CompletedNot Applicable

Breast Reshaping Following Massive Weight Loss

Egypt20 participantsStarted 2021-08-01

Plain-language summary

Reliability of Chest Wall Perforator Flaps for Breast Reshaping following Massive Weight Loss

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

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: * Age: 18-45 years old. * Weight: * Loss of 50% or greater of excess weight, following surgical or non-surgical interventions (MWL). * Stable weight for at least 6 months, to achieve metabolic and nutritional homeostasis and decrease the risk of surgical complications (Rubin et al., 2004). * BMI: 18.5 - 30 kg/m2. * Ptotic and deflated breasts with Pittsburgh Rating Scale (PRS) score 2-3 (Song, et al., 2005). * Patients seeking autologous augmentation or refusing implants. * Patients requiring simultaneous contouring of lateral chest wall redundancy. Exclusion Criteria: * Weight fluctuations in the previous 6 months. * Medical co-morbidities (e.g., uncontrolled diabetes, uncontrolled hypertension, thyroid diseases, hormonal disturbances, cardiopulmonary diseases). * Hereditary conditions that affect wound healing (e.g., Ehler Danlos Syndrome, Progeria). * Active smokers (Smokers are required to stop smoking 1 month before surgery). * Nutritional deficiencies (e.g., iron, vitamin B12, protein, folate). * Previous breast surgery. * Congenital breast deformity (e.g., tuberous breasts). * Breast masses. * Pregnant or lactating patients. * PRS score 1.

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

Measurement of breast volume by sono-mammography

Timeframe: One year follow-up

Trial details

NCT IDNCT06262724

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-01

View on ClinicalTrials.gov More Breast Ptosis trials