Treatment Of Chronic Anal Fissure

• Status: Terminated
• Trial end date: 2018-02-05
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of Levorag Emulgel compared with diltiazem gel on the healing of chronic anal fissures.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bispebjerg Hospital
• Collaborators: Sacomed; Sacomed ApS
• Treatments: Diltiazem

Criteria

Inclusion Criteria:

1. Danish citizens, age ≥ 18 years

2. Presence of a midline anal fissure, dorsal or ventral

3. Pain during and after defecation lasting for more than 8 weeks

4. Presence of a sentinel anal tag or hypertrophic papilla

5. Exposure of the horizontal fibres of the internal anal sphincter

1-3 has to be fulfilled for inclusion. Additionally 4 AND/OR 5 has to be present

Exclusion Criteria:

1. Inflammatory bowel disease, known venereal disease, immunodeficiency disease

2. Anal/perianal abscess

3. Anal or rectal surgery within 12 weeks

4. Pregnancy or breastfeeding females

5. History of migraine or chronic headache requiring treatment with analgetics

6. Any cardiovascular or cerebrovascular disease

7. Current use of calcium channel blockers in general or history of use of calcium channel blockers in the treatment of the fissure

8. Signs of other rectal diseases, fistula, infection including severe perianal eczema and tumours