Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)? (ITCORA)

October 17, 2017 updated by: Meir Medical Center

A leak from a colorectal anastomosis is a post-operative complication surgeons fear the most, following colonic resection. Over the years, there have been multiple suggestions for intraoperative tests for the integrity of the colorectal anastomosis.

Two of the most common tests that are performed routinely are:

  1. Air tight leak test - filling the pelvis with saline and insufflating air trans anal - looking for air bubbles in the saline filled pelvis.
  2. Injecting diluted dye (methylene blue) trans anal, and looking for blue dye stains on gauze pads covering the outer side of anastomosis.

The aim of the study is to compare the two methods, and to assess if there is a superior method. A secondary aim is to establish standards to perform the test, mainly to assess the appropriate pressure to apply on the anastomosis.

In this prospective study patients scheduled to undergo colonic resection of their distal part of the colon/ rectum with colorectal anastomosis, will have both testing methods performed sequentially and will be followed post-operative to assess the yield and sensitivity of the testing methods.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • 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.

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over the age of 18 undergoing elective colonic resection of their distal part of the colon/ rectum with colorectal anastomosis in a laparoscopic or open approach for a benign or malignant colonic disease.

Exclusion Criteria:

  • Emergent colonic resections,
  • Colonic resections with no colorectal anastamosis

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: colorectal resection and anastamosis

Intraoperative testing of colorectal anastomoses

  1. Insert a Foley catheter through the anus into the rectum.
  2. Insufflate the Foley balloon with 5 cc of air.
  3. fill the pelvic space with 500 CC of warm saline
  4. Insufflate air into the rectum up to a pressure of 35 mmH2o as measured by external manometer
  5. Remove the saline from the pelvic space.
  6. Inject methylene blue in to the rectum up to a pressure of 35 mmH2o measured by external manometer
  7. Remove the methylene blue from rectum.

NB the above procedures are standard practice for assessing the quality of colorectal anastomoses during colorectal surgery.

The purpose of the study is to compare these standard methods of evaluation to determinant which method is superior
Procedure: Intraoperative testing of colorectal anastomoses
  1. Insert a Foley catheter through the anus into the rectum.
  2. Insufflate the Foley balloon with 5 cc of air.
  3. Air tight leak test with saline and insufflating air: fill the pelvic space with 500 CC of warm saline
  4. Insufflate air into the rectum up to a pressure of 35 mmH2o as measured by external manometer
  5. Remove the saline from the pelvic space.
  6. Inject diluted dye (methylene blue) in to the rectum up to a pressure of 35 mmH2o measured by external manometer
  7. Remove the methylene blue from rectum.

NB the above procedures are standard practice for assessing the quality of colorectal anastomoses during colorectal surgery.

The purpose of the study is to compare these standard methods of evaluation to determinant which method is superior

Procedure: Stapled colorectal anastomoses
After the resection we do the stapled colorectal anastomosis with a standard circular stapler as part of the regular procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the predictive value of intraoperative anastomosis testing on anastomotic leak.
Time Frame: 30 days
The presence or absence of a post-operative clinical anastomotic leak
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity of the 2 methods of intraoperative anastomosis testing.
Time Frame: Both findings will be obvious (if present) immediately after the test is performed
We will compare the occurence of air leak with the occurence of methylene blue leak in each patient
Both findings will be obvious (if present) immediately after the test is performed

Collaborators and Investigators

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

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Shmuel Avital, MD, Meir medical center, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 15, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (Actual)

October 20, 2017

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC11261-16CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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