Napoleon Trial: Optimal Treatment for Recurrent Haemorrhoidal Disease
Cost-effectiveness and Effectiveness of Rubber Band Ligation Versus Sutured Mucopexy Versus Haemorrhoidectomy in Patients With Recurrent Haemorrhoidal Disease: a Multicentre,Randomized Controlled Trial
1 other identifier
interventional
558
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Typical duration for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2019
CompletedFirst Posted
Study publicly available on registry
September 24, 2019
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedSeptember 24, 2019
September 1, 2019
3 years
September 19, 2019
September 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recurrence
The definition of recurrent HD is: "unchanged or worse symptoms of HD compared with before starting treatment".
Assessed after 12 months post-intervention.
Patient-reported symptoms measured with the PROM-HISS
The Patient-Reported Outcome Measure-Haemorrhoidal Impact and Satisfaction Score (PROM-HISS) is a newly developed questionnaire assessing the symptoms of haemorrhoidal disease over time. These are blood loss, pain, prolapse, soiling and itching. These 5 items are graded using a 5-point Likert scale, ranging from (1) 'not at all', (2) 'a little', (3) 'reasonable', (4)'a lot' and (5) 'very much'. This results in a symptom score correlating with the severity of experienced HD symptoms. The PROM-HISS will be completed by e-mail. The PROM-HISS will assess a change of the symptoms over time. ThePROM-HISS is not validated yet, but an international validation study is being developed. Hence, the scale ranges are not clear yet.
The PROM-HISS will be completed by e-mail at four moments during follow-up: (1) at baseline; (2) 7 days; (3) 6 weeks; and (4) 12 months post-procedure.
Secondary Outcomes (10)
Early complication(s) - Abscess
This outcome measure will be assessed within 7 days post-procedure.
Impact of symptoms on daily life and patient satisfaction with treatment
The PROM-HISS will be completed by e-mail at four moments during follow-up: (1) at baseline; (2) 7 days; (3) 6 weeks; and (4) 12 months post-procedure.
Health Related Quality of Life
The PROM-HISS will be completed by e-mail at four moments during follow-up: (1) at baseline; (2) 7 days; (3) 6 weeks; and (4) 12 months post-procedure.
Early complication(s) - Urinary retention
This outcome measure will be assessed within 7 days post-procedure.
Late complication(s) - Incontinence
Incontinence will be assessed at 52 weeks (1 year) post-procedure.
- +5 more secondary outcomes
Study Arms (3)
Rubber Band Ligation (RBL)
OTHERRBL is generallya simple, inexpensive procedure. It entails a ligation of haemorrhoids using rubber bands. In RBL, a disposable suction device applies a rubber band at least 2 cm proximal to the dentate line at the base of each haemorrhoidal cushion by using an anoscope. The banding process causes necrosis of the banded tissue and slough. The resultant inflammatory reaction causes refixation of the mucosa to the underlying tissue, helping to eliminate haemorrhoidal prolapse.The end result is a return of the haemorrhoidal cushions to a more normal size and configuration, with resolution of haemorrhoidal symptoms.
Sutured mucopexy
OTHERA sutured mucopexy is an operation performed under general anaesthesia. At 4 cm proximal of the dentate line, a Z- shaped stitch through the rectal wall is placed and then at the upper level of the haemorrhoidal tissue, pulling up the prolapsing haemorrhoid high into the anal canal.
Haemorrhoidectomy
OTHERHaemorrhoidectomy involves excision of the haemorrhoidal tissue. An elliptical incision is made in the external haemorrhoidal tissue extending proximally through the dentate line to the upper limit of the haemorrhoids. The base of the haemorrhoidal complex is ligated and the haemorrhoid is excised.
Interventions
All 3 interventions are part of Dutch usual care, and serve as each other's control.
Eligibility Criteria
You may qualify if:
- Men and women aged 18 years or older
- Recurrent grade 2 or 3 HD
- Patients underwent at least 2 RBL treatments in the last 3 years based on hospital electronic patient file (EPD)
- Eligible for e-mail questionnaires
- Sufficient understanding of the Dutch written language (reading and writing)
- Obtained written informed consent
You may not qualify if:
- Previous rectal or anal surgery with the exception of rubber band ligation
- Patients that have had previous surgery treatment for HD (at any time)
- Previous rectal radiation
- Pre-existing sphincter injury
- Pathologies of the colon and rectum
- Medically unfit for surgery or for completion of the trial (ASA\>III)
- Pregnancy
- Patients with hypercoagulability disorders
- Patients using Warfarin or Clopidogrel or oral anticoagulance therapy
- Patients that are unable to give full informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Maastricht University Medical Centre
Maastricht, Limburg, 6229HX, Netherlands
Ziekenhuisgroep Twente
Almelo, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
IJsselland Ziekenhuis
Capelle aan den IJssel, Netherlands
Reinier de Graaf Gasthuis
Delft, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Elkerliek Ziekenhuis
Helmond, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Laurentius Ziekenhuis
Roermond, Netherlands
Diakonessenhuis
Utrecht, Netherlands
Máxima Medisch Centrum
Veldhoven, Netherlands
VieCurie Medisch Centrum
Venlo, Netherlands
Related Publications (1)
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. 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. Contemp Clin Trials. 2020 Dec;99:106177. doi: 10.1016/j.cct.2020.106177. Epub 2020 Oct 17.
PMID: 33080380DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stephanie Breukink, MD PhD
Maastricht University Medical Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Due to the comparison of outpatient-based and surgical treatment strategies in this study, blinding to the treatment allocation for patients and medical staff is not possible. The trial statistician will be blinded for the treatment allocation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2019
First Posted
September 24, 2019
Study Start
March 1, 2020
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
September 24, 2019
Record last verified: 2019-09