Chronic Anal Fissure. Chronic Anal Fissure
Conditions
Interventions
Intervention 1: Intervention group: Under local anesthesia (with lidocaine 5% gel) on left sided or knee elbow position. BTA is injected into the internal anal sphincter on the both sides of anterior
internal sphincter muscle fibers were partially
cut at 3 o’clock position under direct visualization with a transverse incision up to the height of
the fissure apex using a cautery. In this study, s
Treatment - Drugs
Treatment - Surgery
Intervention group: Under local anesthesia (with lidocaine 5% gel) on left sided or knee elbow position. BTA is injected into the internal anal sphincter on the both sides of anterior midline in equal
Control group:
under spinal anesthesia in the lithotomy position
internal sphincter muscle fibers were partially
cut at 3 o’clock position under direct visualization with a transverse incision up to the height of
the fissure apex using a cautery. In this study,
Sponsors
Vice chancellor for research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: diagnosis of chronic anal fissure on physical examination (based on having indurations at the edges and having at least two criteria of these three including skin tag; hypertrophied anal papillae and exposed internal sphincter muscle fiber) by an experienced colorectal surgeon associated with painful defecation for at least 2 month; age between 18 and 100 years old. Exclusion criteria: acute anal fissure (experiencing symptoms less than two months); pregnancy; secondary anal fissure; hypersensitivity to DTZ or BTA; cardiovascular disease; previous history of anal surgery; atypical fissure and chronic headache.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing. Timepoint: one week, 1,2,6 and 12 months postoperatively. Method of measurement: Complete Wound Healing (macroscopic epithelialization). | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications. Timepoint: , one week, 1,2,6,12 months postoperatively. Method of measurement: physical examination and history taking, VAS.;Induration, hypertrophied papilla, exposing internal anal sphincter,skin tag. Timepoint: before and after surgery. Method of measurement: physical examination.;Pain. Timepoint: before treatment, 1 week, 1,2,6 and 12 months postoperatively. Method of measurement: visual analog scale.;Chronicity of fissure. Timepoint: before treatment. Method of measurement: history taking.;Fissure localization. Timepoint: before treatment. Method of measurement: physical examination.;Bleeding. Timepoint: before treatment, 1 week, 1,2,6 and 12 months postoperatively. Method of measurement: history taking.;Pain at night. Timepoint: before treatment, 1 week, 1,2,6 and 12 months postoperatively. Method of measurement: history taking.;Recurrence. Timepoint: 1 ,2,6 and 12 month postoperatively. Method of measurement: history taking and physical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReza Heydari
Tehran University of Medical Sciences, Medical School
Outcome results
None listed