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Completed

NCT Number: NCT01786694

Feasibility of Microdialysis by Laparoscopy

The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Amiens University Hospital

Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cma microdialysis catheter placement

Device

the microdialysis catheters are sold by CMA

Primary outcomes

  1. functional success of microdialysis

    Time frame: postoperative day 5

    the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter

Secondary outcomes

  1. 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

  2. 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

  3. the mortality rate

    Time frame: postoperative day 30

    the mortality rate is defined as the number of death after the surgery

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: MTM-COLON-I

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2013
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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