Efficacy and Safety of Colorectal Anastomotic Leak Testing

March 29, 2026 updated by: Nanchong Central Hospital

A Comparative Study of Clinical Outcomes Between Leak Testing and No Leak Testing for Anastomosis in Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.

To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. The primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
264

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Sichuan
      • Nanchong, Sichuan, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients diagnosed with colorectal cancer by pathology and scheduled for surgical treatment who meet the surgical indications.
  2. Aged between 18 and 85 years.
  3. American Society of Anesthesiologists (ASA) physical status classification is I - III.
  4. The patient or his/her legal representative can understand and sign the informed consent form and is willing to cooperate throughout the study process.

Exclusion Criteria:

  1. Patients with preoperatively diagnosed anastomotic leak or other severe abdominal infections.
  2. Patients with severe cardiovascular and cerebrovascular diseases (such as recent myocardial infarction, unstable angina pectoris, severe heart failure, acute cerebral infarction, etc.) who cannot tolerate surgery and related tests.
  3. Patients with severely impaired liver and kidney function (liver function Child - Pugh classification C or above, creatinine clearance rate < 30 ml/min).
  4. Patients with coagulation disorders (such as platelet count < 50×10⁹/L, international normalized ratio (INR) > 1.5, etc.) that cannot be corrected or are receiving anticoagulant therapy that cannot be adjusted.
  5. Patients with a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures.
  6. Patients with other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy.
  7. Patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ≤5cm Rectal, Pre-chemo, Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy and intraoperative leak testing.
Procedure: Intraoperative leak testing
◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.
No Intervention: ≤5cm Rectal, Pre-chemo, No Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing.
Experimental: ≤5cm Rectal, No pre-chemo, Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing.
Procedure: Intraoperative leak testing
◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.
No Intervention: ≤5cm Rectal, No pre-chemo, No Leak Test
Patients with rectal cancer ≤ 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing.
Experimental: >5cm Colorectal, Pre-chemo, Leak Test
Patients with colorectal cancer > 5 cm from the anus, received preoperative chemotherapy, and underwent intraoperative leak testing.
Procedure: Intraoperative leak testing
◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.
No Intervention: >5cm Colorectal, Pre-chemo, No Leak Test
Patients with colorectal cancer > 5 cm from the anus, received preoperative chemotherapy, and had no intraoperative leak testing.
Experimental: >5cm Colorectal, No pre-chemo, Leak Test
Patients with colorectal cancer > 5 cm from the anus, didn't receive preoperative chemotherapy, and underwent intraoperative leak testing.
Procedure: Intraoperative leak testing
◦After anastomosis was completed, the integrity of anastomosis was tested intraoperatively. The methods include directly observing the integrity of the anastomosis under gastroscopy, immersing the anastomosis in 500 - 1000 mL of warm saline and temporarily occluding the distal end, filling the anastomotic bowel with air, and injecting 60 mL of methylene blue through colonoscopy. Wrapping a white gauze pad around the anastomosis and observing for methylene blue leakage.
No Intervention: >5cm Colorectal, No pre-chemo, No Leak Test
Patients with colorectal cancer > 5 cm from the anus, didn't receive preoperative chemotherapy, and had no intraoperative leak testing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanchong Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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