necrosis factor (TNF) treatment and suggest considering surgical closure for patients with surgically amenable disease. However, long-term outcomes following these two strategies have not been directly compared. The aim of this study was to assess radiological healing in patients who received short-term anti-TNF treatment and surgical closure compared with those who received anti-TNF treatment alone. METHODS The PISA-II trial was a multicentre, patient preference study done in nine hospitals in the Netherlands and one hospital in Italy. Adult patients with Crohn's disease and an active high perianal fistula with a single internal opening were eligible for inclusion. After counselling, patients with no treatment preference were randomly assigned (1:1) using random block randomisation (block sizes of six without statification), to 4-month anti-TNF therapy and surgical closure or anti-TNF therapy for 1 year, after seton insertion. Patients with a treatment preference received their preferred therapy. The primary outcome was radiological healing assessed by MRI at 18 months, defined as a complete fibrotic tract or a MAGNIFI-CD (Magnetic Resonance Index for Fistula Imaging in Crohn's Disease) score of 0, assessed according to the intention-to-treat principle. Secondary outcomes included clinical closure, number of patients undergoing surgical reintervention and number of reinterventions, recurrences, and impact on quality of life measured by the Perianal Disease Activity Index (PDAI). Analyses were performed on an intention-to-treat basis and additionally an as-treated analysis for radiological healing and clinical closure. This study was registered at the Dutch Trial Registry, NL7625, and with EudraCT, 2018-002064-15, and is closed to accrual due to completion. FINDINGS Between Sept 14, 2013, and Dec 7, 2019, 94 patients were enrolled onto the trial, of whom 32 (34%) were randomly assigned and 62 (66%) chose a specific treatment. 38 (40%) patients were assigned to the surgical closure group and 56 (60%) patients to the anti-TNF group. At 18 months, radiological healing was significantly more common in the surgical closure group (12 [32%] patients) than in the anti-TNF group (five [9%] patients; p=0·005). By contrast, clinical closure was not significantly different between the two treatment groups (26 [68%] patients in the surgical closure group vs 29 [52%] patients in the anti-TNF group; p=0·076). Significantly fewer patients required a reintervention in the surgical closure group than in the anti-TNF therapy group (five [13%] patients in the surgical closure group, median one reintervention [IQR one to three] vs 24 [43%] patients in the anti-TNF group, median two reinterventions [one to two]; p=0·005). Among patients who reached clinical closure during follow-up, four (14%) of 29 in the surgical closure group and five (16%) of 31 in the anti-TNF therapy group had a recurrence, which occurred only in patients without radiological healing. PDAI was significantly lower in the surgical closure group than in the anti-TNF group after 18 months (p=0·031). Adverse events and serious adverse events were similar in both treatment groups and mostly entailed reinterventions. Ten (11%) patients had side-effects associated with anti-TNF treatment. Two serious adverse events unrelated to study treatment occurred (appendicitis and myocardial infarction). One patient died from a tongue base carcinoma, unrelated to study treatment. INTERPRETATION Short-term anti-TNF treatment combined with surgical closure induces long-term MRI healing more frequently than anti-TNF therapy in patients with Crohn's perianal fistulas. These data suggest that patients with Crohn's perianal fistula amenable for surgical closure should be counselled for this therapeutic approach. FUNDING Netherlands Organisation for Health Research and Development and Broad Medical Research Program.
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Affiliation(s)
- Elise M Meima-van Praag
- Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Kyra L van Rijn
- Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Karin A T G M Wasmann
- Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Harmanna J Snijder
- Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Jaap Stoker
- Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Geert R D'Haens
- Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Krisztina B Gecse
- Department of Gastroenterology and Hepatology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | - Michael F Gerhards
- Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands
| | - Jeroen M Jansen
- Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands
| | - Marcel G W Dijkgraaf
- Department of Epidemiology and Data Science, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands
| | | | - Marco W Mundt
- Department of Gastroenterology and Hepatology, Flevoziekenhuis, Almere, Netherlands
| | - Antonino Spinelli
- Department of Biomedical Sciences, Humanitas University, IRCCS Humanitas Research Hospital, Milan, Italy
| | - Silvio Danese
- Department of Gastroenterology and Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy
| | - Willem A Bemelman
- Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands; Department of Gastroenterology and Endoscopy, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Italy
| | - Christianne J Buskens
- Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
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Garg P. Comparison between recent sphincter-sparing procedures for complex anal fistulas-ligation of intersphincteric tract vs transanal opening of intersphincteric space. World J Gastrointest Surg 2022; 14:374-382. [PMID: 35734614 PMCID: PMC9160686 DOI: 10.4240/wjgs.v14.i5.374] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/29/2021] [Revised: 01/29/2022] [Accepted: 04/26/2022] [Indexed: 02/06/2023] Open
Abstract
Complex anal fistulas are difficult to treat. The main reasons for this are a higher recurrence rate and the risk of disrupting the continence mechanism because of sphincter involvement. Due to this, several sphincter-sparing procedures have been developed in the last two decades. Though moderately successful in simple fistulas (50%-75% healing rate), the healing rates in complex fistulas for most of these procedures has been dismal. Only two procedures, ligation of intersphincteric fistula tract and transanal opening of intersphincteric space have been shown to have good success rates in complex fistulas (60%-95%). Both of these procedures preserve continence while achieving high success rates. In this opinion review, I shall outline the history, compare the pros and cons, indications and contraindications and future application of both these procedures for the management of complex anal fistulas.
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Affiliation(s)
- Pankaj Garg
- Department of Colorectal Surgery, Garg Fistula Research Institute, Panchkula 134113, India
- Department of Colorectal Surgery, Indus International Hospital, Mohali 140507, India
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Current practice in the measurement and interpretation of intervention adherence in randomised controlled trials: A systematic review. Contemp Clin Trials 2022; 118:106788. [PMID: 35562000 DOI: 10.1016/j.cct.2022.106788] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/18/2022] [Revised: 05/04/2022] [Accepted: 05/05/2022] [Indexed: 11/24/2022]
Abstract
BACKGROUND Ideally all participants in a randomised controlled trial (RCT) should fully receive their allocated intervention; however, this rarely occurs in practice. Intervention adherence affects Type II error so influences the interpretation of trial results and subsequent implementation. We aimed to describe current practice in the definition, measurement, and reporting of intervention adherence in non-pharmacological RCTs, and how this data is incorporated into a trial's interpretation and conclusions. METHODS We conducted a systematic review of phase III RCTs published between January 2018 and June 2020 in the National Institute for Health Research Journals Library for the Health Technology Assessment, Programme Grants for Applied Research, and Public Health Research funding streams. RESULTS Of 237 reports published, 76 met the eligibility criteria and were included. Most RCTs (n = 68, 89.5%) reported adherence, though use of terminology varied widely; nearly three quarters of these (n = 49, 72.1%) conducted a sensitivity analysis. Adherence measures varied between intervention types: behavioural change (n = 10, 43.5%), psychological therapy (n = 5, 83.3%) and physiotherapy/rehabilitation (n = 8, 66.7%) interventions predominately measured adherence based on session attendance. Whereas medical device and surgical interventions (n = 17, 73.9%) primarily record the number of participants receiving the allocated intervention, a third (n = 33, 67.3%) of studies reported a difference in findings between primary and sensitivity analyses. CONCLUSIONS Although most trials report elements of adherence, terminology was inconsistent, and there was no systematic approach to its measurement, analyses, interpretation, or reporting. Given the importance of adherence within clinical trials, there is a pressing need for a standardised approach or framework.
