Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery

NCT ID: NCT01401426

Last Updated: 2016-05-19

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-09-30

Brief Summary

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Vertical Sleeve Gastrectomy 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. The investigators 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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Obesity Nutrition Disorders Body Weight

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 vertical sleeve gastrectomy

Active Comparator Patients in this group will undergo laparoscopic vertical sleeve gastrectomy through a single periumbilical incision.

Group Type ACTIVE_COMPARATOR

Laparoscopic vertical sleeve gastrectomy

Intervention Type PROCEDURE

Laparoscopic vertical sleeve gastrectomy for the treatment of morbid obesity.

Five port laparoscopic vertical sleeve gastrectomy

Patients in this group will undergo conventional laparoscopic vertical sleeve gastrectomy using 5 small incisions.

Group Type ACTIVE_COMPARATOR

Laparoscopic vertical sleeve gastrectomy

Intervention Type PROCEDURE

Laparoscopic vertical sleeve gastrectomy

Interventions

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Laparoscopic vertical sleeve gastrectomy

Laparoscopic vertical sleeve gastrectomy for the treatment of morbid obesity.

Intervention Type PROCEDURE

Laparoscopic vertical sleeve gastrectomy

Laparoscopic vertical sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* BMI \>40
* ASA 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

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Luke's-Roosevelt Hospital Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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NCT01401426

Identifier Type: -

Identifier Source: org_study_id

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