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Recruiting NCT07208786

Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery

No phase Interventional Colorectal Cancer Colorectal Surgery Complications Anastomotic Leakage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PEVT.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Colorectal Surgery, Complications, Anastomotic Leakage. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device PEVT
    PEVT Procedures After the anastomosis is completed and endoscopy confirms that the anastomotic site is intact and without bleeding, the following procedures are carried out immediately (usually within 30 minutes after the completion of the anastomosis): 1. EVT device selection: Use an open-pore polyurethane sponge (OPPS) connected to a 16Fr nasogastric tube, with the sponge cut to a size of 2 cm × 3 cm. 2. Placement method: Insert the sponge through the anus to the anastomotic site in the inte

Primary outcome measures

  • Number of Participants with Anastomotic Leak within 30 days [Time frame: 30 days]
Secondary outcome measures (1)
  • Number of Participants with Postoperative Complications within 30 days [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Nanchong Central Hospital — Nanchong

Identifiers

NCT: NCT07208786 · 2025166

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