An interventional study of Intraoperative testing of colorectal anastomoses and Stapled colorectal anastomoses in ColoRectal Cancer, Colonic Diverticulitis and Anastomotic Leak, sponsored by Meir Medical Center. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-20.
Sponsored by Meir Medical Center · Not applicable, Interventional, and Diagnostic
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:
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.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,483 are open to participants now.
This study's planned enrollment of 150 is above the median of 77 across 4,226 interventional studies indexed under Colorectal Neoplasms.
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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 · Procedure: Stapled 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
After the resection we do the stapled colorectal anastomosis with a standard circular stapler as part of the regular procedure
the predictive value of intraoperative anastomosis testing on anastomotic leak.
The presence or absence of a post-operative clinical anastomotic leak
Time frame: 30 days
The sensitivity of the 2 methods of intraoperative anastomosis testing.
We will compare the occurence of air leak with the occurence of methylene blue leak in each patient
Time frame: Both findings will be obvious (if present) immediately after the test is performed
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This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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