Partial Stapled Hemorrhoidopexy Versus Circumferential Stapled Hemorrhoidopexy for Grade III to IV Prolapsing Hemorrhoids: A Randomized, Noninferiority Trial.
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中山大学附属第六医院[2]Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China中山大学附属第六医院[3]Guangdong Institute of Gastroenterology, The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, China中山大学附属第六医院[4]Department of Anaesthesiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China中山大学附属第一医院[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
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.
基金:
Touchstone International
Medical Sciences Co, Ltd (Suzhou, China), and it was used for the
launch meeting of this study. Dr Lin is supported by the National Key
Clinical Discipline Medical Scientific Research Foundation of Guangdong
Province, China (grant A2015180), the National Natural Science
Foundation of China (grant 81603628), and Sun Yat-Sen University
Clinical Research 5010 Program (grant 2017017).
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.
推荐引用方式(GB/T 7714):
Lin Hong-Cheng,He Qiu-Lan,Shao Wan-Jin,et al.Partial Stapled Hemorrhoidopexy Versus Circumferential Stapled Hemorrhoidopexy for Grade III to IV Prolapsing Hemorrhoids: A Randomized, Noninferiority Trial.[J].DISEASES OF THE COLON & RECTUM.2019,62(2):223-233.doi:10.1097/DCR.0000000000001261.
APA:
Lin Hong-Cheng,He Qiu-Lan,Shao Wan-Jin,Chen Xin-Lin,Peng Hui...&Ren Dong-Lin.(2019).Partial Stapled Hemorrhoidopexy Versus Circumferential Stapled Hemorrhoidopexy for Grade III to IV Prolapsing Hemorrhoids: A Randomized, Noninferiority Trial..DISEASES OF THE COLON & RECTUM,62,(2)
MLA:
Lin Hong-Cheng,et al."Partial Stapled Hemorrhoidopexy Versus Circumferential Stapled Hemorrhoidopexy for Grade III to IV Prolapsing Hemorrhoids: A Randomized, Noninferiority Trial.".DISEASES OF THE COLON & RECTUM 62..2(2019):223-233