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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01039077
First Posted: December 24, 2009
Last Update Posted: August 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding

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 ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: 1 week and 3 months post-operative ]
  • perioperative complication rate [ Time Frame: 1 month ]

Enrollment: 32
Study Start Date: December 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039077


Locations
United States, New York
St. Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Julio Teixeira, MD St. Luke's-Roosevelt Hospital Center
  More Information

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01039077     History of Changes
Other Study ID Numbers: SLR IRB#08-148
First Submitted: December 22, 2009
First Posted: December 24, 2009
Last Update Posted: August 6, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms