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Withdrawn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

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.
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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.
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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 |
- 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 ]
- 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 ]

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

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
United States, Louisiana | |
Pennington Biomedical Research Center | |
Baton Rouge, Louisiana, United States, 70808 |
Principal Investigator: | Drake Bellanger, MD | Pennington Biomedial Research Center |
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 |
Laparoscopic Sleeve Gastrectomy Laparoscopic Gastric Bypass |
Obesity Obesity, Morbid Overnutrition |
Nutrition Disorders Overweight Body Weight |