Anal fissure. Anal fissure, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Topical ointment of 3% sodium pentaborate, which is made under GLP and GMP conditions at Yeditpe University in Turkey and is applied to the wound for 14 days (2 wee
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Chronic anal fissure that is detected in the perineal area by direct observation or rigid anoscopy or flexible colonoscopy.
Exclusion criteria
Exclusion criteria: Existence of any perineal complications including dermatitis, wart, condyloma, hemorrhoids, fistula, anal abscess 2. Proven Crohn's disease 3. Existence of lateral fissure 4. Patients with sodium pentaborate allergy 5. Pregnancy or breastfeeding 6. Patients with a history of serious cardiovascular, hepatic, renal and blood diseases 7. Taking any topical anal medication during the last 7 days 8. Prohibition of topical use of sodium pentaborate being under the age of 18
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anal itching. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient.;Anal bleeding. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient, inspection of anus and digital rectal examination.;Anal pain at rest. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient.;Anal pain during defecation. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient.;Bleeding from the fissure during the examination. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Inspection of anus and digital rectal examination.;Pain at the Fissure site during the examination. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient, inspection of anus and digital rectal examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anal pain during defecation. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient.;Feeling of a mass around the anus. Timepoint: At the beginning of the study (before the intervention) and 14 days (2 weeks) after starting the ointment. Method of measurement: Ask the patient. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactManouchehr Khoshbaten
Tabriz University of Medical Sciences
Outcome results
None listed