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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR941 |
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Date of registration:
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27/03/2007 |
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Primary sponsor: |
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Public title:
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Prevention of lymphedema by therapeutic elastic compression hoses; treatment efficacy.
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Scientific title:
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The efficacy of therapeutic compression hoses for prevention of lymphedema after inguinal lymph node dissection in cancer patients ? a randomized controlled trial. - PROTECT |
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Date of first enrolment:
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1/10/2006 |
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Target sample size:
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80 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=941 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.M.
Stuiver |
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Address:
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The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Dpt of Physiotherapy, Plesmanlaan 121
1066 CX
Amsterdam
The Netherlands |
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Telephone:
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+31 20-5122586 |
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Email:
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m.stuiver@nki.nl |
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Affiliation:
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Name:
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M.M.
Stuiver |
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Address:
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The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Dpt of Physiotherapy, Plesmanlaan 121
1066 CX
Amsterdam
The Netherlands |
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Telephone:
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+31 20-5122586 |
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Email:
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m.stuiver@nki.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 18 years or older;
2. Inguinal lymphnode dissection because of metastases of melanoma or urogenital tumour.
Exclusion criteria: 1. 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Inguinal lymph node dissection, Lymphedema, Elastic stockings
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Intervention(s)
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Therapeutic elastic compression hose for a period of 6 months, in addition to standard regimen of early ambulation and patient education.
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Primary Outcome(s)
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Incidence of lymphedema (survival without lymphedema).
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Secondary Outcome(s)
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1. 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.
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Secondary ID(s)
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ISRCTN23026635
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N/A
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Source(s) of Monetary Support
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Netherlands Cancer Institute - Antoni van Leeuwenhoek
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