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Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy (GTLEND)

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Convetional laparoscopic Sleeve Gastrectomy
SILS Sleeve gastrectomy
Sponsored by
Hospitales Universitarios Virgen del Rocío
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Virgen del Rocio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lap

SILS

Arm Description

Patients candidate to bariatric surgery undergoing Conventional laparoscopic Sleeve Gastrectomy

Patients candidate to bariatric surgery undergoing Single Incision Laparoscopic Sleeve Gastrectomy supported by Endograb

Outcomes

Primary Outcome Measures

Postoperative Pain
Postoperative pain is assessed using a visual analog scale (VAS)on the first 3 postoperative days

Secondary Outcome Measures

Cosmestic results
Cosmetic results will be assess using visual analog scale (VAS)at 1,3 and 6 months after surgery
Operative time
operative time will be compared between two thechniques

Full Information

First Posted
December 10, 2013
Last Updated
December 23, 2013
Sponsor
Hospitales Universitarios Virgen del Rocío
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1. Study Identification

Unique Protocol Identification Number
NCT02023294
Brief Title
Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy
Acronym
GTLEND
Official Title
Prospective Randomized Clinical Trial Comparing COnventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospitales Universitarios Virgen del Rocío

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lap
Arm Type
Active Comparator
Arm Description
Patients candidate to bariatric surgery undergoing Conventional laparoscopic Sleeve Gastrectomy
Arm Title
SILS
Arm Type
Experimental
Arm Description
Patients candidate to bariatric surgery undergoing Single Incision Laparoscopic Sleeve Gastrectomy supported by Endograb
Intervention Type
Procedure
Intervention Name(s)
Convetional laparoscopic Sleeve Gastrectomy
Intervention Description
Convetional laparoscopic sleeve gastrectomy using 5 ports (incisions) in the abdominal wall
Intervention Type
Procedure
Intervention Name(s)
SILS Sleeve gastrectomy
Other Intervention Name(s)
Endograb™ (Virtual Ports, Misgav, Israel)
Intervention Description
Single incision Sleeve gastrectomy using only one port (incision) on the abdominal wall assisted by an special Traction Device for single port surgery (Endograb)
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Postoperative pain is assessed using a visual analog scale (VAS)on the first 3 postoperative days
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Cosmestic results
Description
Cosmetic results will be assess using visual analog scale (VAS)at 1,3 and 6 months after surgery
Time Frame
1,3 and 6 months
Title
Operative time
Description
operative time will be compared between two thechniques
Time Frame
Surgery
Other Pre-specified Outcome Measures:
Title
Perioperative complications
Description
Appearence of intraoperative and postoperative complications derived from the technique will be recorded an compared with the two techniques.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morales Conde Salvador, phD
Organizational Affiliation
Hospital Universitario Virgen del Rocio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alarcón del Agua Isaías, PhD
Organizational Affiliation
Hospital Universitario Virgen del Rocio
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Virgen del Rocio
City
Seville
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19880099
Citation
Morales-Conde S, Garcia Moreno J, Canete Gomez J, Barranco Moreno A, Socas Macias M. [Single incision laparoscopic right hemicolectomy due to cancer of the colon]. Cir Esp. 2010 Aug;88(2):129-31. doi: 10.1016/j.ciresp.2009.07.016. Epub 2009 Oct 31. No abstract available. Spanish.
Results Reference
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PubMed Identifier
17593452
Citation
Martin-Cartes J, Morales-Conde S, Suarez-Grau J, Lopez-Bernal F, Bustos-Jimenez M, Cadet-Dussort H, Socas-Macias M, Alamo-Martinez J, Tutosaus-Gomez JD, Morales-Mendez S. Use of hyaluronidase cream to prevent peritoneal adhesions in laparoscopic ventral hernia repair by means of intraperitoneal mesh fixation using spiral tacks. Surg Endosc. 2008 Mar;22(3):631-4. doi: 10.1007/s00464-007-9423-5.
Results Reference
background
PubMed Identifier
11965467
Citation
Feliu-Pala X, Martin-Gomez M, Morales-Conde S, Fernandez-Sallent E. The impact of the surgeon's experience on the results of laparoscopic hernia repair. Surg Endosc. 2001 Dec;15(12):1467-70. doi: 10.1007/s00464-001-9017-6.
Results Reference
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Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy

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