PRevention Of lymphoedema by Therapeutic Elastic Compression hoses: Treatment efficacy

ISRCTN	ISRCTN23026635
DOI	https://doi.org/10.1186/ISRCTN23026635
Protocol serial number	NL917 (NTR941)
Sponsor	Netherlands Cancer Institute (NKI) (The Netherlands)
Funder	Netherlands Cancer Institute (NKI) (The Netherlands)

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

The Netherlands Cancer Institute
Antoni van Leeuwenhoek Hospital
Department of Physiotherapy
Amsterdam
1066 CX
Netherlands

Phone	+31 (0)20 512 2586
Email	m.stuiver@nki.nl

Study information

Primary study design	Interventional
Study design	Randomised, active controlled, parallel group, multicentre trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

23/09/2021: Proactive update review. No publications found. Search options exhausted.