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

Primary Purpose

ColoRectal Cancer, Colonic Diverticulitis, Anastomotic Leak

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intraoperative testing of colorectal anastomoses
Stapled colorectal anastomoses
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ColoRectal Cancer focused on measuring anastomotic leak, colorectal, anastomosis testing, Intraoperative testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    colorectal resection and anastamosis

    Arm Description

    Intraoperative testing of colorectal anastomoses Insert a Foley catheter through the anus into the rectum. Insufflate the Foley balloon with 5 cc of 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 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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    January 15, 2017
    Last Updated
    October 17, 2017
    Sponsor
    Meir Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03316677
    Brief Title
    Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?
    Acronym
    ITCORA
    Official Title
    Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2017 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Meir Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: Air tight leak test - filling the pelvis with saline and insufflating air trans anal - looking for air bubbles in the saline filled pelvis. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ColoRectal Cancer, Colonic Diverticulitis, Anastomotic Leak, Anastomotic Complication, Anastomosis
    Keywords
    anastomotic leak, colorectal, anastomosis testing, Intraoperative testing

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    colorectal resection and anastamosis
    Arm Type
    Other
    Arm Description
    Intraoperative testing of colorectal anastomoses Insert a Foley catheter through the anus into the rectum. Insufflate the Foley balloon with 5 cc of 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 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
    Intervention Type
    Procedure
    Intervention Name(s)
    Intraoperative testing of colorectal anastomoses
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Stapled colorectal anastomoses
    Intervention Description
    After the resection we do the stapled colorectal anastomosis with a standard circular stapler as part of the regular procedure
    Primary Outcome Measure Information:
    Title
    the predictive value of intraoperative anastomosis testing on anastomotic leak.
    Description
    The presence or absence of a post-operative clinical anastomotic leak
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    The sensitivity of the 2 methods of intraoperative anastomosis testing.
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yaron Rudnicki, MD
    Phone
    +972523263775
    Email
    yaron217@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shmuel Avital, MD
    Organizational Affiliation
    Meir Medical Center, Israel
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33905010
    Citation
    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.
    Results Reference
    derived

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