RecruitingNot ApplicableNCT06865638

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.

Sponsor

Nanchong Central Hospital

Enrollment

264 participants

Start Date

Dec 22, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Colorectal Surgery Complications Anastomotic Leakage Leakage Testing

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

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a method for checking whether a bowel connection (anastomosis) is secure and leak-free during colorectal cancer surgery, in order to reduce dangerous complications. **You may be eligible if...** - You have been diagnosed with colorectal cancer confirmed by pathology - You are scheduled for colorectal surgery - You are between 18 and 85 years old - You are in reasonably good health for surgery (ASA class I–III) **You may NOT be eligible if...** - You have a serious coagulation disorder - You have significant kidney or liver problems - You are pregnant - You have had a severe allergic reaction to the testing materials used in this procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntraoperative 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

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NCT06865638

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