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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 121 participants or records.
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