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OpenTrials
Completed

NCT Number: NCT02023294

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Convetional laparoscopic Sleeve Gastrectomy

Procedure

Convetional laparoscopic sleeve gastrectomy using 5 ports (incisions) in the abdominal wall

SILS Sleeve gastrectomy

Procedure

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)

Primary outcomes

  1. Postoperative Pain

    Time frame: 3 days

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

Secondary outcomes

  1. Cosmestic results

    Time frame: 1,3 and 6 months

    Cosmetic results will be assess using visual analog scale (VAS)at 1,3 and 6 months after surgery

  2. Operative time

    Time frame: Surgery

    operative time will be compared between two thechniques

Other outcomes

  1. Perioperative complications

    Time frame: 1 month

    Appearence of intraoperative and postoperative complications derived from the technique will be recorded an compared with the two techniques.

Sponsors and collaborators

Lead sponsor

Hospitales Universitarios Virgen del Rocío

Other

Registry information

Official study title

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

Acronym: GTLEND

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2013
Registry last updated
Dec 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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