D2 | Abstract 13

Annual NUTRIM Symposium 18 November 2020


Napoleon Trial: Study protocol for a multicentre randomized controlled trial in recurrent haemorrhoidal disease

S.Z. Kuiper1, C.D. Dirksen2, S.M.J. Van Kuijk2, M.L. Kimman2, R.R. Van Tol3, J.W.M. Muris4, A.J.M. Watson5, J.M.C. Maessen6, J. Melenhorst1, S.O. Breukink1.

1 Department of Surgery, School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, the Netherlands
2 Department of Clinical Epidemiology and Medical Technology, Maastricht University Medical Centre, Maastricht, the Netherlands
3 Department of Surgery, Diakonessenhuis Medical Centre, Utrecht, the Netherlands
4 Department of Family Medicine, Maastricht University, Care and Public Health Research Institute (CAPHRI), Maastricht, the Netherlands
5 Department of Surgery, Raigmore hospital, Inverness, UK
6 Department of Quality and Safety, Maastricht University Medical Centre, Maastricht, the Netherlands
The first management step for haemorrhoidal disease (HD) is basic treatment, including high fibre diet and laxatives. If basic treatment fails, the next step is often rubber band ligation (RBL). Approximately 30% of patients develop a recurrence of HD after RBL. Currently, there is no consensus regarding the best treatment option in recurrent HD, due to a lack of solid evidence. Treatment options include repeat RBL or surgical intervention. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat RBL versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD.

This is a multicentre randomized controlled Dutch 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, oral anticoagulant medication, with the exception of carbasalate calcium (Ascal), 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. Recurrence is defined as “unchanged or worse symptoms of HD”. Secondary outcomes are treatment satisfaction, costs, health-related quality of life, and cost-effectiveness. Cost-effectiveness will be expressed in societal costs per QALY (based on EQ-5D-5L), and healthcare costs per recurrence avoided.

The Napoleon trial is a multicentre randomized controlled trial of patients with recurrent HD grade II and III. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most effective treatment.

Trial registration:
ClinicalTrials.gov NCT04101773

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