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

  • France
      • Amiens, France
        • Amiens University Hospital

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
Device: cma microdialysis catheter placement
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
postoperative day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

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

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.

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