Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA study).
Recruiting
- Conditions
- malignant colorectal disease
- Registration Number
- NL-OMON28382
- Lead Sponsor
- Academisch Medisch Centrum, Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
1. Age between 40 and 80 years;
2. Colorectal cancer including colon and rectosigmoid cancers;
3. Informed consent.
Exclusion Criteria
1. Prior midline laparotomy;
2. ASA IV;
3. Laparoscopic surgeon not available;
4. Prior upper and/or lower midline laparotomy;
5. Emergency colectomy;
6. Contraindications for epidural (coagulation disorders);
7. Planned stoma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Total postoperative hospital stay including readmission within 30 days;<br>2. Quality of life measured by validated questionnaires (SF-36/Gigli) at two and four weeks after surgery;<br>3. Medical and non medical costs.
- Secondary Outcome Measures
Name Time Method 1. Morbidity; <br>2. Patient satisfaction measured by standardised questionnaires; <br>3. Readmission percentage.