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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN85367943 |
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Date of registration:
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27/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Patient satisfaction in the treatment of anal fissure
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Scientific title:
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Date of first enrolment:
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08/11/2004 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN85367943 |
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Study type:
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Interventional |
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Study design:
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Multicentre randomised single blind active controlled parallel trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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W.F.
Tets |
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Address:
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Sint Lucas Andreas Ziekenhuis
Department Surgery
P.O. Box 9243
1006 AE
Amsterdam
Netherlands |
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Telephone:
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Email:
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w.vantets@slaz.nl |
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Affiliation:
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Name:
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Address:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Diagnosed anal fissure with complaints
2. Complaints longer than 2 months
3. Age 21-60 years
4. Dutch speaking
5. Will-competent
6. Informed consent
Exclusion criteria: 1. Pregnancy, lactation
2. Muscle-sicknesses such as myasthenia gravis
3. Simultaneous use of medication interacting with neuromuscular transmission
4. Fistulas
5. Coagulation disorders or the use of anticoagulants
6. Anal surgery in the past
7. Haemorrhoids or inflammatory bowel sicknesses as a cause of anal fissure
8. Major secondary changes because of the anal fissure
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anal fissure
Digestive System
Fissure and fistula of anal and rectal region
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Intervention(s)
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ISDN 1% cream versus Botuline Toxine A for a duration of 12 weeks.
ISDN cream application every 4 hours for 12 weeks.
Botulinum Toxin A injection at week 0 and if necessary again at week 6.
Botulinum Toxin A Dysport® is made by Ipsen.
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Primary Outcome(s)
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1. Patient satisfaction after 6 weeks
2. Visual Analogue Score on weeks 0, 6 and 12
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Secondary Outcome(s)
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1. Patient satisfaction after 12 weeks
2. Pain after defecation at night
3. Incontinence after 6 and 12 weeks
4. Healing of fissure after 6 and 12 weeks
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Secondary ID(s)
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NTR441; 2004/149
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Source(s) of Monetary Support
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Ipsen Farmaceutica B.V. (Netherlands)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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