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

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ClinicalTrials.gov Identifier: NCT01063959
Recruitment Status : Withdrawn (No Enrollment)
First Posted : February 5, 2010
Last Update Posted : December 18, 2015
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Laparoscopic Sleeve Gastrectomy Procedure: Laparoscopic Gastric Bypass Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Advantages of Sleeve Gastrectomy Over Gastric Bypass for Private Pay Patients Seeking Obesity Surgery
Study Start Date : February 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arms and Interventions
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Arm Intervention/treatment
Safety
Chart review will evaluate the safety of the two procedures, incidence of complications operatively, hospital stay, and 6-week post-operative periods.
 Procedure: 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.
Other Name: Lap Surgery

Procedure: Laparoscopic Gastric Bypass
Presently, the laparoscopically performed gastric bypass accounts for 80% of obesity surgery in the United States, predominantly covered by insurance.
Other Name: Gastric Bypass
Experimental: 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.
 Procedure: 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.
Other Name: Lap Surgery

Procedure: Laparoscopic Gastric Bypass
Presently, the laparoscopically performed gastric bypass accounts for 80% of obesity surgery in the United States, predominantly covered by insurance.
Other Name: Gastric Bypass
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.
 Procedure: 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.
Other Name: Lap Surgery

Procedure: Laparoscopic Gastric Bypass
Presently, the laparoscopically performed gastric bypass accounts for 80% of obesity surgery in the United States, predominantly covered by insurance.
Other Name: Gastric Bypass


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of the incidence of weight loss and complications operatively and in the first 6 weeks post-operatively after gastric bypass compared to sleeve gastrectomy. [ Time Frame: 18 Months ]

Secondary Outcome Measures :
  1. Comparison of the incidence of complications in gastric bypass patients covered by insurance vs. private pay patients during surgery, in the hospital and during the first 6 weeks post-operatively. [ Time Frame: 18 Months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063959


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Ethicon, Inc.
Investigators
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Principal Investigator: Drake Bellanger, MD Pennington Biomedial Research Center
More Information
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Responsible Party: Frank Greenway, Principal INvestigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01063959    
Other Study ID Numbers: PBRC 294EX
FWA 00006218 ( Other Identifier: Ethicon Endosurgery )
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015
Keywords provided by Frank Greenway, Pennington Biomedical Research Center:
Laparoscopic Sleeve Gastrectomy
Laparoscopic Gastric Bypass
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
 Nutrition Disorders
Overweight
Body Weight