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

NCT07208786 — Not applicable, Recruiting, 110 participants, Nanchong Central Hospital

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

Registry	NCT07208786
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	110 (Estimated)
Sponsor	Nanchong Central Hospital (Other gov)
Conditions	Colorectal Cancer, Colorectal Surgery, Complications, Anastomotic Leakage, Endoscopic Vacuum Therapy
Interventions	PEVT (Device)
Dates	start 2025-09-22, primary completion 2026-10-10 (estimated), completion 2026-12-30 (estimated), first posted 2025-10-06, last updated 2026-04-02
Locations	1 site in China

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Pre-emptive Endoscopic Vacuum Therapy	Experimental	Device: PEVT	After the anastomosis is completed and confirmed by endoscopy to be intact and free of bleeding, immediately perform Pre-emptive Endoscopic Vacuum Therapy(PEVT).
No Pre-emptive Endoscopic Vacuum Therapy	No intervention		After the anastomosis, only routine colonoscopy was performed without PEVT device, and other steps were consistent with the PEVT group.

PEVT (Device): 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 intestinal lumen, set the negative pressure to low intensity (-50 to -100 mmHg), and connect to an external negative pressure suction device for continuous suction.

+Outcome measures

Primary outcomes

Number of Participants with Anastomotic Leak within 30 days [30 days]: Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery.

Secondary outcomes

Number of Participants with Postoperative Complications within 30 days [30 days]: Count the number of participants who develop postoperative bleeding, anastomotic stenosis, and intra-abdominal infection within 30 days after colorectal cancer surgery.

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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.

+Locations (1)

Facility	City	Country	Status
Nanchong Central Hospital	Nanchong, Sichuan	China	Recruiting