Ileostomy versus fecal diversion device to protect anastomosis after rectal surgery: a randomized clinical trial
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Abstract
Purpose
Patients with rectal anastomosis commonly experience various ileostomy-related complications. This study aimed to elucidate the usefulness of a fecal diversion device (FDD) as an alternative to ileostomy for protecting rectal anastomosis.
Methods
Patients with rectal anastomosis were randomly assigned to the ileostomy and FDD groups except in cases of emergency surgery. The primary endpoint was the clinical safety and effectiveness of FDD. The mean operation time, delay of diet advancement, length of hospital stay, FDD and stoma durations, and anastomotic leakage (AL) management methods were compared.
Results
A total of 54 patients were enrolled in this study. No cases of mortality occurred. Overall morbidity was similar between groups (P = 0.551). Six patients (22.2%) in the FDD group and nine (29.0%) in the stoma group (P = 0.555) had AL. The mean total hospital stay was 16.4 ± 6.7 and 23.4 ± 8.7 days in the FDD and stoma groups, respectively (P = 0.002). The mean total hospital cost was 12,726.8 ± 3422.8 USD and 17,954.9 ± 9040.3 USD in the FDD and stoma groups, respectively (P = 0.008). The mean FDD and stoma durations were 21.6 ± 6.1 days and 114.9 ± 41.3 days, respectively (P < 0.0001).
Conclusions
This study demonstrated FDD safety and effectiveness. We identified the possibility of FDD as an alternative technique to conventional stoma procedures.
Keywords
Anastomotic leakage Stoma Ileostomy Low anterior resection Fecal diverting deviceIntroduction
Patients undergoing rectal surgery showed a high incidence (≥ 10%) of anastomotic leakage (AL), which causes fatal abdominopelvic sepsis and leads to severe morbidity and mortality [1, 2]. Although defunctioning ileostomy protects the anastomosis, various complications can arise, including peristomal skin breakdown, stoma necrosis, stoma hernia, stoma retraction, and dehydration [3]. Another study demonstrated that patients with ileostomy immediately felt anxiety and depression [4].
Studies have aimed to reduce stoma-associated complications and rapidly achieve intestinal continuity. Some studies introduced a ghost ileostomy, which allowed for easy ileostomy creation regardless of the primary operation in patients requiring ileostomy [5]. The use of ghost ileostomy was intended to secure the terminal ileum loop to the abdominal wall using a rubber band [5]. The Coloshield, introduced in 1988, is a soft, pliable tube that is secured to the proximal colon to protect the anastomosis as an intracolonic bypass procedure [6, 7].
Here, we tested a device to protect anastomosis and replace ileostomy. Based on previous animal experiments, we developed a fecal diversion device (FDD) with an absorbable mesh band for fixation [8]. Thus, this study aimed to identify the clinical safety and efficacy of the FDD.
Methods
This single-center randomized clinical trial of stoma versus FDD was conducted at a tertiary referral hospital in accordance with the declaration of Helsinki and approved by the Institutional Review Board of Yeungnam University Hospital (2015-04-008). When an eligible patient was identified, study inclusion was proposed. After providing informed consent, patients were randomly assigned in a 1:1 ratio to the stoma or FDD group.
Inclusion and exclusion criteria
The inclusion criteria were as follows: 1) benign or malignant disease of the left colon and rectum, 2) extraperitoneal colorectal anastomosis, 3) age > 18 years, and 4) an American Society of Anesthesiologists (ASA) score of 1–3.
The exclusion criteria were as follows: 1) need for emergent surgery for obstruction or perforation, 2) abdominoperineal resection or total proctocolectomy, 3) no curative resection of the primary lesion, 4) anastomosis above the peritoneal reflex, and 5) refusal to participate.
FDD and band
Fecal diversion device (FDD): a head portion of FDD; b a tail portion of FDD; c a catheter of FDD
Details of fecal diversion device: a inner balloon: open and close the inner lumen; b external balloon: affix the FDD to the colon; c a catheter for inner balloon; d catheter for external balloon; e catheter for irrigation: water to enter the colon from the outside
Band and automatic tension measuring instrument: a automatic tension measuring instrument; b band
Surgical procedure
All procedures were performed by experienced colorectal surgeons with an open or laparoscopic technique. Bowel preparation using a polyethylene glycol solution was performed the day before the surgery. After colon mobilization was confirmed, the diseased segment was resected. The colorectal anastomosis was performed using the double stapling technique or handsewn method, followed by a loop ileostomy or FDD procedure.
