- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03007173
Umbilical Pilonidal Sinus: a Case Report
Umbilical Pilonidal Sinus: an Underestimated and Little-known Clinical Entity - Report of Two Cases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction: Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men with deep navels and poor personal hygiene. It is being diagnosed and reported more frequently; however, there is still no consensus regarding its best treatment options.
Presentation of cases: In this report, we present two cases of UPS, one in a man and one in a woman who had typical symptoms with pain, swelling and intermittent malodorous discharge from the umbilicus. They had small sinus openings with hair protruding deep in the navel. Because patients had previous history of failed conservative treatments an umbilicus preserving surgery was performed for both cases.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gaziantep, Turkey, 27090
- Mehmet Kaplan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- no limitation
Exclusion Criteria:
- patients followed-up less than 2 years
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cure rate
Time Frame: within 2 years of follow-up
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Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure. Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy. |
within 2 years of follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
healing time
Time Frame: within the postoperative 1 month
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the time form initial treatment to healing the wound and/or sinus and/or granulation tissue and no any sign of drainage with no longer need for dressing and wound care in either treatment arms.
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within the postoperative 1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehmet Kaplan, M.D., Medical Park Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MK-013-UPS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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Clinical Trials on Pilonidal Sinus
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