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Clinical Trials/NCT02023294
NCT02023294
Completed
Not Applicable

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

Hospitales Universitarios Virgen del Rocío1 site in 1 country30 target enrollmentApril 2011
ConditionsMorbid Obesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Morbid Obesity
Sponsor
Hospitales Universitarios Virgen del Rocío
Enrollment
30
Locations
1
Primary Endpoint
Postoperative Pain
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
December 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospitales Universitarios Virgen del Rocío
Responsible Party
Principal Investigator
Principal Investigator

Salvador Morales Conde

Innovation and Minimally Invasive Surgery Unit Cordinator

Hospitales Universitarios Virgen del Rocío

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.

Outcomes

Primary Outcomes

Postoperative Pain

Time Frame: 3 days

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

Secondary Outcomes

  • Cosmestic results(1,3 and 6 months)
  • Operative time(Surgery)

Study Sites (1)

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