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RECRUITING
NCT06036862
NA

Utilization of Transanal Endoscopy in the Treatment of Anastomotic Stenosis

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

Official title: A Prospective Clinical Study of Transanal and Transabdominal Combined Endoscopic Resection of Rectal Stenosis and Anal Reconstruction for Severe Rectal Anastomotic Stenosis

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-08-01

Completion Date

2026-12-31

Last Updated

2023-09-14

Healthy Volunteers

No

Interventions

PROCEDURE

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

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.

Locations (1)

Sixth Affiliated Hospital of Sun yat-sen University

Guangzhou, Guangdong, China