All stoma group patients underwent ileostomy using standard conventional methods [9]. All patients received enterostomal care education.
Insertion of the fecal diversion device
All patients were allowed to drink water immediately after the surgery. Once gas was released into the stoma or the anus, a soft diet was started. Patients were discharged if they were able to consume soft diets for 2 consecutive days without problems.
Irrigation of fecal diversion device after primary surgery
All patients routinely underwent abdominopelvic computed tomography (CT) scans at 1 week and a contrast study at 3 weeks postoperative, while an additional contrast study was performed in the stoma group at 10–12 weeks to confirm anastomosis integrity prior to stoma reversal. AL was defined as a defect in the intestinal wall integrity at the anastomosis site regardless of clinical symptoms [10]. The defect was proven by a contrast study or CT scan. Clinical peritonitis without evidence of defects as well as perianastomotic fluid collection with or without gas were considered as AL. The FDD was removed when no evidence of AL was found in the contrast study at 3 weeks postoperative. If AL was found, the FDD was maintained for up to 3 additional weeks and the contrast study was repeated. If the anastomosis was normal on the last contrast study, the FDD was removed. The stoma takedown was performed when no evidence of AL was found in the contrast study at 10–12 weeks; otherwise, it was delayed by 1–2 months. If a persistent sinus was observed, stoma takedown was performed once it had stabilized. The clinical trial was ended after 6 months postoperative.
Randomization
Patients were randomly assigned 1:1 to the two groups the day before surgery using a computer-generated simple randomization.
Endpoints
The primary endpoints of the study were FDD safety and effectiveness. FDD safety was defined as FDD-related morbidity and mortality. Complications were observed for 6 months. FDD effectiveness was defined as the capability of fecal diversion to prevent sepsis in cases of AL. The total hospital stay was defined as the postoperative hospital stay after the primary surgery. In the stoma group, the total hospital stay included hospitalization for ileostomy reversal. The total hospital costs included: 1) primary surgery and admission, 2) radiologic examination and sigmoidoscopy until FDD removal in the FDD group, 3) second admission including ileostomy takedown surgery in the stoma group, 4) stoma care products, and 5) treatment of complications. The total hospital costs did not include: 1) those not related to trials such as hepatectomy due to hepatic metastases or chemotherapy, and 2) examinations in regular follow-up appointments. The secondary endpoints included FDD and stoma use duration, operation time, and delay of starting the soft diet. The clinical AL results were reviewed. Data were collected during the preoperative study until FDD removal or stoma reversal, and at 6 months of postoperative follow-up.
Sample size estimation
A preliminary study was conducted to estimate the sample size for this study because the FDD had never been used before. The authors analyzed the clinical data of 10 patients who underwent the FDD or stoma procedure. In the preliminary study, no cases of FDD-related morbidity or mortality occurred. Several complications occurred, including wound site discharge and urinary tract infections. However, these complications were not considered directly related to the FDD or the stoma since they were common and might occur in other surgeries. The authors calculated the sample size as the total medical expense from the first operation to the FDD or stoma removal. For sample size estimation, G Power (version 3.1.9.2) was used; accordingly, 19 patients must be recruited in each arm to demonstrate a statistically significant difference between groups with 80% power at the 0.05 level of significance. Allowing for a dropout rate of 10% after the randomization, the sample size was estimated as 21 patients in each group.
Statistical analysis
All analyses were conducted using IBM SPSS version 23 (IBM, Armonk, NY, USA) and R version 3.5 with the rms and Hmisc package (web-r.org). All analyses were performed using an intention-to-treat approach. Morbidity and mortality related to surgery, failure to protect the anastomosis, and other AL-related complications were compared using the Pearson χ2 test or Fisher’s exact test. Total hospital days, total cost, duration of FDD or stoma, operation time, and delay in establishing soft diets were analyzed using Student’s t test. Values of P < 0.05 were considered statistically significant.
