Is the use of a transanal drainage tube effective in treating anastomotic leakage for mid-low rectal cancer

Abstract

BACKGROUND

Anastomotic leakage (AL) is a severe surgical complication for mid-low rectal cancers. The efficacy of transanal drainage tube (TDT) has rarely been reported.

AIM

To evaluate the efficacy of TDT after AL.

METHODS

A retrospective analysis was conducted on 68 patients with mid-low rectal cancer who underwent laparoscopic low anterior resection (LAR) and developed ALs. Leakage were identified using imaging studies and digital rectal examinations when local abscesses or systemic infections were present. In each patient, the leakage site was determined using the index finger and a drainage tube was inserted transanally to drain the abscesses and exudates outside the anus. The clinical outcomes of the patients following transanal drainage were analyzed.

RESULTS

A total of 43 patients received TDT treatment, while 25 patients did not receive TDT treatment. Among the patients in the TDT group, 9 required reoperation compared to 12 in the non-TDT group. In the TDT group, 76.74% of the patients were able to restore intestinal continuity, whereas only 40% of the patients in the non-TDT group achieved restored intestinal continuity. In the TDT group, 48.48% of patients developed LAR syndrome (LARS), whereas in the non-TDT group, 90% of patients developed LARS. The median drainage time was 7 days, the median postoperative hospital stay was 21 days, the median fasting time was 6.5 days, and the median hospitalization cost was 109205.93 RMB.

CONCLUSION

TDT use lowered reoperation rate but did not increase hospitalization expenses. After ≥ 1 year of follow-up, its use improved intestinal patency rate and reduced the incidence of LARS.

Key Words: Rectal cancer; Anastomotic leakage; Transanal drainage tube; Low anterior resection syndrome; Therapy

Core Tip: This study compared the efficacy of transanal drainage tubes (TDTs) in patients with middle-to-low rectal cancer who underwent low anterior resection (LAR) and anastomotic leakage (AL). The TDT group had a lower reoperation rate and no increase in hospitalization costs. After at least one year of follow-up, TDT improved the intestinal patency rate and reduced the incidence of LAR syndrome. TDT is an economic and effective method for treating AL after surgery. This study may assist surgeons in making better decisions regarding postoperative AL treatment.

INTRODUCTION

Postoperative anastomotic leakage (AL) is the most serious complication of colorectal surgery, particularly in cases of low anterior resection (LAR) or colorectal-anal anastomosis. However, there is currently no consensus regarding the treatment of AL after colorectal surgery[1]. Different definitions of AL can lead to variations in treatment approaches[2]. In addition, whether the patient undergoes a diverting stoma during initial surgery can potentially alter the treatment strategy[3]. The commonly used surgical treatment options for AL include diverting loop ileostomy, resection of the anastomosis, and closure of the rectal stump with an end colostomy (Hartmann’s procedure). However, based on the patient's clinical presentation and the timing of the leakage, surgeons tend to favor more conservative treatment measures and reserve surgical intervention as a last-resort option[4,5].

MATERIALS AND METHODS

Study patients

All patients (n = 68) underwent laparoscopic anterior rectal resection (LAR) of the rectum at The First Affiliated Hospital of Chongqing Medical University, China. We conducted a retrospective comparison of 43 patients who received transanal drainage tube (TDT) treatment for AL after LAR and a historical cohort of 25 patients who did not receive TDT treatment. These 68 patients were selected from our colorectal cancer database (838 patients who underwent anterior resection for rectal cancer from 2018 to 2023). All the patients underwent surgery between 2018 and 2023. The inclusion criteria were as follows: (1) Age ≥ 18 years; (2) Preoperative or postoperative pathological diagnosis of rectal cancer; (3) Elective laparoscopic anterior resection of the rectum and total mesorectal excision; (4) Distance from the tumor to the anal verge ≤ 10 cm; and (5) Tumor achieved R0 resection.

