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NCT Number: NCT05316389

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut de Cancerologie de L'Ouest (Ico)

Angers, 49055, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breast reconstruction

Procedure

Muscle sparing Latissimus Dorsi Flap or prothesis

Primary outcomes

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

    Time frame: 6 month

    Disabilities of the Arm, Shoulder and Hand (DASH) (0 = no disability to 100 = maximum disability)

Secondary outcomes

  1. satisfaction of aesthetic by the patient and by the surgeon

    Time frame: 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

  2. occurrence of postoperative complications

    Time frame: 6 month

    complications

  3. quality of life through the Breast-Q questionnaire

    Time frame: 6 months

    Breast-Q questionnaire

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

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

Acronym: QUARLAMI

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 7, 2022
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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