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Garg P, Yagnik VD, Dawka S, Kaur B, Menon GR. A Novel MRI and Clinical-Based Scoring System to Assess Post-Surgery Healing and to Predict Long-Term Healing in Cryptoglandular Anal Fistulas. Clin Exp Gastroenterol 2022; 15:27-40. [PMID: 35210804 PMCID: PMC8860728 DOI: 10.2147/ceg.s343254] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2021] [Accepted: 02/07/2022] [Indexed: 12/12/2022] Open
Abstract
Background Anal fistulas cause great uncertainty and anxiety in patients and surgeons alike. This is largely because of the inability to accurately confirm postoperative fistula healing, especially long-term healing. There is no scoring system available that can objectively assess cryptoglandular anal fistulas for postoperative healing and can also accurately predict long-term healing. Methods Several parameters that could indicate anal fistula healing were assessed. Out of these, six parameters (four MRI-based and two clinical) were finalized, and a weighted score was given to each parameter. A novel scoring system (NSS) was developed. A minimum possible score (zero) indicated complete healing whereas the maximum weighted score (n = 20) indicated confirmed non-healing. Scoring was done with postoperative MRI (at least 3 months post-surgery), then compared with the actual healing status, and subsequently correlated with the final long-term clinical outcome. Results The NSS was validated in 183 operated cryptoglandular fistula-in-ano patients over a 3-year period in whom 283 MRIs (preoperative plus postoperative) were performed. The postoperative follow-up was 12–48 months (median-30 months). The NSS was found to have a very high positive predictive value (98.2%) and moderately high negative predictive value (83.7%) for long-term fistula healing. Additionally, its sensitivity and specificity in predicting healing were 93.9% and 94.7%, respectively. Conclusion Thus, this new scoring system is highly accurate and would be a useful tool for surgeons and radiologists managing anal fistulas. By objectivizing the assessment of postoperative healing, it can both ease and streamline management. Moreover, reliable prediction of recurrence-free long-term healing will greatly allay the apprehensions associated with this dreaded disease.
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Affiliation(s)
- Pankaj Garg
- Department of Colorectal Surgery, Indus Super Specialty Hospital, Mohali, Punjab, India
- Department of Colorectal Surgery, Garg Fistula Research Institute Surgery, Panchkula, Haryana, India
- Correspondence: Pankaj Garg, Department of Colorectal Surgery, Indus Super Specialty Hospital, Mohali, Punjab, 140507, India, Fax +91 9501011000, Email
| | - Vipul D Yagnik
- Department of Surgical Gastroenterology, Nishtha Surgical Hospital and Research Centre, Patan, Gujarat, India
| | - Sushil Dawka
- Department of Surgery, SSR Medical College, Belle Rive, Mauritius
| | - Baljit Kaur
- Department of Radiology, SSRD MRI Imaging Centre, Chandigarh, Haryana, India
| | - Geetha R Menon
- National Institute of Medical Statistics, Indian Council of Medical Research, New Delhi, India
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12
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Adegbola SO, Sahnan K, Tozer P, Warusavitarne J. Emerging Data on Fistula Laser Closure (FiLaC) for the Treatment of Perianal Fistulas; Patient Selection and Outcomes. Clin Exp Gastroenterol 2021; 14:467-475. [PMID: 34908858 PMCID: PMC8664604 DOI: 10.2147/ceg.s269464] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2021] [Accepted: 11/22/2021] [Indexed: 12/14/2022] Open
Abstract
Fistula laser closure (FiLaC) is a relatively new sphincter-sparing technique in fistula surgery that was initially reported in 2011. It involves the radial dissipation of laser energy in the fistula tract and, through a combination of coagulation and shrinkage of the tract, is proposed to result in progressive sealing of fistulas. Early studies have suggested minimal impact on continence and touted the advantage of minimal morbidity with potential of repeat procedures if the technique fails initially. Despite early promising results, ten years on, questions remain on the technique, patient selection and long-term outcomes. This narrative review assesses the evidence reported to-date of radially emitting laser fistula surgery in the treatment of perianal fistulas.
