Replication data for: Long and short-term outcomes of open excisional haemorrhoidectomy versus transanal haemorrhoidal dearterialization for grade III haemorrhoids: an open-label randomised controlled trial-NCT06420986

The aim of the data set is to recopilate data about the followin topic: Open excisional haemorrhoidectomy (OEH) remains the standard treatment for advanced haemorrhoidal disease, offering low recurrence but notable postoperative pain. Transanal haemorrhoidal dearterialization (THD) is a less invasive alternative with reduced pain but potentially higher recurrence. This study introduces the Clinical Failure Rate (CFR), an objective definition of failure based on the Haemorrhoidal Disease Symptom Score (HDSS) and the Short Health Scale in HD (SHS-HD), comparing the CFR of OEH and THD at one year.
Methods: A prospective, single-centre, randomised, superiority, open-label trial was conducted in patients with grade III haemorrhoids, assigned to OEH or THD. The primary outcome was relative change at 12 months in HDSS and in SHS-HD from baseline. Additionally, we included a predefined, pragmatic composite endpoint, denominated Clinical Failure Rate (CFR) defined as ≤50% improvement in both HDSS and SHS-HD. Secondary outcomes included postoperative pain, time to return to work, complications and need for reoperation. Based on expected failure of 5% (OEH) and 35% (THD), 25 patients per group were required.