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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Clinical Trial Comparing COnventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Convetional laparoscopic Sleeve Gastrectomy
* Procedure: SILS Sleeve gastrectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lap<br>Patients candidate to bariatric surgery undergoing Conventional laparoscopic Sleeve Gastrectomy | Procedure: Convetional laparoscopic Sleeve Gastrectomy<br>* Convetional laparoscopic sleeve gastrectomy using 5 ports (incisions) in the abdominal wall<br>|
| Experimental: SILS<br>Patients candidate to bariatric surgery undergoing Single Incision Laparoscopic Sleeve Gastrectomy supported by Endograb | Procedure: SILS Sleeve gastrectomy<br>* Single incision Sleeve gastrectomy using only one port (incision) on the abdominal wall assisted by an special Traction Device for single port surgery (Endograb)<br>* Other names: Endograb™ (Virtual Ports, Misgav, Israel);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Postoperative pain is assessed using a visual analog scale (VAS)on the first 3 postoperative days | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmestic results | Cosmetic results will be assess using visual analog scale (VAS)at 1,3 and 6 months after surgery | 1,3 and 6 months | 
| Operative time | operative time will be compared between two thechniques | Surgery |