Comparison of Rubber Band Ligation and Haemorrhoidectomy in Patients With Symptomatic Haemorrhoids Grade III

  • STATUS
    Recruiting
  • End date
    Nov 25, 2023
  • participants needed
    360
  • sponsor
    Proctos Kliniek
Updated on 22 March 2021

Summary

Rationale: Haemorrhoidal disease is one of the most common anorectal disorders which affects nearly half of the general population1. 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. 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.

Objective: To establish the best treatment of patients with symptomatic haemorrhoids grade III: haemorrhoidectomy versus rubber band ligation (RBL). Patient bound effectiveness, clinical effectiveness and cost-utility of both treatments is compared; primary outcome is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. The assumption is that treatment with rubber band ligation is equally effective in comparison with haemorrhoidectomy in terms of quality of life.

Study design:Multicentre randomized controlled non-inferiority trial with cost-utility analysis. Two treatment protocols are compared: haemorrhoidectomy and rubber band ligation.

Study population: Patients aged 18 years with symptomatic haemorrhoids gr III. Patients are recruited in multiple clinics during 18-24 months.

Intervention: Participants are allocated to either rubber band ligation or haemorrhoidectomy.

Main study parameters/endpoints: Primary outcome measure is quality of life at 24 months measured with the EQ-5D-5L with Dutch rating and recurrence at one year post procedure. Secondary outcomes are: complaint reduction with proctology specific patient-related outcome measure (HSS, PROM, PROMHISS), vaizey score, resumption of work, pain (VAS), complications and recurrence at two years.

Details
Condition Intestinal Diseases, Premature rupture of membranes, Rectal disorder, Hemorrhoids, Vascular Diseases, Passive Range of Motion, Rectal Disorders, Bowel Dysfunction, Internal Hemorrhoids, rectal disease
Treatment Hemorrhoidectomy, RBL
Clinical Study IdentifierNCT04621695
SponsorProctos Kliniek
Last Modified on22 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Haemorrhoids grade III (Goligher classification)
Age 18 years and older
Sufficient understanding of the Dutch written language (reading and writing)

Exclusion Criteria

Previous rectal or anal surgery with the exception of rubber band ligation
Previous surgery for haemorrhoids (at any time)
More than one injection treatment for haemorrhoids in the past 3 years
More than one rubber band ligation procedure in the past 3 years
Previous rectal radiation
Pre-existing sphincter injury
Inflammatory bowel disease
Medically unfit for surgery or for completion of the trial (ASA>III)
Pregnancy
Hyper-coagulability disorders
Patients previously randomised to this trial
Not able or willing to provide written informed consent
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