Open excisional haemorrhoidectomy versus transanal haemorrhoidal dearterialization for grade III haemorrhoids: open-label randomized clinical trial.

Abstract

BACKGROUND Open excisional haemorrhoidectomy (OEH) remains the standard treatment for advanced haemorrhoidal disease, offering low recurrence but notable postoperative pain. Transanal haemorrhoidal dearterialization (THD) is an alternative with reduced pain but potentially higher recurrence. The aim of this trial was to compare the 1-year efficacy of both techniques using validated symptom and quality-of-life scores. METHODS A prospective, single-centre, randomized, open-label trial was conducted in patients with grade III haemorrhoids. The primary outcome was the relative change at 12 months in Haemorrhoidal Disease Symptom Score (HDSS) and Short Health Scale adapted for Haemorrhoidal Disease (SHS-HD) from baseline. Additionally, the predefined, pragmatic composite endpoint-the clinical failure rate (CFR), defined as a ≤50% improvement in both HDSS and SHS-HD-was compared. Secondary outcomes included postoperative pain, time to return to work, complications, and reoperation. RESULTS From August 2021 to February 2023, 50 patients were randomized (25 OEH patients and 25 THD patients). Three patients were lost to follow-up (2 THD patients and 1 OEH patient). CFR was significantly higher in the THD group (14 of 23 (61%)) versus the OEH group (2 of 24 (8%)) (P <0.001). All eigth reoperations occurred in the THD group (P = 0.001). Both procedures reduced symptom and quality-of-life scores (P = 0.002 and P < 0.001). OEH was associated with greater early postoperative pain and a longer time to return to work (median of 21 versus 14 days; P = 0.010). CONCLUSION OEH is more effective than THD but is associated with greater early postoperative pain. REGISTRATION NUMBER NCT06420986 (http://www.clinicaltrials.gov).