Contact information
Type
Scientific
Primary contact
Mr M.M. Stuiver
ORCID ID
Contact details
The Netherlands Cancer Institute
Antoni van Leeuwenhoek Hospital
Department of Physiotherapy
Amsterdam
1066 CX
Netherlands
+31 (0)20 512 2586
m.stuiver@nki.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PROTECT
Study hypothesis
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
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).
Study design
Randomised, active controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/10/2006
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. 18 years or older
2. Inguinal lymph node dissection because of metastases of melanoma or urogenital tumour
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
80
Participant 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
Recruitment start date
01/10/2006
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
The Netherlands Cancer Institute
Amsterdam
1066 CX
Netherlands
Sponsor information
Organisation
Netherlands Cancer Institute (NKI) (The Netherlands)
Sponsor details
Antoni van Leeuwenhoek Hospital (AVL)
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Cancer Institute (NKI) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary