Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease

Pilonidal Sinus Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Sinus
• Sinus; Dermal, Pilonidal
• Umbilical Granuloma

• NCT number: NCT01662765
• Study type: Interventional
• Source: Medical Park Gaziantep Hospital
• Status: Completed
• Phase: N/A
• Start date: November 2003
• Completion date: May 2012