Partial Stapled Hemorrhoidopexy Versus Circumferential Stapled Hemorrhoidopexy for Grade III to IV Prolapsing Hemorrhoids: A Randomized, Noninferiority Trial
Partial Stapled Hemorrhoidopexy Versus Circumferential Stapled Hemorrhoidopexy for Grade III to IV Prolapsing Hemorrhoids: A Randomized, Noninferiority Trial
复制标题
部分吻合器痔疮固定术与环周吻合器痔疮固定术治疗 III 至 IV 级脱垂痔疮：一项随机、非劣效性试验。
DOI：
10.1097/dcr.0000000000001261
复制
发表时间：
2019-02-01
影响因子：
3.9
通讯作者：
Ren, Dong-Lin
中科院分区：
文献类型：
--
作者：
Lin, Hong-Cheng;He, Qiu-Lan;Ren, Dong-Lin
背景：尚不清楚部分吻合器痔固定术的长期结局和疗效。目的：本研究旨在比较部分吻合器痔固定术与环形吻合器痔固定术的长期临床疗效和安全性。设计：平行组、随机、非劣效性临床试验。设置：该研究在一个学术中心进行。患者：纳入了2011年8月至2013年11月期间患有III/IV级痔疮的患者。干预措施：300例患者被随机分配接受部分吻合器痔固定术（组1，n = 150）或环形吻合器痔固定术（组2，n = 150）。主要观察指标：主要结局是中位随访5年时脱垂复发率，预定的非劣效性界值为3.75%。次要结局包括术后疼痛、便急、肛门失禁的发生率和严重程度，以及特殊并发症的发生率，包括肛门直肠狭窄和直肠阴道瘘。结果：第1组的视觉模拟评分低于第2组（p < 0.001）。与第2组相比，第1组发生术后尿急的患者较少（p = 0.001）。两种手术后肛门括约肌均显著恶化，但第2组术前和术后括约肌评分之间的差异高于第1组。第1组患者未发生术后直肠狭窄，但第2组有8例患者（5%）发生（p = 0.004）。第1组（9%（95% CI，4%-13%））和第2组（12%（95% CI，7%-17%））之间的5年累积复发率无显著差异（p = 0.137），差异在非劣效性界值范围内（绝对差异，3.33%（95% CI，10.00%-3.55%））。局限性：这项研究是有限的，因为它是一个单中心试验.结论：在中位随访期5年时，对于III至IV级痔患者，部分吻合器痔固定术不劣于环形吻合器痔固定术。然而，部分吻合器痔固定术与术后疼痛和尿急减少、术后肛门扩张更好以及直肠狭窄风险最小相关。
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.