The exclusion criteria were as follows: (1) Patients whose initial surgery was performed in other hospitals; (2) Patients who received neoadjuvant treatment; (3) Patients diagnosed with delayed AL > 30 days after surgery; (4) Patients with Crohn's disease, ulcerative colitis, or iatrogenic perforation; and (5) Patients with other concurrent digestive tract tumors or abdominal metastases. Patient diagnostic and treatment data were retrieved from hospital medical records. Basic patient information, preoperative albumin levels, surgical approach, the distance of the tumor from the anus, tumor diameter, American Society of Anesthesiologists score, TNM stage, diverting stoma, and duration of anal canal treatment were collected (Table 1). Operation time, distance of anastomosis from the anus, intraoperative bleeding, reoperation, bacterial cultures of abdominal drainage fluid negative, neutrophil number back to normal, the time of procalcitonin (PCT) to be less than 0.25 ng/mL, recovery of enteral nutrition, albumin at discharge, use of antibiotics, cost, discharge after surgery, and death were collected (Table 2).

Table 1 Biological data and comorbidity in the transanal drainage tube and non-transanal drainage tube groups, n (%).

Variables	All patients (n = 68)	Non-TDT (n = 25)	TDT (n = 43)	Statistic	P value
Sex			χ² = 1.06	0.304
Male	46 (67.65)	15 (60.00)	31 (72.09)
Female	22 (32.35)	10 (40.00)	12 (27.91)
Age (years)	62.44 ± 12.04	60.64 ± 12.45	63.49 ± 11.81	t = -0.94	0.351
Preoperative albumin (g/L)	41.00 (38.00, 44.00)	41.00 (38.00, 43.00)	41.00 (38.50, 44.00)	Z = -0.03	0.98
Body mass index (kg/m2)	23.71 ± 2.95	23.55 ± 3.21	23.80 ± 2.82	t = -0.34	0.736
Comorbidity	35 (51.47)	12 (48.00)	23 (53.49)	χ² = 0.19	0.662
Diabetes	13 (19.12)	5 (20.00)	8 (18.60)	χ² = 0.00	1
Hypertension	22 (32.35)	6 (24.00)	16 (37.21)	χ² = 1.26	0.262
Chronic obstructive pulmonary disease	2 (2.94)	0 (0.00)	2 (4.65)	-	0.528
Cardiovascular	10 (14.71)	4 (16.00)	6 (13.95)	-	1
Hepatic insufficiency	2 (2.94)	1 (4.00)	1 (2.33)	-	1
Surgical approach				χ² = 0.39	0.531
Laparoscope	62 (91.18)	24 (96.00)	38 (88.37)
Robot assisted	6 (8.82)	1 (4.00)	5 (11.63)
Distance of tumor from the anus (cm)	7.00 (5.00, 8.00)	7.00 (5.00, 7.50)	7.00 (5.00, 8.00)	Z = -0.08	0.933
Tumor diameter (cm)	4.00 (3.00, 4.00)	3.00 (3.00, 4.00)	4.00 (3.00, 4.00)	Z = -1.29	0.196
American Society of Anesthesiologists				χ² = 0.56	0.455
1-2	48 (70.59)	19 (76.00)	29 (67.44)
3	20 (29.41)	6 (24.00)	14 (32.56)
TNM				χ² = 1.25	0.536
I	16 (23.53)	4 (16.00)	12 (27.91)
II	32 (47.06)	13 (52.00)	19 (44.19)
III	20 (29.41)	8 (32.00)	12 (27.91)
Diverting stoma	21 (30.88)	7 (28.00)	14 (32.56)	χ² = 0.15	0.695
Duration of anal canal treatment (days)			7.00 (5.00, 10.50)

TDT: Transanal drainage tube.

Table 2 Intention-to-treat analysis of the transanal drainage tube and non-transanal drainage tube groups, n (%).

