Research with human participants

Overview of medical research in the Netherlands

Prevention of lymphedema by therapeutic elastic compression hoses; treatment efficacy.

No registrations found.

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Ethical review
Positive opinion
Status
Recruitment stopped
Health condition type
-
Study type
Interventional

ID

NL-OMON22336

Source

NTR

Brief title

PROTECT

Health condition

inguinal lymph node dissection
lymphedema
lymfoedeem
oppervlakkige liesklierdissectie
therapeutisch elastische kousen
compression hoses

Sponsors and support

Primary sponsor :
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (dpt of physiotherapy)
Source(s) of monetary or material Support :
initiator

Intervention

Outcome measures

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.

Background 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.

Study objective

H0: incidence of lymphedema in hose-group equals non-hose group;

H1: incidence of lymphedema in hose group does not equal non-hose group.

Study design

N/A

Intervention

Therapeutic elastic compression hose for a period of 6 months, in addition to standard regimen of early ambulation and patient education.

Public
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Dpt of Physiotherapy
M.M. Stuiver
Plesmanlaan 121
Amsterdam 1066 CX
The Netherlands
+31 20-5122586
m.stuiver@nki.nl
Scientific
The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Dpt of Physiotherapy
M.M. Stuiver
Plesmanlaan 121
Amsterdam 1066 CX
The Netherlands
+31 20-5122586
m.stuiver@nki.nl

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.

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
80
Type :
Actual

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL917
NTR-old NTR941
Other : N/A
ISRCTN ISRCTN23026635