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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic gastric banding
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI > 40
  • ASA Class I or II

Exclusion Criteria:

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

Sites / Locations

  • St. Luke's-Roosevelt Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single incision laparoscopic gastric banding

Five port laparoscopic gastric banding

Arm Description

Patients in this group will undergo laparoscopic gastric banding through a single periumbilical incision.

Patients in this group will undergo conventional laparoscopic gastric banding using 5 small incisions.

Outcomes

Primary Outcome Measures

weight loss

Secondary Outcome Measures

quality of life
perioperative complication rate

Full Information

First Posted
December 22, 2009
Last Updated
August 5, 2015
Sponsor
St. Luke's-Roosevelt Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT01039077
Brief Title
Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding
Official Title
Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single incision laparoscopic gastric banding
Arm Type
Active Comparator
Arm Description
Patients in this group will undergo laparoscopic gastric banding through a single periumbilical incision.
Arm Title
Five port laparoscopic gastric banding
Arm Type
Active Comparator
Arm Description
Patients in this group will undergo conventional laparoscopic gastric banding using 5 small incisions.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic gastric banding
Intervention Description
Laparoscopic gastric banding for the treatment of morbid obesity.
Primary Outcome Measure Information:
Title
weight loss
Time Frame
1 month and 1 year post-operative
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
1 week and 3 months post-operative
Title
perioperative complication rate
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI > 40 ASA Class I or II Exclusion Criteria: Comorbid cardiac, pulmonary, renal, hepatic disease Bleeding disorder Previous gastric/esophageal surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Teixeira, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States

12. IPD Sharing Statement

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

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