Variables	All patients (n = 68)	non-TDT (n = 25)	TDT (n = 43)	Statistic	P value
Operation time (minute)	240.00 (203.75, 296.50)	240.00 (200.00, 296.00)	240.00 (212.50, 289.00)	Z = -0.03	0.975
Distance of anastomosis from the anus (cm)	4.00 (3.00, 6.00)	4.00 (3.00, 5.00)	4.00 (2.90, 6.00)	Z = -0.45	0.653
Intraoperative bleeding (mL)	50.00 (50.00, 100.00)	100.00 (50.00, 100.00)	50.00 (50.00, 100.00)	Z = -1.43	0.152
Reoperation	21 (30.88)	12 (48.00)	9 (20.93)	χ² = 5.43	0.02
Bacterial cultures of abdominal drainage fluid negative (days)	9.00 (6.00, 16.00)	10.00 (7.00, 16.00)	8.00 (5.00, 15.50)	Z = -0.92	0.355
Neutrophil number back to normal (days)	8.50 (5.00, 14.25)	10.00 (5.00, 15.00)	7.00 (5.00, 13.50)	Z = -0.53	0.596
Procalcitonin < 0.25 (days)	9.00 (5.00, 14.00)	10.00 (7.00, 14.00)	7.00 (5.00, 13.00)	Z = -0.61	0.545
Recovery enteral nutrition (days)	6.50 (3.00, 13.00)	8.00 (5.00, 10.00)	6.00 (2.00, 13.00)	Z = -1.45	0.146
Discharge albumin (g/L)	34.00 (32.00, 36.00)	35.00 (32.00, 36.00)	33.00 (31.00, 35.00)	Z = -1.48	0.14
Use of antibiotics (days)	10.00 (6.00, 16.00)	10.00 (7.00, 18.00)	10.00 (6.00, 15.00)	Z = -0.79	0.429
Cost (RMB)	109205.93 ± 57366.51	116891.43 ± 65540.44	104737.62 ± 52341.15	t = 0.84	0.404
Discharge after surgery (days)	21.00 (12.00, 29.00)	23.00 (15.00, 32.00)	19.00 (10.00, 28.00)	Z = -1.64	0.102
Death	1 (1.5)	1 (2.4)	0	-	1

TDT: Transanal drainage tube.

The primary endpoints were reoperation rate and long-term preservation of intestinal continuity, defined as patients who remained without a stoma 12 months after the initial surgery (Table 3). Preoperative evaluations, including enhanced computed tomography (CT) and colonoscopy, were performed for patients scheduled for stoma closure. Both imaging and endoscopic examinations confirmed patency of the anastomosis without stenosis or tumor recurrence before the responsible physician performed stoma closure.

Table 3 Incidence of long-term preservation of continuity, n (%).

Variables	All patients (n = 68)	non-TDT (n = 25)	TDT (n = 43)	Statistic	P value
Long-term preservation of continuity				χ² = 9.18	0.002
No	25 (36.76)	15 (60.00)	10 (23.26)
Yes	43 (63.24)	10 (40.00)	33 (76.74)

TDT: transanal drainage tube.

Secondary outcome measures included the time for abdominal drainage fluid cultures to turn negative after AL, time for neutrophil count recovery, time for PCT to be less than 0.25 ng/mL, time for recovery enteral nutrition, discharge after surgery, duration of antibiotic use, costs and the incidence of LAR syndrome (LARS). All patients were followed up for at least 12 months.

This study employed an intention-to-treat analysis to compare the prognoses of patients with and without TDT placement. Informed consent for the intervention was obtained from all patients or their legal representatives.

Definition of AL

When there is an abnormal increase in PCT or white blood cell count, accompanied by clinical symptoms such as abdominal pain, distension, high fever, fatigue, and the abdominal drainage fluid contains gas, pus, or feces, with a fecal odor or a dark green color, the pathogenic culture of the drainage fluid is positive, and AL is diagnosed through procedures such as digital rectal examination, endoscopy, or CT scan[6].

TDT

Once the patient was diagnosed with AL and after obtaining consent from the patient, the attending physician inserts a 28F silicone tube through the anus. The distal end of the TDT is cut into a "V" shape, and 3-4 side holes are created along different directions near the proximal end. The catheter was placed approximately 2 cm above the anastomotic site. The drainage tube was fixed using skin sutures or adhesive dressings without being connected to a drainage bag. The duration of the drainage tube placement was determined based on the patient's condition. All patients underwent the same postoperative treatment plan, and the abdominal drainage fluid was sent for pathogenic culture. After consultation with the Department of Infectious Diseases and Pharmacy, sensitive antibiotics were administered in a standardized manner. The surgeon determined the management approach for AL.

