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

Nanchong Central Hospital

Status: Enrolling

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

Treatments: Device: PEVT

Study type: Interventional

Funder types: Other

Identifiers

NCT07208786

2025166

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Pre-emptive Endoscopic Vacuum Therapy

Experimental group

Description:

After the anastomosis is completed and confirmed by endoscopy to be intact and free of bleeding, immediately perform Pre-emptive Endoscopic Vacuum Therapy(PEVT).

Treatment:

Device: PEVT

No Pre-emptive Endoscopic Vacuum Therapy

No Intervention group

Description:

After the anastomosis, only routine colonoscopy was performed without PEVT device, and other steps were consistent with the PEVT group.