Monitoring by Microdialysis of Postoperative Complications After Proctectomy
Phase 3
Completed
- Conditions
- Rectal Cancer
- Interventions
- Device: cma microdialysis catheter placement
- 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
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
- 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 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