Effect of Low Level Laser (660 nano meter) on Human Fecal Incontinence

Not Applicable

• Conditions: Faecal incontinence.; Faecal incontinence

• Registration Number: IRCT2016092830033N1
• Lead Sponsor: Vice Chancellor for research of Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Fecal Incontinence with sphincter deficiency; wexner score More than or equal to 8; External sphincter deficiency confirmation with endorectal sonography ; age between 18 to 50 years; Consent for inclusion

Exclusion criteria: Fecal Incontinence without sphincter deficiency; Pregnancy or breast-feeding; Participating in a clinical trial within 30 days ago; History of artificial sphincter; history of vaginal delivery over the last 6 months; Chronic and autoimmune disease; age less than 18 and more than 50 years.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wexner Score. Timepoint: 2 months after intervention. Method of measurement: Wexner Schedule (Standard schedule for assessment of fecal incontinence according to patient history).

Secondary Outcome Measures

Name	Time	Method
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.;Muscle specific marker identification. Timepoint: Four weeks after intervention. Method of measurement: Immunohistochemistry.;Measurement of wound healing growth factors. Timepoint: Four weeks after intervention. Method of measurement: western blotting.