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

NAUnknownINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

November 1, 2017

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2022

Conditions
ColoRectal CancerColonic DiverticulitisAnastomotic LeakAnastomotic ComplicationAnastomosis
Interventions
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

Sponsors
All Listed Sponsors
lead

Meir Medical Center

OTHER