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

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ClinicalTrials.gov Identifier: NCT03316677
Recruitment Status : Not yet recruiting
First Posted : October 20, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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:

  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.


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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316677


Contacts
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Contact: Yaron Rudnicki, MD +972523263775 yaron217@gmail.com

Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Shmuel Avital, MD Meir Medical Center, Israel

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT03316677     History of Changes
Other Study ID Numbers: MMC11261-16CTIL
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: January 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Meir Medical Center:
anastomotic leak
colorectal
anastomosis testing
Intraoperative testing

Additional relevant MeSH terms:
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Colorectal Neoplasms
Diverticulitis
Anastomotic Leak
Diverticulitis, Colonic
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Postoperative Complications
Pathologic Processes
Diverticulosis, Colonic
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action