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Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial


N/A
N/A
N/A
Not Enrolling
Both
Pilonidal Sinus, Sinus; Dermal, Pilonidal, Umbilical Granuloma

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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

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