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Prevention of lymphedema by therapeutic elastic compression hoses; treatment efficacy.


- candidate number2532
- NTR NumberNTR941
- ISRCTNISRCTN23026635
- Date ISRCTN created2-mei-2007
- date ISRCTN requested20-apr-2007
- Date Registered NTR27-mrt-2007
- Secondary IDsN/A 
- Public TitlePrevention of lymphedema by therapeutic elastic compression hoses; treatment efficacy.
- Scientific TitleThe efficacy of therapeutic compression hoses for prevention of lymphedema after inguinal lymph node dissection in cancer patients a randomized controlled trial.
- ACRONYMPROTECT
- hypothesisH0: incidence of lymphedema in hose-group equals non-hose group;
H1: incidence of lymphedema in hose group does not equal non-hose group.
- Healt Condition(s) or Problem(s) studiedInguinal lymph node dissection, Lymphedema, Elastic stockings
- Inclusion criteria1. 18 years or older;
2. Inguinal lymphnode dissection because of metastases of melanoma or urogenital tumour.
- Exclusion criteria1. Deep venous thrombosis;
2. Manifest lymphedema or episodes of lymphedema 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2006
- planned closingdate31-dec-2007
- Target number of participants80
- InterventionsTherapeutic elastic compression hose for a period of 6 months, in addition to standard regimen of early ambulation and patient education.
- Primary outcomeIncidence of lymphedema (survival without lymphedema).
- Secondary outcome1. Early surgical complications (wound breakdown, lymphocele formation, wound infection);
2. Genital oedema;
3. Health related quality of life;
4. Body image;
5. Ccompliance to usage of the hose;
6. Use of professional homecare;
7. Lymphedema requiring treatment.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESBSc. PT M.M. Stuiver
- CONTACT for SCIENTIFIC QUERIESBSc. PT M.M. Stuiver
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI/AVL)
- Publications
- Brief summaryPatients after inguinal lymphnode dissection will be followed up to 12 months post-surgery. Patients in hose group will wear a class II therapeutic compression hose in addition to patient education as provided to no-hose group. Survival analysis (cox regression) will be used to estimate treatment effect.
- Main changes (audit trail)
- RECORD27-mrt-2007 - 18-jan-2010


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