Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23459
Enrollment
30
Registered
2020-10-12
Start date
2020-11-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lymphedema

Interventions

an inguinal lymph node transplant during the standard DIEP- flap breast reconstruction

Sponsors

n.a.
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Degree of lymphedema at affected arm measured by Inverse water volumetry and difference in mobility and ROMrange of motion .:

Secondary

MeasureTime frame
Patient reported satisfaction and Quality of Life as measured by multiple questionnaires: - Range of motion of the shoulder joint in the following directions: abduction, ante flexion, retro flexion, medial and lateral rotation - Lymph-ICF questionnaire - The Breast-Q reconstruction Module

Contacts

Public ContactIris Holt-Kedde

Medical University of groningen

i.l.holt@umcg.nl+31655256091

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)