Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding

This study is currently recruiting participants.

Verified February 2011 by St. Luke's-Roosevelt Hospital Center

First Received on December 22, 2009. Last Updated on February 22, 2011 History of Changes

Sponsor:	St. Luke's-Roosevelt Hospital Center
Information provided by:	St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:	NCT01039077

Purpose

Gastric banding has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. We have developed a technique for performing this operation through a single incision at the belly button. This study compares this method to the conventional 5-incision approach.

Condition	Intervention
Morbid Obesity	Procedure: Laparoscopic gastric banding

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:

weight loss [ Time Frame: 1 month and 1 year post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

quality of life [ Time Frame: 1 week and 3 months post-operative ] [ Designated as safety issue: No ]
perioperative complication rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	December 2009
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Single incision laparoscopic gastric banding Patients in this group will undergo laparoscopic gastric banding through a single periumbilical incision.	Procedure: Laparoscopic gastric banding Laparoscopic gastric banding for the treatment of morbid obesity.
Active Comparator: Five port laparoscopic gastric banding Patients in this group will undergo conventional laparoscopic gastric banding using 5 small incisions.	Procedure: Laparoscopic gastric banding Laparoscopic gastric banding for the treatment of morbid obesity.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

BMI > 40
ASA Class I or II

Exclusion Criteria:

Comorbid cardiac, pulmonary, renal, hepatic disease
Bleeding disorder
Previous gastric/esophageal surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039077

Contacts

Contact: Julio Teixeira, MD

212-523-2184

jteixeira@chpnet.org

Locations

United States, New York
St. Luke's-Roosevelt Hospital Center	Recruiting
New York, New York, United States, 10025
Contact: Julio Teixeira, MD 212-523-2184 jteixeira@chpnet.org
Principal Investigator: Julio Teixeira, MD

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

More Information

No publications provided

Responsible Party:	Julio Teixeira, MD, St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:	NCT01039077 History of Changes
Other Study ID Numbers:	SLR IRB#08-148
Study First Received:	December 22, 2009
Last Updated:	February 22, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012