Clinical trial NCT05278741: Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.
Official title: Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast
Latissimus dorsi flap
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-centre, non-randomized interventional study in a single arm
Primary purpose: TREATMENT

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 quality of life questionnaires) allow a precise, multidisciplinary, objective evaluation of the capacity of the latissimus dorsi muscle before surgery, 3 months, 6 months and 12 months after surgery. A function deficit is expected (decreased moment of adduction and internal rotation) 3 months after surgery and a return to the preoperative state 6 months and 12 months after surgery.


Eligibility criteria: * Inclusion Criteria:

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

  1. Patient with metastasis or disease progression
  2. 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)
  3. Patient with a poor understanding of the French language
  4. Patient having presented a failure of a first breast reconstruction (failure of DIEP, prosthesis removal)
  5. 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
  6. Patient with a history of contralateral MR (all techniques combined)
  7. Patient with a history of contralateral breast cancer
  8. Patient does not have internet access to be able to connect to the "Exolis" software

Primary outcomes:
measure: Measurement of the muscular moment
timeFrame: During the 12 months post operation
Secondary outcomes:
measure: Evaluation of muscle moments
timeFrame: During the 12 months post operation
measure: Comparison of muscular moments
timeFrame: During the 12 months post operation
measure: Calculation of adduction deficit
timeFrame: During the 12 months post operation
measure: Measurement of surface electromyographic activity
timeFrame: During the 12 months post operation
measure: Functional clinical impact and quality of life
timeFrame: During the 12 months post operation
measure: Functional clinical impact and quality of life
timeFrame: During the 12 months post operation
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges-François Leclerc
state: Côte d'Or
Study officials:
affiliation: Centre Georges François Leclerc
name: Clémentine CJ JANKOWSI, Dr
role: PRINCIPAL_INVESTIGATOR
References: