combining a standard DIEP-flap breast reconstruction (BR) with an inguinal lymph node transplant will lead to an improvement of the BCR
ID
Bron
Verkorte titel
Aandoening
lymphedema
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Degree of lymphedema at affected arm measured by Inverse water volumetry and difference in mobility and ROMrange of motion .:
Achtergrond van het onderzoek
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.
Doel van het onderzoek
combining a standard DIEP-flap breast reconstruction (BR) with an inguinal lymph node transplant will lead to an improvement of the BCR
Onderzoeksopzet
pre- surgery,
2 weeks post surgery,
6 weeks post surgery
6 months post surgery,
12 months post surgery
Onderzoeksproduct en/of interventie
an inguinal lymph node transplant during the standard DIEP- flap breast reconstruction
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Recurrent malignancy
• Lipoedema of the upper extremetiesextremities
• Lymphedema of the lower extremetieextremity(s)
• Patients with untreated lymphedema
• Patients with bilateral upper arm lymphedema
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8965 |
| Ander register | METC UMCG : METc 2020/427 |