Feasibility of Microdialysis by Laparoscopy (MTM-COLON-I)
January 31, 2017 updated by: Centre Hospitalier Universitaire, Amiens
The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Amiens, France
- Amiens University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- rectal disease requiring proctectomy with anastomosis and stomy
- proctectomy by laparoscopy
- written consent
Exclusion Criteria:
- history of colorectal surgery
- rectal surgery without anastomosis
- breastfeeding or pregnancy
- ASA score IV
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: cma microdialysis catheter placement
At the end of the surgery the cma microdialysis catheter is placed near the anastomosis
|
the microdialysis catheters are sold by CMA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional success of microdialysis
Time Frame: postoperative day 5
|
the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter
|
postoperative day 5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
superficial surgical site infection rate
Time Frame: postoperative day 30
|
the surgical site infection rate is defined as the number of infection near the incision
|
postoperative day 30
|
|
anastomotic leaks rate
Time Frame: postoperative day 30
|
the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan
|
postoperative day 30
|
|
the mortality rate
Time Frame: postoperative day 30
|
the mortality rate is defined as the number of death after the surgery
|
postoperative day 30
|
|
the quality of life after the surgery
Time Frame: postoperative day 30
|
the quality of life will be evaluated with the QLQ C30 CR 29 prior to the surgery, at the hospital discharge and on postoperative day 30
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postoperative day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hogberg N, Carlsson PO, Hillered L, Meurling S, Stenback A. Intestinal ischemia measured by intraluminal microdialysis. Scand J Clin Lab Invest. 2012 Feb;72(1):59-66. doi: 10.3109/00365513.2011.629307. Epub 2011 Nov 21.
- Deeba S, Corcoles EP, Hanna GB, Pareskevas P, Aziz O, Boutelle MG, Darzi A. Use of rapid sampling microdialysis for intraoperative monitoring of bowel ischemia. Dis Colon Rectum. 2008 Sep;51(9):1408-13. doi: 10.1007/s10350-008-9375-4. Epub 2008 May 24. Erratum In: Dis Colon Rectum. 2008 Nov;51(11):1741. Hanna, B G [corrected to Hanna, G B].
- Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002. doi: 10.1097/01.sla.0000225092.45734.e6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
February 1, 2013
First Submitted That Met QC Criteria
February 7, 2013
First Posted (Estimate)
February 8, 2013
Study Record Updates
Last Update Posted (Estimate)
February 1, 2017
Last Update Submitted That Met QC Criteria
January 31, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2012_843_0022
- 2012-A01218-35 (Other Identifier: ID-RCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.