Safety and efficacy of exosome Injection in perianal fistula
Phase 2
Recruiting
- Conditions
- Complex perianal fistula.
- Registration Number
- IRCT20211212053361N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Age between 18-70 years old
Complex perianal fistula
Informed consent
Exclusion Criteria
Active inflammatory bowel disease
Synchronous perianalabcess
Alcohol, narcotic and stimulant consumption
Having active hepatitis B,C, HIV or TB
Pregnancy and lactation
Uncontrolled diabetes mellitus
Evidence of surgical contraindication
Psychological disorders and noncooperative pateint
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Discharge amount. Timepoint: before and during and 12 weeks after the study. Method of measurement: due to pateint's history.;External orifice reepithelialisation. Timepoint: before and 12 weeks after the study. Method of measurement: clinical examination and MRI.;Inflammation and abcess larger than 2 cm. Timepoint: before and 12 weeks after the study. Method of measurement: MRI.;Quality of life questionair score. Timepoint: before and 12 weeks after the study. Method of measurement: Quality of life questionair in perianal fistula patients.
- Secondary Outcome Measures
Name Time Method