Prospective Randomized Clinical Trial Comparing COnventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Morbid Obesity
- Sponsor
- Hospitales Universitarios Virgen del Rocío
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Postoperative Pain
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Salvador Morales Conde
Innovation and Minimally Invasive Surgery Unit Cordinator
Hospitales Universitarios Virgen del Rocío
Eligibility Criteria
Inclusion Criteria
- •Body Mass Index \> 40
- •Body Mass Index \> 35 with 2 mayor comorbidities
Exclusion Criteria
- •Severe gastroesophageal reflux
- •Esophagitis grade B or higher
- •Midline periumbilical incision
- •Umbilical hernia \>4cms.
Outcomes
Primary Outcomes
Postoperative Pain
Time Frame: 3 days
Postoperative pain is assessed using a visual analog scale (VAS)on the first 3 postoperative days
Secondary Outcomes
- Cosmestic results(1,3 and 6 months)
- Operative time(Surgery)