NCT06865638

Efficacy and Safety of Colorectal Anastomotic Leak Testing

A Comparative Study of Clinical Outcomes Between Leak Testing and No Leak Testing for Anastomosis in Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Nanchong Central Hospital · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. The primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery

Conditions

• Colorectal Cancer
• Leakage Testing
• Colorectal Surgery
• Complications
• Anastomotic Leakage

Interventions

Type	Name	Description
PROCEDURE	Intraoperative leak testing	◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.

Timeline

• Start date: 2024-12-22
• Primary completion: 2029-01-31
• Completion: 2029-04-01
• First posted: 2025-03-10
• Last updated: 2026-03-31

Locations

1 site across 1 country: China