Open Wide Excision Versus Minimal Surgery for Pilonidal Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2010 by United States Naval Medical Center, Portsmouth
Sponsor:
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT01241136
First received: November 15, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

November 15, 2010
November 15, 2010
November 2010
December 2014   (final data collection date for primary outcome measure)
Rate of early recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
After surgical interventions, to see after 2 years the rate of recurrence of pilonidal disease
Same as current
No Changes Posted
  • Tolerance of the procedure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Determine wound healing times and amount of convalescence associated with each procedure
  • Patient satisfaction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Determine patient satisfaction factors using the quality of life survey and the post-operative visual analog pain scale.
Same as current
Not Provided
Not Provided
 
Open Wide Excision Versus Minimal Surgery for Pilonidal Disease
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Pilonidal Disease
  • Procedure: open wide-excision pilonidal cystectomy
    traditional open wide-excisional pilonidal cystectomy
  • Procedure: minimal invasive pilonidal cystotomy
    unroofing the cyst cavity and curettage the cyst
  • Placebo Comparator: Open traditional pilonidal cystectomy
    traditional complete wide-excision pilonidal cystectomy
    Intervention: Procedure: open wide-excision pilonidal cystectomy
  • Experimental: Minimal invasive pilonidal cystotomy
    Using only Keyes Trephines to unroof and curette the pilonidal cyst cavity
    Intervention: Procedure: minimal invasive pilonidal cystotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
106
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients who are scheduled for elective surgical treatment for their pilonidal disease

Exclusion Criteria:

  • 1. Any patient with active purulent infection (i.e. abscess). 2. Any patient who has had surgical intervention, excepting incisions and drainage for abscess for pilonidal disease.
Both
17 Years and older
No
Contact: Ellie Mentler, MD 757-953-2454 ellie.mentler@med.navy.mil
United States
 
NCT01241136
CIP# 10.0041
Yes
LT Ellie Mentler, United States navy
United States Naval Medical Center, Portsmouth
Not Provided
Not Provided
United States Naval Medical Center, Portsmouth
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP