Trials / Active Not Recruiting
Active Not RecruitingNCT05316389
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 190 (actual)
- Sponsor
- Institut Cancerologie de l'Ouest · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Retrospective Cohort : * Clinical data reconstruction and follow-up up to 1 year * DASH questionnaire * Breast Q * aesthetic evaluation (patient and surgeon and other health professional) Prospective Cohort : * Clinical data reconstruction and follow-up up to 1 year * DASH questionnaire (pre-op, at 6 month and at 12 month) * Breast Q(pre-op, at 6 month and at 12 month) * aesthetic evaluation (patient and surgeon and other health professional) (at 6 month and at 12 month)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Breast reconstruction | Muscle sparing Latissimus Dorsi Flap or prothesis |
Timeline
- Start date
- 2022-02-21
- Primary completion
- 2026-06-11
- Completion
- 2027-02-21
- First posted
- 2022-04-07
- Last updated
- 2026-03-11
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05316389. Inclusion in this directory is not an endorsement.