Results
CONSORT diagram for the trial. FDD, fecal diversion device
Patients characteristics
FDD group (n = 27) | Stoma group (n = 27) | P | |
---|---|---|---|
Sex | 0.398 | ||
Female | 8 (29.6%) | 12 (44.4%) | |
Male | 19 (70.4%) | 15 (55.6%) | |
Age (year), mean | 65.4 (range 39–83) | 65.4 (range 39–82) | 0.991 |
Preoperative chemoradiotherapy* | 0.477 | ||
No | 20 (83.3%) | 18 (75.0%) | |
Yes | 4 (16.7%) | 6 (25.0%) | |
Body mass index, mean ± SD | 23.3 ± 4.0 | 23.7 ± 3.3 | 0.685 |
ASA score | 1.000 | ||
1 | 13 (48.1%) | 13 (48.1%) | |
2 | 10 (38.5%) | 10 (37.0%) | |
3 | 4 (15.4%) | 4 (14.8%) | |
Disease | 1.000 | ||
Benign | 1 (3.7%) | 2 (7.4) | |
Malignancy | 26 (96.3%) | 25 (92.6) | |
Operation | 0.514 | ||
Laparoscopic | 19 (70.4%) | 22 (81.5%) | |
Open | 5 (18.5%) | 4 (14.8%) | |
Robotic | 3 (11.1%) | 1 (3.7%) | |
Location of lesion | 1.000 | ||
Sigmoid | 2 (7.4) | 1 (3.7%) | |
Rectum | 25 (92.6) | 26 (96.3%) | |
Ligation of IMA | 1.000 | ||
High | 18 (66.7%) | 18 (66.7%) | |
Low | 9 (33.3%) | 9 (33.3%) | |
Method of anastomosis | 0.142 | ||
Stapler | 25 (96.2) | 20 (74.1) | |
Handsewn | 2 (7.4) | 7 (25.9) | |
Anastomosis location from the anus (cm) | 4.9 ± 1.2 | 5.0 ± 1.5 | 0.844 |
Clinical safety of FDD
Overall complications
FDD group (n = 27) | Stoma group (n = 27) | P | |
---|---|---|---|
Overall morbidity | 0.551 | ||
No | 7 (25.9) | 9 (33.3) | |
Yes | 20 (74.1) | 18 (66.7) | |
Dindo complication grades | 0.584 | ||
0/1 | 16 (59.3) | 14 (51.9) | |
2/3 | 11 (40.7) | 13 (48.1) | |
Anastomosis leakage | 0.555 | ||
No | 21 (77.8) | 22 (71.0) | |
Yes | 6 (22.2) | 9 (29.0) | |
Intestinal obstruction | 1.000 | ||
No | 22 (84.5) | 22 (84.5) | |
Yes | 5 (18.5) | 5 (18.5) | |
Ileus | 0.484 | ||
No | 21 (77.8%) | 23 (85.2%) | |
Yes | 6 (22.2%) | 4 (14.8%) | |
Wound infection | 1.000 | ||
No | 23 (85.2%) | 23 (85.2%) | |
Yes | 4 (14.8%) | 4 (14.8%) | |
Urinary tract infection | 0.111 | ||
No | 23 (85.2%) | 27 (100.0%) | |
Yes | 4 (14.8%) | 0 |
Classification of anastomotic leakage
FDD group (n = 6) | Stoma group (n = 9) | P | |
---|---|---|---|
Grade A* | 2 | 4 | 0.870 |
Grade B* | 2 | 3 | |
Grade C* | 2 | 2 |
Clinical effectiveness of FDD
Total hospital stay and cost
FDD group (n = 27) | Stoma group (n = 27) | P | |
---|---|---|---|
Length of hospital stay (day) | |||
Initial surgery | 13.9 ± 8.8 | 10.5 ± 4.2 | 0.072 |
Total (including stoma reversal) | 16.4 ± 6.7 | 23.4 ± 8.7 | 0.002 |
Total cost (USD) | 12,726.8 ± 3422.8 | 17,954.9 ± 9040.3 | 0.008 |
Immediate intraoperative and postoperative outcomes
Clinical results of intraoperative and postoperative outcomes
FDD group (n = 27) | Stoma group (n = 27) | P | |
---|---|---|---|
Operation time (min) | 233.9 ± 58.4 | 208.1 ± 60.6 | 0.187 |
Intraoperative bleeding amount (ml) | 62.6 (range 10–500) | 40.0 (range 10–200) | 0.321 |
First bowel movement (day) | 3.1 ± 1.7 | 2.3 ± 1.1 | 0.034 |
Establishment of soft diet (day) | 6.3 ± 2.1 | 5.6 ± 2.2 | 0.204 |
Fecal diversion procedure duration
Clinical results of anastomosis leakage patients
FDD group (n = 6) | Stoma group (n = 9) | P | ||
---|---|---|---|---|
Leakage examination | ||||
CT at 1st week | No | 0 (0.0) | 1 (11.1) | 1.000 |
Yes | 6 (100.0) | 8 (88.9) | ||
Gastrografin enema at 3rd week | No | 1 (16.7) | 4 (44.4) | 0.580 |
Yes | 5 (83.3) | 5 (55.6) | ||
Gastrografin enema at 6th week* | No | 1(33.3) | ||
Yes | 2 (66.7) | |||
Successful fecal diversion | Yes | 4 (66.7) | 6 (66.7) | 1.000 |
No | 2 (33.3) | 3 (33.3) | ||
Total duration of stoma or FDD (day) | 21 ± 6.1 | 114.9 ± 41.3 | < 0.001 |
Discussion and conclusion
The overall complication rates were similar between the FDD and stoma groups. The AL rate was also similar in both groups, and FDD did not prevent AL. FDD placement provided rapid intestinal continuity without anesthesia compared to stoma creation. There was no additional cost for maintaining the FDD. However, the FDD did not completely replace the stoma because some patients required a stoma due to AL despite FDD use.
