Sleeve Gastrectomy Versus Gastric Bypass for Private Pay Patients Seeking Obesity Surgery

NCT ID: NCT01063959

Last Updated: 2015-12-18

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WITHDRAWN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

2010-02-28

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to determine laparoscopic sleeve gastrectomy is a safer surgery than the gastric bypass, gives similar weight losses and that the safety of gastric in private pay patients versus insurance patients will be similar. This is a retrospective chart review of intervention charts.

Detailed Description

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This study is a retrospective chart review of 800 intervention charts each for consecutive laparoscopic sleeve gastrectomies compared to consecutive laparoscopic gastric bypasses performed by two surgeons in a Louisiana private practice. This retrospective chart review will evaluate the safety of the two procedures during the operative and 6-week post-operative periods, compare the insurance patients to the private pay patients having the gastric bypass, and comparative weight loss in subjects with a follow-up of at least 18 months. This offers the unique opportunity to compare any differences in surgical complications in subjects paying by insurance versus those paying personally for the gastric bypass operation.

Conditions

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Morbid Obesity

Keywords

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Laparoscopic Sleeve Gastrectomy Laparoscopic Gastric Bypass

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Safety

Chart review will evaluate the safety of the two procedures, incidence of complications operatively, hospital stay, and 6-week post-operative periods.

Group Type OTHER

Laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

Sleeve Gastrectomy was originally reported as the first step in an alternative two-staged procedure for the super obese patient to decrease morbidity, predominantly private pay.

Laparoscopic Gastric Bypass

Intervention Type PROCEDURE

Presently, the laparoscopically performed gastric bypass accounts for 80% of obesity surgery in the United States, predominantly covered by insurance.

Weight Loss

Chart review will evaluate weight loss in subjects during the operative, 6-week post-operative, and follow-up of at least 18 months.

Group Type EXPERIMENTAL

Laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

Sleeve Gastrectomy was originally reported as the first step in an alternative two-staged procedure for the super obese patient to decrease morbidity, predominantly private pay.

Laparoscopic Gastric Bypass

Intervention Type PROCEDURE

Presently, the laparoscopically performed gastric bypass accounts for 80% of obesity surgery in the United States, predominantly covered by insurance.

Insurance versus Private Pay

An insurance company issues an insurance policy to cover specific complications from the gastric bypass or the sleeve gastrectomy surgery which allows the surgeon to offer a fixed price to the patient. Comparison of surgical complications in subjects paying by insurance versus paying personally for the gastric bypass operation.

Group Type OTHER

Laparoscopic Sleeve Gastrectomy

Intervention Type PROCEDURE

Sleeve Gastrectomy was originally reported as the first step in an alternative two-staged procedure for the super obese patient to decrease morbidity, predominantly private pay.

Laparoscopic Gastric Bypass

Intervention Type PROCEDURE

Presently, the laparoscopically performed gastric bypass accounts for 80% of obesity surgery in the United States, predominantly covered by insurance.

Interventions

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Laparoscopic Sleeve Gastrectomy

Sleeve Gastrectomy was originally reported as the first step in an alternative two-staged procedure for the super obese patient to decrease morbidity, predominantly private pay.

Intervention Type PROCEDURE

Laparoscopic Gastric Bypass

Presently, the laparoscopically performed gastric bypass accounts for 80% of obesity surgery in the United States, predominantly covered by insurance.

Intervention Type PROCEDURE

Other Intervention Names

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Lap Surgery Gastric Bypass

Eligibility Criteria

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Inclusion Criteria

* The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic sleeve gastrectomy.
* The last 800 consecutive patients in the surgical practice of Drake Bellanger and Andrew Hargroder who had a laparoscopic gastric bypass.

Exclusion Criteria

* Subjects having any other obesity surgical procedure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon, Inc.

INDUSTRY

Sponsor Role collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Frank Greenway

Principal INvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Drake Bellanger, MD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedial Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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FWA 00006218

Identifier Type: OTHER

Identifier Source: secondary_id

PBRC 294EX

Identifier Type: -

Identifier Source: org_study_id