NCT02023294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
Last Updated

December 30, 2013

Status Verified

December 1, 2013

Enrollment Period

2.3 years

First QC Date

December 10, 2013

Last Update Submit

December 23, 2013

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

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

    3 days

Secondary Outcomes (2)

  • Cosmestic results

    1,3 and 6 months

  • Operative time

    Surgery

Other Outcomes (1)

  • Perioperative complications

    1 month

Study Arms (2)

Lap

ACTIVE COMPARATOR

Patients candidate to bariatric surgery undergoing Conventional laparoscopic Sleeve Gastrectomy

Procedure: Convetional laparoscopic Sleeve Gastrectomy

SILS

EXPERIMENTAL

Patients candidate to bariatric surgery undergoing Single Incision Laparoscopic Sleeve Gastrectomy supported by Endograb

Procedure: SILS Sleeve gastrectomy

Interventions

Convetional laparoscopic Sleeve GastrectomyPROCEDURE

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

Lap
SILS Sleeve gastrectomyPROCEDURE

Single incision Sleeve gastrectomy using only one port (incision) on the abdominal wall assisted by an special Traction Device for single port surgery (Endograb)

Also known as: Endograb™ (Virtual Ports, Misgav, Israel)
SILS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index \> 40
  • Body Mass Index \> 35 with 2 mayor comorbidities

You may not qualify if:

  • Severe gastroesophageal reflux
  • Esophagitis grade B or higher
  • Midline periumbilical incision
  • Umbilical hernia \>4cms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen del Rocio

Seville, Seville, 41013, Spain

Location

Related Publications (3)

  • 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.

    PMID: 19880099BACKGROUND

  • 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.

    PMID: 17593452BACKGROUND

  • 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.

    PMID: 11965467BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Morales Conde Salvador, phD

    Hospital Universitario Virgen del Rocio

    PRINCIPAL INVESTIGATOR

  • Alarcón del Agua Isaías, PhD

    Hospital Universitario Virgen del Rocio

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Innovation and Minimally Invasive Surgery Unit Cordinator

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 30, 2013

Study Start

April 1, 2011

Primary Completion

August 1, 2013

Study Completion

December 1, 2013

Last Updated

December 30, 2013

Record last verified: 2013-12

Locations

ES(1)