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Affiliation(s)
- Samuel O Adegbola
- Robin Phillips Fistula Research Unit, St Mark's Hospital and Academic Institute, Harrow, UK.,Department of Surgery and Cancer, Imperial College, London, UK
| | - Kapil Sahnan
- Robin Phillips Fistula Research Unit, St Mark's Hospital and Academic Institute, Harrow, UK.,Department of Surgery and Cancer, Imperial College, London, UK
| | - Phillip Tozer
- Robin Phillips Fistula Research Unit, St Mark's Hospital and Academic Institute, Harrow, UK.,Department of Surgery and Cancer, Imperial College, London, UK
| | - Janindra Warusavitarne
- Robin Phillips Fistula Research Unit, St Mark's Hospital and Academic Institute, Harrow, UK.,Department of Surgery and Cancer, Imperial College, London, UK
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Getting the most out of MRI in perianal fistula: update on surgical techniques and radiological features that define surgical options. Clin Radiol 2021; 76:784.e17-784.e25. [PMID: 34266658 DOI: 10.1016/j.crad.2021.06.018] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/17/2021] [Accepted: 06/18/2021] [Indexed: 12/16/2022]
Abstract
Perianal fistulas affect approximately 2 in 10,000 people, causing symptoms such as pain and discharge, which can have a debilitating effect on a patient's quality of life. Surgical treatment, which can offer a potential cure or palliation of symptoms, must be considered carefully in cases with extensive sphincter involvement. In complex cases, the use of preoperative magnetic resonance imaging (MRI) can help to determine the best course of operative action. This review describes common and contemporary surgical procedures for perianal fistula, highlighting technical features, as well as important surgical considerations associated with each method and how these can be assessed radiologically. We focus on the anatomical features and MRI findings that take procedural elements into account and help determine the most appropriate method of treatment. The aim of this article is to provide a basis for informed and focused discussion between surgeons and radiologists to ensure the most appropriate procedure is selected for each case, with the ultimate aim of obtaining the most favourable outcomes for patients.
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14
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Garg P, Kaur B, Goyal A, Yagnik VD, Dawka S, Menon GR. Lessons learned from an audit of 1250 anal fistula patients operated at a single center: A retrospective review. World J Gastrointest Surg 2021; 13:340-354. [PMID: 33968301 PMCID: PMC8069067 DOI: 10.4240/wjgs.v13.i4.340] [Citation(s) in RCA: 16] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/28/2020] [Revised: 01/18/2021] [Accepted: 03/30/2021] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND A complex anal fistula is a challenging disease to manage.
AIM To review the experience and insights gained in treating a large cohort of patients at an exclusive fistula center.
METHODS Anal fistulas operated on by a single surgeon over 14 years were analyzed. Preoperative magnetic resonance imaging was done in all patients. Four procedures were performed: fistulotomy; two novel sphincter-saving procedures, proximal superficial cauterization of the internal opening and regular emptying and curettage of fistula tracts (PERFACT) and transanal opening of intersphincteric space (TROPIS), and anal fistula plug. PERFACT was initiated before TROPIS. As per the institutional GFRI algorithm, fistulotomy was done in simple fistulas, and TROPIS was done in complex fistulas. Fistulas with associated abscesses were treated by definitive surgery. Incontinence was evaluated objectively by Vaizey incontinence scores.
RESULTS A total of 1351 anal fistula operations were performed in 1250 patients. The overall fistula healing rate was 19.4% in anal fistula plug (n = 56), 50.3% in PERFACT (n = 175), 86% in TROPIS (n = 408), and 98.6% in fistulotomy (n = 611) patients. Continence did not change significantly after surgery in any group. As per the new algorithm, 1019 patients were operated with either the fistulotomy or TROPIS procedure. The overall success rate was 93.5% in those patients. In a subgroup analysis, the overall healing rate in supralevator, horseshoe, and fistulas with an associated abscess was 82%, 85.8%, and 90.6%, respectively. The 90.6% healing rate in fistulas with an associated abscess was comparable to that of fistulas with no abscess (94.5%, P = 0.057, not significant).
