Faecal Incontinance. Faecal incontinence
Conditions
Interventions
Intervention 1: Intervention group: Surgical repair of external anal sphincter and 6×106 .3ml human adipose drived stem cells implantation in the external anal sphincter by Syringe. Intervention 2: C
Treatment - Surgery
Control group: Surgical repair of external anal sphincter and PBS (3ml) injection in the External anal sphincter by Syringe
Intervention group: Surgical repair of external anal sphincter and 6×106 .3ml human adipose drived stem cells implantation in the external anal sphincter by Syringe
Sponsors
Vice Chancellor for research of Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
25 Years to 55 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Fecal Incontinence with sphincter deficiency; age between 25 to 55 years Exclusion criteria: Fecal Incontinence without sphincter deficiency; age less than 25 and more than 55 years.
Exclusion criteria
Exclusion criteria:
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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of wound closure. Timepoint: Immediately after surgery to wound closure. Method of measurement: Experienced surgeon view.;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
Colorectal Research Center, Iran University of Medical Sciences
Outcome results
None listed