Clinical trial · Interventional
Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery for unilateral breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surgery for unilateral breast reconstruction
- description
- Patients treated in oncological surgery at the Center Georges-François Leclerc (CGFL) in Dijon for unilateral breast reconstruction after therapeutic total mastectomy. Before the surgery, 2 questionnaires will be completed by patients : BREAST-Q and DASH. Also, the isokinetic test and EMG will be performed. After the surgery, 2 questionnaires will be completed at one month, 3 months, 6 months and 12 months. The Two tests will be performed at 3 months, 6 months and 12 months after the surgery.
- interventionNames
- Procedure: Surgery for unilateral breast reconstruction
Primary outcomes (1)
- measure
- Measurement of the muscular moment
- timeFrame
- During the 12 months post operation
- description
- Measurement of the muscular moment of shoulder adduction preoperatively and at 3 months on an isokinetic dynamometer (Biodex®, New York, USA) at an adduction speed of 60 degrees per second during a maximal voluntary contraction
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
* 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
References
Publications (0)
Data not yet available