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RECRUITING
NCT06865638
NA

Efficacy and Safety of Colorectal Anastomotic Leak Testing

Sponsor: Nanchong Central Hospital

View on ClinicalTrials.gov

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

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

264

Start Date

2024-12-22

Completion Date

2029-04-01

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

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.

Locations (1)

Nanchong Central Hospital

Nanchong, Sichuan, China