Partial Stapled Hemorrhoidopexy Versus Circumferential Stapled Hemorrhoidopexy for Grade III to IV Prolapsing Hemorrhoids: A Randomized, Noninferiority Trial. Issue 2 (February 2019)

• Record Type: Journal Article
• Authors: Lin, Hong-Cheng; He, Qiu-Lan; Shao, Wan-Jin; Chen, Xin-Lin; Peng, Hui; Xie, Shang-Kui; Wang, Xiao-Xue; Ren, Dong-Lin
• Is Part Of: Diseases of the colon & rectum. Volume 62:Issue 2(2019)
• Publication Date: 2019-02
• Subjects: Circumferential stapled hemorrhoidopexy -- Partial stapled hemorrhoidopexy -- Prolapsing hemorrhoids -- Rectal compliance -- Rectal stricture -- Rectovaginal fistula -- Tissue selecting technique; Colon (Anatomy) -- Diseases -- Periodicals; Rectum -- Diseases -- Periodicals; Colonic Diseases -- Periodicals; Colorectal Surgery -- Periodicals; 616.34
• DOI: 10.1097/DCR.0000000000001261
• Languages: English
• ISSNs: 0012-3706

Abstract

Abstract : 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. SeeVideo Abstract athttp://links.lww.com/DCR/A790 . Trial registration (chictr.org) identifier is chiCTR-trc-11001506.