Feasibility of Microdialysis by Laparoscopy

Phase 3

Completed

• Conditions: Rectal Cancer
• Interventions: Device: cma microdialysis catheter placement

• Registration Number: NCT01786694
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-08
• Study Start: 2013-10
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cma microdialysis catheter placement	cma microdialysis catheter placement	At the end of the surgery the cma microdialysis catheter is placed near the anastomosis

Primary Outcome Measures

Name	Time	Method
functional success of microdialysis	postoperative day 5	the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter

Secondary Outcome Measures

Name	Time	Method
anastomotic leaks rate	postoperative day 30	the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan
the mortality rate	postoperative day 30	the mortality rate is defined as the number of death after the surgery
superficial surgical site infection rate	postoperative day 30	the surgical site infection rate is defined as the number of infection near the incision
the quality of life after the surgery	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

Trial Locations

Locations (1)

Amiens University Hospital; 🇫🇷 Amiens, France