- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06036862
Utilization of Transanal Endoscopy in the Treatment of Anastomotic Stenosis
A Prospective Clinical Study of Transanal and Transabdominal Combined Endoscopic Resection of Rectal Stenosis and Anal Reconstruction for Severe Rectal Anastomotic Stenosis
Study Overview
Status
Conditions
Detailed Description
Colorectal cancer is the most common malignant tumor of the digestive tract. At present, surgery is still the main treatment for rectal cancer. Although stapler anastomosis improves the safety of surgical resection and reconstruction for middle and low rectal cancer, surgical complications, especially anastomotic leakage, are inevitable, especially for middle and low rectal cancer, where the incidence of anastomotic leakage reaches 8-11%. The outcome of anastomotic leakage will lead to anastomotic stenosis, especially in middle and low rectal cancer after neoadjuvant radiotherapy, and the incidence of anastomotic stenosis is as high as 3%-10%. Previous studies have suggested that anastomotic diameter < 20mm is considered as an anastomotic stenosis, and it has also been shown that an anastomotic diameter less than 1/3 of the original diameter of the intestinal lumen is considered as an anastomotic stenosis. Anastomotic stenosis can not only cause intestinal obstruction symptoms, such as abdominal distension and abdominal pain, but also be accompanied by frequent defecation, which affects the quality of life, and many patients face the outcome of permanent stoma or temporary stoma again.
Anastomotic stenosis is divided into membranous stenosis and tubular stenosis according to the degree of stenosis. For anastomotic membranous stenosis, endoscopic incision of the stenosis ring or balloon dilatation is the preferred method for the treatment of membranous stenosis. However, endoscopic scar incision and balloon dilation require repeated, multiple treatments to achieve long-term effectiveness, with the risk of perforation, pelvic infection, and bleeding. Balloon dilatation or scar incision has little effect on patients with low anastomosis position or tubular stenosis, and nearly 30% of patients need to undergo resection and reconstruction of the stenotic anastomosis. As anastomotic stenosis is often caused by anastomotic leakage, anastomotic ischemia, radiotherapy and chemotherapy, use of stapler, pelvic infection and low anastomosis, the anatomical structure is unclear, the scar around the bowel is dense, and complications such as ureteral and urethral injury and massive bleeding of presacral veins are more likely to occur during the resection and reconstruction of the stricture. Lefevre et al. reported 33 patients who underwent resection and reconstruction of transabdominal rectal anastomotic stenosis, and the incidence of perioperative complications was 54.5%, including anastomotic leakage of 18%(6/33) and postoperative intestinal obstruction of 12%. Genser et al. reported 50 patients with surgical treatment of anastomotic stenosis, of whom 12(24%) received intraoperative blood transfusion, with an average blood transfusion volume of 2.5 units. The incidence of intraoperative complications was 12%, including 5 cases of bladder injury and 1 case of splenectomy due to splenic injury due to unclear anatomical location. Westerduin et al. summarized 59 patients who underwent secondary surgery for anastomotic leakage and stenosis, and 41% of them had recurrent anastomotic leakage 14 months after surgery. During the follow-up of 27 months, only 66% of the patients regained intestinal continuity,24%of the patients received permanent colostomy, and 10% of the patients retained ileostomy.
Due to the difficulty of surgery, it is difficult to remove the scar tissue around the anastomosis in the traditional abdominal resection and reconstruction surgery. The new rectorectum cannot be pulled out and anastomosed with the distal rectoanal canal again. After reluctant anastomosis, the incidence of anastomotic leakage is still high due to the high tension of rectorectum, and many patients have to accept permanent stoma. Transanal total mesorectal excision (taTME), which uses a transanal approach to perform total mesorectal excision, has been demonstrated by our team for the surgical treatment of middle and low rectal cancer with difficult pelvis. However, the use of taTME in the treatment of anastomotic stenosis is rarely explored at present. Our team first reported this surgical method in 2021. The investigators retrospectively summarized 17 patients who underwent resection and reconstruction of anastomotic stenosis by transabdominal transanal endoscopic surgery. The ileostomy or colostomy was closed in 15 patients, which proved the safety and effectiveness of this surgical method. Transabdominal transanal endoscopic resection and reconstruction surgery has obvious advantages in the treatment of patients with rectal anastomotic stenosis. First, it can accurately separate the narrow distal intestine, and transanal anastomosis of the substitute rectum and the distal rectoanal canal can be performed, which reduces the difficulty of reconstruction. Secondly, from the distal normal anorectal canal, it can enter the normal anatomical structure space, and the narrow scar segment can be completely resected by endoscopic magnification. At the same time, it can reduce the accidental injury of the surrounding normal tissue and significantly reduce the incidence of intraoperative complications. Finally, the mobilization of the left hemicolon and splenic flexure of the abdomen was completed laparoscopically, and the specimen was removed through the anus, which did not require additional abdominal incision and thus reduced trauma. Although the advantages of transanal transabdominal combined with laparoscopic resection and reconstruction in the treatment of severe rectal anastomotic stenosis are very obvious in theory and preliminary clinical practice, there is a lack of prospective studies.
