Pilonidal Sinus Clinical Trial
Official title:
Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial
The Investigator's information in the Responsible Party data elements is not properly
formatted. Please provide the investigator's "Official Title" (e.g., Director, Head of
Otolaryngology, Principal Investigator, Clinical Professor).Pilonidal sinus disease is a
common health problem. It is seen most frequently in the sacrococcygeal region. However, it
can also observed in the umbilicus. Although rare, umbilical pilonidal sinus (UPS) disease,
is still poorly understood both in terms of diagnosis or pathophysiology and the best
treatment options. The incidence and the prevelance of the disease is thought to be 0.6% and
%0.1, respectively, and is more common in males.
Pilonidal sinus disease of the umbilicus is caused by hair penetrating the skin, causing a
foreign-body reaction and development of a sinus lined with granulation tissue. Most of the
patients complain of pain, discharge or bleeding from the umbilicus when symptoms develop.
It can be diagnosed with a careful examination, in which hairs can be seen deep in the
umbilicus and usually protrude from a small sinus.
The first article, which can be considered as umbilical pilonidal sinus disease was first
published by Dr. Warren in 1854, and he described the removal of a sprinkle of hair from the
umbilicus. But the term "umbilical pilonidal sinus" was first described and used by Williams
and Patey in 1956. Since this initial reference to umbilical pilonidal sinus there have been
approximately only 30 reports in the literature. Most of them are case reports and remaining
consists of small case series. But until now no prospective randomised studies have been
published related to UPS.
UPS is one of the most neclected disease that few reported studies and lack of the
prospective randomised studies in the literature, and no cosensus about the treatment of the
disease supports this idea. However, it may be actually more common than thought and may be
found more frequently if sought specifically.
The aim of the study was to compare the results of conservative and surgical treatment, to
create an algorithm for the management of the disease, and gain more information about the
etiologiy, pathogenesis, and course of the disease. The investigators hypothesise that
surgical treatment of UPS will be better than conservative management in terms of recurrence
rate, healing time, patient comfort and satisfaction, and cost effectiveness.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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