Clinical trial NCT02023294: Conventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy
Official title: Prospective Randomized Clinical Trial Comparing COnventional Laparoscopic Sleeve Gastrectomy Versus Endograb-assisted Single-port Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Postoperative Pain
timeFrame: 3 days
Secondary outcomes:
measure: Cosmestic results
timeFrame: 1,3 and 6 months
measure: Operative time
timeFrame: Surgery
Other outcomes:
measure: Perioperative complications
timeFrame: 1 month
Locations:
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocio
Study officials:
affiliation: Hospital Universitario Virgen del Rocio
name: Morales Conde Salvador, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen del Rocio
name: Alarcón del Agua Isaías, PhD
role: STUDY_CHAIR
References:
citation: Morales-Conde S, Garcia Moreno J, Canete Gomez J, Barranco Moreno A, Socas Macias 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. No abstract available. Spanish.
citation: Martin-Cartes J, Morales-Conde S, Suarez-Grau J, Lopez-Bernal F, Bustos-Jimenez M, Cadet-Dussort H, Socas-Macias M, Alamo-Martinez J, Tutosaus-Gomez 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. doi: 10.1007/s00464-007-9423-5.
citation: Feliu-Pala X, Martin-Gomez M, Morales-Conde S, Fernandez-Sallent E. The impact of the surgeon's experience on the results of laparoscopic hernia repair. Surg Endosc. 2001 Dec;15(12):1467-70. doi: 10.1007/s00464-001-9017-6.