CONCLUSION Fistulotomy had a high 98.6% healing rate in simple fistulas without deterioration of continence if the patient selection was done judiciously. The sphincter-sparing procedure, TROPIS, was safe, with a satisfactory 86% healing rate for complex fistulas. This is the largest anal fistula series to date.
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Affiliation(s)
- Pankaj Garg
- Department of Colorectal Surgery, Garg Fistula Research Institute, Panchkula 134113, Haryana, India
- Department of Colorectal Surgery, Indus International Hospital, Mohali 140201, Punjab, India
| | - Baljit Kaur
- Department of Radiology, SSRD Magnetic Resonance Imaging Institute, Chandigarh 160011, Chandigarh, India
| | - Ankita Goyal
- Department of Pathology, Gian Sagar Medical College and Hospital, Patiala 140601, Punjab, India
| | - Vipul D Yagnik
- Department of Surgical Gastroenterology, Nishtha Surgical Hospital and Research Center, Patan 384265, Gujarat, India
| | - Sushil Dawka
- Department of Surgery, SSR Medical College, Belle Rive 744101, Mauritius
| | - Geetha R Menon
- Department of Statistics, Indian Council of Medical Research, New Delhi 110029, New Delhi, India
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15
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Meima ‐ van Praag EM, van Rijn KL, Monraats MA, Buskens CJ, Stoker J. Magnetic resonance imaging after ligation of the intersphincteric fistula tract for high perianal fistulas in Crohn's disease: a retrospective cohort study. Colorectal Dis 2021; 23:169-177. [PMID: 32767809 PMCID: PMC7891352 DOI: 10.1111/codi.15296] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/18/2020] [Accepted: 07/28/2020] [Indexed: 12/16/2022]
Abstract
AIM Ligation of the intersphincteric fistula tract (LIFT) is increasingly being used for surgical closure of high perianal fistulas in Crohn's disease. Currently, data on postoperative MRI findings are scarce, although they are considered important for assessing healing and recurrence. Our aim, therefore, was to evaluate fistula characteristics on MRI and their relationship with clinical outcomes after LIFT. METHOD Consecutive Crohn's patients treated with LIFT between 2007 and 2018 who underwent baseline and follow-up MRI were retrospectively included. MRIs were scored by two radiologists according to characteristics based on the original and modified Van Assche indices. MRI findings, with emphasis on fibrosis, and the relationship with clinical healing, re-interventions and recurrences are described. RESULTS Twelve patients were included [four men, median age 34 (interquartile range 28-39) years]. Follow-up MRI was performed at a median of 5.5 months (interquartile range 2.5-6.0) after LIFT. At baseline, all patients showed a tract with predominantly granulation tissue, which changed to predominantly fibrotic in seven (in three of whom it was completely fibrotic). All patients with a (predominantly) fibrotic tract had clinical closure and no re-interventions or recurrences during long-term follow-up. In contrast, of the five patients with persisting granulation tissue, two reached clinical healing, two needed re-intervention and one had a recurrence. CONCLUSION Markedly decreased fistula activity can be observed on MRI after LIFT. The majority of patients develop a predominantly fibrotic tract relatively soon after LIFT without clinical recurrence, suggesting a highly effective therapy. Unfavourable clinical outcomes were only present in patients with persisting granulation tissue, indicating the potential prognostic value of MRI.
