| - candidate number | 2532 |
| - NTR Number | NTR941 |
| - ISRCTN | ISRCTN23026635 |
| - Date ISRCTN created | 2-mei-2007 |
| - date ISRCTN requested | 20-apr-2007 |
| - Date Registered NTR | 27-mrt-2007 |
| - Secondary IDs | N/A |
| - Public Title | Prevention of lymphedema by therapeutic elastic compression hoses; treatment efficacy. |
| - Scientific Title | The efficacy of therapeutic compression hoses for prevention of lymphedema after inguinal lymph node dissection in cancer patients – a randomized controlled trial. |
| - ACRONYM | PROTECT |
| - hypothesis | H0: 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) studied | Inguinal lymph node dissection, Lymphedema, Elastic stockings |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-okt-2006 |
| - planned closingdate | 31-dec-2007 |
| - Target number of participants | 80 |
| - Interventions | Therapeutic elastic compression hose for a period of 6 months, in addition to standard regimen of early ambulation and patient education. |
| - Primary outcome | Incidence of lymphedema (survival without lymphedema). |
| - Secondary outcome | 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. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | BSc. PT M.M. Stuiver |
| - CONTACT for SCIENTIFIC QUERIES | BSc. 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 |
| - Publications | |
| - Brief summary | Patients 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) | |
| - RECORD | 27-mrt-2007 - 18-jan-2010 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl