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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01044589
Other study ID # 09-008
Secondary ID
Status Completed
Phase N/A
First received January 7, 2010
Last updated April 17, 2017
Start date May 2010
Est. completion date December 2014

Study information

Verified date April 2017
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Female

- Age 18 years or older

- fecal incontinence due to an anterior defect in the external anal sphincter or both external and internal anal sphincter muscles

- Fecal incontinence severity score of 10 or more

- Fecal incontinence episodes of 4 or more over a 2 week period

Exclusion Criteria:

- History of diabetes

- History of allergy to porcine derivatives

- History of infection in the anal area (abscess, fistula)

- History of inflammatory bowel disease

- History of hidradenitis suppurativa

- History of immunosuppression

- History of HIV positivity

- History of radiation to the study site within the last 12 months

- Patients who cannot travel to keep follow up appointments

- Patients who are prisoners

- Patients who are mentally handicapped

- Patients who are pregnant or plan to become pregnant during the study period, or who are currently breastfeeding

- Patients with significant posterior pelvic organ prolapse and who would be candidates for concomitant treatment.

- Patients with a FIQL baseline score of = 4

- Patients participating in another clinical trial for the same indication

- Patients unwilling to give informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Biodesign Tissue Repair Graft
Biodesign Tissue Repair Graft reinforcement
Other:
Overlapping Sphincter Repair
Overlapping Sphincter Repair Alone

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
Massarat Zutshi Cook

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of incontinence episodes per week 12 months
Secondary Change in Quality of Life 24 months
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