Rectal Cancer
Conditions
Keywords
rectum, microdialysis, quality of life
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.
Interventions
the microdialysis catheters are sold by CMA
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
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 * 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 |
|---|---|---|
| functional success of microdialysis | postoperative day 5 | the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter |
Secondary
| 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 |
| superficial surgical site infection rate | postoperative day 30 | the surgical site infection rate is defined as the number of infection near the incision |
| the mortality rate | postoperative day 30 | the mortality rate is defined as the number of death after the surgery |
| 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 |
Countries
France
Outcome results
None listed