Clinical trial NCT05316389: Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life
Official title: Minimal Harvest Dorsalis Major Flap Breast Reconstruction: Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at the ICO Angers site with an indication for immediate or deferred breast reconstruction for their breast cancer

Brief 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)

Eligibility 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.

Primary outcomes:
measure: functional evaluation of the shoulder and upper limb (mobility and pain)
timeFrame: 6 month
Secondary outcomes:
measure: satisfaction of aesthetic by the patient and by the surgeon
timeFrame: 6 month
measure: occurrence of postoperative complications
timeFrame: 6 month
measure: quality of life through the Breast-Q questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancerologie de L'Ouest (Ico)
Study officials:
affiliation: ICO
name: Julia DE FREITAS
role: PRINCIPAL_INVESTIGATOR
References: