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New instrument in Fistula-in-ano

Development and Validation of Flexible fistuloscope in the diagnosis of Bhagandar (Fistula-in-ano) - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072409
Enrollment
30
Registered
2024-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K603- Anal fistula Health Condition 2: K928- Other specified diseases of the digestive system

Interventions

None listed

Sponsors

KLE Ayurveda Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients above the age of 18 years and below 70 years irrespective of caste, gender, religion and socio-economic status. 2. Clinical signs and symptoms of all types of Bhagandara [10] 3. All Bhagandara including Recurrent Fistula- in-Ano 4. Patients fit for surgery 5. Patients who are willing to enrol in the study by giving written consent

Exclusion criteria

Exclusion criteria: 1. Patients with H/O secondary fistula like- Ulcerative colitis, Crohn’s disease, Tuberculosis, Hidradenitis Suppurativa, Carcinoma of rectum& anal canal [11] 2. Patients with H/O other systemic illness like uncontrolled hypertension and uncontrolled diabetes mellitus, HIV and HBsAg positive patient 3. Pregnancy and lactating women. 4. Patients with H/O fistula having no discharge, no external opening and chronic with history more than 5 years. 5. High anal fistula.

Design outcomes

Primary

MeasureTime frame
To enhance the accuracy and efficiency of diagnosing Bhagandar (Fistula-in-Ano) through the development and clinical validation of an innovative flexible fistuloscope.Timepoint: 1 day

Secondary

MeasureTime frame
NilTimepoint: N/A

Countries

India

Contacts

Public ContactDr Pradeep S.Shindhe

KAHERs Shri BMK Ayurved Mahavidyalaya Shahapur Belagavi Karnataka India

pshindhe@gmail.com9986331357

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026