PRevention Of lymphoedema by Therapeutic Elastic Compression hoses: Treatment efficacy
| ISRCTN | ISRCTN23026635 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23026635 |
| Secondary identifying numbers | NL917 (NTR941) |
- Submission date
- 02/05/2007
- Registration date
- 02/05/2007
- Last edited
- 23/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr M.M. Stuiver
Scientific
Scientific
The Netherlands Cancer Institute
Antoni van Leeuwenhoek Hospital
Department of Physiotherapy
Amsterdam
1066 CX
Netherlands
| Phone | +31 (0)20 512 2586 |
|---|---|
| m.stuiver@nki.nl |
Study information
| Study design | Randomised, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | PRevention Of lymphoedema by Therapeutic Elastic Compression hoses: Treatment efficacy |
| Study acronym | PROTECT |
| Study objectives | H0: incidence of lymphoedema in hose-group equals non-hose group. H1: incidence of lymphoedema in hose group does not equal non-hose group. |
| Ethics approval(s) | Approval received from the Medical Ethical Comittee of The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital on the 4th September 2006 (ref: PTC06.1170/MO6PRO). |
| Health condition(s) or problem(s) studied | Compression hoses, lymphoedema, inguinal lymph node dissection |
| Intervention | Therapeutic elastic compression hose for a period of six months, in addition to standard regimen of early ambulation and patient education. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 | 1. Early surgical complications (wound breakdown, lymphocele formation, wound infection), measured at T2 2. Genital oedema, measured at T0, T1, T2, T3, T4 and T5 3. Health related quality of life, measured at T0, T4 and T5 4. Body image, measured at T4 and T5 5. Compliance to usage of the hose, measured at T2, T3 and T4 6. Use of professional homecare 7. Lymphoedema requiring treatment T0: day of admittance T1: day of dismissal T2: first outpatient visit two months after dismissal T3: second outpatient visit four months after dismissal T4: third outpatient visit six months after dismissal T5: fourth outpatient visit 12 months after dismissal |
| Overall study start date | 01/10/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 80 |
| Key inclusion criteria | 1. 18 years or older 2. Inguinal lymph node dissection because of metastases of melanoma or urogenital tumour |
| Key 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 |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
The Netherlands Cancer Institute
Amsterdam
1066 CX
Netherlands
1066 CX
Netherlands
Sponsor information
Netherlands Cancer Institute (NKI) (The Netherlands)
Research organisation
Research organisation
Antoni van Leeuwenhoek Hospital (AVL)
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
| Website | http://www.nki.nl/ |
|---|---|
"ROR" |
https://ror.org/03xqtf034 |
Funders
Funder type
Research organisation
Netherlands Cancer Institute (NKI) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
23/09/2021: Proactive update review. No publications found. Search options exhausted.
