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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-21

Study Completion Date

2025-02-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Unilateral Secondary Breast Reconstruction Using a Muscle-sparing Pedicled Dorsal Flap After Breast Cancer

NCT06230250

Patient Satisfaction

ACTIVE_NOT_RECRUITING

Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction

NCT06319157

Breast Neoplasms

RECRUITING NA

Satisfaction and QUality of Life After Breast REconstruction

NCT04329819

Mammaplasty Breast Neoplasm Female

COMPLETED

Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales

NCT04526561

Breast Cancer

COMPLETED NA

Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.

NCT05278741

Breast Cancer

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A Retrospective

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

Breast reconstruction

Intervention Type PROCEDURE

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)

Breast reconstruction

Intervention Type PROCEDURE

Muscle sparing Latissimus Dorsi Flap or prothesis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Breast reconstruction

Muscle sparing Latissimus Dorsi Flap or prothesis

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No