Monitoring by Microdialysis of Postoperative Complications After Proctectomy

Phase 3

Completed

• Conditions: Rectal Cancer

• Registration Number: NCT01999634
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-03
• Study Start: 2014-02-05
• Primary Completion: 2017-03-23
• Study Completion: 2017-03-23
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary 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 or at the clinical examination

Secondary 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
superficial surgical site infection rate	postoperative day 30	the surgical site infection rate is defined as the number of infection near the incision

Trial Locations

Locations (1)

Amiens university hospital; 🇫🇷 Amiens, France