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HART Collaborative, Torkington J, Harries R, O'Connell S, Knight L, Islam S, Bashir N, Watkins A, Fegan G, Cornish J, Rees B, Cole H, Jarvis H, Jones S, Russell I, Bosanquet D, Cleves A, Sewell B, Farr A, Zbrzyzna N, Fiera N, Ellis-Owen R, Hilton Z, Parry C, Bradbury A, Wall P, Hill J, Winter D, Cocks K, Harris D, Hilton J, Vakis S, Hanratty D, Rajagopal R, Akbar F, Ben-Sassi A, Francis N, Jones L, Williamson M, Lindsey I, West R, Smart C, Ziprin P, Agarwal T, Faulkner G, Pinkney T, Vimalachandran D, Lawes D, Faiz O, Nisar P, Smart N, Wilson T, Myers A, Lund J, Smolarek S, Acheson A, Horwood J, Ansell J, Phillips S, Davies M, Davies L, Bird S, Palmer N, Williams M, Galanopoulos G, Rao PD, Jones D, Barnett R, Tate S, Wheat J, Patel N, Rahmani S, Toynton E, Smith L, Reeves N, Kealaher E, Williams G, Sekaran C, Evans M, Beynon J, Egan R, Qasem E, Khot U, Ather S, Mummigati P, Taylor G, Williamson J, Lim J, Powell A, Nageswaran H, Williams A, Padmanabhan J, Phillips K, Ford T, Edwards J, Varney N, Hicks L, Greenway C, Chesters K, Jones H, et alHART Collaborative, Torkington J, Harries R, O'Connell S, Knight L, Islam S, Bashir N, Watkins A, Fegan G, Cornish J, Rees B, Cole H, Jarvis H, Jones S, Russell I, Bosanquet D, Cleves A, Sewell B, Farr A, Zbrzyzna N, Fiera N, Ellis-Owen R, Hilton Z, Parry C, Bradbury A, Wall P, Hill J, Winter D, Cocks K, Harris D, Hilton J, Vakis S, Hanratty D, Rajagopal R, Akbar F, Ben-Sassi A, Francis N, Jones L, Williamson M, Lindsey I, West R, Smart C, Ziprin P, Agarwal T, Faulkner G, Pinkney T, Vimalachandran D, Lawes D, Faiz O, Nisar P, Smart N, Wilson T, Myers A, Lund J, Smolarek S, Acheson A, Horwood J, Ansell J, Phillips S, Davies M, Davies L, Bird S, Palmer N, Williams M, Galanopoulos G, Rao PD, Jones D, Barnett R, Tate S, Wheat J, Patel N, Rahmani S, Toynton E, Smith L, Reeves N, Kealaher E, Williams G, Sekaran C, Evans M, Beynon J, Egan R, Qasem E, Khot U, Ather S, Mummigati P, Taylor G, Williamson J, Lim J, Powell A, Nageswaran H, Williams A, Padmanabhan J, Phillips K, Ford T, Edwards J, Varney N, Hicks L, Greenway C, Chesters K, Jones H, Blake P, Brown C, Roche L, Jones D, Feeney M, Shah P, Rutter C, McGrath C, Curtis N, Pippard L, Perry J, Allison J, Ockrim J, Dalton R, Allison A, Rendell J, Howard L, Beesley K, Dennison G, Burton J, Bowen G, Duberley S, Richards L, Giles J, Katebe J, Dalton S, Wood J, Courtney E, Hompes R, Poole A, Ward S, Wilkinson L, Hardstaff L, Bogden M, Al-Rashedy M, Fensom C, Lunt N, McCurrie M, Peacock R, Malik K, Burns H, Townley B, Hill P, Sadat M, Khan U, Wignall C, Murati D, Dhanaratne M, Quaid S, Gurram S, Smith D, Harris P, Pollard J, DiBenedetto G, Chadwick J, Hull R, Bach S, Morton D, Hollier K, Hardy V, Ghods M, Tyrrell D, Ashraf S, Glasbey J, Ashraf M, Garner S, Whitehouse A, Yeung D, Mohamed SN, Wilkin R, Suggett N, Lee C, Bagul A, McNeill C, Eardley N, Mahapatra R, Gabriel C, Datt P, Mahmud S, Daniels I, McDermott F, Nodolsk M, Park L, Scott H, Trickett J, Bearn P, Trivedi P, Frost V, Gray C, Croft M, Beral D, Osborne J, Pugh R, Herdman G, George R, Howell AM, Al-Shahaby S, Narendrakumar B, Mohsen Y, Ijaz S, Nasseri M, Herrod P, Brear T, Reilly JJ, Sohal A, Otieno C, Lai W, Coleman M, Platt E, Patrick A, Pitman C, Balasubramanya S, Dickson E, Warman R, Newton C, Tani S, Simpson J, Banerjee A, Siddika A, Campion D, Humes D, Randhawa N, Saunders J, Bharathan B, Hay O. Incisional hernia following colorectal cancer surgery according to suture technique: Hughes Abdominal Repair Randomized Trial (HART). Br J Surg 2022; 109:943-950. [PMID: 35979802 PMCID: PMC10364691 DOI: 10.1093/bjs/znac198] [Show More Authors] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/03/2022] [Revised: 05/09/2022] [Accepted: 05/13/2022] [Indexed: 11/14/2022]
Abstract
BACKGROUND Incisional hernias cause morbidity and may require further surgery. HART (Hughes Abdominal Repair Trial) assessed the effect of an alternative suture method on the incidence of incisional hernia following colorectal cancer surgery. METHODS A pragmatic multicentre single-blind RCT allocated patients undergoing midline incision for colorectal cancer to either Hughes closure (double far-near-near-far sutures of 1 nylon suture at 2-cm intervals along the fascia combined with conventional mass closure) or the surgeon's standard closure. The primary outcome was the incidence of incisional hernia at 1 year assessed by clinical examination. An intention-to-treat analysis was performed. RESULTS Between August 2014 and February 2018, 802 patients were randomized to either Hughes closure (401) or the standard mass closure group (401). At 1 year after surgery, 672 patients (83.7 per cent) were included in the primary outcome analysis; 50 of 339 patients (14.8 per cent) in