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

Recruiting

Conditions: DIEP flap BR
lymphedema
10041641
10025309

Registration Number: NL-OMON50140

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

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
<p>Degree of lymphedema at affected arm measured by Inverse water volumetry and<br /><br>difference in mobility and ROMrange of motion .:</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Patient reported satisfaction and Quality of Life as measured by multiple<br /><br>questionnaires:<br /><br>- Range of motion of the shoulder joint in the following directions: abduction,<br /><br>ante flexion, retro flexion, medial and lateral rotation<br /><br>- Lymph-ICF questionnaire [Appendix C]<br /><br>- The Breast-Q reconstruction Module [Appendix D]</p><br>