NCT07346534

Reinforced Versus Conventional Anastomosis in Laparoscopic Low Rectal Cancer Resection: A Comparative Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Shanghai 10th People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Study Description This prospective, controlled clinical study aims to compare the clinical outcomes of reinforced anastomosis using 8-10 interrupted sutures versus the conventional Dixon procedure in patients undergoing laparoscopic low anterior resection for low rectal cancer. Anastomotic leakage remains one of the most significant postoperative complications following low rectal cancer surgery, particularly in laparoscopic procedures due to limited tactile feedback and maneuverability in the pelvic cavity. Reinforcement of the anastomotic site through additional interrupted suturing may provide better mechanical strength and improved healing, potentially reducing the incidence of anastomotic leakage and related morbidities. In this study, eligible patients will be assigned to receive either a conventional laparoscopic Dixon procedure or the same procedure with added reinforcement of the anastomosis using 8-10 interrupted sutures circumferentially. Perioperative outcomes including the rate of anastomotic leakage, postoperative complications, operation time, length of hospital stay, return of bowel function, and quality of life will be assessed and compared between the two groups. The study seeks to provide evidence for optimizing surgical techniques in low rectal cancer treatment and improving patient prognosis.

Conditions

• Low Rectal Cancer
• Rectal Neoplasms
• Colorectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Reinforced Anastomotic Suturing (8-10 Interrupted Sutures)	After completing the laparoscopic low anterior resection (Dixon procedure) for low rectal cancer, the surgeon performs additional reinforcement of the colorectal anastomosis. This is done by placing 8 to 10 interrupted seromuscular sutures circumferentially around the anastomotic site. The goal of this reinforcement is to enhance anastomotic stability, promote healing, and reduce the risk of anastomotic leakage.
PROCEDURE	Conventional Laparoscopic Dixon Procedure	Patients undergo standard laparoscopic low anterior resection (Dixon procedure) for low rectal cancer. The colorectal anastomosis is performed using a circular stapler without any additional suturing or reinforcement. This represents the conventional surgical approach widely used in clinical practice.

Timeline

• Start date: 2022-06-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: China