Endoscopic Assisted Latissimus Dorsi Musculocutaneous Flap for Breast Reconstruction (NCT07691294) | Clinical Trial Compass
CompletedNot Applicable
Endoscopic Assisted Latissimus Dorsi Musculocutaneous Flap for Breast Reconstruction
Egypt15 participantsStarted 2023-01-25
Plain-language summary
This prospective single-arm case series evaluates the feasibility, safety, and clinical outcomes of endoscopic-assisted latissimus dorsi musculocutaneous flap harvest for breast reconstruction. The study includes women with post-oncologic or post-burn breast deformities requiring autologous tissue reconstruction with a skin paddle measuring 6 cm or less in its greatest dimension.
The primary objective is to assess the feasibility of minimally invasive flap harvest while preserving reconstructive effectiveness. Secondary outcomes include flap viability, operative time, postoperative pain, drain duration, donor-site morbidity, scar quality, complications, and patient satisfaction. Patients are followed for one year after surgery, with clinical assessment and patient-reported outcome measures used to evaluate reconstructive and aesthetic results.
Who can participate
Age range
18 Years – 65 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:
* Female patients aged 18 to 65 years.
* Patients with post-oncologic or post-burn breast deformities requiring autologous breast reconstruction.
* Patients requiring reconstruction with a latissimus dorsi musculocutaneous flap incorporating a skin paddle measuring ≤6 cm in its greatest dimension.
* Defects considered unsuitable for correction with local tissue rearrangement.
* Intact latissimus dorsi muscle and thoracodorsal vascular pedicle.
* Ability to provide written informed consent and comply with the study follow-up schedule.
Exclusion Criteria:
* Age younger than 18 years or older than 65 years.
* Body mass index (BMI) \>35 kg/m².
* Uncontrolled medical comorbidities or immunosuppressive conditions.
* Absence of a skin defect requiring reconstruction.
* Cutaneous defects requiring a skin paddle \>6 cm in its greatest dimension.
* Inadequate oncologic control or evidence of active disease.
* Ongoing adjuvant chemotherapy or radiotherapy at the time of reconstruction.
* Previous thoracic surgery or trauma compromising the latissimus dorsi muscle or thoracodorsal vascular pedicle.
* Inability or unwillingness to comply with study follow-up.
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
1
Number of patients with successful endoscopic-assisted latissimus dorsi musculocutaneous flap harvest and reconstruction without conversion to open technique
Timeframe: During surgery through 30 days postoperatively