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

ColoRectal Cancer Clinical Trial

— ITCORA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03316677
• Other study ID #: MMC11261-16CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: January 15, 2017
• Last updated: October 17, 2017
• Start date: November 1, 2017
• Est. completion date: December 2022

Study information

• Verified date: January 2017
• Source: Meir Medical Center
• Contact: Yaron Rudnicki, MD
• Phone: +972523263775
• Email: yaron217[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2022
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomosis
• Anastomotic Complication
• Anastomotic Leak
• Colonic Diverticulitis
• ColoRectal Cancer
• Colorectal Neoplasms
• Diverticulitis
• Diverticulitis, Colonic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the predictive value of intraoperative anastomosis testing on anastomotic leak.	The presence or absence of a post-operative clinical anastomotic leak	30 days
Secondary	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	Both findings will be obvious (if present) immediately after the test is performed