Discharge criteria

The discharge criteria are met when the patient, after undergoing surgical or non-surgical treatment, can tolerate oral intake of a liquid diet, has a smooth and regular passage of gas and stool through the diverted stoma or anus, maintains a normal body temperature, shows no obvious signs of peritoneal irritation, does not exhibit severe electrolyte imbalance, and laboratory indicators at the time of discharge do not indicate the presence of severe infection.

LARS

LARS, a common complication of colorectal surgery, has received extensive attention in the medical field in recent years[7]. This syndrome usually occurs after patients with rectal cancer undergo surgery to preserve the anus and manifests as a series of symptoms, such as defecation and sexual dysfunction[8]. Studies have indicated that AL increase the risk of developing LARS[9]. Therefore, when conducting telephone follow-ups on the intestinal patency of patients, we used the scale designed by Emmertsen and Laurberg[10]. in 2012 to score anterior resection syndrome and evaluate the scope and severity of the patients' current intestinal dysfunction (Table 4).

Table 4 Incidence of low anterior resection syndrome, n (%).

Variables	All patients (n = 43)	non-TDT (n = 10)	TDT (n = 33)	Statistic	P value
LARS			χ² = 3.86	0.049
No	18 (41.86)	1 (10.00)	17 (51.52)
Yes	25 (58.14)	9 (90.00)	16 (48.48)
LARS				-	0.059
No	18 (41.86)	1 (10.00)	17 (51.52)
Minor	14 (32.56)	5 (50.00)	9 (27.27)
Major	11 (25.58)	4 (40.00)	7 (21.21)

LARS: Low anterior resection syndrome; TDT: Transanal drainage tube.

Statistical analysis

For measurement data following a normal distribution, it is expressed as the mean ± SD, and the independent samples Student's t-test is used. Measurement data that did not follow a normal distribution were expressed as median (interquartile range), and the Mann-Whitney U test was used. The count data were expressed as frequency (n) and percentage (%), and the test (including the continuity correction method and Fisher's exact probability method) was used. Statistical significance was set at P value of < 0.05. All statistical analyses were performed using IBM Statistical Package for the Social Sciences version 27.

RESULTS

In this study, 838 patients with middle-to-low rectal cancer were included, of whom 68 were diagnosed with AL postoperatively, resulting in an AL incidence rate of 8.11%. There were no statistically significant differences in preoperative clinical characteristics between the two groups of patients. Additionally, there was no statistically significant difference in mortality rate between the two groups (overall, n = 1, 1.5%; TDT 2.4% vs non-TDT 0%, P = 1.00). In the TDT group, one patient died of severe systemic infection, and two did not complete at least 12 months of follow-up. In the non-TDT group, there were no deaths, but one patient did not complete at least 12 months of follow-up.

Compared to non-TDT, TDT reduced the reoperation rate (20.93% vs 48.00%, P = 0.02). After treatment with TDT, there was a trend toward reduced postoperative discharge, but the difference was not statistically significant (19 days vs 23 days, P = 0.102). The two groups of patients showed no statistically significant differences in changes in inflammatory and infection-related indicators after AL, tolerance to enteral nutrition duration, and costs. However, the two groups of patients exhibited a significant difference in the long-term preservation of continuity (76.74% vs 40.00%, P = 0.002). Meanwhile, we found a statistically significant difference in the incidence of LARS between the two groups of patients (48.48% vs 90.00%, P = 0.049). However, no statistical difference was found when we further explored the severity of LARS in the two patient groups.

DISCUSSION

With improvements in surgical techniques and continuous iteration and updating of surgical instruments, the safety of surgical treatment for rectal cancer is constantly increasing[11,12]. However, AL remains one of the most challenging and life-threatening complications associated with rectal cancer surgery. Studies have indicated that AL after surgery leads to increased hospitalization costs and length of stay in the short term, and in the long term, it is closely related to local recurrence and even distant metastasis in patients, ultimately impacting patient survival[13-15].

Several studies have discussed the role of TDTs in preventing postoperative AL. There is still controversy over whether TDT has a preventive effect on postoperative AL[16,17]. The therapeutic effect of TDT, however, is seldom mentioned[18]. This is due to the influence of various factors, such as the size and location of the anastomotic defect, indications for reoperation, and the presence of a diverting ostomy, for which there is currently no internationally standardized approach[1]. Non-surgical treatment options include the use of sensitive antibiotics, drainage via an anal drainage tube, percutaneous drainage, or recently developed endoscopic surgeries, such as intraluminal stent placement or intracavitary negative pressure therapy. Surgical treatment options include diverting loop ileostomy or colostomy and proximal stoma closure with distal resection (Hartmann’s procedure).

