Condition category
Surgery
Date applied
02/05/2007
Date assigned
02/05/2007
Last edited
03/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nki.nl/

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

Publication citations

Additional files

Editorial Notes