In rectal cancer, a stoma has commonly been used to prevent resultant clinical complications of AL, but the stoma itself can cause many complications [3, 11]. The most common complication of the stoma is skin excoriation [3, 12]. Some patients experienced stomal retraction or obstruction [12]. Rarely, such patients require surgical treatment. In particular, many patients with ileostomy showed dehydration and an electrolyte imbalance such as hypokalemia due to discharge of the contents of the small intestine [3, 12]. Complications related to ileostomy also occurred during ileostomy takedown at a reported 20% incidence [13, 14]. In addition, 25% of patients with rectal cancer did not undergo ileostomy takedown [3]. To reduce those complications, several studies performed early ileostomy takedown [15, 16]. In these studies, there were no significant differences in complications between early and late ileostomy takedown [15, 16]. However, these studies demonstrated that it was possible to reduce ileostomy duration but not reduce the complications caused by the ileostomy itself.
Although the risk of AL is reportedly high in rectal surgery, not all patients who undergo this procedure require an ileostomy. AL was observed in approximately 10–12% of patients who underwent low anterior resection surgery [2, 17, 18]. Several studies demonstrated that ileostomy did not prevent AL [17, 19]. In fact, approximately 90% of patients without AL after rectal surgery did not require an ileostomy. The FDD could protect the anastomosis and provide rapid intestinal continuity in these patients. Thus, the FDD could safely replace the ileostomy in patients without AL.
In this study, the overall leakage rate was 27.8% higher than that reported by other studies [1, 2, 20]. In many studies, AL was defined differently [21]. In some studies, clinical signs of AL were considered important for defining leakage [22, 23]. In this study, all patients underwent abdominopelvic CT at 1 week and contrast enema as a contrast study at 3 weeks regardless of symptom status. If patients showed findings of leakage on the tests at week 1 or 3, whether there were symptoms or not, they were identified as having leakage. In the present study, the contrast enema performed at 3 weeks occasionally showed leakage even if there was no leakage on the CT scan at 1 week. We believe that the leakage rate was high due to our active effort to identify AL.
In this study, colonic erosion was the most common FDD-related complication. We created a band of the same material as Vicryl® (Ethicon) for safety. However, erosion was confirmed in two patients without symptoms of peritonitis. Although few studies have examined colonic erosion, an animal study of FDD had similar results [8]. In the animal study, a non-absorbable band was used. However, there were no serious symptoms requiring reintervention. Thus far, gastric band erosion has been reported [24, 25]. In the gastric band erosion, complete erosion and obstruction were also reported [25]. We believe that the lack of serious complications due to the erosions noted in this study was due to the process occurring very slowly and the fibrosis around the mesh creating a firm seal that prevented local sepsis. We noted this phenomenon in our previous animal experiments [8]. Furthermore, we used an absorbable mesh band instead of the non-absorbable mesh in the animal study. We are currently upgrading the instrument used to measure the pressure applied to the bowel wall to prevent erosion and believe that safer operations will be possible in the next round of trials.
