An interventional study of open wide-excision pilonidal cystectomy and minimal invasive pilonidal cystotomy in Pilonidal Disease, sponsored by United States Naval Medical Center, Portsmouth. Withdrawn at 1 site in United States. Open to participants aged 17 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-10-09.
Sponsored by United States Naval Medical Center, Portsmouth · Not applicable, Interventional, and Other
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.
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.
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Exclusion Criteria:
traditional complete wide-excision pilonidal cystectomy
Procedure: open wide-excision pilonidal cystectomy
Using only Keyes Trephines to unroof and curette the pilonidal cyst cavity
Procedure: minimal invasive pilonidal cystotomy
traditional open wide-excisional pilonidal cystectomy
unroofing the cyst cavity and curettage the cyst
Rate of early recurrence
After surgical interventions, to see after 2 years the rate of recurrence of pilonidal disease
Time frame: 2 years
Tolerance of the procedure
Determine wound healing times and amount of convalescence associated with each procedure
Time frame: 30 days
Patient satisfaction
Determine patient satisfaction factors using the quality of life survey and the post-operative visual analog pain scale.
Time frame: 30 days
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United States Naval Medical Center, Portsmouth