Comparison of rubber band ligation and haemorrhoidectomy in
patients with symptomatic haemorrhoids, a multicentre,
randomized controlled trial and cost-utility analysis

Haemorrhoidal disease is one of the most common anorectal disorders which
affects nearly half of the general population1. In the Dutch population
prevalence is 9 per 1,000 patients per year [DIS]. Symptoms vary from blood
loss, itching, soiling and prolapse and can be severe having a substantial
impact on a patients activities. Haemorrhoids are described most often by the
Goligher classification: a universally used classification focusing on the
degree of prolapse 2However in a large colonoscopy-based study no significant
association could be demonstrated between haemorrhoid grade and haemorrhoid
symptoms [Iyer 2004]. Treatment consists initially of conservative measures
such as lifestyle advice, diet and toilet behavior 3 In addition, various
surgical procedures are possible, of which haemorrhoidectomy is considered the
gold standard, an assumption recently confirmed in two British trials [Hubble,
Ethos]. The most commonly used, low-invasive procedure is the rubber band
ligation (RBL). With better understanding of origin and pathogenesis of
haemorrhoids new surgical techniques were developed. Given the current numerous
modalities the obvious question which needs to be answered is which treatment
is the best. An interesting conclusion from a recent systematic review
regarding operative procedures for haemorrhoidal disease is that all procedures
have their own advantages and disadvantages 4. Therefore items like patient
expectations and priorities and costs should be taken into account when
deciding which procedure to advice and perform. There is a need for evaluating
treatment from the patient*s point of view and transparency in surgical and
non-surgical treatment outcome. So far there is no sufficiently large trial
that meets that demand. A recent national survey amongst Dutch surgeons with
expertise in haemorrhoidal disease demonstrated varying practices in treatment
of haemorrhoids. A similar survey was conducted in Italy including more than
32000 patients. Although (and maybe because of) the most frequently used
treatment modalities differed from the ones in the Dutch study the conclusion
is the same: necessity of developing practical (Dutch and European) guidelines
for treatment of haemorrhoidal disease 5, 6. Therefore, a well-designed study
is essential to compare efficacy and safety of repeated rubber band ligation
and haemorrhoidectomy for grade III hemorrhoids in a multicenter randomized
setting.

This study investigates the two most commonly performed surgical procedures for
treatment of grade III hemorrhoids. It aims to identify the best surgical
treatment for this patient group considering quality of life.. Other outcomes
measured are other patient related outcome measures, clinical outcome andcost
utility.. Patients will be followed up for two years.

The study concerns a randomized, controlled, multicenter trial comparing rubber
band ligation with hemorrhoidectomy for treatment of grade III hemorrhoids.
Patients will be accrued by all participating clinics. The design involves
allocation of all appropriate consecutive patients with symptomatic grade III
hemorrhoids to either rubber band ligation or hemorrhoidectomy. After
eligibility has been established and patient details noted patients will be
randomized to either one of the study groups. Assignment to one of the two
groups is not blinded. Randomization is performed by computer and will be done
through internet. Data will be analysed on *intention to treat* basis in case
patients are not subjected to the randomised treatment modality. Exclusion
criteria are former radiotherapy, inflammatory bowel disease and former anal
surgery.

Rubber band ligation:
Rubber band ligation, first described by Barron, is performed by a suction
device that allows a rubber band to be applied at the base of the haemorrhoid
via a proctoscope. Maximal suction force used is 40 mmHg. A maximum of 3-4
bands are used per session. This rubber band constricts the blood supply
causing it to become ischaemic before being sloughed approximately 1-2 weeks
later. The resultant fibrosis reduces any element of haemorrhoidal prolapse
that may have been present. No sedation is required for this day-care
procedure. Patients are asked to administer an enema 2 hours prior to the
procedure. This is a very commonly performed procedure in all participating
clinics.
Haemorrhoidectomy:
There are two main excisional procedures currently carried out: open (Milligan
and Morgan) and closed (Ferguson). Both have the intention of excising the
haemorrhoidal cushions. The procedure is performed under either general or
spinal anaesthesia in a day-care setting. Patients were asked to administer an
enema 2 hours prior to the procedure.

Questionnaires at 6 different time points - baseline, 1,and 6 weeks, 6,12 and
24 months postoperative. (6 x 30 minutes)