Results of the double-blind randomized controlled trial comparing laser hemorrhoidoplasty with sutured mucopexy and excisional hemorrhoidectomy

Abstract

PURPOSE: To compare the results of laser hemorrhoidoplasty (LHP), excisional hemorrhoidectomy (EH), and sutured mucopexy (MP). METHODS: A randomized, parallel-group, double-blinded, single-center prospective study. PATIENTS: Symptomatic 2nd- or 3rd-degree hemorrhoids patients. INTERVENTIONS: Computer randomization sequence, patient blinding, operating surgeon blinding, and surgeon-evaluator blinding. LHP was performed using a 1470 nm diode laser. Up to 250 J of energy delivered per 1 hemorrhoid. The procedure was performed circumferentially. MP ligations were placed in the area of visible hemorrhoidal tissue. Standard EH was performed up to the level of the hemorrhoidal pedicle. Follow-up at 1 and 6 weeks and 1 year. OUTCOME MEASURES: Recurrence of symptoms requiring treatment, intensity, and duration of pain after the operation, patients' quality of life, fecal incontinence, and patients' evaluation of treatment. RESULTS: A total of 121 patients. Groups were even preoperatively. LHP took 15 min (SD 5.6), MP took 16 min (SD 5.58), and EH took 29 min (SD 10.3). Recurrence requiring treatment rate was 0% after EH, 10% after LHP, and 22% after MP, p = 0.004. LHP and MP were less painful than EH, p < 0.001. Patients after LHP returned to regular activity after 15 days, after MP after 22 days, and after EH after 30 days, p < 0.001. SF-36 scores were better after EH. Symptoms of fecal incontinence improved in all the groups. Patients evaluate LHP better than EH and MP. LIMITATIONS: Single-center study. CONCLUSIONS: Laser hemorrhoidoplasty is a safe, minimally invasive option for hemorrhoids, more effective than MP and less effective than EH. Patients evaluate this technique better than the other two.

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