Quality of Life Following Gastric Bypass Surgery.

Obesity Clinical Trial

Official title:

A Prospective Analysis of Changes in Health-Related Quality of Life Following Roux-en-Y Gastric Bypass.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032199
• Other study ID #: nbhsf36
• Status: Completed
• Phase: N/A
• First received: January 8, 2014
• Last updated: January 8, 2014
• Start date: April 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2014
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients referred for gastric bypass.

Exclusion Criteria:

• Patients who did not fulfill the national criteria.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
René Klinkby Støving

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	36-Item Short Form Health Survey v2 (SF-36)		24 months	No