Actively Recruiting
Randomized Clinical Trial on Pre-emptive Endoscopic Vacuum Therapy Versus Conventional Management for Prevention of Anastomotic Leakage After Colorectal Cancer Surgery
Led by Nanchong Central Hospital · Updated on 2026-04-02
110
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of postoperative Pre-emptive Endoscopic Vacuum Therapy (PEVT) in reducing anastomotic leaks within 30 days after colorectal cancer surgery. The study compares patients receiving PEVT with those receiving standard care without PEVT, focusing on differences in operation time, hospital stay length, medical costs, and other postoperative complications like wound infection, abdominal abscess, and intestinal obstruction. The study involves two groups: one group receives PEVT immediately after confirming the anastomosis is intact via endoscopy, where a specialized sponge device is placed at the surgical site to provide continuous low-intensity suction. The other group receives routine colonoscopy without the PEVT device, with all other procedures being the same. The therapy is applied shortly after surgery and monitored for related adverse events such as device displacement, bleeding, and infection. Participants will be closely monitored through various assessments including postoperative recovery indicators like time to first flatus, first defecation, and ambulation. Researchers will track the presence of anastomotic leaks and other complications within 30 days after surgery. The study will also measure operation time, length of hospital stay, total medical costs, and any PEVT-related side effects. The total participation period includes the initial surgery and a 30-day follow-up.
CONDITIONS
Brief Title
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically diagnosed with colorectal cancer and planned for radical surgery such as right hemicolectomy, left hemicolectomy, or anterior resection of the rectum
- Age between 18 and 85 years
- American Society of Anesthesiologists (ASA) classification stage I to III
- Planned single-stage anastomosis meeting anastomotic criteria
- Able to understand and sign informed consent and comply with follow-up
You will not qualify if you...
- Existing anastomotic leakage or severe intra-abdominal infection before surgery
- Severe cardiovascular or cerebrovascular disease such as recent heart attack or acute stroke
- Severe liver dysfunction (Child-Pugh class C) or kidney dysfunction (creatinine clearance less than 30 ml/min)
- Blood clotting disorders or anticoagulant therapy that cannot be adjusted
- History of abdominal radiotherapy or multiple abdominal surgeries causing severe adhesions
- Presence of other malignant tumors undergoing radiotherapy or chemotherapy
- Psychiatric illness or cognitive impairment preventing study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Immediately after surgery
After colorectal cancer surgery and anastomosis, participants receive either Pre-emptive Endoscopic Vacuum Therapy (PEVT) or routine colonoscopy without PEVT.
1 visit (in-person)
Duration - 30 days
Participants are monitored for anastomotic leakage and other postoperative complications.
Regular assessments during 30 days after surgery
Trial Site Locations
Total: 1 location
1
Nanchong Central Hospital
Nanchong, Sichuan, China, 637000
Actively Recruiting
Research Team
Y
Yunhong Tian Tian, doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here