Utilization of Transanal Endoscopy in the Treatment of Anastomotic Stenosis

Recruiting now · Not applicable

Conditions studied: Anastomotic Stenosis

In brief

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.

Key facts

Study ID

NCT06036862

Run by

Sun Yat-sen University

People needed

50

Starts

2023-08-01

Expected to finish

2026-12-31

Last updated by the study team

2023-09-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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;

Where it is running

• Sixth Affiliated Hospital of Sun yat-sen University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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