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

This study has been withdrawn prior to enrollment.
(No Enrollment)
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01063959
First received: February 4, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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 Intervention
Morbid Obesity
Procedure: Laparoscopic Sleeve Gastrectomy
Procedure: Laparoscopic Gastric Bypass

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Advantages of Sleeve Gastrectomy Over Gastric Bypass for Private Pay Patients Seeking Obesity Surgery

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: February 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063959

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Ethicon, Inc.
Investigators
Principal Investigator: Drake Bellanger, MD Pennington Biomedial Research Center
  More Information

No publications provided

Responsible Party: Frank Greenway, Principal INvestigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01063959     History of Changes
Other Study ID Numbers: FWA 00006218
Study First Received: February 4, 2010
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Laparoscopic Sleeve Gastrectomy
Laparoscopic Gastric Bypass

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014