Deep inferior epigastric perforator flap breast reconstruction with or without inguinal lymph node transplant for treatment of breast cancer related arm lymphedema: A multicenter randomized controlled trial
- Conditions
- lymphedema
- Registration Number
- NL-OMON23459
- Lead Sponsor
- n.a.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
•All patients with complaints of lymphedema with an indication for secondary BR
•Persistent volume excess of more than 5-10% of the affected arm (arm at side of mastectomy) in comparison to the contralateral arm measured by inverse water volumetry with pitting oedema
•Persistent volume excess of the affected arm, patients are in maintenance phase of treatment for BCRL
•Good patient coherence and willingness to wear therapeutic garments
•Operability
Exclusion Criteria
•Recurrent malignancy
•Lipoedema of the upper extremetiesextremities
•Lymphedema of the lower extremetieextremity(s)
•Patients with untreated lymphedema
•Patients with bilateral upper arm lymphedema
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Degree of lymphedema at affected arm measured by Inverse water volumetry and difference in mobility and ROMrange of motion .:
- Secondary Outcome Measures
Name Time Method Patient reported satisfaction and Quality of Life as measured by multiple questionnaires: <br>-Range of motion of the shoulder joint in the following directions: abduction, ante flexion, retro flexion, medial and lateral rotation<br>-Lymph-ICF questionnaire <br>-The Breast-Q reconstruction Module