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

NCT01063959 | Withdrawn

• 2 other identifiers: PBRC 294EXFWA 00006218
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

Laparoscopic Sleeve Gastrectomy; Laparoscopic Gastric Bypass

Outcome Measures

Primary Outcomes (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.

  18 Months

Secondary Outcomes (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.

  18 Months

Study Arms (3)

Safety

OTHER

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; Procedure: Laparoscopic Gastric Bypass

Weight Loss

EXPERIMENTAL

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; Procedure: Laparoscopic Gastric Bypass

Insurance versus Private Pay

OTHER

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; Procedure: Laparoscopic Gastric Bypass

Interventions

Laparoscopic Sleeve Gastrectomy 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.

Also known as: Lap Surgery

Insurance versus Private Pay; Safety; Weight Loss

Laparoscopic Gastric Bypass PROCEDURE

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

Also known as: Gastric Bypass

Insurance versus Private Pay; Safety; Weight Loss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects having any other obesity surgical procedure

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Ethicon, Inc.: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Drake Bellanger, MD

  Pennington Biomedial Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal INvestigator

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

US (1)