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Completed

NCT Number: NCT01999634

Monitoring by Microdialysis of Postoperative Complications After Proctectomy

The aim of this study is to monitor by microdialysis the postoperative outcomes in order to identify anastomotic leaks after rectal surgery.

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Key information

Conditions

Rectal Cancer Anastomotic Leak Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications 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, 80054, 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 or laparotomy
  • 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. 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 or at the clinical examination

Secondary outcomes

  1. 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

  2. functional success of microdialysis

    Time frame: postoperative day 5

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Evaluation of Microdialysis to Monitor Postoperative Outcomes After Proctectomy

Acronym: MTM-COLON-II

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2013
Registry last updated
Sep 22, 2025

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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