Clinical trial · Interventional

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

NCT03316677CI-TRIAL-00029989ITCORAunknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Anastomosis	—	UNRESOLVED	—
Anastomotic Complication	—	UNRESOLVED	—
Anastomotic Leak	—	UNRESOLVED	—
Colonic Diverticulitis	—	UNRESOLVED	—
ColoRectal Cancer	Malignant Colorectal Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Intraoperative testing of colorectal anastomoses	Procedure	—	UNRESOLVED
Stapled colorectal anastomoses	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
OTHER
label
colorectal resection and anastamosis
description
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
interventionNames
1. Procedure: Intraoperative testing of colorectal anastomoses
2. Procedure: Stapled colorectal anastomoses

Primary outcomes (1)

measure
the predictive value of intraoperative anastomosis testing on anastomotic leak.
timeFrame
30 days
description
The presence or absence of a post-operative clinical anastomotic leak

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

DERIVEDRudnicki 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