LaseRF trial: radiofrequency ablation vs. laser hemorrhoidoplasty procedure for grade II–III hemorrhoidal disease—prospective randomized controlled trial

Minimally invasive surgical approaches such as laser hemorrhoidoplasty (LH) and radiofrequency ablation (RFA) are increasingly used in hemorrhoidal disease owing to their associated low morbidity and faster return to daily life. This study aimed to compare these minimally invasive methods in terms of healing, complications, and pain. A randomized, multicenter, single-blind trial was conducted in patients aged 18–60 years with stage II–III hemorrhoidal disease unresponsive to medical therapy. Eligible patients were randomized to RFA or LH. Hemorrhoid Severity Score (HSS) and Visual Analog Scale (VAS) were recorded at baseline, 1 week, 1 month, and 4 months. The primary outcome, healing, was defined as ≥ 1-grade reduction in hemorrhoidal stage (Goligher classification) at 4 months. Of 246 patients screened between August 2021 and January 2023, 92 were randomized and 86 treated. At 4 months, recovery rates were 90% in the LH group and 92% in the RFA group ( p = 0.52). Post-procedure VAS was significantly lower in the LH group (1.92 ± 1.59 vs. 3.48 ± 2.53, p = 0.003), but no differences were observed at 1 week or 1 month ( p = 0.95, p = 0.55). Improvement in HSS was greater with RFA ( p = 0.02). Longitudinal changes in both VAS and HSS were significant within groups ( p < 0.001). Both LH and RFA are safe and effective for stage II–III hemorrhoidal disease with acceptable complication rates. Pain in the very immediate postoperative period is less severe with LH, whereas RFA offers superior symptom control. Larger, long-term trials are warranted. NCT04981600.