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

NCT05316389 | Active Not Recruiting

• 1 other identifier: ICO-2021-05
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• satisfaction of aesthetic by the patient and by the surgeon

  6 month

• occurrence of postoperative complications

  6 month

• quality of life through the Breast-Q questionnaire

  6 months

Study Arms (2)

A Retrospective

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

Procedure: Breast reconstruction

B Prospective

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

Procedure: Breast reconstruction

Interventions

Breast reconstruction PROCEDURE

Muscle sparing Latissimus Dorsi Flap or prothesis

A Retrospective; B Prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with a desire for breast reconstruction
• Indication for mastectomy or with a history of mastectomy, with or without preservation of the skin skin,
• Breast reconstruction procedure by LDPM performed between January 2017 and September2021, (retrospective cohort )
• Breast reconstruction procedure by LDPM or by prosthesis performed from February 2022 (prospective cohort)
• Information to the patient and collection of her non-opposition
• Affiliation to a social security system, or beneficiary of such a system

You may not qualify if:

• Performance of a breast reconstruction by a technique other than LDPM or prosthesis
• Patient opposed to the use of her data for research
• 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,
• Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological psychological reasons.

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (1)

Institut de Cancerologie de L'Ouest (Ico)

Angers, 49055, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Julia DE FREITAS

  ICO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 7, 2022
• Study Start: February 21, 2022
• Primary Completion (Estimated): June 11, 2026
• Study Completion (Estimated): February 21, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)