Monitoring by Microdialysis of Postoperative Complications After Proctectomy

Phase 3CompletedNCT01999634

Centre Hospitalier Universitaire, Amiens21 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Rectal Cancer

Interventions

cma microdialysis catheter placementDEVICE

the microdialysis catheters are sold by CMA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Amiens university hospital

Amiens, France

Outcomes

Primary Outcomes

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

Time frame: postoperative day 30

Secondary Outcomes

superficial surgical site infection rate

the surgical site infection rate is defined as the number of infection near the incision

Time frame: postoperative day 30

functional success of microdialysis

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

Time frame: postoperative day 5

Data from ClinicalTrials.gov

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