the Hughes group and 57 of 333 (17.1 per cent) in the standard closure group had incisional hernia (OR 0.84, 95 per cent c.i. 0.55 to 1.27; P = 0.402). At 2 years, 78 patients (28.7 per cent) in the Hughes repair group and 84 (31.8 per cent) in the standard closure group had incisional hernia (OR 0.86, 0.59 to 1.25; P = 0.429). Adverse events were similar in the two groups, apart from the rate of surgical-site infection, which was higher in the Hughes group (13.2 versus 7.7 per cent; OR 1.82, 1.14 to 2.91; P = 0.011). CONCLUSION The incidence of incisional hernia after colorectal cancer surgery is high. There was no statistical difference in incidence between Hughes closure and mass closure at 1 or 2 years. REGISTRATION NUMBER ISRCTN25616490 (http://www.controlled-trials.com).
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O'Connell S, Islam S, Sewell B, Farr A, Knight L, Bashir N, Harries R, Jones S, Cleves A, Fegan G, Watkins A, Torkington J. Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT. Health Technol Assess 2022; 26:1-100. [PMID: 35938554 DOI: 10.3310/cmwc8368] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/22/2022] Open
Abstract
BACKGROUND Incisional hernias can cause chronic pain and complications and affect quality of life. Surgical repair requires health-care resources and has a significant associated failure rate. A prospective, multicentre, single-blinded randomised controlled trial was conducted to investigate the clinical effectiveness and cost-effectiveness of the Hughes abdominal closure method compared with standard mass closure following surgery for colorectal cancer. The study randomised, in a 1 : 1 ratio, 802 adult patients (aged ≥ 18 years) undergoing surgical resection for colorectal cancer from 28 surgical departments in UK centres. INTERVENTION Hughes abdominal closure or standard mass closure. MAIN OUTCOME MEASURES The primary outcome was the incidence of incisional hernias at 1 year, as assessed by clinical examination. Within-trial cost-effectiveness and cost-utility analyses over 1 year were conducted from an NHS and a social care perspective. A key secondary outcome was quality of life, and other outcomes included the incidence of incisional hernias as detected by computed tomography scanning. RESULTS The incidence of incisional hernia at 1-year clinical examination was 50 (14.8%) in the Hughes abdominal closure arm compared with 57 (17.1%) in the standard mass closure arm (odds ratio 0.84, 95% confidence interval 0.55 to 1.27; p = 0.4). In year 2, the incidence of incisional hernia was 78 (28.7%) in the Hughes abdominal closure arm compared with 84 (31.8%) in the standard mass closure arm (odds ratio 0.86, 95% confidence interval 0.59 to 1.25; p = 0.43). Computed tomography scanning identified a total of 301 incisional hernias across both arms, compared with 100 identified by clinical examination at the 1-year follow-up. Computed tomography scanning missed 16 incisional hernias that were picked up by clinical examination. Hughes abdominal closure was found to be less cost-effective than standard mass closure. The mean incremental cost for patients undergoing Hughes abdominal closure was £616.45 (95% confidence interval -£699.56 to £1932.47; p = 0.3580). Quality of life did not differ significantly between the study arms at any time point. LIMITATIONS As this was a pragmatic trial, the control arm allowed surgeon discretion in the approach to standard mass closure, introducing variability in the techniques and equipment used. Intraoperative randomisation may result in a loss of equipoise for some surgeons. Follow-up was limited to 2 years, which may not have been enough time to see a difference in the primary outcome. CONCLUSIONS Hughes abdominal closure did not significantly reduce the incidence of incisional hernias detected by clinical examination and was less cost-effective at 1 year than standard mass closure in colorectal cancer patients. Computed tomography scanning may be more effective at identifying incisional hernias than clinical examination, but the clinical benefit of this needs further research. FUTURE WORK An extended follow-up using routinely collected NHS data sets aims to report on incisional hernia rates at 2-5 years post surgery to investigate any potential mortality benefit of the closure methods. Furthermore, the proportion of incisional hernias identified by a computed tomography scan (at 1 and 2 years post surgery), but not during clinical examination (occult hernias), proceeding to surgical repair within 3-5 years after the initial operation will be explored. TRIAL REGISTRATION This trial is registered as ISRCTN25616490. FUNDING This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 34. See the NIHR Journals Library website for further project information.
