Effectiveness and cost-effectiveness of rubber band ligation versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent haemorrhoidal disease (Napoleon trial): Study protocol for a multicentre randomized controlled trial |
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| Affiliation: | 1. Groene Hart Medical Centre, Gouda, the Netherlands;2. Reinier de Graaf Medical Centre, Delft, the Netherlands;3. Onze Lieve Vrouwe Medical Centre, Amsterdam, the Netherlands;4. Meander Medical Centre, Amersfoort, the Netherlands;5. Máxima Medical Centre, Veldhoven, the Netherlands;6. IJsselland Medical Centre, Capelle a/d IJssel, the Netherlands;7. Laurentius Medical Centre, Roermond, the Netherlands;8. Hospital Group Twente, Almelo, the Netherlands;9. Gelre Medical Centre, Apeldoorn, the Netherlands;10. Canisius Wilhelmina Medical Centre, Nijmegen, the Netherlands;11. Diakonessenhuis, Utrecht, the Netherlands;12. Elkerliek Medical Centre, Helmond, the Netherlands;13. Albert Schweitzer Medical Centre, Dordrecht, the Netherlands;14. Rijnstate Medical Centre, Arnhem, the Netherlands;15. VieCuri Medical Centre, Venlo, the Netherlands;1. Department of Surgery, Maastricht University, School of Nutrition and Translational Research in Metabolism (NUTRIM), Universiteitssingel 50, 6229, ER, Maastricht, the Netherlands;2. Department of Clinical Epidemiology and Medical Technology, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Oxfordlaan 10, 6202, AZ, Maastricht, the Netherlands;3. Department of Surgery, Diakonessenhuis Medical Centre, Bosboomstraat 1, 3582, KE, Utrecht, the Netherlands;4. Department of Family Medicine, Maastricht University, Care and Public Health Research Institute (CAPHRI), Universiteitssingel 40, 6229, ER, Maastricht, the Netherlands;5. Department of Surgery, Raigmore Hospital, Old Perth Road, IV2 3UJ Inverness, United Kingdom;6. Department of Quality and Safety, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands;7. Department of Surgery, Maastricht University Medical Centre, P. Debyelaan 25, 6229 HX Maastricht, the Netherlands;8. Department of Surgery, Maastricht University, School of Nutrition and Translational Research in Metabolism (NUTRIM), School for Oncology and Developmental Biology (GROW), Universiteitssingel 50, 6229, ER, Maastricht, the Netherlands |
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| Abstract: | BackgroundCurrently, 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.MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.gov identifier: NCT04101773 |
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