Rectal Cancer
Conditions
Keywords
rectum, microdialysis, anastomotic leaks
Brief summary
The aim of this study is to monitor by microdialysis the postoperative outcomes in order to identify anastomotic leaks after rectal surgery.
Interventions
the microdialysis catheters are sold by CMA
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| superficial surgical site infection rate | postoperative day 30 | the surgical site infection rate is defined as the number of infection near the incision |
| functional success of microdialysis | postoperative day 5 | the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter |
Countries
France
Outcome results
None listed