Utilization of Transanal Endoscopy in the Treatment of Anastomotic Stenosis

NCT06036862 | Recruiting

• 1 other identifier: GIHSYSU-TLCAS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anastomotic Stenosis

Outcome Measures

Primary Outcomes (1)

• Stoma recovery rate

  whether the stoma recovery and restoration of bowel continuation

  3 months after surgery

Secondary Outcomes (19)

• incidence of postoperative anastomotic leakage

  1 month after surgery

• incidence of postoperative anastomotic bleeding

  Duration of 7 days after surgery

• Incidence of severe bowel dysfunction

  3 months after stoma recovery

• Incidence of severe bowel dysfunction

  6 months after stoma recovery

• Incidence of severe bowel dysfunction

  1 year after stoma recovery

Study Arms (1)

Patients with severe rectal anastomotic stenosis

EXPERIMENTAL

Focusing on Patients with severe rectal anastomotic stenosis, espically long length and ultra lower firbrotic stenosis

Procedure: Transanal and transabdominal combined endoscopic resection of rectal stenosis and anal reconstruction

Interventions

Transanal and transabdominal combined endoscopic resection of rectal stenosis and anal reconstruction PROCEDURE

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.

Patients with severe rectal anastomotic stenosis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital of Sun yat-sen University

Guangzhou, Guangdong, China

RECRUITING

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Study Officials

• Yanhong Deng, Doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Huang, Doctor

CONTACT

15989101216; huangl75@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator of the sixth affiliated hospital of Sun Yat-sen University

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 14, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

CN (1)