BACKGROUND:Long-term outcomes and efficacy of partial stapled hemorrhoidopexy are not known.OBJECTIVE:The purpose of this study was to compare the long-term clinical efficacy and safety of partial stapled hemorrhoidopexy with circumferential stapled hemorrhoidopexy.DESIGN:This was a parallel group, randomized, noninferiority clinical trial.SETTINGS:The study was conducted at a single academic center.PATIENTS:Patients with grade III/IV hemorrhoids between August 2011 and November 2013 were included.INTERVENTIONS:Three hundred patients were randomly assigned to undergo either partial stapled hemorrhoidopexy (group 1, n = 150) or circumferential stapled hemorrhoidopexy (group 2, n = 150).MAIN OUTCOME MEASURES:The primary outcome was the rate of recurrent prolapse at a median follow-up period of 5 years with a predefined noninferiority margin of 3.75%. Secondary outcomes included incidence and severity of postoperative pain, fecal urgency, anal continence, and the frequency of specific complications, including anorectal stenosis and rectovaginal fistula.RESULTS:The visual analog scores in group 1 were less than those in group 2 (p < 0.001). Fewer patients in group 1 experienced postoperative urgency compared with those in group 2 (p = 0.001). Anal continence significantly worsened after both procedures, but the difference between preoperative and postoperative continence scores was higher for group 2 than for group 1. Postoperative rectal stenosis did not develop in patients in group 1, although it occurred in 8 patients (5%) in group 2 (p = 0.004). The 5-year cumulative recurrence rate between group 1 (9% (95% CI, 4%–13%)) and group 2 (12% (95% CI, 7%–17%)) did not differ significantly (p = 0.137), and the difference was within the noninferiority margin (absolute difference, –3.33% (95% CI, –10.00% to 3.55%)).LIMITATIONS:The study was limited because it was a single-center trial.CONCLUSIONS:Partial stapled hemorrhoidopexy is noninferior to circumferential stapled hemorrhoidopexy for patients with grade III to IV hemorrhoids at a median follow-up period of 5 years. However, partial stapled hemorrhoidopexy was associated with reduced postoperative pain and urgency, better postoperative anal continence, and minimal risk of rectal stenosis. See Video Abstract at http://links.lww.com/DCR/A790.Trial registration (chictr.org) identifier is chiCTR-trc-11001506.
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