Pre-emptive endoscopic vacuum therapy to reduce anastomotic leaks 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

This will try using pre-emptive endoscopic vacuum therapy after colorectal cancer surgery to see if it lowers early anastomotic leaks in adults having radical colorectal operations.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Nanchong Central Hospital (other gov)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanchong, Sichuan)
• Trial ID: NCT07208786 on ClinicalTrials.gov

What this trial studies

Adults with pathologically confirmed colorectal cancer undergoing single-stage radical resection will be allocated to receive postoperative pre-emptive endoscopic vacuum therapy (PEVT) or standard care and followed for at least 30 days. The primary outcome is the incidence of anastomotic leakage within 30 days after surgery, with secondary comparisons of operation time, length of hospital stay, total medical costs, other postoperative complications, and recovery milestones such as time to first flatus and ambulation. The protocol also includes monitoring for PEVT-related adverse events like device displacement, bleeding, and infection. The trial is conducted at Nanchong Central Hospital in Nanchong, Sichuan.

Who should consider this trial

Good fit: Adults aged 18–85 with pathologically confirmed colorectal cancer scheduled for single-stage radical colorectal resection and with ASA I–III who can give informed consent are ideal candidates.

Not a fit: Patients with preexisting anastomotic leakage or severe intra-abdominal infection, severe cardiac/cerebrovascular disease, advanced liver or kidney failure, uncorrectable coagulation disorders, or a history of abdominal radiotherapy are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, PEVT could reduce early anastomotic leak rates after colorectal cancer surgery and shorten hospital stays and costs.

How similar studies have performed: Endoscopic vacuum therapy is an established treatment for existing anastomotic leaks, but using it pre-emptively to prevent leaks is a relatively new approach with limited supporting data so far.

Eligibility criteria

Inclusion Criteria:

1. Pathologically diagnosed with colorectal cancer, planned for radical surgery (right hemicolectomy, left hemicolectomy, or anterior resection of the rectum, etc.).
2. Age 18-85 years, American Society of Anesthesiologists (ASA) classification I-III.
3. Anastomosis to be performed in a single stage (meeting anastomotic criteria).
4. Patient or legal guardian is able to understand and sign the informed consent form and comply with follow-up.

Exclusion Criteria:

1. Preexisting anastomotic leakage or severe intra-abdominal infection before surgery.
2. Complicated by severe cardiovascular or cerebrovascular diseases (e.g., acute myocardial infarction, acute phase of cerebral infarction).
3. Severe liver or kidney dysfunction (liver function Child-Pugh class C, creatinine clearance \<30 ml/min).
4. Coagulation disorders (platelets \<50×10⁹/L, INR \>1.5) or receiving anticoagulant therapy that cannot be adjusted.
5. History of abdominal radiotherapy or multiple abdominal surgeries leading to severe intra-abdominal adhesions.
6. Complicated by other malignant tumors and currently undergoing radiotherapy or chemotherapy.
7. Psychiatric illness or cognitive impairment preventing compliance with the study.

Where this trial is running

Nanchong, Sichuan

• Nanchong Central Hospital — Nanchong, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Yunhong Tian Tian, doctor

Conditions: Colorectal Cancer, Colorectal Surgery, Complications, Anastomotic Leakage, Endoscopic Vacuum Therapy