NCT07208786

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Nanchong Central Hospital · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer
• Colorectal Surgery
• Complications
• Anastomotic Leakage
• Endoscopic Vacuum Therapy

Interventions

Type	Name	Description
DEVICE	PEVT	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.

Timeline

• Start date: 2025-09-22
• Primary completion: 2026-10-10
• Completion: 2026-12-30
• First posted: 2025-10-06
• Last updated: 2026-04-02

Locations

1 site across 1 country: China