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Affiliation(s)
- E. M. Meima ‐ van Praag
- Department of SurgeryAmsterdam Gastroenterology, Endocrinology and MetabolismAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
| | - K. L. van Rijn
- Department of Radiology and Nuclear MedicineAmsterdam Gastroenterology, Endocrinology and MetabolismAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
| | - M. A. Monraats
- Department of Radiology and Nuclear MedicineAmsterdam Gastroenterology, Endocrinology and MetabolismAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
| | - C. J. Buskens
- Department of SurgeryAmsterdam Gastroenterology, Endocrinology and MetabolismAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
| | - J. Stoker
- Department of Radiology and Nuclear MedicineAmsterdam Gastroenterology, Endocrinology and MetabolismAmsterdam UMCUniversity of AmsterdamAmsterdamThe Netherlands
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Tao Y, Zheng Y, Han JG, Wang ZJ, Cui JJ, Zhao BC, Yang XQ. Long-Term Clinical Results of Use of an Anal Fistula Plug for Treatment of Low Trans-Sphincteric Anal Fistulas. Med Sci Monit 2020; 26:e928181. [PMID: 33279927 PMCID: PMC7727077 DOI: 10.12659/msm.928181] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND An anal fistula plug is a sphincter-sparing procedure that uses biological substances to close an anorectal fistula. This study aimed to evaluate the long-term therapeutic effect of an anal fistula plug procedure in patients with trans-sphincteric fistula-in-ano and to determine the risk factors affecting fistula healing. MATERIAL AND METHODS A single-center retrospective study was performed assessing long-term treatment outcomes of patients with low trans-sphincteric anal fistulas who initially underwent anal fistula plug procedures between August 2008 and September 2012. Risk factors affecting fistula healing were identified using univariate and multivariate analyses. RESULTS A total of 135 patients who had low trans-sphincteric anal fistulas and underwent anal fistula plug procedures were analysed. The overall healing rate was 56% (75/135) with a median follow-up time of 8 years (range, 72-121 months). The primary reasons for treatment failure were plug extrusion (n=12, 20%) and surgical site infection (n=9, 15%), occurring within 30 days after surgery. Multiple logistic regression analysis showed that the duration of anal fistula ≥6 months was significantly associated with treatment failure using an anal fistula plug (OR=3.187, 95% CI: 1.361-7.466, P=0.008). Of the patients who failed initial treatment with an anal fistula plug, 6 (9%) had anal fistulas that healed spontaneously after 2-3 years without additional treatment. CONCLUSIONS As a sphincter-preserving procedure, the anal fistula plug can effectively promote healing of low trans-sphincteric anal fistulas. The long-term efficacy is good and the procedure warrants wider use in clinical practice.
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Affiliation(s)
- Yu Tao
- Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China (mainland)
| | - Yi Zheng
- Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China (mainland)
| | - Jia Gang Han
- Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China (mainland)
| | - Zhen Jun Wang
- Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China (mainland)
| | - Jin Jie Cui
- Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China (mainland)
| | - Bao Cheng Zhao
- Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China (mainland)
| | - Xin Qing Yang
- Department of General Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China (mainland)
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Garg P, Sodhi SS, Garg N. Management of Complex Cryptoglandular Anal Fistula: Challenges and Solutions. Clin Exp Gastroenterol 2020; 13:555-567. [PMID: 33204136 PMCID: PMC7667587 DOI: 10.2147/ceg.s198796] [Citation(s) in RCA: 27] [Impact Index Per Article: 5.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/27/2020] [Accepted: 10/15/2020] [Indexed: 12/16/2022] Open
Abstract
Anal fistulae can be a very difficult disease to manage. The management of complex fistulae is even more challenging. The risk to the fecal continence mechanism due to damage to the anal sphincters and refractoriness to the treatment (high recurrence rate) pose the two biggest challenges in the management of this disease. Apart from these, there are several other challenges in the treatment of complex fistulae. The intriguing and uphill task is that satisfactory solutions to most of these challenges are still not known, and there is hardly any consensus on whatever treatment solutions are available. To summarize, there is no gold-standard treatment available for treating complex anal fistulae, and the search for a satisfactory treatment option is still on. In this review, the endeavor has been to discuss and highlight recent path-breaking updates in the management of complex anal fistulae.
