Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease: a multicentre randomized controlled trial

Haemorrhoidal disease (HD) is the most common type of anorectal complaint in
the Netherlands, with an annual prevalence of
10% in general practice. There is level I evidence in literature that the first
management step of HD is basic treatment,
including laxatives and high fibre diet. The general practitioner usually
offers basic treatment. If basic treatment fails
patients are referred to the hospital. About 50.000 patients are referred to a
hospital for HD in the Netherlands annually. The
next treatment modality after basic treatment in case of persistent symptoms is
rubber band ligation (RBL), which can be
repeated if necessary. RBL is an easy, cheap and outpatient-based procedure.
Thirty per cent of the patients, approximately
15.000 patients a year, develop recurrent symptoms after basic treatment and
repeat RBL. There is currently no consensus
and a lack of evidence regarding the best treatment option for these patients
having recurrent HD: continuing RBL or a surgical
intervention. Literature indicates that haemorrhoidectomy is the surgical
treatment of choice based on outcomes like recurrence
rate. The major drawback of this technique is that it is very painful and more
costly compared to RBL. A relatively novel,
but regular surgical alternative is the sutured mucopexy. Although hospital
costs of sutured mucopexy are comparable to
haemorrhoidectomy, the operation is less painful and requires less recuperation
time. The recurrence rate of sutured mucopexy
is ranked between that of RBL and haemorrhoidectomy.
Up till now, trials were mostly powered on traditional outcomes like
recurrence, a definition that differs widely between studies.
To improve transparency between studies and facilitate the ability to compare
and combine (future) studies, our research group
developed a European Society of Coloproctology (ESCP) Core Outcome Set (COS)
for HD. This international COS for HD
selected *patient-reported symptoms* as primary outcome. Additionally, we
recently developed a patient reported symptom
score for HD: the PROM-HISS. This PROM is based on most cited symptoms in
literature and patient interviews. The patient
advisory board (PAB) of this project underlines the clinical relevance of this
PROM. As the PROM-HISS has not yet been used
in other studies and has to be validated, we will additionally use
patient-reported symptoms assessed by the PROM-HISS, next
to recurrence, as primary outcome in this trial.

The primary objective of this RCT is to compare the effectiveness of RBL,
sutured mucopexy and haemorrhoidectomy regarding recurrence and
patient-reported symptoms for recurrent grade 2 and 3 HD after at least 2
previous RBL treatments. Secondary objectives are to compare RBL, sutured
mucopexy and haemorrhoidectomy for recurrent grade 2 and 3 HD after previous
RBL treatments in terms of early and late complications, impact of symptoms on
daily activities, patient satisfaction with treatment, health-related quality
of life, costs and cost-effectiveness, and budget impact.

Dutch prospective multicentre randomized controlled trial. This RCT will take
place in 20 Dutch medical centers.

Rubber band ligation versus sutured mucopexy versus haemorrhoidectomy. All
three interventions are part of Dutch usual care, and serve as each other*s
control.

For this study, patients are asked to take part in a study comparing treatment
of haemorrhoids by rubber band ligation, sutured mucopexy and
haemorrhoidectomy. Patients will not have extra hospital visits. Patients will
be asked to complete online questionnaires on 4 different occasions (4 x 20
minutes): at baseline, at 1 and 6 weeks and 12 months after the intervention.
The content includes general and disease specific QoL, and health related
costs. We do not expect any adverse reactions or events in respect to
participation in the study because all three procedures are considered standard
care.
Since we compare a non-surgical intervention with 2 surgical interventions,
this may place both surgical groups in a less favourable position. However, all
three interventions are usual care and are accepted treatments in the arsenal
of options for haemorrhoidal disease patients.