Five-Year Follow-up of the Double-Blind Randomized Controlled Trial Comparing Laser Hemorrhoidoplasty With Sutured Mucopexy and Excisional Hemorrhoidectomy.
rct · Level II
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- Also identified by DOI 10.1097/DCR.0000000000004372.
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Abstract
Patients, randomized to laser hemorrhoidoplasty, excisional hemorrhoidectomy, and sutured mucopexy were followed-up at 5 years after surgery. The aim of this study was to compare the long-term results of laser hemorrhoidoplasty, excisional hemorrhoidectomy, and sutured mucopexy. A follow-up of randomized, parallel-group, double-blinded, single-center prospective study. From April 2016 to April 2017, a total of 121 patients were included in the study. Patients with symptomatic second- or third-degree hemorrhoids 5 years after surgery were interviewed via telephone or online questionnaire. Recurrence of symptoms was the primary outcome; patients' quality of life, fecal incontinence, and patients' evaluation of treatment were secondary outcomes. A total of 102 patients were evaluated at 5 years (34 per group). Kaplan-Meier estimates of 5-year symptom recurrence were 24% for excisional hemorrhoidectomy, 29% for laser hemorrhoidoplasty, and 44% for sutured mucopexy; these differences did not reach statistical significance (log-rank p = 0.076). While recurrence-free probability was numerically higher in the excisional hemorrhoidectomy and laser hemorrhoidoplasty groups, the timing of events varied across cohorts. Specific recurrences included bleeding in 18% (excisional hemorrhoidectomy), 31% (sutured mucopexy), and 31% (laser hemorrhoidoplasty), and prolapse in 12% (excisional hemorrhoidectomy), 23% (laser hemorrhoidoplasty), and 34% (sutured mucopexy). General health evaluation scores were highest in the laser hemorrhoidoplasty group. Mixed-effect model for repeated measures analysis showed a continued trend of physical and social activity improvement between 1 and 5 years across all groups (p = 0.021). Decision regret was lowest in the sutured mucopexy group (mean score 1.33). This is a single-center study, with relatively small sample size. Patients after excisional hemorrhoidectomy report best outcomes, however laser hemorrhoidoplasty produces only slightly worse results with significantly shorter and less painful postoperative course. See Video Abstract.