For the above reasons, the investigators plan to conduct a prospective clinical study to observe the safety and efficacy of transanal laparoscopic resection and reconstruction in patients with rectal anastomotic stenosis, in order to improve the quality of life of patients with rectal anastomotic stenosis, and to provide high-level evidence-based medical basis for the selection of resection and reconstruction surgery for patients with rectal anastomotic stenosis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Liang Huang, Doctor
- Phone Number: 15989101216
- Email: huangl75@mail.sysu.edu.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China
- Recruiting
- Sixth Affiliated Hospital of Sun Yat-sen University
-
Contact:
- Liang Huang, Doctor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age of 18-70 years old;
- ECOG performance status score 0-2;
- previous rectal resection;
- patients diagnosed with middle and low rectal anastomotic tubular stenosis;
- can tolerate general anesthesia;
- The subjects and their family members, who could understand the study protocol and were willing to participate, signed the informed consent form.
Exclusion Criteria:
- patients with acute intestinal obstruction, intestinal perforation or intestinal bleeding requiring emergency surgery;
- severe pelvic adhesion and frozen pelvis;
- patients with unstable primary tumors or combined with tumors at other sites;
- previous history of left hemicolectomy;
- ASA grade IV to V;
- combined organ resection;
- severe mental illness;
- pregnant or lactating women;
- severe cardiovascular disease, uncontrolled infection or other uncontrolled comorbidities;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with severe rectal anastomotic stenosis
Focusing on Patients with severe rectal anastomotic stenosis, espically long length and ultra lower firbrotic stenosis
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Laparoscopic or open surgery was selected according to the patient's condition, surgical history and surgeon's experience.According to the extent of the rectal stenosis, the proximal colon was dissected.A circular incision was made above the dentate line and the broken end was sutured.
After the intestinal cavity was closed, a single port was inserted through the anus, and a transanal endoscopic platform was established after pneumoperitoneum infusion.The stenotic and scar segments were removed free upward.Through the pelvic cavity and into the abdominal cavity from the bottom up.
The narrow rectum and proximal colon were pulled out of the anus through the anus, and the diseased bowel was removed.
According to the distance of the remaining distal rectum, stapler or manual anastomosis or Bacon operation was selected.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stoma recovery rate
Time Frame: 3 months after surgery
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whether the stoma recovery and restoration of bowel continuation
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3 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of postoperative anastomotic leakage
Time Frame: 1 month after surgery
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whether the occurence of anastomotic leakage
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1 month after surgery
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incidence of postoperative anastomotic bleeding
Time Frame: Duration of 7 days after surgery
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whether the occurence of anastomotic bleeding
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Duration of 7 days after surgery
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Incidence of severe bowel dysfunction
Time Frame: 3 months after stoma recovery
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Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)
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3 months after stoma recovery
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Incidence of severe bowel dysfunction
Time Frame: 6 months after stoma recovery
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Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)
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6 months after stoma recovery
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Incidence of severe bowel dysfunction
Time Frame: 1 year after stoma recovery
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Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)
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1 year after stoma recovery
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Incidence of severe bowel dysfunction
Time Frame: 2 years after stoma recovery
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Low Anterior Resection Syndrome Score (0-20: No LARS 21-29: Minor LARS 30-42: Major LARS)
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2 years after stoma recovery
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Anorectal function
Time Frame: 1 year after stoma recovery
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Anorectal pressure Rectal sensory function Rectoanal reflex function
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1 year after stoma recovery
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Anorectal function
Time Frame: 2 year after stoma recovery
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Anorectal pressure Rectal sensory function Rectoanal reflex function
