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

NCT03316677 | Unknown

• 1 other identifier: MMC11261-16CTIL
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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. 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. 2.Injecting diluted dye (methylene blue) trans anal, and looking for blue dye stains on gauze pads covering the outer side of anastomosis.

Conditions

ColoRectal Cancer; Colonic Diverticulitis; Anastomotic Leak; Anastomotic Complication; Anastomosis

Keywords

anastomotic leak; colorectal; anastomosis testing; Intraoperative testing

Outcome Measures

Primary Outcomes (1)

• the predictive value of intraoperative anastomosis testing on anastomotic leak.

  The presence or absence of a post-operative clinical anastomotic leak

  30 days

Secondary Outcomes (1)

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

  Both findings will be obvious (if present) immediately after the test is performed

Study Arms (1)

colorectal resection and anastamosis

OTHER

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

Interventions

Intraoperative testing of colorectal anastomoses PROCEDURE

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

colorectal resection and anastamosis

Stapled colorectal anastomoses PROCEDURE

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

colorectal resection and anastamosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Meir Medical Center: lead

Related Publications (1)

• Rudnicki Y, White I, Tiomkin V, Lahav L, Raguan B, Avital S. Intraoperative evaluation of colorectal anastomotic integrity: a comparison of air leak and dye leak tests. Tech Coloproctol. 2021 Jul;25(7):841-847. doi: 10.1007/s10151-021-02453-4. Epub 2021 Apr 27.

  PMID: 33905010 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Diverticulitis, Colonic; Anastomotic Leak

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Diverticulitis; Diverticular Diseases; Gastroenteritis; Diverticulosis, Colonic; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shmuel Avital, MD

  Meir Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaron Rudnicki, MD

CONTACT

+972523263775; yaron217@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: October 20, 2017
• Study Start: November 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: October 20, 2017

Record last verified: 2017-01