Abstract:
BACKGROUND:Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. METHODS:This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. DISCUSSION:The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT04101773.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Kuiper SZ,Dirksen CD,Kimman ML,Van Kuijk SMJ,Van Tol RR,Muris JWM,Watson AJM,Maessen JMC,Melenhorst J,Breukink SO,Napoleon Trial Study Group.doi
10.1016/j.cct.2020.106177subject
Has Abstractpub_date
2020-12-01 00:00:00pages
106177eissn
1551-7144issn
1559-2030pii
S1551-7144(20)30255-Xjournal_volume
99pub_type
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Contemporary clinical trials
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pub_type: 杂志文章,多中心研究,随机对照试验
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