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Monitoring by Microdialysis of Postoperative Complications After Proctectomy (MTM-COLON-II)

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
cma microdialysis catheter placement
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Cancer focused on measuring rectum, microdialysis, anastomotic leaks

Eligibility Criteria

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

Inclusion Criteria:

  • rectal disease requiring proctectomy with anastomosis and stomy
  • proctectomy by laparoscopy or laparotomy
  • 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

anastomotic leaks rate
the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan or at the clinical examination

Secondary Outcome Measures

superficial surgical site infection rate
the surgical site infection rate is defined as the number of infection near the incision
functional success of microdialysis
the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter

Full Information

First Posted
November 26, 2013
Last Updated
July 17, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01999634
Brief Title
Monitoring by Microdialysis of Postoperative Complications After Proctectomy
Acronym
MTM-COLON-II
Official Title
Evaluation of Microdialysis to Monitor Postoperative Outcomes After Proctectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 5, 2014 (Actual)
Primary Completion Date
March 23, 2017 (Actual)
Study Completion Date
March 23, 2017 (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 study is to monitor by microdialysis the postoperative outcomes 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, anastomotic leaks

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (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
anastomotic leaks rate
Description
the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan or at the clinical examination
Time Frame
postoperative day 30
Secondary Outcome Measure Information:
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
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

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 or laparotomy 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
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
17693938
Citation
Solligard E, Juel IS, Spigset O, Romundstad P, Gronbech JE, Aadahl P. Gut luminal lactate measured by microdialysis mirrors permeability of the intestinal mucosa after ischemia. Shock. 2008 Feb;29(2):245-51. doi: 10.1097/SHK.0b013e3180cab3ce.
Results Reference
background
PubMed Identifier
17184153
Citation
Cibicek N, Zivna H, Zadak Z, Kulir J, Cermakova E, Palicka V. Colon submucosal microdialysis: a novel in vivo approach in barrier function assessment - a pilot study in rats. Physiol Res. 2007;56(5):611-617. doi: 10.33549/physiolres.931004. Epub 2006 Dec 19.
Results Reference
background
PubMed Identifier
16878039
Citation
Krejci V, Hiltebrand L, Buchi C, Ali SZ, Contaldo C, Takala J, Sigurdsson GH, Jakob SM. Decreasing gut wall glucose as an early marker of impaired intestinal perfusion. Crit Care Med. 2006 Sep;34(9):2406-14. doi: 10.1097/01.CCM.0000233855.34344.29.
Results Reference
background

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Monitoring by Microdialysis of Postoperative Complications After Proctectomy

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