Status:
UNKNOWN
Napoleon Trial: Optimal Treatment for Recurrent Haemorrhoidal Disease
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Hemorrhoids
Eligibility:
All Genders
18+ years
Phase:
NA
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 treatm...
Detailed Description
Haemorrhoidal disease (HD) is the most common type of anorectal complaint in the Netherlands, with an annual prevalence of 10% in general practice. There is level I evidence in literature that the fir...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT04101773
Start Date
March 1 2020
End Date
March 1 2023
Last Update
September 24 2019
Active Locations (16)
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1
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6229HX
2
Ziekenhuisgroep Twente
Almelo, Netherlands
3
Meander Medisch Centrum
Amersfoort, Netherlands
4
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands