BODY-Q Longitudinal Result Study and Comparison With Normative Scores
NCT05272215 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20000
Last updated 2022-03-09
Summary
Obesity is a global epidemic that has nearly tripled since 1975. Worldwide, over 650 million people live with obesity, and it is therefore a growing cause for concern. Bariatric surgery (BaS) is the most effective long-term weight loss method in morbidly obese patients. BaS can result in sustained weight loss and resolve obesity-related comorbidities. However, BaS most often results in various extremes of excess skin, where subsequent body contouring surgery (BC) can be needed. The excess skin following massive weight loss is known to negatively impacts patients' body image, physical and psychological well-being, which previous studies have indicated to improve after BC.
The purpose of this study is to assess change in patients' health-related quality of life (HRQL) relative to the general population score. To the best of our knowledge, there are no studies measuring change of patient's HRQL throughout the entire weight loss journey and comparing these scores with the scores of the general population.
It is hypothesized that 1) BaS will improve patients' quality of life on short terms (1-2 years) after surgery, however patients' HRQL will decrease with increasing amounts of excess skin. 2) Patients' HRQL will improve after post-BC equivalent of the scores of the general population.
Conditions
- Weight Loss
- Excess Skin
Interventions
- PROCEDURE
-
Bariatric surgery
Pre- and post-bariatric surgery (3, 6, 12 months postoperative and yearly)
- PROCEDURE
-
Body contouring surgery
Pre- and post body contouring surgery (3, 6, 12 months postoperative and yearly)
Sponsors & Collaborators
-
Hospital of Southwest Jutland, Esbjerg, Denmark
collaborator UNKNOWN - collaborator OTHER
-
OLVG West Hospital, Amsterdam, the Netherlands
collaborator UNKNOWN -
Catharina Ziekenhuis Eindhoven
collaborator OTHER -
Tampere University Hospital
collaborator OTHER -
Department of Plastic Surgery, Wroclaw, Poland
collaborator UNKNOWN -
Department of Plastic Surgery, Eberhard Karls Universität Tübingen, Tübingen, Germany
collaborator OTHER -
Campus Bio-Medico University
collaborator OTHER -
Odense University Hospital
lead OTHER
Principal Investigators
-
Jens A Sørensen, MD, PhD · Odense University Hospital
-
Lotte Poulsen, MD, PhD · Odense University Hospital
-
Farima Dalaei, MD · Odense University Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-30
- Primary Completion
- 2022-05-31
- Completion
- 2022-05-31
Countries
- Denmark
Study Locations
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