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

NCT ID: NCT01039077

Last Updated: 2015-08-06

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Single incision laparoscopic gastric banding

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

Group Type ACTIVE_COMPARATOR

Laparoscopic gastric banding

Intervention Type PROCEDURE

Laparoscopic gastric banding for the treatment of morbid obesity.

Five port laparoscopic gastric banding

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

Group Type ACTIVE_COMPARATOR

Laparoscopic gastric banding

Intervention Type PROCEDURE

Laparoscopic gastric banding for the treatment of morbid obesity.

Interventions

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Laparoscopic gastric banding

Laparoscopic gastric banding for the treatment of morbid obesity.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI \> 40
* ASA Class I or II

Exclusion Criteria

* Comorbid cardiac, pulmonary, renal, hepatic disease
* Bleeding disorder
* Previous gastric/esophageal surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julio Teixeira, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's-Roosevelt Hospital Center

Locations

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St. Luke's-Roosevelt Hospital Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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SLR IRB#08-148

Identifier Type: -

Identifier Source: org_study_id

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