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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Pathologically diagnosed with colorectal cancer, planned for radical surgery (right hemicolectomy, left hemicolectomy, or anterior resection of the rectum, etc.).

• Age 18-85 years, American Society of Anesthesiologists (ASA) classification I-III.

• Anastomosis to be performed in a single stage (meeting anastomotic criteria).

• Patient or legal guardian is able to understand and sign the informed consent form and comply with follow-up.

Locations
Other Locations
China
Nanchong Central Hospital
RECRUITING
Nanchong
Contact Information
Primary
Yunhong Tian Tian, doctor
drtianyunhong@126.com
+8613508087719
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 110
Treatments
Experimental: Pre-emptive Endoscopic Vacuum Therapy
After the anastomosis is completed and confirmed by endoscopy to be intact and free of bleeding, immediately perform Pre-emptive Endoscopic Vacuum Therapy(PEVT).
No_intervention: No Pre-emptive Endoscopic Vacuum Therapy
After the anastomosis, only routine colonoscopy was performed without PEVT device, and other steps were consistent with the PEVT group.
Related Therapeutic Areas
Sponsors
Leads: Nanchong Central Hospital

This content was sourced from clinicaltrials.gov