- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01039077
Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding
August 5, 2015 updated by: St. Luke's-Roosevelt Hospital Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10025
- St. Luke's-Roosevelt Hospital Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI > 40
- ASA Class I or II
Exclusion Criteria:
- Comorbid cardiac, pulmonary, renal, hepatic disease
- Bleeding disorder
- Previous gastric/esophageal surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Single incision laparoscopic gastric banding
Patients in this group will undergo laparoscopic gastric banding through a single periumbilical incision.
|
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.
|
Laparoscopic gastric banding for the treatment of morbid obesity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weight loss
Time Frame: 1 month and 1 year post-operative
|
1 month and 1 year post-operative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
quality of life
Time Frame: 1 week and 3 months post-operative
|
1 week and 3 months post-operative
|
perioperative complication rate
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Julio Teixeira, MD, St. Luke's-Roosevelt Hospital Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
December 22, 2009
First Submitted That Met QC Criteria
December 23, 2009
First Posted (Estimate)
December 24, 2009
Study Record Updates
Last Update Posted (Estimate)
August 6, 2015
Last Update Submitted That Met QC Criteria
August 5, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLR IRB#08-148
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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