Pre-emptive endoscopic vacuum therapy to reduce anastomotic leaks after colorectal cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nanchong Central Hospital
  Nanchong, Sichuan, China Recruiting

Study contacts

• Study coordinator: Yunhong Tian Tian, doctor
• Email: drtianyunhong@126.com
• Phone: +8613508087719

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.