MedDataX Logo

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

NCT ID: NCT02023294

Last Updated: 2013-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Morbid Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lap

Patients candidate to bariatric surgery undergoing Conventional laparoscopic Sleeve Gastrectomy

Group Type ACTIVE_COMPARATOR

Convetional laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

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

SILS

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

Group Type EXPERIMENTAL

SILS Sleeve gastrectomy

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Convetional laparoscopic Sleeve Gastrectomy

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

Intervention Type PROCEDURE

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)

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Endograb™ (Virtual Ports, Misgav, Israel)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Salvador Morales Conde

Innovation and Minimally Invasive Surgery Unit Cordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Morales Conde Salvador, phD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen del Rocio

Alarcón del Agua Isaías, PhD

Role: STUDY_CHAIR

Hospital Universitario Virgen del Rocio

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitario Virgen del Rocio

Seville, Seville, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19880099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17593452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11965467 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GTL-EG-01

Identifier Type: -

Identifier Source: org_study_id