Early identification, diagnosis, and emergency intervention for postoperative AL are crucial. Delayed treatment of AL can be life-threatening. Therefore, aggressive surgical intervention is necessary in patients with severe systemic inflammation. However, surgeons often avoid overly aggressive measures primarily because the bowel involved in the leakage is extremely edematous and fragile, making repair difficult and increasing the risk of recurrent anastomotic failure. In some cases, this may result in permanent stomata[19].

In the present study, patients diagnosed with postoperative AL were treated with transanal drainage. This procedure is simple, straightforward, requires no special equipment or techniques, and can be performed at the patient's bedside. In the short term, it reduces the reoperation rate and, in the long term, helps maintain intestinal patency, making it an economically feasible postoperative treatment measure. Meticulous care and close monitoring of the patient's local and systemic conditions are key factors in the success of non-surgical treatment. Thick intestinal fluid and feces, along with discontinuous anastomosis, can easily cause drainage tube obstruction, leading to poor drainage effectiveness, increased anastomotic tension, and worsened symptoms, such as fever and perianal pain. Therefore, regular radiological and pathological examinations should be conducted, and the drainage volume should be monitored to assess the drainage situation fully. If necessary, the drainage tube should be replaced or its position should be adjusted. When the patient's abdominal symptoms subsided, laboratory indicators showed a downward trend, abdominal drainage remained unobstructed, TDT was removed, and enteral nutrition was gradually resumed.

In this study, in addition to the reoperation rate, which showed a statistically significant difference (20.93% vs 48.00%, P = 0.02), restoration of intestinal continuity was an exciting and interesting finding. We followed the prognosis of all patients in the study for at least 12 months, with two patients lost to follow-up in the TDT group and one patient lost to follow-up in the non-TDT group. Among patients treated with TDT, 76.74% restored intestinal continuity compared to only 40% of patients who did not receive transanal drainage treatment (P = 0.002). This difference is likely closely related to the difference in reoperation rates between the two groups, as unplanned reoperations may further exacerbate abdominal adhesions, delay, or even result in a permanent stoma status. Moreover, the use of an anal drainage tube to treat AL postoperatively does not increase the patient costs.

LARS is defined as bowel dysfunction that occurs after LAR, resulting in a decline in quality of life, especially with impaired defecation function[20]. In 2012, researchers scored LARS and developed relevant scales to measure the intestinal function status of patients[10]. LARS is common among patients with rectal cancer, with a prevalence ranging from 50% to 70%[21]. Some studies have pointed out that LARS may gradually improve within 6-12 months, but there is no difference in LARS scores at two different follow-up points five years apart[22]. Moreover, several studies have suggested a high correlation between AL and LARS[9,23,24]. In this study, we investigated whether patients developed LARS at least one year after the initial surgery and compared its severity. We found that 48.48% of patients in the TDT group had LARS, whereas 90% of patients in the non-TDT group had LARS, with a statistically significant difference between the groups. However, no statistically significant difference was found when comparing the severity grades of LARS between the two groups. Therefore, we believe that TDT can reduce the prevalence of LARS in patients with AL after rectal cancer surgery, which may be attributed to active surgical site drainage.

It must be noted that this was a retrospective study with a small sample size and that the two groups had incomplete comparability in terms of baseline characteristics. The initial stoma rate was lower in the TDT group than in the non-TDT group, leading to a significantly lower reoperation rate in the TDT group. Therefore, caution should be exercised when interpreting the collected data. The possibility of selection bias cannot be excluded in this study; thus, all results should be considered trends. However, there is a lack of relevant data in the existing literature, and I believe that this study contributes to the better rehabilitation of patients with AL after surgery for mid-low rectal cancer.

CONCLUSION

TDT use lowered reoperation rate but did not increase hospitalization expenses. After ≥ 1 year of follow-up, its use improved intestinal patency rate and reduced the incidence of LARS.