Pilonidal Disease Clinical Trial
Official title:
Open Wide Excision Versus Minimal Surgery for Pilonidal Disease: A Randomized Control Trial Evaluating for Early Recurrence and Patient Satisfaction
Pilonidal disease, a chronic infection involving the skin and subcutaneous tissues along the
sacrococcygeal area (natal cleft) is a common disease affecting mostly young adult males who
make up the majority of our military workforce. Surgical treatment options for pilonidal
disease vary widely from the invasive (e.g. wide open excisions) to minimally invasive
procedures (e.g. removal of lined sinus tracts using minimal excisions) as well as other
popular treatments involving myocutaneous or skin flaps (Limberg flap and Z-plasty). All of
these surgical procedures are associated with varying degrees of early and late recurrence
rates; however, the current, more popular procedure for the treatment of pilonidal disease
involves wide open excisions.
A recent advancement in the minimally invasive surgical technique for pilonidal disease
involves the use of Keyes trephines (a 2-to-9 mm diameter biopsy instrument) to excise the
individual pits and to drain the cyst cavities. Although this procedure has been proven to
be effective against pilonidal disease with an overall low early recurrence rate, no
clinical trial has been performed to rate this procedure of minimal excisions against the
current, more common procedure of wide open excisions. A recent report has suggested that
the recurrence rate of pilonidal disease for minimal excisions may be comparable to that of
wide excisions. Furthermore, reports have also suggested that this minimally invasive
procedure can be performed with minimal (and possibly local) anesthesia, less post-operative
pain medication, and may involve a shorter convalescence time for patients.
In order to compare the early recurrence rates of pilonidal disease and overall patient
satisfaction between procedures involving minimal and wide open excisions, we propose to
perform a prospective, randomized clinical trial comparing these two surgical procedures.
Randomly assigned patients will undergo either 1) wide excisions of all pilonidal-diseased
tissue (e.g. pits, cavity, sinus tracts), including a surrounding rim of normal tissue and
left open to heal, or 2) minimal excisions of lined sinus tracts using varying sized
trephines. Overall patient satisfaction will be evaluated by the amount of analgesic used
for the procedure, the number of dressing changes, the length of convalescence, and overall
patient tolerance of the procedures, both intra- and post-operatively. In addition, varying
data points will be collected with the use of a quality of life survey and visual analog
pain scale to analyze overall patient satisfaction. Patients will be followed for a period
of two years following surgery to evaluate for early recurrence of their pilonidal disease.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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