Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Quality of Life Following Gastric Bypass Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032199
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
René Klinkby Støving, Odense University Hospital

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.


Condition or disease
Obesity

Layout table for study information
Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Analysis of Changes in Health-Related Quality of Life Following Roux-en-Y Gastric Bypass.
Study Start Date : April 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2013



Primary Outcome Measures :
  1. 36-Item Short Form Health Survey v2 (SF-36) [ Time Frame: 24 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with Roux -en-Y gastric bypass surgery in 2008-2010 i Region of Southern Denmark.
Criteria

Inclusion Criteria:

  • Patients referred for gastric bypass.

Exclusion Criteria:

  • Patients who did not fulfill the national criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032199


Locations
Layout table for location information
Denmark
Department of Endocrinology, Odense University Hospital
Odense, Denmark, DK-5000
Sponsors and Collaborators
René Klinkby Støving
Investigators
Layout table for investigator information
Principal Investigator: René K Støving, PhD Odense Univesity Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: René Klinkby Støving, MD, PhD, associate professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02032199     History of Changes
Other Study ID Numbers: nbhsf36
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Keywords provided by René Klinkby Støving, Odense University Hospital:
Gastric bypass
Health-related quality of life
SF-36
Questionnaire
Treatment guidelines