Clinical trial NCT06036862: Utilization of Transanal Endoscopy in the Treatment of Anastomotic Stenosis
Official title: A Prospective Clinical Study of Transanal and Transabdominal Combined Endoscopic Resection of Rectal Stenosis and Anal Reconstruction for Severe Rectal Anastomotic Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anastomotic Stenosis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Severe rectal anastomotic stenosis can not only cause intestinal obstruction, but also be accompanied by frequent defecation, which affects the quality of life, and patients face the outcome of permanent stoma or temporary stoma again. Traditional transabdominal resection and reconstruction of rectal anastomotic stenosis is more likely to occur due to unclear anatomical structure, dense scars around the intestinal canal, complications such as ureteral and urethral injury and massive presacral hemorrhage. In addition,41%of patients with anastomotic stenosis who underwent reoperation through abdominal surgery had anastomotic leakage again, and up to 30% of patients could not close the stoma. The advantages of transanal total mesorectal excision (taTME) using a transanal approach for total mesorectal excision in the treatment of middle and low rectal cancer with difficult pelvis have been demonstrated by our group. However, taTME has rarely been explored in the treatment of anastomotic stenosis. Our team retrospectively summarized the patients who underwent transabdominal transanal endoscopic resection and reconstruction of anastomotic stenosis (l-taTME), and initially demonstrated the safety and effectiveness of this surgical method, with a stoma closure rate of 90%. Although the advantages of l-taTME in the treatment of severe rectal anastomotic stenosis are obvious in theory and preliminary clinical practice, there is a lack of prospective studies. Therefore, the investigators plan to conduct a prospective clinical study to observe the safety and efficacy of l-taTME reconstruction surgery, and to provide high-level evidence-based medical basis for the selection of resection and reconstruction surgery for patients with rectal anastomotic stenosis.

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.

Eligibility criteria: Inclusion Criteria:

1. Age of 18-70 years old;
2. ECOG performance status score 0-2;
3. previous rectal resection;
4. patients diagnosed with middle and low rectal anastomotic tubular stenosis;
5. can tolerate general anesthesia;
6. The subjects and their family members, who could understand the study protocol and were willing to participate, signed the informed consent form.

Exclusion Criteria:

1. patients with acute intestinal obstruction, intestinal perforation or intestinal bleeding requiring emergency surgery;
2. severe pelvic adhesion and frozen pelvis;
3. patients with unstable primary tumors or combined with tumors at other sites;
4. previous history of left hemicolectomy;
5. ASA grade IV to V;
6. combined organ resection;
7. severe mental illness;
8. pregnant or lactating women;
9. severe cardiovascular disease, uncontrolled infection or other uncontrolled comorbidities;

Primary outcomes:
measure: Stoma recovery rate
timeFrame: 3 months after surgery
Secondary outcomes:
measure: incidence of postoperative anastomotic leakage
timeFrame: 1 month after surgery
measure: incidence of postoperative anastomotic bleeding
timeFrame: Duration of 7 days after surgery
measure: Incidence of severe bowel dysfunction
timeFrame: 3 months after stoma recovery
measure: Incidence of severe bowel dysfunction
timeFrame: 6 months after stoma recovery
measure: Incidence of severe bowel dysfunction
timeFrame: 1 year after stoma recovery
measure: Incidence of severe bowel dysfunction
timeFrame: 2 years after stoma recovery
measure: Anorectal function
timeFrame: 1 year after stoma recovery
measure: Anorectal function
timeFrame: 2 year after stoma recovery
measure: bowel function
timeFrame: 3 months after stoma recovery
measure: bowel function
timeFrame: 6 months after stoma recovery
measure: bowel function
timeFrame: 1 year after stoma recovery
measure: bowel function
timeFrame: 2 year after stoma recovery
measure: Quality of life evaluation after stoma closure
timeFrame: 3 months
measure: Quality of life evaluation after stoma closure
timeFrame: 6 months
measure: Quality of life evaluation after stoma closure
timeFrame: 1 year
measure: Quality of life evaluation after stoma closure
timeFrame: 2 years
measure: Quality of life evaluation after stoma closure
timeFrame: 3 years
measure: Inraoperative condition
timeFrame: In the process of operation
measure: Perioperative recovery time
timeFrame: perioperative period
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital of Sun yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yanhong Deng, Doctor
role: PRINCIPAL_INVESTIGATOR
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