PRevention Of lymphoedema by Therapeutic Elastic Compression hoses: Treatment efficacy
Not Applicable
Completed
- Conditions
- Compression hoses, lymphoedema, inguinal lymph node dissectionSurgeryLymphoedema
- Registration Number
- ISRCTN23026635
- Lead Sponsor
- etherlands Cancer Institute (NKI) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. 18 years or older
2. Inguinal lymph node dissection because of metastases of melanoma or urogenital tumour
Exclusion Criteria
1. Deep venous thrombosis
2. Manifest lymphoedema or episodes of lymphoedema in the past
3. Isolated limb perfusion treatment
4. Oedema as a result of venous insufficiency
5. Psychiatric disorders
6. Lacking basic proficiency in Dutch
7. Skin diseases of the leg
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of lymphoedema (survival without lymphoedema); surface measurements are used to calculate limb volume to establish the diagnosis of lymphoedema at T0, T1, T2, T3, T4 and T5.
- Secondary Outcome Measures
Name Time Method <br> 1. Early surgical complications (wound breakdown, lymphocele formation, wound infection), measured at T2<br> 2. Genital oedema, measured at T0, T1, T2, T3, T4 and T5<br> 3. Health related quality of life, measured at T0, T4 and T5<br> 4. Body image, measured at T4 and T5<br> 5. Compliance to usage of the hose, measured at T2, T3 and T4<br> 6. Use of professional homecare<br> 7. Lymphoedema requiring treatment<br><br> T0: day of admittance<br> T1: day of dismissal<br> T2: first outpatient visit ? two months after dismissal<br> T3: second outpatient visit ? four months after dismissal<br> T4: third outpatient visit ? six months after dismissal<br> T5: fourth outpatient visit ? 12 months after dismissal<br>