Research with human participants

Overview of medical research in the Netherlands

Treatment of Hemorrhoids: Rubber band ligation Or Sclerotherapy

Published:
Last updated:

We want to compare the effectiveness of sclerotherapy and rubberband ligation when it comes to symptoms. We will secondarily consider patient satisfaction, complications and recurrences. We hypothesize that both treatments are equally effective.

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Ethical review
Approved WMO
Status
Recruitment started
Health condition type
Gastrointestinal therapeutic procedures
Study type
Interventional research previously applied in human subjects

ID

NL-OMON52967

Source

ToetsingOnline

Brief title

THROS trial

Condition

  • Gastrointestinal therapeutic procedures

Synonym

hemorrhoids piles

Research involving

Human

Sponsors and support

Primary sponsor :
Flevoziekenhuis
Source(s) of monetary or material Support :
Flevoziekenhuis

Intervention

  • Other intervention
Keyword :
hemorrhoids, rubber band ligation, sclerotherapy
Explanation

N.a.

Outcome measures

Primary outcome

<p>Symptoms (ESCP core outcomes): pain, bloodloss, itchiness, prolapse</p>

Secondary outcome

<p>Satisfaction, treatment numbers, cross-over, work-leave</p>

Background summary

Hemorrhoids are a frequent problem in society; it is a problem that can be treated with rubberband ligation or sclerotherapy. Until now there has not been a randomised controlled trial which looks at effectiveness and patient satisfaction of these treatments.

Study objective

We want to compare the effectiveness of sclerotherapy and rubberband ligation when it comes to symptoms. We will secondarily consider patient satisfaction, complications and recurrences. We hypothesize that both treatments are equally effective.

Study design

Randomised controlled trial, multicenter

Intervention

Intervention: Sclerotherapy - 2 injections aethoxysklerol 3% (polidocanol) 

(Control: Rubberband ligation, 3 rubberbands per session)

Study burden and risks

3 moments to fill in questionnaires; roughly 10-20min per session. 

The rest of the treatment is the usual protocol.

Scientific
Flevoziekenhuis
R Schouten
Hospitaalweg 1
Almere 1315RA
Netherlands
036-8688888
ruschouten@flevoziekenhuis.nl
Public
Flevoziekenhuis
R Schouten
Hospitaalweg 1
Almere 1315RA
Netherlands
036-8688888
ruschouten@flevoziekenhuis.nl

Trial sites in the Netherlands

Dijklander Ziekenhuis
Target size :
125
Flevoziekenhuis
Target size :
300
Proctos Kliniek Bilthoven
Target size :
125
Annadal Kliniek
Target size :
110

Listed location countries

Netherlands

Age

Elderly (65 years and older)
Adults (18-64 years)

Inclusion criteria

grade 1 or 2 hemorrhoids, >18 years old

Exclusion criteria

grade 3-4 hemorrhoids, treatment for hemorrhoids in the last year

Design

Study phase :
N/A
Study type :
Interventional research previously applied in human subjects
Intervention model
:
Other
Allocation :
Randomized controlled trial
Masking :
Single blinded (masking used)
Control :
Other type of control
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment started
Start date (anticipated) :
Enrollment :
660
Duration
:
6 months (per patient)
Type :
Actual

Medical products/devices used

Product type :
N.a.

IPD sharing statement

Plan to share IPD :
Undecided

Plan description

N.a.

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Amsterdam UMC
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Amsterdam UMC
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Amsterdam UMC
Notification accepted
Date :
Application type :
Amendment
Review commission :
METC Amsterdam

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 NL8377
CCMO NL73111.018.20
Research portal NL-008043