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

NCT07208786 | Recruiting

• 1 other identifier: 2025166
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Anastomotic Leak within 30 days

  Count the number of participants who develop anastomotic leak within 30 days after colorectal cancer surgery.

  30 days

Secondary Outcomes (1)

• Number of Participants with Postoperative Complications within 30 days

  30 days

Study Arms (2)

Pre-emptive Endoscopic Vacuum Therapy

EXPERIMENTAL

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

Device: 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.

Interventions

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.

Pre-emptive Endoscopic Vacuum Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanchong Central Hospital: lead

Study Sites (1)

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Anastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yunhong Tian Tian, doctor

CONTACT

+8613508087719; drtianyunhong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (1)