Back to resultsFeasibility of Microdialysis by Laparoscopy (MTM-COLON-I)
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
cma microdialysis catheter placement
Sponsored by
About this trial
This is an interventional prevention trial for Rectal Cancer focused on measuring rectum, microdialysis, quality of life
Eligibility Criteria
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
Sites / Locations
- Amiens University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cma microdialysis catheter placement
Arm Description
At the end of the surgery the cma microdialysis catheter is placed near the anastomosis
Outcomes
Primary Outcome Measures
functional success of microdialysis
the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter
Secondary Outcome Measures
anastomotic leaks rate
the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan
superficial surgical site infection rate
the surgical site infection rate is defined as the number of infection near the incision
the mortality rate
the mortality rate is defined as the number of death after the surgery
the quality of life after the surgery
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
Full Information
NCT ID
NCT01786694
First Posted
February 1, 2013
Last Updated
January 31, 2017
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT01786694
Brief Title
Feasibility of Microdialysis by Laparoscopy
Acronym
MTM-COLON-I
Official Title
Feasibility of Microdialysis by Laparoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectum, microdialysis, quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cma microdialysis catheter placement
Arm Type
Experimental
Arm Description
At the end of the surgery the cma microdialysis catheter is placed near the anastomosis
Intervention Type
Device
Intervention Name(s)
cma microdialysis catheter placement
Intervention Description
the microdialysis catheters are sold by CMA
Primary Outcome Measure Information:
Title
functional success of microdialysis
Description
the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter
Time Frame
postoperative day 5
Secondary Outcome Measure Information:
Title
anastomotic leaks rate
Description
the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan
Time Frame
postoperative day 30
Title
superficial surgical site infection rate
Description
the surgical site infection rate is defined as the number of infection near the incision
Time Frame
postoperative day 30
Title
the mortality rate
Description
the mortality rate is defined as the number of death after the surgery
Time Frame
postoperative day 30
Title
the quality of life after the surgery
Description
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
Time Frame
postoperative day 30
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean marc regimbeau, MD, PhD
Organizational Affiliation
CHU amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22103734
Citation
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.
Results Reference
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PubMed Identifier
18500500
Citation
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].
Results Reference
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PubMed Identifier
17122625
Citation
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.
Results Reference
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Feasibility of Microdialysis by Laparoscopy
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