RecruitingNot ApplicableNCT07208786

Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery

Randomized Clinical Trial on Pre-emptive Endoscopic Vacuum Therapy Versus Conventional Management for the Prevention of Anastomotic Leakage After Colorectal Cancer Surgery


Sponsor

Nanchong Central Hospital

Enrollment

110 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Evaluate the safety and efficacy of postoperative Pre-emptive EVT (PEVT) in reducing the incidence of anastomotic leaks within 30 days after surgery in patients with colorectal cancer. Compare the differences between the PEVT group and the control group in terms of operation time, length of hospital stay, and total medical costs. Analyze the incidence of other postoperative complications in the two groups, such as wound infection, abdominal abscess, and intestinal obstruction. Assess the impact of PEVT on postoperative recovery indicators, including time to first flatus, time to first defecation, and time to ambulation. Observe the occurrence of PEVT-related adverse events, such as device displacement, bleeding, and infection.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether placing a temporary vacuum device (called endoscopic vacuum therapy) inside the bowel right after colorectal cancer surgery can reduce the risk of a dangerous complication called anastomotic leakage — where the surgically reconnected bowel develops a leak. **You may be eligible if...** - You are 18–85 years old - You have been diagnosed with colorectal cancer and are scheduled for surgery to remove it - Your surgery will involve reconnecting parts of the bowel in one operation - Your overall health status is acceptable for surgery (ASA class I–III) **You may NOT be eligible if...** - You already have a bowel leak or severe abdominal infection before surgery - You have had a recent serious heart attack or stroke - You have severe liver or kidney failure - You have certain other conditions that make this procedure too risky 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

DEVICEPEVT

PEVT Procedures After the anastomosis is completed and endoscopy confirms that the anastomotic site is intact and without bleeding, the following procedures are carried out immediately (usually within 30 minutes after the completion of the anastomosis): 1. EVT device selection: Use an open-pore polyurethane sponge (OPPS) connected to a 16Fr nasogastric tube, with the sponge cut to a size of 2 cm × 3 cm. 2. Placement method: Insert the sponge through the anus to the anastomotic site in the intestinal lumen, set the negative pressure to low intensity (-50 to -100 mmHg), and connect to an external negative pressure suction device for continuous suction.


Locations(1)

Nanchong Central Hospital

Nanchong, Sichuan, China

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NCT07208786


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