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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01662765
• Other study ID #: MK-003-UPS
• Status: Completed
• Phase: N/A
• First received: August 8, 2012
• Last updated: August 9, 2012
• Start date: November 2003
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: Medical Park Gaziantep Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Intervention

Procedure:
• Surgery
modified umbilectomy

Other:
• conservative
this treatment will include conservative procedures under local anesthesia for patient comfort.

Locations

Country	Name	City	State
Turkey	25 Aralik Familiy Physician Health Center	Gaziantep
Turkey	Dr.Ersin Arslan State Hospital	Gaziantep
Turkey	Hatem Hospital	Gaziantep
Turkey	Medical Park Gaziantep Hospital	Gaziantep
Turkey	Sehitkamil State Hospital	Gaziantep

Sponsors (2)

Lead Sponsor	Collaborator
Medical Park Gaziantep Hospital	Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	costs	from initial treatment to the complete healing, all kind of cost will be calculated.	two year	No
Primary	cure rate	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.	2 year after initial treatment	No
Secondary	healing time	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.	two year	No
Secondary	complications	formation chronic non-healing wound, bleeding, and infection	two years	No
Secondary	patient satisfaction	it will evaluated in five categories as follow: very satisfied, satisfied, not bad, unsatisfied, worst	two years	No

External Links

•   main study center