Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07208786

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Colorectal Cancer Anastomotic Leak Anastomotic Leakage Colonic Diseases Colorectal Neoplasms Colorectal Surgery Complications Digestive System Diseases Digestive System Neoplasms Endoscopic Vacuum Therapy Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanchong Central Hospital

Nanchong, Sichuan, 637000, China

Location status: Recruiting

Location contact

Yunhong Tian, doctor

CONTACT

[email protected]

+8613508087719

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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):

  • 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.
  • 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.

Primary outcomes

  1. Number of Participants with Anastomotic Leak within 30 days

    Time frame: 30 days

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

Secondary outcomes

  1. Number of Participants with Postoperative Complications within 30 days

    Time frame: 30 days

    Count the number of participants who develop postoperative bleeding, anastomotic stenosis, and intra-abdominal infection within 30 days after colorectal cancer surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Yunhong Tian Tian, doctor

CONTACT

[email protected]

+8613508087719

Sponsors and collaborators

Lead sponsor

Nanchong Central Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.