Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02023294

Acronym

GTLEND

Enrollment

Registered

2013-12-30

Start date

2011-04-30

Completion date

2013-12-31

Last updated

2013-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

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.

Interventions

PROCEDUREConvetional laparoscopic Sleeve Gastrectomy

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

PROCEDURESILS 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

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

Secondary

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

Other

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026