Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality … (NCT05316389) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life
France190 participantsStarted 2022-02-21
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Patients with a desire for breast reconstruction
✓. Indication for mastectomy or with a history of mastectomy, with or without preservation of the skin skin,
✓. Breast reconstruction procedure by LDPM performed between January 2017 and September2021, (retrospective cohort )
✓. Breast reconstruction procedure by LDPM or by prosthesis performed from February 2022 (prospective cohort)
✓. Information to the patient and collection of her non-opposition
✓. Affiliation to a social security system, or beneficiary of such a system
Exclusion criteria
✕. Performance of a breast reconstruction by a technique other than LDPM or prosthesis
✕. Patient opposed to the use of her data for research
✕. 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,
What they're measuring
1
functional evaluation of the shoulder and upper limb (mobility and pain)