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2 year after stoma recovery
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bowel function
Time Frame: 3 months after stoma recovery
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Memorial Sloan-Kettering Cancer Center bowel function instrument
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3 months after stoma recovery
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bowel function
Time Frame: 6 months after stoma recovery
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Memorial Sloan-Kettering Cancer Center bowel function instrument
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6 months after stoma recovery
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bowel function
Time Frame: 1 year after stoma recovery
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Memorial Sloan-Kettering Cancer Center bowel function instrument
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1 year after stoma recovery
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bowel function
Time Frame: 2 year after stoma recovery
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Memorial Sloan-Kettering Cancer Center bowel function instrument
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2 year after stoma recovery
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Quality of life evaluation after stoma closure
Time Frame: 3 months
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European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0:poor 100:best)
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3 months
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Quality of life evaluation after stoma closure
Time Frame: 6 months
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European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0:poor 100:best)
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6 months
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Quality of life evaluation after stoma closure
Time Frame: 1 year
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European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0:poor 100:best)
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1 year
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Quality of life evaluation after stoma closure
Time Frame: 2 years
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European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0:poor 100:best)
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2 years
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Quality of life evaluation after stoma closure
Time Frame: 3 years
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European Organization for Research and Treatment of Cancer QLQ-C30 (0-100 0:poor 100:best)
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3 years
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Inraoperative condition
Time Frame: In the process of operation
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operation time and whether to convert to laparotomy
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In the process of operation
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Perioperative recovery time
Time Frame: perioperative period
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Duration of analgesics in hours For the first time the exhaust time in hours Time to first defecation in hours Time to first fluid intake in hours Time to resume normal diet in hours Abdominal drainage tube removal time in days Catheter removal time in days Length of postoperative hospital stay in days
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perioperative period
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yanhong Deng, Doctor, Sun Yat-sen University
Publications and helpful links
General Publications
- Moran BJ. Stapling instruments for intestinal anastomosis in colorectal surgery. Br J Surg. 1996 Jul;83(7):902-9. doi: 10.1002/bjs.1800830707.
- Vignali A, Fazio VW, Lavery IC, Milsom JW, Church JM, Hull TL, Strong SA, Oakley JR. Factors associated with the occurrence of leaks in stapled rectal anastomoses: a review of 1,014 patients. J Am Coll Surg. 1997 Aug;185(2):105-13. doi: 10.1016/s1072-7515(97)00018-5.
- Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-1502. doi: 10.1016/S0140-6736(13)61649-9. Epub 2013 Nov 11.
- Lu P, Fields AC, Vise AS, Shabat G, Irani JL, Bleday R, Goldberg JE, Melnitchouk N. Anatomic Distribution of Colorectal Adenocarcinoma in Young Patients. Dis Colon Rectum. 2019 Aug;62(8):920-924. doi: 10.1097/DCR.0000000000001422.
- Braunschmid T, Hartig N, Baumann L, Dauser B, Herbst F. Influence of multiple stapler firings used for rectal division on colorectal anastomotic leak rate. Surg Endosc. 2017 Dec;31(12):5318-5326. doi: 10.1007/s00464-017-5611-0. Epub 2017 Jun 20.
- Lee SY, Kim CH, Kim YJ, Kim HR. Anastomotic stricture after ultralow anterior resection or intersphincteric resection for very low-lying rectal cancer. Surg Endosc. 2018 Feb;32(2):660-666. doi: 10.1007/s00464-017-5718-3. Epub 2017 Jul 19.
- Fegiz G, Angelini L, Bezzi M. Rectal cancer: restorative surgery with the EEA stapling device. Int Surg. 1983 Jan-Mar;68(1):13-8.
- Hughes DL, Cornish J, Morris C; LARRIS Trial Management Group. Functional outcome following rectal surgery-predisposing factors for low anterior resection syndrome. Int J Colorectal Dis. 2017 May;32(5):691-697. doi: 10.1007/s00384-017-2765-0. Epub 2017 Jan 27.
