Study Protocol for the Use of Conventional Open Haemorrhoidectomy versus Laser Haemorrhoidoplasty in the Treatment of Symptomatic Haemorrhoids: A Randomized Controlled Trial

Background: Haemorrhoids result in a variety of symptoms that cause significant patient anxiety. Treatment has long been associated with post-operative complications, which cause significant symptoms and may result in readmissions. The open conventional haemorrhoidectomy (COH) is still regarded as the gold standard treatment for non-circumferential grade II-IV haemorrhoids. Laser haemorrhoidoplasty (LAH) has recently been studied and the initial results appear promising. This study aims to compare these 2 techniques in the treatment of symptomatic haemorrhoids. We hypothesize that LAH has significantly less pain and bleeding and better quality of life (QoL) scores 1, 3 and 12 months post-operatively.

Methods: A prospective, randomized, double-blind, single-centre clinical trial will be conducted. All patients aged between 21 and 90 years who present with symptomatic grade II-IV haemorrhoids will be recruited. Exclusion criteria include those who have had previous operations for haemorrhoids and those with an increased risk of bleeding. Data collected will include patient demographics, pre- and intra-operative characteristics of the haemorrhoids, operative details and post-operative pain Visual Analogue Scale (VAS) score, complications, readmissions, and haemorrhoid-specific QoL surveys. Primary outcome will be median post-operative pain VAS score on post-operative days (POD) 1-10. Secondary outcomes include operative duration, bleeding on the first 10 days post-operatively, readmissions, procedure-related complications (fistulation, incontinence, stenosis), QoL scores, and recurrence of symptoms up to 12 months.

Discussion: Results from this trial may demonstrate the superiority of LAH over COH in terms of post-operative pain and recovery. This would likely increase the adoption of LAH for the treatment of symptomatic haemorrhoids.

Trial registration: This trial was registered on 1/4/2020 at ClinicalTrials.gov. URL: https://www.clinicaltrials.gov/ct2/show/NCT04329364?term=NCT04329364&draw=2&rank=1.