NCT04101773

Napoleon Trial: Optimal Treatment for Recurrent Haemorrhoidal Disease

Status unknown NA Last updated 24 September 2019

What this trial tests

NA trial testing RBL versus sutured mucopexy versus haemorrhoidectomy. in Hemorrhoids in 558 participants. Status unknown.

Timeline

1 March 2020

Primary endpoint
1 March 2023

1 March 2023

Quick facts

Lead sponsor	Maastricht University Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	558
Start date	1 March 2020
Primary completion	1 March 2023
Estimated completion	1 March 2023
Sites	16 locations across Netherlands

Drugs / interventions tested

• RBL versus sutured mucopexy versus haemorrhoidectomy.

Conditions studied

• Hemorrhoids — all drugs for Hemorrhoids →

Sponsor

Maastricht University Medical Center

Who can join

18 and older, any sex, with Hemorrhoids. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: There is level I evidence in literature that the first management step of HD is basic treatment, including laxatives and high fibre dieti, ii. The next treatment modality after basic treatment in case of persistent symptoms is rubber band ligation (RBL), which can be repeated if necessary.

There is currently no consensus and a lack of evidence regarding the best treatment option for these patients having recurrent HD: continuing RBL or a surgical intervention. Furthermore, there is no estimate of costs and cost-effectiveness in this patient group.

Objective: The primary objective of this RCT is to compare the effectiveness of RBL, sutured mucopexy and haemorrhoidectomy regarding recurrence and patient-reported symptoms for recurrent grade 2 and 3 HD after at least 2 previous RBL treatments. Secondary objectives are to compare RBL, sutured mucopexy and haemorrhoidectomy for recurrent grade 2 and 3 HD after previous RBL treatments in terms of early and late complications, impact of symptoms on daily activities, patient satisfaction with treatment, health-related quality of life, costs and cost-effectiveness, and budget impact.

Study design: Dutch prospective multicentre randomized controlled trial.

Study population: Patients ≥18 who have recurrent grade 2 or 3 haemorrhoidal disease and who had at least 2 rubber band ligation treatments. In total, 558 patients will be included.

Intervention: Rubber band ligation versus sutured mucopexy versus haemorrhoidectomy. All three interventions are part of Dutch usual care, and serve as each other's control.

Main study parameters/endpoints: Primary outcomes are (1) recurrence and (2) patient-reported symptoms assessed after 12 months. Secondary outcome variables are early and late complications, impact of symptoms on daily activities, patient satisfaction with treatment, health-related quality of life, costs, cost-effectiveness and budget-impact.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Kuiper SZ, Dirksen CD, Kimman ML, Van Kuijk SMJ, et al · · 2020 · cited 7× · PMID 33080380 · DOI 10.1016/j.cct.2020.106177