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ID
Source
Brief title
Health condition
lymphedema
Sponsors and support
Intervention
Outcome measures
Primary outcome
Degree of lymphedema at affected arm measured by Inverse water volumetry and difference in mobility and ROMrange of motion .:
Secondary outcome
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
Background summary
Although the prevalence of breast cancer related lymphedema (BCRL) has decreased over the years, BCRL remains a very debilitating, devastating complication which is hard to treat. At this moment, most patients with lymphedema are treated conservatively. Surgical interventions for lymphedema are divided in reductive and reconstructive treatment. For reconstructive treatment as lympho-venous anastomosis and or free lymph node transplantations are performed. In this study we want willto evaluate if combining a standard DIEP-flap breast reconstruction (BR) combined with an inguinal lymph node transplant will lead to an improvement of the BCRL
The aim of this study is to evaluate investigate whether BCRL will improve in patients with BCRL undergoing DIEP-flap BR combined with an inguinal lymph node transplant have statistically significant improvement of their BCRL (primary objective), and Quality of life (secondary objective) compared to the patients group receiving a solemnly DIEP-flap BR without an inguinal lymph node transplant. Furthermore, this study will investigate the Quality of life (secondary objective) in these two patient groups.
Study objective
combining a standard DIEP-flap breast reconstruction (BR) with an inguinal lymph node transplant will lead to an improvement of the BCR
Study design
pre- surgery,
2 weeks post surgery,
6 weeks post surgery
6 months post surgery,
12 months post surgery
Intervention
an inguinal lymph node transplant during the standard DIEP- flap breast reconstruction
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL8965 |
Other | METC UMCG : METc 2020/427 |