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

Not Applicable
Withdrawn
Conditions
Morbid Obesity
Interventions
Procedure: Laparoscopic Sleeve Gastrectomy
Procedure: Laparoscopic Gastric Bypass
Registration Number
NCT01063959
Lead Sponsor
Pennington Biomedical Research Center
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.

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
SafetyLaparoscopic Sleeve GastrectomyChart review will evaluate the safety of the two procedures, incidence of complications operatively, hospital stay, and 6-week post-operative periods.
SafetyLaparoscopic Gastric BypassChart review will evaluate the safety of the two procedures, incidence of complications operatively, hospital stay, and 6-week post-operative periods.
Weight LossLaparoscopic Gastric BypassChart review will evaluate weight loss in subjects during the operative, 6-week post-operative, and follow-up of at least 18 months.
Insurance versus Private PayLaparoscopic Gastric BypassAn 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.
Weight LossLaparoscopic Sleeve GastrectomyChart review will evaluate weight loss in subjects during the operative, 6-week post-operative, and follow-up of at least 18 months.
Insurance versus Private PayLaparoscopic Sleeve GastrectomyAn 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.
Primary Outcome Measures
NameTimeMethod
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.18 Months
Secondary Outcome Measures
NameTimeMethod
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.18 Months

Trial Locations

Locations (1)

Pennington Biomedical Research Center

🇺🇸

Baton Rouge, Louisiana, United States

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