- Bruns ERJ, Borstlap WA, van Duijvendijk P, van der Zaag-Loonen HJ, Buskens CJ, van Munster BC, Bemelman WA, Tanis PJ. The Association of Preoperative Anemia and the Postoperative Course and Oncological Outcome in Patients Undergoing Rectal Cancer Surgery: A Multicenter Snapshot Study. Dis Colon Rectum. 2019 Jul;62(7):823-831. doi: 10.1097/DCR.0000000000001360.
- Garcea G, Sutton CD, Lloyd TD, Jameson J, Scott A, Kelly MJ. Management of benign rectal strictures: a review of present therapeutic procedures. Dis Colon Rectum. 2003 Nov;46(11):1451-60. doi: 10.1007/s10350-004-6792-x.
- Artifon EL, Castano Llano R, Otoch JP, Tchekmedyian AJ. [Endoscopic dilation of the gastrointestinal tract]. Rev Gastroenterol Peru. 2015 Jan;35(1):45-61. Spanish.
- Nguyen-Tang T, Huber O, Gervaz P, Dumonceau JM. Long-term quality of life after endoscopic dilation of strictured colorectal or colocolonic anastomoses. Surg Endosc. 2008 Jul;22(7):1660-6. doi: 10.1007/s00464-007-9679-9. Epub 2007 Dec 11.
- Suchan KL, Muldner A, Manegold BC. Endoscopic treatment of postoperative colorectal anastomotic strictures. Surg Endosc. 2003 Jul;17(7):1110-3. doi: 10.1007/s00464-002-8926-3. Epub 2003 May 6.
- Kawada K, Sakai Y. Preoperative, intraoperative and postoperative risk factors for anastomotic leakage after laparoscopic low anterior resection with double stapling technique anastomosis. World J Gastroenterol. 2016 Jul 7;22(25):5718-27. doi: 10.3748/wjg.v22.i25.5718.
- Lefevre JH, Bretagnol F, Maggiori L, Ferron M, Alves A, Panis Y. Redo surgery for failed colorectal or coloanal anastomosis: a valuable surgical challenge. Surgery. 2011 Jan;149(1):65-71. doi: 10.1016/j.surg.2010.03.017. Epub 2010 May 7.
- Genser L, Manceau G, Karoui M, Breton S, Brevart C, Rousseau G, Vaillant JC, Hannoun L. Postoperative and long-term outcomes after redo surgery for failed colorectal or coloanal anastomosis: retrospective analysis of 50 patients and review of the literature. Dis Colon Rectum. 2013 Jun;56(6):747-55. doi: 10.1097/DCR.0b013e3182853c44.
- Westerduin E, Borstlap WAA, Musters GD, Westerterp M, van Geloven AAW, Tanis PJ, Wolthuis AM, Bemelman WA, D'Hoore A. Redo coloanal anastomosis for anastomotic leakage after low anterior resection for rectal cancer: an analysis of 59 cases. Colorectal Dis. 2018 Jan;20(1):35-43. doi: 10.1111/codi.13844.
- Remzi FH, El Gazzaz G, Kiran RP, Kirat HT, Fazio VW. Outcomes following Turnbull-Cutait abdominoperineal pull-through compared with coloanal anastomosis. Br J Surg. 2009 Apr;96(4):424-9. doi: 10.1002/bjs.6458.
- Liu H, Zeng Z, Zhang H, Wu M, Ma D, Wang Q, Xie M, Xu Q, Ouyang J, Xiao Y, Song Y, Feng B, Xu Q, Wang Y, Zhang Y, Hao Y, Luo S, Zhang X, Yang Z, Peng J, Wu X, Ren D, Huang M, Lan P, Tong W, Ren M, Wang J, Kang L; Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group. Morbidity, Mortality, and Pathologic Outcomes of Transanal Versus Laparoscopic Total Mesorectal Excision for Rectal Cancer Short-term Outcomes From a Multicenter Randomized Controlled Trial. Ann Surg. 2023 Jan 1;277(1):1-6. doi: 10.1097/SLA.0000000000005523. Epub 2022 Jul 11.
- Luo S, Zhang X, Hou Y, Hu H, Dong J, Wang L, Kang L. Transanal and transabdominal combined endoscopic resection of rectal stenosis and anal reconstruction based on transanal endoscopic technique. Surg Endosc. 2021 Dec;35(12):6827-6835. doi: 10.1007/s00464-020-08188-x. Epub 2021 Jan 4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIHSYSU-TLCAS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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