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Patient satisfaction in the treatment of anal fissure.


- candidate number1529
- NTR NumberNTR441
- ISRCTNISRCTN85367943
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR9-sep-2005
- Secondary IDs2004/149 
- Public TitlePatient satisfaction in the treatment of anal fissure.
- Scientific TitleProspective randomised multicentre trial of satisfaction of treatment of anal fissure with isosorbide dinitrate or botuline toxin A injections.
- ACRONYMN/A
- hypothesisTreatment of anal fissura with isorsorbide dinitrate or Botuline toxine A gives approximately comparative outcomes. Because of intensive treatment with isosorbide dintrate creme, patient treated with Botuline toxine A wil be more satisfactioned. After six weeks treatment with Botuline toxine A, the patient satisfaction wil be significant more than patients treated with isosorbide dinitrate.
- Healt Condition(s) or Problem(s) studiedAnal fissure
- Inclusion criteria1. Diagnosed anal fissura with complaints;
2. Complaints longer than 2 months;
3. Age 21-60 year;
4. Speaking dutch;
5. Will-competent;
6. Informed consent.
- Exclusion criteria1. Pregnancy, lactation;
2. Muscle-sicknesses such as myasthenia gravis;
3. Simultaneous use of medication interacting with neuromusculair transmission;
4. Fistulas;
5. Coagulation disorders or th use of anticoagulantia;
6. Anal surgery in the past;
7. Haemorrhoiden or inflammatory bowel sicknesses as a cause of anal fissure;
8. Major secundaire changes because of the anal fissure.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 8-nov-2004
- planned closingdate1-jul-2007
- Target number of participants50
- InterventionsISDN1% Creme versus Botuline Toxine A Duration 12 weeks.
ISDN creme application every 4 ours for 12 weeks.
Or Botuline Toxine A injection at week 0 and if neccesary at week 6 again Botuline Toxine A Dysport fabrikant Ipsen.
- Primary outcome1. Patient satisfaction after 6 weeks;
2. Visual Analoge Score on week 0,6 and 12.
- Secondary outcome1. Patientsatisfaction after 12 weeks;
2. Pain after defecation en at night;
3. Incontinence after 6 and 12 weeks;
4. Healing of fissura after 6 and 12 weeks.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. W.F. Tets
- CONTACT for SCIENTIFIC QUERIESDr. Bas Wallis Vries, de
- Sponsor/Initiator Ipsen Farmatherapeutica bv
- Funding
(Source(s) of Monetary or Material Support)
Ipsen Farmatherapeutica bv
- PublicationsN/A
- Brief summaryProspective randomised multicentre trial of satisfaction of treatment of anal fissure with isosorbide dinitrate or botuline toxin A injections.
- Main changes (audit trail)
- RECORD12-sep-2005 - 2-dec-2009


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