CompletedNot Applicable

The Impact of Abdominal Body Contouring Surgery on Physical Function After a Massive Weight Loss (BCSP)

Canada27 participantsStarted 2020-08-18

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Weight has not deviated by greater than 5 percent for 3 months * Have excess grade skin of greater or equal to 2 * Percent total weight loss pre-body contouring of greater or equal to 25 percent * Fluently read and write English Exclusion Criteria: * Any musculoskeletal issues that would prevent participants from doing the physical function tests. * Current medication history indicating atypical antipsychotics including but not limited to clozapine, olanzapine, quetiapine, risperidone, aripiprazole, amisulpride, ziprasidone, asenapine, iloperidone, lurasidone and paliperidone. * Severe pulmonary conditions such as severe chronic obstructive pulmonary disease (COPD) and or severe asthma. * Participants who actively aiming to lose weight * Have diabetes with diabetic neuropathy or experienced hypoglycemic event within 6 months prior to the study * Severe kidney disease with estimated glomerular filtration rate (eGFR) less than 60 ml/min * Pregnant individuals * Uncontrolled hypertension with resting blood pressure greater than 160/90 mmHg * Uncontrolled obstructive sleep apnea with symptoms * On statin therapy with myopathy * Unstable atrial fibrillation * Weight pre-body contouring greater than 340 lbs (154 kg) * Current smoker

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in physical function aggregate score

Timeframe: 8-12 weeks

Trial details

NCT IDNCT04516473

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-29

View on ClinicalTrials.gov More Weight Loss trials