Health Condition 1: K602- Anal fissure, unspecified Health Condition 2: 8- Other Procedures
Conditions
Interventions
Intervention1: Sitz Bath + Topical Agents: In addition to the topical agents, patients will perform standardized warm sitz baths: sit in warm (38 40 C) water for 10 minutes, thrice daily and after eac
Sponsors
All India Institute of Medical Sciences Bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 15 to 75 years Clinical diagnosis of acute fissure-in-ano symptom duration less than 6 weeks and confirmed on examination Able to give informed consent and comply with study procedures
Exclusion criteria
Exclusion criteria: Chronic fissure (duration less than 6 weeks sentinel pile hypertrophied papilla or previous fissure surgery Concurrent anorectal pathology requiring surgery eg abscess fistula malignancy Active inflammatory bowel disease tuberculosis immune suppression, or uncontrolled diabetes HbA1c more than 8.5 percent Pregnancy Known allergy intolerance to study topical agents nifedipine diltiazem GTN Inability to perform sitz baths eg severe mobility issues or lack of access to facilities Participation in another interventional trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with complete fissure healing at 4 weeks, defined as epithelialisation of fissure on clinical examination by a blinded assessor.Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pain worst pain during defecation from baseline to 4 weeks measured by VAS 0 10 REALISE Score from baseline to 4 weeks Patient satisfaction by PGI-I at 4 weeks Health-related quality of life change HEMO-FISS Questionnaire baseline to 4 weeks Proportion with recurrence or persistent symptoms at 3 months Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Pankaj Kumar
All India Institute of Medical Sciences Bhubaneswar
Outcome results
None listed