Status:

RECRUITING

Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery: a Randomized Controlled Study

Lead Sponsor:

Nanchong Central Hospital

Conditions:

Colorectal Cancer

Colorectal Surgery

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief 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 dif...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

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

Key Trial Info

Start Date :

September 22 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2026

Estimated Enrollment :

110 Patients enrolled

Trial Details

Trial ID

NCT07208786

Start Date

September 22 2025

End Date

December 30 2026

Last Update

October 6 2025

Active Locations (1)

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1

Nanchong Central Hospital

Nanchong, Sichuan, China, 637000