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Randomized Controlled Trial Comparative Study
Partial Stapled Hemorrhoidopexy Versus Circumferential Stapled Hemorrhoidopexy for Grade III to IV Prolapsing Hemorrhoids: A Randomized, Noninferiority Trial.
- Hong-Cheng Lin, Qiu-Lan He, Wan-Jin Shao, Xin-Lin Chen, Hui Peng, Shang-Kui Xie, Xiao-Xue Wang, and Dong-Lin Ren.
- Guangdong Institute of Gastroenterology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
- Dis. Colon Rectum. 2019 Feb 1; 62 (2): 223-233.
BackgroundLong-term outcomes and efficacy of partial stapled hemorrhoidopexy are not known.ObjectiveThe purpose of this study was to compare the long-term clinical efficacy and safety of partial stapled hemorrhoidopexy with circumferential stapled hemorrhoidopexy.DesignThis was a parallel group, randomized, noninferiority clinical trial.SettingsThe study was conducted at a single academic center.PatientsPatients with grade III/IV hemorrhoids between August 2011 and November 2013 were included.InterventionsThree 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 MeasuresThe 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.ResultsThe 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%)).LimitationsThe study was limited because it was a single-center trial.ConclusionsPartial 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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