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

NCT ID: NCT07208786

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2026-12-30

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 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Pre-emptive Endoscopic Vacuum Therapy

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

Group Type: EXPERIMENTAL

PEVT

Intervention Type: 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.

No Pre-emptive Endoscopic Vacuum Therapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanchong Central Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanchong Central Hospital

Nanchong, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunhong Tian Tian, doctor

Role: CONTACT

drtianyunhong@126.com

+8613508087719

Facility Contacts

Yunhong Tian, doctor

Role: primary

drtianyunhong@126.com

+8613508087719

Other Identifiers

2025166

Identifier Type: -

Identifier Source: org_study_id