In this study, one patient in the FDD group underwent reoperation due to ischemic necrosis. At the time of surgery, postoperative intestinal adhesion due to previous surgery was severe in the upper abdomen. In the ultra-low anterior resection, we performed high ligation of inferior mesenteric artery and mobilization of spleen flexure for tension-free anastomosis. During the patient’s reoperation, the position of the FDD was found to be satisfactory. The ischemic colitis was located 10 cm above the FDD insertion site. The authors concluded that the cause of ischemic necrosis was caused by an injury to the marginal artery of colon during mobilization of splenic flexure. We reported this situation to the IRB and independent reviewers who were appointed at the time of the study approval. Finally, we concluded that this complication could have occurred during the colon surgery regardless of FDD. We performed end colostomy for the patient’s safety during re-operation.
Furthermore, we recommend using FDD within 6 weeks for safety, because the half-life of the band is 6 weeks. The FDD band is absorbable and weakens over time. If patients use FDD for more than 6 weeks, loose bands can lead to dislocation. Secondly, patients using FDD need irrigation twice a day. Hard stool can block the FDD tube. We conducted irrigation to change the hard stool to a loose stool. Patients are placed in the colon with FDD catheters for 1 l of water for colonic irrigation. Most patients feel bowel movement when they add 1 L of water, and usually one irrigation takes about 30 min.
This study had several limitations. First, it may have been underpowered. No FDD clinical study has been conducted at any other institution. Thus, FDD-related complications were undefined regardless of the preliminary study. The aim of this study was to assess the safety and effectiveness of FDD. However, we used total medical costs to indirectly calculate sample size. It may have been better to calculate the complication rate to evaluate the safety and effectiveness, but since the estimated sample size required too many cases for the study, we used medical expenses as an indirect factor. Higher expenses indicate more complications or lower safety, thus resulting in the sample size of this study. Second, this study was conducted in a single institution. We could not adopt a double-blind technique because of the need for FDD preparation. Finally, the quality of life was not evaluated in this study. However, we identified the possibility of FDD as an alternative technique to conventional stoma procedures.
This study showed the possibility of replacing ileostomy with a new device, FDD. The use of FDD provided faster bowel continuity for patients. This study has several limitations and further research is needed to ensure the safety and efficacy of FDD. However, this study confirms the possible outcomes and complications of FDD use.
Notes
Funding
This study was supported by a grant from the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI) funded by the Ministry of Health & Welfare, Republic of Korea (grant number HI15C2041).
Compliance with ethical standards
Conflicts of interest
Correspondence is inventor of FDD.
Research involving human participants and/or animals
This study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Yeungnam University Hospital (2015-04-008).
Informed consent
Informed consent was obtained from all study participants.
References
- 1.Matthiessen P, Hallböök O, Rutegård J, Simert G, Sjödahl R (2007) Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg 246:207–214CrossRefGoogle Scholar
- 2.Eriksen MT, Wibe A, Norstein J, Haffner J, Wiig J (2005) Anastomotic leakage following routine mesorectal excision for rectal cancer in a national cohort of patients. Color Dis 7:51–57CrossRefGoogle Scholar
- 3.Chun LJ, Haigh PI, Tam MS, Abbas MA (2012) Defunctioning loop ileostomy for pelvic anastomoses: predictors of morbidity and nonclosure. Dis Colon rectum 55:167–174CrossRefGoogle Scholar
- 4.Knowles SR, Tribbick D, Connell WR, Castle D, Salzberg M, Kamm MA (2014) Exploration of health status, illness perceptions, coping strategies, and psychological morbidity in stoma patients. J Wound Ostomy Continence Nurs 41:573–580CrossRefGoogle Scholar
- 5.Mori L, Vita M, Razzetta F, Meinero P, D’Ambrosio G (2013) Ghost ileostomy in anterior resection for rectal carcinoma: is it worthwhile? Diseases of the Colon & Rectum 56:29–34CrossRefGoogle Scholar
