Clinical Trial: Study on Surgical Treatment of Pilonidal Sinus Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

Brief 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.

Detailed Summary:

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 th
Sponsor: Bezmialem Vakif University

Current Primary Outcome: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: through study completion at an average of 36 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bezmialem Vakif University

Dates:
Date Received: July 20, 2016
Date Started: January 2011
Date Completion:
Last Updated: July 26, 2016
Last Verified: July 2016