Trial Information
Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial
Inclusion Criteria:
- all patients willing to participate to the study with the diagnosis of umbilical
pilonidal sinus
Exclusion Criteria:
- no informed consent
- serious coagulation abnormalities
- known allergy to local anesthetics
- pregnancy, or women who refused contraception at the time of treatment
- other concomitant umbilical pathologies such as umbilical hernia, granuloma, dermoid
cyst
- the patients who diagnosed with urachal and omphalomesenteric anomalies through
radiological investigation
- patients who underwent umbilical operation
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
cure rate
Outcome Description:
Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure. In contrast, a 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.
Outcome Time Frame:
2 year after initial treatment
Safety Issue:
No
Principal Investigator
Mehmet KAPLAN, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical Park Gaziantep Hospital, Gaziantep, Turkey
Authority:
Turkey: Ethics Committee
Study ID:
MK-003-UPS
NCT ID:
NCT01662765
Start Date:
November 2003
Completion Date:
May 2012
Related Keywords:
- Pilonidal Sinus
- Sinus; Dermal, Pilonidal
- Umbilical Granuloma
- Umbilical pilonidal sinus
- Treatment
- Surgery
- Conservative
- Investigational treatment
- After care
- Granuloma
- Pilonidal Sinus