Study on Surgical Treatment of Pilonidal Sinus Disease

Pilonidal Sinus Clinical Trial

Official title:

Comparative Analysis of the Same technique-the Same Surgeon Approach in the Surgical Treatment of Pilonidal Sinus Disease: A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849197
• Other study ID #: PilonidalSinus-EK/MH
• Status: Completed
• Phase: N/A
• First received: July 20, 2016
• Last updated: July 26, 2016
• Start date: January 2011
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Buyukmekmece State Hospital
• Study type: Observational

Clinical Trial Summary

Comparison of limited excision-primary closure, Limberg, and modified Limberg flap techniques for the surgical treatment of pilonidal sinus disease, each performed by a separate surgeon, in terms of postoperative outcomes and recurrence rates.

Description:

Pilonidal sinus disease (PSD) is a common chronic disease that generally affects young adults below the age of 45. It is most commonly observed at the inter-gluteal region, though it may also affect other sites like the umbilicus and the inter-digital area, particularly among in barbers. The disease was long thought to be either congenital or acquired; although in recent years it has been more widely viewed as an acquired disease. The etiology of PSD is not fully understood, however, the most important cause is believed to be fallen hairs accumulating within skin folds and implanting within the skin. The skin becomes more prone to maceration, sweating and bacterial contamination, which facilitates implantation of fallen hairs, creating the necessary conditions for development of the disease. Although PSD is a benign disease, it produces symptoms such as pain and discharge, which adversely affect patient quality of life.

There are many approaches for treatment of the disease, including several surgical methods such as limited or large excision, primary closure, or flap techniques, and many other non-surgical methods. However, no consensus has been reached regarding the ideal treatment method. An ideal surgical treatment reduces recurrence and complication rates, and allows for minimal hospitalization and rapid return to daily activities. Among patients treated using the limited excision and primary closure method, the presence of a natal cleft is associated with higher morbidity, resulting in recurrence rates of 7-42%. For techniques that use the flap approach, this rate decreases to 0-3%. In patients undergoing the Rhomboid excision and Limberg flap techniques, which require a larger surgical area compared to the limited excision and primary closure methods, complication rates are lower, and length of hospital-stay and time to return to work are reduced. However, using the classical Limberg flap technique, maceration and scar formation due to sutures in the inter-gluteal sulcus, and the accumulation of hair at the midline may result in recurrence. Application of a modified Limberg technique that includes lateralization of the middle line can help reduce wound complications and recurrence rates. Several publications report contradicting results regarding surgical outcomes using the same technique, which may be attributable to differences in practice between surgeons. Therefore, it can be logical to explore the superiority of any type of surgical technique performed by the same surgeon for the surgical treatment of pilonidal sinus disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 802
• Est. completion date: April 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients who were diagnosed with pilonidal sinus disease and who underwent surgical treatment in a governmental hospital between January 2011 and June 2015

Exclusion Criteria:

• patients with incomplete personal and medical data and who could not be contacted by direct interview or by telephone

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

Procedure:
• surgery for pilonidal sinus disease
surgical treatment of pilonidal sinus disease via primary closure, Limberg flap0 technique and Modified Limberg flap technique.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		through study completion at an average of 36 months	No