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Affiliation(s)
- Pankaj Garg
- Department of Colorectal Surgery, Garg Fistula Research Institute, Panchkula, Haryana, India
| | - Sohail Singh Sodhi
- Department of General Surgery, Dayanand Medical College and Hospital, Ludhiana, Punjab, India
| | - Navdeep Garg
- Department of General Surgery, Government Medical College and Hospital, Chandigarh, India
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18
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Longterm outcome of anal fistula - A retrospective study. Sci Rep 2020; 10:6483. [PMID: 32300218 PMCID: PMC7162908 DOI: 10.1038/s41598-020-63541-3] [Citation(s) in RCA: 22] [Impact Index Per Article: 4.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/04/2019] [Accepted: 03/27/2020] [Indexed: 12/19/2022] Open
Abstract
This retrospective observational study analyses the outcomes of patients undergoing surgery for anal fistula at a single centre in order to assess recurrence and re-operation rates after different surgical techniques. During January 2005 and May 2013, all patients with anal fistula were included. Baseline characteristics, details of presentation, fistula anatomy, type of surgery, post-surgical outcomes and follow-up data were collected. The primary endpoints were long-term closure rate and recurrence rate after 2 years. Secondary endpoints were persistent pain, postoperative complications and continence status. A total of 65 patients were included. From a total amount of 93 operations, 65 were fistulotomies, 13 mucosal advancement flaps, 7 anal fistula plugs and 8 cutting-setons. The mean follow up was 80 months. Healing was achieved in 85%. The highest recurrence rate was seen in anal fistula plug with 42%. On the other hand, no recurrence was observed in the cutting-seton procedures. For all included operation no persistent postoperative pain nor incontinence was observed. In conclusion, despite all existing anal fistula operations up to date, the optimal technique with low recurrence rate and assured safety for the anal sphincter is still lacking. Nonetheless, according to our promising results for the cutting-seton technique, this technique, otherwise considered obsolete, should be further evaluated in a prospective study.
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Amato A, Bottini C, De Nardi P, Giamundo P, Lauretta A, Realis Luc A, Piloni V. Evaluation and management of perianal abscess and anal fistula: SICCR position statement. Tech Coloproctol 2020; 24:127-143. [PMID: 31974827 DOI: 10.1007/s10151-019-02144-1] [Citation(s) in RCA: 54] [Impact Index Per Article: 10.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2019] [Accepted: 12/23/2019] [Indexed: 02/07/2023]
Abstract
Perianal sepsis is a common condition ranging from acute abscess to chronic anal fistula. In most cases, the source is considered to be a non-specific cryptoglandular infection starting from the intersphincteric space. Surgery is the main treatment and several procedures have been developed, but the risks of recurrence and of impairment of continence still seem to be an unresolved issue. This statement reviews the pertinent literature and provides evidence-based recommendations to improve individualized management of patients.
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Affiliation(s)
- A Amato
- Coloproctology Unit, Department of Surgery, Borea Hospital, Sanremo, Italy.
