Quality of Life Following Gastric Bypass Surgery.

NCT02032199 | Completed

• 1 other identifier: nbhsf36
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

A central goal of health care is to maximize patient functioning and well-being. This has prompted measurement of health-related quality of life (HRQOL) that encompasses physical, psychological, and social functioning. While obese people have generally impaired HRQOL, people seeking bariatric surgery for obesity appear to have poorer HRQOL than obese individuals seeking non-surgical treatment or obese individuals not seeking weight-loss treatment. HRQOL improves significantly after bariatric surgery, but often with large individual variations in outcome. As gastric bypass is an invasive procedure with irreversible influences on eating behaviour and possible serious adverse events, it is important to identify potential risk factors for a poorer long-term result. In Denmark, bariatric surgery is free of charge for patients fulfilling the Danish Health and Medicines Authority guidelines, which until 2011 were in line with international guidelines. However, in 2011 access to surgery was dramatically restricted and the annual number of operations reduced from 0.9 per 1000 inhabitants (2010) to 0.2 per 1000 inhabitants (2012). The restrictions involved a tightening of the criteria for patients without manifest obesity comorbidities, raising lower body mass index (BMI) threshold from 40 to 50 and increasing the lower age limit from 18 to 25 years (11). It is not known whether patients fulfilling the tighter criteria benefit more from surgery than patients who only met the previous criteria. This study assessed HRQOL changes associated with Roux-en-Y gastric bypass with follow-up over an average of 22 months. The aim was to explore whether postoperative HRQOL variations were associated with identifiable socio-demographic or clinical characteristics. In particular, whether HRQOL changes differed for patients fulfilling the current Danish criteria and patients only fulfilling the previous criteria.

Conditions

Obesity

Keywords

Gastric bypass; Health-related quality of life; SF-36; Questionnaire; Treatment guidelines

Outcome Measures

Primary Outcomes (1)

• 36-Item Short Form Health Survey v2 (SF-36)

  24 months

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Roux -en-Y gastric bypass surgery in 2008-2010 i Region of Southern Denmark.

You may qualify if:

• Patients referred for gastric bypass.

You may not qualify if:

• Patients who did not fulfill the national criteria.

Sponsors & Collaborators

• René Klinkby Støving: lead

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, DK-5000, Denmark

Location

Related Publications (1)

• Hansen NB, Gudex C, Stoving RK. Improvement in health-related quality of life following Roux-en-Y gastric bypass. Dan Med J. 2014 Jul;61(7):A4870.

  PMID: 25123120 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• René K Støving, PhD

  Odense Univesity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, associate professor

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 9, 2014
• Study Start: April 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 9, 2014

Record last verified: 2014-01

Locations

DK (1)