No registrations found.
ID
Source
Brief title
Sponsors and support
Hoofdweg Oostzijde 620
2132 MJ Hoofddorp nederland
tel: 023-5541600
fax: 0235541609
www.IPSEN.NL@IPSEN.com
www.ipsen.com
Hoofdweg Oostzijde 620
2132 MJ Hoofddorp nederland
tel: 023-5541600
fax: 0235541609
www.IPSEN.NL@IPSEN.com
www.ipsen.com
Intervention
Outcome measures
Primary outcome
1. Patient satisfaction after 6 weeks;
2. Visual Analoge Score on week 0,6 and 12.
Secondary outcome
1. 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.
Background summary
Prospective randomised multicentre trial of satisfaction of treatment of anal fissure with isosorbide dinitrate or botuline toxin A injections.
Study objective
Treatment 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.
Study design
N/A
Intervention
ISDN1% 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.
Department of Surgery,
P.O. Box 9243
W.F. Tets
Jan Tooropstraat 164
Amsterdam 1006 AE
The Netherlands
w.vantets@slaz.nl
Department of Surgery,
P.O. Box 9243
W.F. Tets
Jan Tooropstraat 164
Amsterdam 1006 AE
The Netherlands
w.vantets@slaz.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL402 |
| NTR-old | NTR441 |
| Other | : 2004/149 |
| ISRCTN | ISRCTN85367943 |