Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life (QUARLAMI)

Institut Cancerologie de l'Ouest

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: Breast reconstruction

Study type: Observational

Funder types: Other

Identifiers

NCT05316389

ICO-2021-05

Details and patient eligibility

About

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.

Full 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)

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

A Retrospective

Description:

A = retrospective cohort including all patients treated at the ICO Angers between January 2017 and September 2021

Treatment:

Procedure: Breast reconstruction

B Prospective

Description:

B = prospective including all patients treated at the ICO from February 2022 (2 years of recruitment)

Treatment:

Procedure: Breast reconstruction