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

H

Hospitales Universitarios Virgen del Rocío

Status

Completed

Conditions

Morbid Obesity

Treatments

Procedure: Convetional laparoscopic Sleeve Gastrectomy
Procedure: SILS Sleeve gastrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT02023294
GTL-EG-01

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Lap
Active Comparator group
Description:
Patients candidate to bariatric surgery undergoing Conventional laparoscopic Sleeve Gastrectomy
Treatment:
Procedure: Convetional laparoscopic Sleeve Gastrectomy
SILS
Experimental group
Description:
Patients candidate to bariatric surgery undergoing Single Incision Laparoscopic Sleeve Gastrectomy supported by Endograb
Treatment:
Procedure: SILS Sleeve gastrectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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