1. Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial)
- Author
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Carmen D. Dirksen, S.M.M. de Castro, Angus Watson, Merel Kimman, S.W. Polle, E. Schipper, C. I. M. Baeten, A.H.W. Schiphorst, Sara Z. Kuiper, Jean W M Muris, Sander M. J. van Kuijk, Jarno Melenhorst, R.M. Smeenk, M.F. Lutke Holzik, J. M. T. Omloo, A.L.A. Bloemendaal, Robin R. Van Tol, Pascal G. Doornebosch, José M.C. Maessen, Esther C. J. Consten, Stéphanie O. Breukink, W. Vening, Jeroen Heemskerk, F.J. Vogelaar, F. M. H. van Dielen, Surgery, RS: NUTRIM - R2 - Liver and digestive health, MUMC+: KIO Kemta (9), Health Services Research, RS: CAPHRI - R2 - Creating Value-Based Health Care, Epidemiologie, Family Medicine Education, RS: CAPHRI - R5 - Optimising Patient Care, MUMC+: MA Heelkunde (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, and Robotics and image-guided minimally-invasive surgery (ROBOTICS)
- Subjects
Hemorrhoidectomy ,Quality of life ,medicine.medical_specialty ,Haemorrhoidectomy ,Cost effectiveness ,IMPACT ,medicine.medical_treatment ,Cost-Benefit Analysis ,Rectum ,Rubber band ligation ,GUIDELINES ,DIAGNOSIS ,Hemorrhoids ,GUIDE ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,ARTERY LIGATION ,Randomized controlled trial ,law ,Recurrence ,medicine ,MANAGEMENT ,Humans ,Multicenter Studies as Topic ,Pharmacology (medical) ,030212 general & internal medicine ,Randomized Controlled Trials as Topic ,Pregnancy ,030505 public health ,business.industry ,General Medicine ,medicine.disease ,Surgery ,Quality-adjusted life year ,medicine.anatomical_structure ,Treatment Outcome ,Sutured mucopexy ,Haemorrhoidal disease ,Sphincter ,UPDATE ,Neoplasm Recurrence, Local ,0305 other medical science ,business - 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
- Published
- 2020