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

Effect of Low Level Laser (660 nano meter) application on External Anal Sphincter Repair and Fecal Incontinence

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016092830033N1
Enrollment
30
Registered
2016-10-13
Start date
2016-12-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Faecal incontinence. Faecal incontinence

Interventions

Intervention 1: Intervention group: Surgical repair of external anal sphincter and laser 660 nano meter irradiation for two weeks period, daily, two minutes per day. Intervention 2: Control group: Sur
Treatment - Surgery
Intervention group: Surgical repair of external anal sphincter and laser 660 nano meter irradiation for two weeks period, daily, two minutes per day
Control group: Surgical repair of external anal sphincter

Sponsors

Vice Chancellor for research of Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime 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

MeasureTime 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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArash Sarveazad

Colorectal Research Center, Iran University of Medical Sciences

Arashsarveazad@yahoo.com+98 21 6655 4790

Outcome results

None listed

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