Colorectal Cancer
Conditions
Keywords
Rehabilitation program, Fast track surgery, Laparoscopic colorectal resection, Colorectal cancer, Morbidity
Brief summary
Rehabilitation program improves operative results following conventional open colorectal surgery. Very few data are available on such program in laparoscopic colorectal surgery.
Detailed description
The aim is to assess rehabilitation program in laparoscopic colorectal surgery in terms of 30 days peri operative complications
Interventions
OTHERRehabilitation program
Rehabilitation program including specific anesthetic drugs, post operative fast track recovery (early diet, mobilisation, antalgics)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years old * Colorectal cancer * Inform and consent form signed * Patient has valid health insurance/coverage * Functional capacity ≥ 4 METs (metabolic equivalents) (up 1 floor without stopping, walking down the street 5-7km / h, major domestic activities) * Patients with laparoscopic resection for colorectal cancer including abdominoperineal resection Inclusion Criteria (arm : Laparoscopy + Rehabilitation program): * Tobacco and alcohol weaning
Exclusion criteria
* MBI \< 18kg/m2 * severe malnutrition * Metastatic colorectal cancer * Buzby Index \<83 * Combined surgery (hepatic resection or segmental resection of small intestine) * Urgent surgery * Pregnancy or maternal breastfeeding * Body mass index (BMI)\> 30 kg/m2 * Abdominoperineal resection * Subtotal colectomy * Total proctocolectomy * Cons to Naropin Xylocaine, droperidol, ketamine * Patient with a history of peptic ulcer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative morbidity at 30 days according to DINDO CLAVIEN classification | 30 days | Post operative morbidity at 30 days according to DINDO CLAVIEN classification (grade I to IV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital stay and readmissions | up to first month | Initial hospital stay and possible unscheduled readmissions |
| Intravenous perfusion stay | participants will be followed until the end of hospitalization an expected average of 2 weeks | — |
| Mortality according to DINDO CLAVIEN classification | up to 30 days | Mortality according to DINDO CLAVIEN classification (grade V) |
| Specific (GIQLI) quality of life | Preoperative and at 1, 3, 6 months | Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months |
| Duration of laxation (gas and stool) | up to hospital discharge | — |
| Global (SF36) quality of life | Preoperative and at 1, 3, 6 months | Global (SF36) and specific (GIQLI) quality of life Preoperative and at 1, 3, 6 months |
Countries
France
Outcome results
None listed