Patient satisfaction in the treatment of anal fissure.

Prospective randomised multicentre trial of satisfaction of treatment of anal fissure with isosorbide dinitrate or botuline toxin A injections.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27756

Enrollment

Registered

2005-09-09

Start date

2004-11-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
1. Patient satisfaction after 6 weeks; 2. Visual Analoge Score on week 0,6 and 12.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactW.F. Tets

Sint Lucas Andreas Ziekenhuis, Department of Surgery, P.O. Box 9243

w.vantets@slaz.nl

Outcome results