Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy
- Conditions
- Morbid Obesity
- Registration Number
- NCT02023294
- Lead Sponsor
- Hospitales Universitarios Virgen del Rocío
- Brief Summary
Bariatric surgery has been established as the best treatment for morbid obesity, compared with diet or medical treatment. Laparoscopic approach have improved the results of this surgery in terms of postoperative pain, reduction in the number of complications and hospital stay, as well as better cosmetic results. Conventional laparoscopic technique requires five to seven abdominal incisions to facilitate placement of the multiple trocars. New Single Incision Laparoscopic Surgery (SILS)has been developed as a new technique where only one incision is needed for the introduction of all trocars. Altough this technique can be performed with conventional laparoscopic instruments, new devides have been developed for facilitate this operations by SILS. The investigators think that reducing the number of incision would decrease the postoperative pain and improve cosmetic results in our patients, being a safe and technically feasible intervention supported by these special devices.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Body Mass Index > 40
- Body Mass Index > 35 with 2 mayor comorbidities
- Severe gastroesophageal reflux
- Esophagitis grade B or higher
- Midline periumbilical incision
- Umbilical hernia >4cms.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Postoperative Pain 3 days Postoperative pain is assessed using a visual analog scale (VAS)on the first 3 postoperative days
- Secondary Outcome Measures
Name Time Method Cosmestic results 1,3 and 6 months Cosmetic results will be assess using visual analog scale (VAS)at 1,3 and 6 months after surgery
Operative time Surgery operative time will be compared between two thechniques
Trial Locations
- Locations (1)
Hospital Universitario Virgen del Rocio
🇪🇸Seville, Spain
Hospital Universitario Virgen del Rocio🇪🇸Seville, Spain