Status:

ACTIVE_NOT_RECRUITING

Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.

Lead Sponsor:

Centre Georges Francois Leclerc

Conditions:

Breast Cancer

Eligibility:

FEMALE

18-80 years

Phase:

NA

Brief Summary

This study will quantify the muscle function after breast reconstruction using a minimally invasive latissimus dorsi flap. The proposed measures (clinical, isokinetic, electrophysiology, function and...

Eligibility Criteria

Inclusion

  • Patient managed for unilateral MR (immediate or secondary) by MSLD after therapeutic mastectomy.
  • Breast assessment (Mammography + ultrasound +/- breast MRI) normal dating less than 6 months
  • Age between 18 and 80 years old
  • Signature of free and informed consent

Exclusion

  • Patient with metastasis or disease progression
  • Patient whose general condition does not allow her to answer a questionnaire or perform physical and functional measurements (neurocognitive disorders and/or neuro-orthopedic disorders)
  • Patient with a poor understanding of the French language
  • Patient having presented a failure of a first breast reconstruction (failure of DIEP, prosthesis removal)
  • Patient not eligible for MR secondary to cancer (prophylactic mastectomy) or for which the flap was intended to cover loss of substance and not reconstruction
  • Patient with a history of contralateral MR (all techniques combined)
  • Patient with a history of contralateral breast cancer
  • Patient does not have internet access to be able to connect to the "Exolis" software

Key Trial Info

Start Date :

November 25 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 4 2026

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT05278741

Start Date

November 25 2022

End Date

December 4 2026

Last Update

December 26 2025

Active Locations (1)

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Centre Georges-François Leclerc

Dijon, Côte d'Or, France, 21000