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

Recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: Breast reconstruction

• Registration Number: NCT05316389
• Lead Sponsor: Institut Cancerologie de l'Ouest

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)

Study Timeline

• Study Start: 2022-02-21
• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-02-21
• Study Completion: 2025-02-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B Prospective	Breast reconstruction	B = prospective including all patients treated at the ICO from February 2022 (2 years of recruitment)
A Retrospective	Breast reconstruction	A = retrospective cohort including all patients treated at the ICO Angers between January 2017 and September 2021

Primary Outcome Measures

Name	Time	Method
functional evaluation of the shoulder and upper limb (mobility and pain)	6 month	Disabilities of the Arm, Shoulder and Hand (DASH) (0 = no disability to 100 = maximum disability)

Secondary Outcome Measures

Name	Time	Method
occurrence of postoperative complications	6 month	complications
quality of life through the Breast-Q questionnaire	6 months	Breast-Q questionnaire
satisfaction of aesthetic by the patient and by the surgeon	6 month	5 numerical scales (from 0 to 5) measuring overall satisfaction with the reconstruction, general appearance of the breast, breast shape, breast consistency and breast volume

Trial Locations

Locations (1)

Institut de Cancerologie de L'Ouest (Ico); 🇫🇷 Angers, France