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Partial Stapled Hemorrhoidopexy Versus Circumferential Stapled Hemorrhoidopexy for Grade III to IV Prolapsing Hemorrhoids: A Randomized, Noninferiority Trial.

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机构: [1]Department of Coloproctology, The Sixth Affiliated Hospital of Sun Yat-sen University (Gastrointestinal & Anal Hospital of Sun Yat-sen University), Guangzhou, China [2]Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China [3]Guangdong Institute of Gastroenterology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China [4]Department of Anaesthesiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China [5]Department of Colorectal Surgery, The Nanjing University of Chinese Medicine Hospital, Nanjing, China [6]School of Basic Medical Science, The Guangzhou University of Chinese Medicine, Guangzhou, China
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关键词: Circumferential stapled hemorrhoidopexy Partial stapled hemorrhoidopexy Prolapsing hemorrhoids Rectal compliance Rectal stricture Rectovaginal fistula Tissue selecting technique

摘要:
Long-term outcomes and efficacy of partial stapled hemorrhoidopexy are not known. The purpose of this study was to compare the long-term clinical efficacy and safety of partial stapled hemorrhoidopexy with circumferential stapled hemorrhoidopexy. This was a parallel group, randomized, noninferiority clinical trial. The study was conducted at a single academic center. Patients with grade III/IV hemorrhoids between August 2011 and November 2013 were included. Three hundred patients were randomly assigned to undergo either partial stapled hemorrhoidopexy (group 1, n = 150) or circumferential stapled hemorrhoidopexy (group 2, n = 150). 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. 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%)). The study was limited because it was a single-center trial. 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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出版当年[2018]版:
大类 | 2 区 医学
小类 | 2 区 外科 3 区 胃肠肝病学
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 外科 3 区 胃肠肝病学
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出版当年[2017]版:
Q1 SURGERY Q2 GASTROENTEROLOGY & HEPATOLOGY
最新[2023]版:
Q1 SURGERY Q2 GASTROENTEROLOGY & HEPATOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2017版] 出版当年五年平均 出版前一年[2016版] 出版后一年[2018版]

第一作者:
第一作者机构: [1]Department of Coloproctology, The Sixth Affiliated Hospital of Sun Yat-sen University (Gastrointestinal & Anal Hospital of Sun Yat-sen University), Guangzhou, China [2]Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China [3]Guangdong Institute of Gastroenterology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China
通讯作者:
通讯机构: [1]Department of Coloproctology, The Sixth Affiliated Hospital of Sun Yat-sen University (Gastrointestinal & Anal Hospital of Sun Yat-sen University), Guangzhou, China [2]Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China [3]Guangdong Institute of Gastroenterology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China [*1]Department of Coloproctology, The Sixth Affiliated Hospital of Sun Yat-sen University, 26 Yuancun Erheng Rd, Guangzhou 510655, China.
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