Faecal incontinence. Faecal incontinence
Conditions
Interventions
Intervention 1: Intervention group: External anal sphincter muscle repair and 20 milions hADSCs ( suspended in 3 ml Phosphate Buffer Solution) implantation in the external anal sphincter is done. Int
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Inclusion criteria
Inclusion criteria: Age?>25 years Wexner score?=?8 Confirmation of external anal sphincter defect with endorectal ultrasonography Patient consent for inclusion
Exclusion criteria
Exclusion criteria: Pregnancy and breastfeeding Participating in other trials within the past 30 days History of artificial sphincter Vaginal delivery within the past 6 months Presence of chronic diseases Autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wexner Score. Timepoint: 2 months after intervention. Method of measurement: Wexner Schedule (Standard schedule for assessment of fecal incontinence according to patient history).;Rate of wound closure. Timepoint: Immediately after surgery to wound closure. Method of measurement: Experienced surgeon view. | — |
Secondary
| Measure | Time frame |
|---|---|
| External anal sphincter action potential record in the defect site. Timepoint: Two months after intervention. Method of measurement: Electromyography.;External anal sphincter morphology. Timepoint: Two months after intervention. Method of measurement: Endorectal Sonography.;Amount of muscle in the external anal sphincter defect site. Timepoint: Two months after intervention. Method of measurement: Image J software. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArash Sarveazad
Iran University of Medical Sciences
Outcome results
None listed