anal fissure. Chronic anal fissure
Conditions
Interventions
Intervention 1: Intervention group:?In this group, each patient receives 0.4 ml of Botox divided into two injections of equal volume on both the right and left lateral sides of the fissure. The inject
Sponsors
Khoram-Abad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Individuals must be 18 years of age or older. must have a history of painful anal fissure (AF) for three months (90 days) or longer prior to screening No history of diabetes Presence of a radial fissure with indurated edges observed on anorectal examination Presence of either anterior or posterior anal fissure Presence of a skin tag observed during anorectal examination For individuals who have been using other topical medications, a washout period of at least two weeks prior to the start of the study will be required.
Exclusion criteria
Exclusion criteria: Individuals who are unwilling to undergo AF examination involving the anal canal or perianal region. Individuals who have undergone lateral sphincterotomy, anal dilation, or any previous interventions the anal canal or perianal region.Individuals who have used glyceryl trinitrate (GTN) ointment for more than one week during the 4 weeks prior to the screening visit, within a 6-month period. Anal fissure associated with other conditions (e.g., trauma, HIV infection, fistula, inflammatory bowel disease, perianal sepsis, or malignancy). Individuals who are expected to undergo another treatment plan requiring hospitalization during the study. History of cardiovascular disease, inflammatory bowel disease, chronic fecal incontinence, prior pelvic radiotherapy, fixed anal stenosis/fibrosis, major psychiatric disorders (including cigarette, drug, or alcohol users), or hematologic . Use of investigational drugs within 8 weeks or a period equal to five half-lives prior to screening, whichever is longer. diseases Individuals who may be unavailable during the trial period, are unlikely to comply with the protocol, or are otherwise deemed unsuitable by the physician for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain. Timepoint: 0,1,6,12 weeks. Method of measurement: Improvement of post-defecation anal pain based on the Numerical Rating Scale (NRS): Changes in pain scores were measured at baseline (i.e., before the start of the study) and at 1, 6, and 12 weeks after the start of the study. Pain was assessed using the Numerical Rating Scale, ranging from 0 to 10, where 0 = no pain and 10 = worst possible pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence of the anal fissure. Timepoint: It is measured at 1 week, 6 weeks, and 12 weeks from the start date of the study. Method of measurement: Anatomical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactmohamadkazem shahmoradi
Khoram-Abad University of Medical Sciences
Outcome results
None listed