Evaluation of breast reconstruction outcomes and quality of life
Minimal Harvest Dorsalis Major Flap Breast Reconstruction: Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life
Institut Cancerologie de l'Ouest · NCT05316389
This study is testing how well two different breast reconstruction methods work and how they affect the quality of life for women who have had breast surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Cancerologie de l'Ouest (other) |
| Locations | 1 site (Angers) |
| Trial ID | NCT05316389 on ClinicalTrials.gov |
What this trial studies
This study evaluates the functional and aesthetic outcomes of breast reconstruction using the minimal harvest dorsalis major flap technique, as well as prosthetic reconstruction. It includes both a retrospective cohort of patients who underwent the procedure between 2017 and 2021 and a prospective cohort of patients undergoing the procedure from 2022 onwards. The study assesses clinical data, quality of life through DASH and Breast Q questionnaires, and aesthetic evaluations by patients and healthcare professionals over a follow-up period of up to one year.
Who should consider this trial
Good fit: Ideal candidates are patients with a desire for breast reconstruction following mastectomy, either with a history of mastectomy or those scheduled for the procedure.
Not a fit: Patients who have undergone breast reconstruction using techniques other than the dorsalis major flap or prosthesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the quality of life and aesthetic satisfaction for patients undergoing breast reconstruction.
How similar studies have performed: Other studies have shown promising results with similar flap techniques in breast reconstruction, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with a desire for breast reconstruction 2. Indication for mastectomy or with a history of mastectomy, with or without preservation of the skin skin, 3. Breast reconstruction procedure by LDPM performed between January 2017 and September2021, (retrospective cohort ) 4. Breast reconstruction procedure by LDPM or by prosthesis performed from February 2022 (prospective cohort) 5. Information to the patient and collection of her non-opposition 6. Affiliation to a social security system, or beneficiary of such a system Exclusion Criteria: 1. Performance of a breast reconstruction by a technique other than LDPM or prosthesis 2. Patient opposed to the use of her data for research 3. Person in an emergency situation, adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice), or unable to express his consent, 4. Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological psychological reasons.
Where this trial is running
Angers
- Institut de Cancerologie de L'Ouest (Ico) — Angers, France (RECRUITING)
Study contacts
- Principal investigator: Julia DE FREITAS — ICO
- Study coordinator: Laëtitia HIMPE, MD
- Email: promotionrc@ico.unicancer.fr
- Phone: 0240679747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer