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

Sponsor

Institut Cancerologie de l'Ouest (Other)

Overall Status

Recruiting

CT.gov ID

NCT05316389

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	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 Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Feb 21, 2022

Anticipated Primary Completion Date :

Feb 21, 2025

Anticipated Study Completion Date :

Feb 21, 2025

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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
occurrence of postoperative complications [6 month]
complications
quality of life through the Breast-Q questionnaire [6 months]
Breast-Q questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut de Cancerologie de L'Ouest (Ico)	Angers		France	49055

Sponsors and Collaborators

Institut Cancerologie de l'Ouest

Investigators

Principal Investigator: Julia DE FREITAS, ICO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Cancerologie de l'Ouest

ClinicalTrials.gov Identifier:

NCT05316389

Other Study ID Numbers:

ICO-2021-05

First Posted:

Apr 7, 2022

Last Update Posted:

Apr 7, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 7, 2022