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

Breast Cancer Clinical Trial

— QUARLAMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316389
• Other study ID #: ICO-2021-05
• Status: Recruiting
• Start date: February 21, 2022
• Est. completion date: February 21, 2025

Study information

• Verified date: August 2023
• Source: Institut Cancerologie de l'Ouest
• Contact: Laëtitia HIMPE, MD
• Phone: 0240679747
• Email: promotionrc[@]ico.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 21, 2025
• Est. primary completion date: February 21, 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Breast reconstruction
Muscle sparing Latissimus Dorsi Flap or prothesis

Locations

Country	Name	City	State
France	Institut de Cancerologie de L'Ouest (Ico)	Angers

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	occurrence of postoperative complications	complications	6 month
Secondary	quality of life through the Breast-Q questionnaire	Breast-Q questionnaire	6 months