Peri-operative strategy in colonic surgery: LAparoscopy and/or FAst track multimodal management versus standard care (LAFA study)
Completed
- Conditions
- aparoscopic surgerySurgery
- Registration Number
- ISRCTN79588422
- Lead Sponsor
- Academic Medical Centre (AMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
1. Aged between 40 and 80 years
2. Colorectal cancer including colon and rectosigmoid cancers
3. Informed consent
Exclusion Criteria
1. Prior midline laparotomy
2. American Society of Anaesthesiologists (ASA) grade 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 post-operative 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