Clinical trial NCT02849197: Study on Surgical Treatment of Pilonidal Sinus Disease
Official title: Comparative Analysis of the Same technique-the Same Surgeon Approach in the Surgical Treatment of Pilonidal Sinus Disease: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pilonidal Sinus
Keywords: pilonidal sinus
complication
recurrence
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 802
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 1082 patients who were diagnosed with pilonidal sinüs disease and who underwent surgical treatment in a governmental hospital between January 2011 and June 2015.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: through study completion at an average of 36 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bezmialem Vakif University
name: mustafa hasbahceci, assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References: