Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: Convetional laparoscopic Sleeve Gastrectomy; Procedure: SILS Sleeve gastrectomy

• 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

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2013-08
• Status Verified: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-23
• Last Update Submitted: 2013-12-23
• Study First Posted: 2013-12-30
• Last Update Posted: 2013-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lap	Convetional laparoscopic Sleeve Gastrectomy	Patients candidate to bariatric surgery undergoing Conventional laparoscopic Sleeve Gastrectomy
SILS	SILS Sleeve gastrectomy	Patients candidate to bariatric surgery undergoing Single Incision Laparoscopic Sleeve Gastrectomy supported by Endograb

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
Operative time	Surgery	operative time will be compared between two thechniques
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

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocio; 🇪🇸 Seville, Spain