Comparison of minimally invasive versus conventional laparoscopic (keyhole) bariatric surgery
Not Applicable
Completed
- Conditions
- aparoscopic sleeve gastrectomySurgery
- Registration Number
- ISRCTN49101970
- Lead Sponsor
- Hôpital Antoine-Béclère
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 176
Inclusion Criteria
1. Consecutive patients undergoing laparoscopic sleeve gastrectomy
2. Decision for intervention after multidisciplinary discussion
3. Sleeve gastrectomy as a primary bariatric procedure
4. Body mass index >40 kg/m² or >35 kg/m² with severe comorbidities.
Exclusion Criteria
1. Previous upper abdominal surgery (except laparoscopic cholecystectomy)
2. Patient under guardianship and trusteeship
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A written questionnaire with 0-10 scales is completed at 3 months evaluating: <br>1. Scar esthetic impact on patients <br>2. Postoperative parietal pain <br>3. Impact of the scar on postoperative sex life<br>4. Scar impact on diurnal quality of life (daily basis movements, work) <br>5. Scar impact on nocturnal quality of life (sleep)
- Secondary Outcome Measures
Name Time Method 1. 6 and 12 months written questionnaires with 0-10 scales evaluating: <br>1.1. Scar esthetic impact on patients <br>1.2. Postoperative parietal pain <br>1.3. Impact of the scar on postoperative sex life<br>1.4. Scar impact on diurnal quality of life (daily basis movements, work) <br>1.5. Scar impact on nocturnal quality of life (sleep) <br>2. 90 days postoperative Morbi-mortality from patient records<br>3. Bodyweight (kg) (at baseline, 3, 6 and 12 months)<br>4. Body Mass index (kg/m²) (at baseline, 3, 6 and 12 months)<br>5. Co-morbidities (at baseline and 12 months) from patient records<br>6. Incisional hernia rate (at 12 months) with clinical and radiological (CT scan) evaluation