CompletedNot Applicable

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

France190 participantsStarted 2022-02-21

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

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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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

functional evaluation of the shoulder and upper limb (mobility and pain)

Timeframe: 6 month

Trial details

NCT IDNCT05316389

SponsorInstitut Cancerologie de l'Ouest

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-19

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