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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 - DIEPLYM

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50140
Enrollment
30
Registered
2020-11-19
Start date
2021-03-23
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

DIEP flap BR lymphedema

Interventions

DIEP-flap BR with or without an inguinal lymph node transplant.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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 [Appendix C] - The Breast-Q reconstruction Module [Appendix D]

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)