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

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

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Convetional laparoscopic Sleeve Gastrectomy; Procedure: SILS Sleeve gastrectomy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative complications	Appearence of intraoperative and postoperative complications derived from the technique will be recorded an compared with the two techniques.	1 month

Collaborators and Investigators

• Sponsor: Hospitales Universitarios Virgen del Rocío
• Investigators: Principal Investigator: Morales Conde Salvador, phD, Hospital Universitario Virgen del Rocio; Study Chair: Alarcón del Agua Isaías, PhD, Hospital Universitario Virgen del Rocio

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (ESTIMATE): December 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 30, 2013
• Last Update Submitted That Met QC Criteria: December 23, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: GTL-EG-01