- 6.Ravo B (1988) The Coloshield®. Diseases of the Colon & Rectum 31:579–580CrossRefGoogle Scholar
- 7.Ravo B, Reggio D, Frattaroli F (1991) Insertion of the coloshield through a colotomy after completion of a colonic anastomosis. Int J Color Dis 6:46–48CrossRefGoogle Scholar
- 8.Kim JH, Jung SH, Kim Y-J, S-l P, Kim D-H (2013) Long-term fecal diverting device for the prevention of sepsis in case of colorectal anastomotic leakage: an animal experiment. Int J Color Dis 28:477–484CrossRefGoogle Scholar
- 9.Yeo CJ, DeMeester SR, McFadden DW, Matthews JB, Fleshman JW (2018) Shackelford’s surgery of the alimentary tract, 8th edn. Elsevier, Philadelphia, pp 991–1004Google Scholar
- 10.Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW (2010) Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery 147:339–351CrossRefGoogle Scholar
- 11.Andersen RM, Klausen TW, Danielsen AK, Vinther A, Gögenur I, Thomsen T (2018) Incidence and risk factors for parastomal bulging in patients with ileostomy or colostomy: a register-based study using data from the Danish stoma database capital region. Color Dis 20(4):331–340. https://doi.org/10.1111/codi.13907
- 12.Thoker M, Wani I, Parray FQ, Khan N, Mir SA, Thoker P (2014) Role of diversion ileostomy in low rectal cancer: a randomized controlled trial. Int J Surg 12:945–951CrossRefGoogle Scholar
- 13.Bhama AR, Batool F, Collins SD, Ferraro J, Cleary RK (2017) Risk factors for postoperative complications following diverting loop ileostomy takedown. J Gastrointest Surg 21:2048–2055CrossRefGoogle Scholar
- 14.Poskus E, Kildusis E, Smolskas E, Ambrazevicius M, Strupas K (2014) Complications after loop ileostomy closure: a retrospective analysis of 132 patients. Visceralmedizin 30:276–280CrossRefGoogle Scholar
- 15.Farag S, Rehman S, Sains P, Baig M (2017) Early versus delayed closure of loop defunctioning ileostomy in patients undergoing distal colorectal resections: an integrated systematic review and meta-analysis of published randomized, controlled trials. Color Dis 19(12):1050–1057CrossRefGoogle Scholar
- 16.Li W, Ozuner G (2017) Does the timing of loop ileostomy closure affect outcome: a case-matched study. Int J Surg 43:52–55CrossRefGoogle Scholar
- 17.Boyce SA, Harris C, Stevenson A, Lumley J, Clark D (2017) Management of low colorectal anastomotic leakage in the laparoscopic era: more than a decade of experience. Dis Colon Rectum 60:807–814CrossRefGoogle Scholar
- 18.Rutegård M, Kverneng Hultberg D, Angenete E, Lydrup M-L (2017) Substantial underreporting of anastomotic leakage after anterior resection for rectal cancer in the Swedish Colorectal Cancer Registry. Acta Oncol 56:1741–1745CrossRefGoogle Scholar
- 19.Hamabe A, Ito M, Nishigori H, Nishizawa Y, Sasaki T (2018) Preventive effect of diverting stoma on anastomotic leakage after laparoscopic low anterior resection with double stapling technique reconstruction applied based on risk stratification. Asian J Endosc Surg 11(3):220–226CrossRefGoogle Scholar
- 20.Phatak UR, Kao LS, You YN, Rodriguez-Bigas MA, Skibber JM, Feig BW, Nguyen S, Cantor SB, Chang GJ (2014) Impact of ileostomy-related complications on the multidisciplinary treatment of rectal cancer. Ann Surg Oncol 21:507–512CrossRefGoogle Scholar
- 21.Bruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park K (2001) Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. BJS 88:1157–1168CrossRefGoogle Scholar
- 22.Tanaka K, Okuda J, Yamamoto S, Ito M, Sakamoto K, Kokuba Y, Yoshimura K, Watanabe M (2017) Risk factors for anastomotic leakage after laparoscopic surgery with the double stapling technique for stage 0/I rectal carcinoma: a subgroup analysis of a multicenter, single-arm phase II trial. Surg Today 47:1215–1222CrossRefGoogle Scholar
- 23.Zhang W, Lou Z, Liu Q, Meng R, Gong H, Hao L, Liu P, Sun G, Ma J (2017) Multicenter analysis of risk factors for anastomotic leakage after middle and low rectal cancer resection without diverting stoma: a retrospective study of 319 consecutive patients. Int J Color Dis 32:1431–1437CrossRefGoogle Scholar
- 24.Naim HJ, Gorecki PJ, Wise L (2005) Early lap-band erosion associated with colonic inflammation: a case report and literature review. JSLS 9:102Google Scholar
- 25.Taskin M, Zengin K, Unal E (2001) Intraluminal duodenal obstruction by a gastric band following erosion. Obes Surg 11:90–92CrossRefGoogle Scholar
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