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

Minimal Harvest Dorsalis Major Flap Breast Reconstruction: Retrospective and Prospective Evaluation of Scapulohumeral Comfort, Aesthetic Result and Quality of Life

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Breast reconstruction

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 Type: Observational
• Enrollment (Actual): 190

Contacts and Locations

Study Locations

• France
  • Angers, France, 49055
    • Institut de Cancérologie de l'Ouest (ICO)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A Retrospective; A = retrospective cohort including all patients treated at the ICO Angers between January 2017 and September 2021	Procedure: Breast reconstruction; Muscle sparing Latissimus Dorsi Flap or prothesis
B Prospective; B = prospective including all patients treated at the ICO from February 2022 (2 years of recruitment)	Procedure: Breast reconstruction; Muscle sparing Latissimus Dorsi Flap or prothesis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
satisfaction of aesthetic by the patient and by the surgeon	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	6 month
occurrence of postoperative complications	complications	6 month
quality of life through the Breast-Q questionnaire	Breast-Q questionnaire	6 months

Collaborators and Investigators

• Sponsor: Institut Cancerologie de l'Ouest
• Investigators: Principal Investigator: Julia DE FREITAS, ICO

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Actual): May 19, 2026
• Study Completion (Actual): May 19, 2026

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Therapeutics; Surgical Procedures, Operative; Plastic Surgery Procedures; Cosmetic Techniques; Mammaplasty
• Other Study ID Numbers: ICO-2021-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No