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Affiliation(s)
- Susan O'Connell
- Cedar Healthcare Technology Research Centre, Cardiff and Vale University Health Board, Cardiff, UK
| | - Saiful Islam
- Swansea Trials Unit, Swansea University, Swansea, UK
| | - Bernadette Sewell
- Swansea Centre for Health Economics, Swansea University, Swansea, UK
| | - Angela Farr
- Swansea Centre for Health Economics, Swansea University, Swansea, UK
| | - Laura Knight
- Cedar Healthcare Technology Research Centre, Cardiff and Vale University Health Board, Cardiff, UK
| | - Nadim Bashir
- Swansea Trials Unit, Swansea University, Swansea, UK
| | - Rhiannon Harries
- Department of Colorectal Surgery, Swansea Bay University Health Board, Swansea, UK
| | | | - Andrew Cleves
- Cedar Healthcare Technology Research Centre, Cardiff and Vale University Health Board, Cardiff, UK
| | - Greg Fegan
- Swansea Trials Unit, Swansea University, Swansea, UK
| | - Alan Watkins
- Swansea Trials Unit, Swansea University, Swansea, UK
| | - Jared Torkington
- Cardiff and Vale University Health Board, University Hospital of Wales, Cardiff, UK
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Scrimgeour DSG, Allan M, Knight SR, East B, Blackwell S, Dames N, Laidlaw L, Light D, Horgan L, Smart NJ, de Beaux A, Wilson MSJ. A modified Delphi process to establish research priorities in hernia surgery. Hernia 2022; 26:751-759. [PMID: 34718903 PMCID: PMC8557712 DOI: 10.1007/s10029-021-02519-0] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/08/2021] [Accepted: 10/04/2021] [Indexed: 11/23/2022]
Abstract
BACKGROUND Abdominal wall hernia repair is one of the most commonly performed surgical procedures worldwide, yet despite this, there remains a lack of high-quality evidence to support best management. The aim of the study was to use a modified Delphi process to determine future research priorities in this field. METHODS Stakeholders were invited by email, using British Hernia Society membership details or Twitter, to submit individual research questions via an online survey. In addition, questions obtained from a patient focus group (PFG) were collated to form Phase I. Two rounds of prioritization by stakeholders (phases II and III) were then completed to determine a final list of research questions. All questions were analyzed on an anonymized basis. RESULTS A total of 266 questions, 19 from the PFG, were submitted by 113 stakeholders in Phase I. Of these, 64 questions were taken forward for prioritization in Phase II, which was completed by 107 stakeholders. Following Phase II analysis, 97 stakeholders prioritized 36 questions in Phase III. This resulted in a final list of 14 research questions, 3 of which were from the PFG. Stakeholders included patients and healthcare professionals (consultant surgeons, trainee surgeons and other multidisciplinary members) from over 27 countries during the 3 phases. CONCLUSION The study has identified 14 key research priorities pertaining to abdominal wall hernia surgery. Uniquely, these priorities have been determined from participation by both healthcare professionals and patients. These priorities should now be addressed by well-designed, high-quality international collaborative research.
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Affiliation(s)
- D S G Scrimgeour
- Department of Colorectal Surgery, Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN, Scotland.
| | - M Allan
- Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, EH4 2XU, Scotland
| | - S R Knight
- Centre for Medical Informatics, Usher Institute, University of Edinburgh, Edinburgh, EH16 4UX, Scotland
| | - B East
- 3rd Department of Surgery, Motol University Hospital, V Uvalu 84, 150 06, Prague, Czech Republic
- Department of General Surgery, Forth Valley Royal Hospital, Larbert, FK5 4WR, UK
| | | | - N Dames
- Patient Representative, Glasgow, UK
| | - L Laidlaw
- Patient Representative, Edinburgh, UK
| | - D Light
- Department of UGI Surgery, Northumbria Healthcare NHSFT, Rake Ln, Tyne and Wear, North Shields, NE29 8NH, UK
| | - L Horgan
- Department of UGI Surgery, Northumbria Healthcare NHSFT, Rake Ln, Tyne and Wear, North Shields, NE29 8NH, UK
| | - N J Smart
- Department of Gastrointestinal Surgery, Royal Devon and Exeter NHS Trust, Barrack Road, Exeter, EX25DW, Devon, UK
| | - A de Beaux
- Department of General Surgery, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, Scotland
| | - M S J Wilson
- Department of General Surgery, Forth Valley Royal Hospital, Larbert, FK5 4WR, UK
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