| | - C Bottini
- Unit of Surgery, Hospital S. Antonio Abate, Gallarate, VA, Italy
| | - P De Nardi
- Gastrointestinal Surgery, San Raffaele Scientific Institute, Milan, Italy
| | - P Giamundo
- Department of Colorectal Surgery, Policlinico di Monza, Monza, Italy
| | - A Lauretta
- Unit of General Oncologic Surgery, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS Aviano, Aviano, Italy
| | - A Realis Luc
- Coloproctology Unit, Hospital S. Rita, Vercelli, Italy
| | - V Piloni
- Diagnostic Imaging Centre "Diagnostica Marche", Osimo Stazione, Ancona, Italy
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21
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Amato A, Bottini C, De Nardi P, Giamundo P, Lauretta A, Realis Luc A, Piloni V. Evaluation and management of perianal abscess and anal fistula: SICCR position statement. Tech Coloproctol 2020; 24:127-143. [DOI: 14) evaluation and management of perianal abscess and anal fistula: siccr position statement.a.amato, c.bottini, p.de nardi, p.giamundo, a.lauretta, a.realis luc & v.piloni.tech coloproctol 2020 24:127-143 doi 10.1007/s10151-019-02144-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/05/2019] [Accepted: 12/23/2019] [Indexed: 09/10/2023]
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22
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Sammut M, Skaife P. The management of cryptoglandular fistula-in-ano. Br J Hosp Med (Lond) 2020; 81:1-9. [PMID: 32003630 DOI: 10.12968/hmed.2019.0353] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Abstract
Idiopathic cryptoglandular fistula-in-ano is a common pathological condition. Fistula-in-ano has been managed by a number of surgical techniques, and there is still no consensus regarding the management of this condition. Surgical techniques aim to treat and cure the fistula-in-ano with minimal risk of recurrence or complications, and to maintain patient continence. This article discusses the evidence available to inform the management of idiopathic cryptoglandular fistula-in-ano, and problems that surgeons face because of the lack of high-quality evidence.
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Affiliation(s)
- Matthew Sammut
- Colorectal Department, Aintree University Hospital NHS Foundation Trust, Liverpool, UK
| | - Paul Skaife
- Colorectal Department, Aintree University Hospital NHS Foundation Trust, Liverpool, UK
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Haddow JB, Musbahi O, MacDonald TT, Knowles CH. Comparison of cytokine and phosphoprotein profiles in idiopathic and Crohn’s disease-related perianal fistula. World J Gastrointest Pathophysiol 2019; 10:42-53. [PMID: 31750007 PMCID: PMC6854389 DOI: 10.4291/wjgp.v10.i4.42] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/29/2019] [Revised: 09/28/2019] [Accepted: 10/18/2019] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Perianal fistulae are either primary (idiopathic) or secondary [commonly associated with Crohn’s disease, (CD)]. It is assumed, although not proven, that the pathophysiology differs.
AIM To systematically compare the clinical phenotypes, cytokine and phosphoprotein profiles of idiopathic and CD-related perianal fistulae.
METHODS Sixty-one patients undergoing surgery for perianal fistula were prospectively recruited (48 idiopathic, 13 CD) into a cohort study. Clinical data, including the Perineal Disease Activity Index (PDAI) and EQ-5D-5L were collected. Biopsies of the fistula tract, granulation tissue, internal opening mucosa and rectal mucosa were obtained at surgery. Concentrations of 30 cytokines and 39 phosphoproteins were measured in each biopsy using a magnetic bead multiplexing instrument and a chemiluminescent antibody array respectively. Over 12000 clinical and 23500 laboratory measurements were made.
RESULTS The PDAI was significantly higher (indicating more active disease) in the CD group with a mean difference of 2.40 (95%CI: 0.52-4.28, P = 0.01). Complex pathoanatomy was more prevalent in the CD group, namely more multiple fistulae, supralevator extensions, collections and rectal thickening. The IL-12p70 concentration at the internal opening specimen site was significantly higher (median difference 19.7 pg/mL, 99%CI: 0.2-40.4, P = 0.008) and the IL-1RA/IL-1β ratio was significantly lower in the CD group at the internal opening specimen site (median difference 15.0, 99%CI = 0.4-50.5, P = 0.008). However in the remaining 27 cytokines and all 39 of the phosphoproteins across the four biopsy sites, no significant differences were found between the groups.
CONCLUSION CD-related perianal fistulae are more clinically severe and anatomically complex than idiopathic perianal fistulae. However, overall there are no major differences in cytokine and phosphoprotein profiles.
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Affiliation(s)
- James B Haddow
- Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 5AT, United Kingdom
| | - Omar Musbahi
- Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 5AT, United Kingdom
| | - Thomas T MacDonald
- Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 5AT, United Kingdom
| | - Charles H Knowles
- Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London E1 5AT, United Kingdom
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