NCT06495853

Prospective Phase II Study on Continuous Circumferential Reinforcement of Laparoscopic Rectal Anastomosis to Prevent Complications

A Prospective Phase II Clinical Study on Continuous Circumferential Reinforcement of the Anastomotic Site With Laparoscopic Rectal Anastomosis to Prevent Complications.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: ZHI-ZHONG PAN · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Anastomotic leakage (AL) is one of the most severe complications following laparoscopic rectal cancer surgery. According to the International Study Group of Rectal Cancer (ISREC), AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomosis leading to a communication between the intra- and extraluminal compartments, including defects of the suture or staple lines of the neorectal reservoir. AL is classified into three grades based on clinical severity: Grade A, identified only radiologically without clinical symptoms; Grade B, presenting with localized or atypical peritonitis requiring antibiotics and local drainage but not surgery; and Grade C, causing severe peritonitis, systemic toxicity symptoms requiring urgent surgical intervention, and potentially leading to life-threatening situations. AL can prolong hospitalization, necessitate reoperation, delay chemotherapy, increase local recurrence rates, and adversely affect survival and quality of life. Emergency surgical management of AL often requires meticulous peritoneal lavage and ileostomy, aiming for subsequent anastomotic healing or future digestive tract reconstruction. However, some patients face significant challenges due to postoperative adhesions and persistent anastomotic defects despite prolonged lavage. Identified risk factors for AL after rectal cancer surgery include male gender, advanced age, hypertension, diabetes, smoking, and advanced TNM staging (III-IV). Additionally, preoperative chemoradiotherapy-induced bowel edema and fibrosis, bowel obstruction, and long-term malnutrition resulting in hypoproteinemia are significant contributors. Mechanical reinforcement of anastomoses using sutures or absorbable barbed sutures has been shown to significantly reduce AL rates in previous studies. This single-center prospective phase II clinical trial aims to evaluate the efficacy and safety of continuous circumferential reinforcement using absorbable barbed sutures in laparoscopic rectal anastomosis to prevent AL. We will compare the incidence of AL and other postoperative complications between patients undergoing reinforced anastomosis and a control group receiving standard laparoscopic rectal anastomosis.

Conditions

• Colorectal Cancer
• Anastomotic Leakage
• Operation

Interventions

Type	Name	Description
PROCEDURE	Continuous Circumferential Reinforcement of the Anastomotic	The reinforcement began on the right side of the anterior wall of the anastomosis, 0.5 cm from the anastomotic line, with continuous full-thickness sutures spaced 1 cm apart. The suture ended with fixation of the suture tail using non-absorbable vascular clips. The decision to perform splenic flexure mobilization depended on the anastomotic tension and the length of the resected bowel segment. The superior mesenteric artery and vein were divided at their roots.

Timeline

• Start date: 2024-07-20
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2024-07-11
• Last updated: 2024-07-11

Locations

1 site across 1 country: China