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

Morbid Obesity Clinical Trial

— GTLEND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023294
• Other study ID #: GTL-EG-01
• Status: Completed
• Phase: N/A
• First received: December 10, 2013
• Last updated: December 23, 2013
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Hospitales Universitarios Virgen del Rocío
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Convetional laparoscopic Sleeve Gastrectomy
Convetional laparoscopic sleeve gastrectomy using 5 ports (incisions) in the abdominal wall
• 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)

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocio	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Feliu-Palà X, Martín-Gómez M, Morales-Conde S, Fernández-Sallent E. The impact of the surgeon's experience on the results of laparoscopic hernia repair. Surg Endosc. 2001 Dec;15(12):1467-70. — View Citation

Martín-Cartes J, Morales-Conde S, Suárez-Grau J, López-Bernal F, Bustos-Jiménez M, Cadet-Dussort H, Socas-Macías M, Alamo-Martínez J, Tutosaus-Gómez 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. — View Citation

Morales-Conde S, García Moreno J, Cañete Gómez J, Barranco Moreno A, Socas Macías 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. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perioperative complications	Appearence of intraoperative and postoperative complications derived from the technique will be recorded an compared with the two techniques.	1 month	Yes
Primary	Postoperative Pain	Postoperative pain is assessed using a visual analog scale (VAS)on the first 3 postoperative days	3 days	No
Secondary	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	No
Secondary	Operative time	operative time will be compared between two thechniques	Surgery	Yes