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

Sponsor

Meir Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03316677

Collaborator

(none)

150

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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:

Air tight leak test - filling the pelvis with saline and insufflating air trans anal - looking for air bubbles in the saline filled pelvis.
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.

Condition or Disease	Intervention/Treatment	Phase
ColoRectal Cancer Colonic Diverticulitis Anastomotic Leak Anastomotic Complication Anastomosis	Procedure: Intraoperative testing of colorectal anastomoses Procedure: Stapled colorectal anastomoses	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: colorectal resection and anastamosis Intraoperative testing of colorectal anastomoses Insert a Foley catheter through the anus into the rectum. Insufflate the Foley balloon with 5 cc of air. fill the pelvic space with 500 CC of warm saline Insufflate air into the rectum up to a pressure of 35 mmH2o as measured by external manometer Remove the saline from the pelvic space. Inject methylene blue in to the rectum up to a pressure of 35 mmH2o measured by external manometer 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 Insert a Foley catheter through the anus into the rectum. Insufflate the Foley balloon with 5 cc of air. Air tight leak test with saline and insufflating air: fill the pelvic space with 500 CC of warm saline Insufflate air into the rectum up to a pressure of 35 mmH2o as measured by external manometer Remove the saline from the pelvic space. Inject diluted dye (methylene blue) in to the rectum up to a pressure of 35 mmH2o measured by external manometer 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

Arm

Intervention/Treatment

Other: colorectal resection and anastamosis

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

Insert a Foley catheter through the anus into the rectum. Insufflate the Foley balloon with 5 cc of air. Air tight leak test with saline and insufflating air: fill the pelvic space with 500 CC of warm saline Insufflate air into the rectum up to a pressure of 35 mmH2o as measured by external manometer Remove the saline from the pelvic space. Inject diluted dye (methylene blue) in to the rectum up to a pressure of 35 mmH2o measured by external manometer 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

Outcome Measures

Primary Outcome Measures

the predictive value of intraoperative anastomosis testing on anastomotic leak. [30 days]
The presence or absence of a post-operative clinical anastomotic leak

Secondary Outcome Measures

The sensitivity of the 2 methods of intraoperative anastomosis testing. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.