ColoRectal CancerITCORANCT03316677
Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?
A study testing Intraoperative testing of colorectal anastomoses and Stapled colorectal anastomoses in people with ColoRectal Cancer and Colonic Diverticulitis, run by Meir Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ColoRectal Cancer, Colonic Diverticulitis, Anastomotic Leak
- What is being tested?
- Intraoperative testing of colorectal anastomoses and Stapled colorectal anastomoses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Emergent colonic resections,
- Colonic resections with no colorectal anastamosis
Trial locations and contacts
No sites are listed yet.
About this study
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:
Read more
- 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.
- Conditions
- ColoRectal Cancer, Colonic Diverticulitis, Anastomotic Leak, Anastomotic Complication, Anastomosis
- Being tested
- Intraoperative testing of colorectal anastomoses, Stapled colorectal anastomoses
- Keywords
- anastomotic leak, colorectal, anastomosis testing, Intraoperative testing
- Medical subject headings
- Colorectal Neoplasms, Diverticulitis, Colonic, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative testing of colorectal anastomosesProcedure or surgery
- 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 anastomosesProcedure or surgery
After the resection we do the stapled colorectal anastomosis with a standard circular stapler as part of the regular procedure
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Intraoperative testing of colorectal anastomoses; Procedure: Stapled colorectal anastomoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
the predictive value of intraoperative anastomosis testing on anastomotic leak.
The presence or absence of a post-operative clinical anastomotic leak
Measured: 30 days
Secondary outcomes (1)
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
Measured: Both findings will be obvious (if present) immediately after the test is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColoRectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shmuel Avital, MD, Principal investigator, Meir Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316677
- Sponsor's protocol ID
- MMC11261-16CTIL
- Acronym
- ITCORA
- Status last verified
- Jan 2017
- First submitted
- 15 Jan 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33905010
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?
- ClinicalTrials.gov ID
- NCT03316677
- Acronym / sponsor ID
- ITCORA / MMC11261-16CTIL
- Conditions
- ColoRectal Cancer, Colonic Diverticulitis, Anastomotic Leak, Anastomotic Complication, Anastomosis
- Keywords
- anastomotic leak, colorectal, anastomosis testing, Intraoperative testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colorectal resection and anastamosis | Other | Procedure: Intraoperative testing of colorectal anastomoses, Procedure: Stapled colorectal anastomosesIntraoperative 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Emergent colonic resections,
- Colonic resections with no colorectal anastamosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative testing of colorectal anastomoses1. 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 or surgery | colorectal resection and anastamosis |
| Stapled colorectal anastomosesAfter the resection we do the stapled colorectal anastomosis with a standard circular stapler as part of the regular procedure | Procedure or surgery | colorectal resection and anastamosis |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Derived from this study: PubMed 33905010Rudnicki 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shmuel Avital, MD principal investigator
Meir Medical Center, Israel
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative testing of colorectal anastomoses and Stapled colorectal anastomoses in people with ColoRectal Cancer and Colonic Diverticulitis, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaron Rudnicki, MD (+972523263775, yaron217@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the predictive value of intraoperative anastomosis testing on anastomotic leak. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03316677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.