Clinical trial · Observational
Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life
Minimal Harvest Dorsalis Major Flap Breast Reconstruction: Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The dorsalis major flap is an interesting therapeutic option in breast reconstruction because of reliability and reproducibility. In recent years, the minimal flap technique has been developed, which consists of removing only a portion of the of the large dorsal muscle to reduce the painful and functional sequelae of this surgery. The objective of this prospective study is to evaluate the functional and aesthetic results in patients who have undergone who have undergone this procedure (prospective cohort) or who will undergo this procedure or prosthetic reconstruction (prospective cohort). The investigators also wish to evaluate the quality of life of patients after reconstruction with a minimal harvest dorsalis flap or a prosthesis or prosthesis in the prospective cohort.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- A Retrospective
- description
- A = retrospective cohort including all patients treated at the ICO Angers between January 2017 and September 2021
- interventionNames
- Procedure: Breast reconstruction
- label
- B Prospective
- description
- B = prospective including all patients treated at the ICO from February 2022 (2 years of recruitment)
- interventionNames
- Procedure: Breast reconstruction
Primary outcomes (1)
- measure
- functional evaluation of the shoulder and upper limb (mobility and pain)
- timeFrame
- 6 month
- description
- Disabilities of the Arm, Shoulder and Hand (DASH) (0 = no disability to 100 = maximum disability)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available