Cost Analysis of Bariatric Surgery in an Employee-based Healthcare System Following Surgery Coverage

NCT02381704 | Completed

• 1 other identifier: 08.03.08
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of the study is to determine prospectively the cost effectiveness of bariatric surgery following partial coverage by a large healthcare system.

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in FHHS expenses pertaining to medical costs incurred by all study participants, as well as those study participants who, prior to their surgery, ranked in the (upper 50th. percentile) vs. (lower 50th. percentile) healthcare utilizing tiers.

  one to two years postop

Secondary Outcomes (1)

• Determine changes in the cost of obesity-related co-morbidities for all study participants and those who, prior to surgery, were within high or low healthcare utilizing tiers.

  At the end of postoperative year 1 and 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects will include any individual having been approved for surgery that consents to the review of their records and additional survey information pertaining to medication use, dosage, anthropometrics and medical-related days taken. Study subjects would include male and female gender, all ethnicities, ages 18 to 65 years, and exclude populations who do not meet the criteria for bariatric surgery

You may qualify if:

• Insured under the FHHS
• Have been approved for bariatric surgery
• Have provided their written consent for study participation.

You may not qualify if:

• Approved bariatric surgery patients covered by (FHHS)Florida Hospital Healthcare Systems will be excluded from the study if they fail to provide written consent.
• BMI less than or equal to 35 without at least two major co-morbidities pregnancy active alcoholism or drug abuse suicidal ideation cancer or another wasting disease mental handicap and inability to provide written consent.

Sponsors & Collaborators

• AdventHealth: lead
• Ethicon Endo-Surgery: collaborator

Study Sites (1)

Advanced Minmially Invasive and Bariatric Surgery Consultants

Celebration, Florida, 34747, United States

Location

Related Publications (45)

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  RESULT

• Brethauer SA, Chand B, Schauer PR. Risks and benefits of bariatric surgery: current evidence. Cleve Clin J Med. 2006 Nov;73(11):993-1007. doi: 10.3949/ccjm.73.11.993.

  PMID: 17128540 RESULT

• Buffington CK, Cowan GSM, Jr. Gastric Bypass in the Treatment of Diabetes, Hypertension and Lipid/lipoprotein Abnormalities of the Morbidly Obese. In Deitel M (ed.): Companion Volume to Obesity Surgery for the Morbidly Obese Patient. 2000 by FD Publications, Toronto, Canada, pp. 435-450.

  RESULT

• North American Association for the Study of Obesity and the National Heart, Lung, and Blood Institute. The practical guide: identification, evaluation and treatment of overweight and obesity in adults. Bethesda, MD. National Institutes of Health, 2000, NIH Publication 00-4084.

  RESULT

• North American Association for the Study of Obesity and the National Heart, Lung, and Blood Institute. Clinical Guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. The Evidence Report. Bethesda, Md: National Institutes of Health, 1998. NIH Publication 98-4083.

  RESULT

• Colquitt J, Clegg A, Loveman E, Royle P, Sidhu MK. Surgery for morbid obesity. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD003641. doi: 10.1002/14651858.CD003641.pub2.

  PMID: 16235331 RESULT

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• Keith C Kim, MD

  Advanced Minimally Invasive and Bariatric Surgery Consultants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Metabolic Medicine & Surgery Institute at Celebration Health

Study Record Dates

• First Submitted: March 5, 2015
• First Posted: March 6, 2015
• Study Start: April 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

US (1)