Patient satisfaction in the treatment of anal fissure
| ISRCTN | ISRCTN85367943 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85367943 |
| Secondary identifying numbers | NTR441; 2004/149 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 14/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr W.F. Tets
Scientific
Scientific
Sint Lucas Andreas Ziekenhuis
Department Surgery
P.O. Box 9243
Amsterdam
1006 AE
Netherlands
| w.vantets@slaz.nl |
Study information
| Study design | Multicentre randomised single blind active controlled parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Treatment of anal fissure with isosorbide dinitrate (ISDN) or Botulinum toxin A gives approximately comparative outcomes. Because of intensive treatment with isosorbide dinitrate cream, patients treated with Botulinum toxin A will be more satisfied. After six weeks treatment with Botulinum toxin A, the patient satisfaction will be significant more than patients treated with isosorbide dinitrate. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Anal fissure |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Botulinum toxin A (Dysport®), isosorbide dinitrate |
| Primary outcome measure | 1. Patient satisfaction after 6 weeks 2. Visual Analogue Score on weeks 0, 6 and 12 |
| Secondary outcome measures | 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 |
| Overall study start date | 08/11/2004 |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/11/2004 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Sint Lucas Andreas Ziekenhuis
Amsterdam
1006 AE
Netherlands
1006 AE
Netherlands
Sponsor information
Ipsen Farmaceutica B.V. (Netherlands)
Not defined
Not defined
Hoofdweg Oostzijde 620
Hoofddorp
2132 MJ
Netherlands
| Website | http://www.ipsen.com |
|---|---|
"ROR" |
https://ror.org/026jmga48 |
Funders
Funder type
Industry
Ipsen Farmaceutica B.V. (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
