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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

TypeNameDescription
PROCEDUREBreast reconstructionMuscle 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.