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NCT04516473: BCSP
The Impact of Abdominal Body Contouring Surgery on Physical Function After a Massive Weight Loss (BCSP)
trial testing Abdominal Body Contouring in Weight Loss in 27 participants. Completed in 29 December 2021.
29 December 2021
Quick facts
| Lead sponsor | University of British Columbia |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 27 |
| Start date | 18 August 2020 |
| Primary completion | 29 December 2021 |
| Estimated completion | 29 December 2021 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Abdominal Body Contouring
Conditions studied
- Weight Loss — all drugs for Weight Loss →
- Obesity — all drugs for Obesity →
Sponsor
University of British Columbia
Who can join
Adults 18 to 65, any sex, with Weight Loss or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Obesity is a growing chronic medical condition in which as of 2015, a total of 107.7 million children and 603.7 million adults were considered obese and since 1980 the prevalence of obesity has doubled in more than 70 countries. It is estimated that 70 percent of individuals who undergo a massive weight loss would develop excess skin and based on patient reported outcome measures, it has been shown that excess skin negatively impacts patients' body image, self-esteem, physical function and body contouring surgeries have been demonstrated to improve these measures. These are surgeries that correct for excess skin and its adverse consequences. The form of the surgery is case dependent and can range from removing an apron of skin to complete contouring of the abdomen with tightening of the abdominal muscle and moving the belly button. Despite previous studies indicating mobility limitation because of excess skin and improvements after abdominal body contouring surgeries with the use of subjective measures of physical function, there are no studies that directly measures physical fitness post body contouring surgeries. Therefore, the purpose of the current study is to evaluate the impact of abdominal body contouring surgeries on direct objective measures of physical function. It is hypothesized that 1) the removal of excess skin will improve direct objective measures of physical function in post massive weight loss participants 2) the removal of excess skin will improve direct measures of gait and balance in post massive weight loss participants 3) the removal of excess skin will improve patient reported outcome measures using quality of life questionnaires in post massive weight loss participants 4) the removal of excess skin will improve aerobic capacity in post massive weight loss participants 5) the removal of excess skin does not change the body composition in post massive weight loss participants.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04516473
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04516473 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of British Columbia
- Last refreshed: 20 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04516473.
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