BODY-Q Longitudinal Result Study and Comparison With Normative Scores

NCT05272215 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2022-03-09

No results posted yet for this study

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

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
  • McMaster University

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05272215 on ClinicalTrials.gov