Partial Stapled Hemorrhoidopexy Versus Circumferential Stapled Hemorrhoidopexy for Grade III to IV Prolapsing Hemorrhoids: A Randomized, Noninferiority Trial
| Autor: | Xiao Xue Wang, Wan Jin Shao, Hong Cheng Lin, Xinlin Chen, Shang Kui Xie, Hui Peng, Dong Lin Ren, Qiu Lan He |
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| Rok vydání: | 2018 |
| Předmět: |
Male
medicine.medical_treatment Original Contributions Anorectal Severity of Illness Index Rectovaginal fistula law.invention Tissue selecting technique 0302 clinical medicine Postoperative Complications Randomized controlled trial law Prolapse Rectal compliance Young adult Digestive System Surgical Procedures Pain Measurement Aged 80 and over Pain Postoperative Incidence (epidemiology) Gastroenterology General Medicine Middle Aged Anorectal Malformations Treatment Outcome 030220 oncology & carcinogenesis Stapled hemorrhoidopexy 030211 gastroenterology & hepatology Female Adult medicine.medical_specialty Equivalence Trials as Topic Hemorrhoids 03 medical and health sciences Young Adult Severity of illness Surgical Stapling medicine Humans Aged business.industry medicine.disease Surgery Clinical trial Circumferential stapled hemorrhoidopexy Rectal stricture Partial stapled hemorrhoidopexy business Prolapsing hemorrhoids Fecal Incontinence |
| Zdroj: | Diseases of the Colon and Rectum |
| ISSN: | 1530-0358 |
| Popis: | 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. See Video Abstract at http://links.lww.com/DCR/A790. Trial registration (chictr.org) identifier is chiCTR-trc-11001506. |
| Databáze: | OpenAIRE |
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