Open Wide Excision Versus Minimal Surgery for Pilonidal Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01241136|
Recruitment Status : Unknown
Verified November 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was: Recruiting
First Posted : November 16, 2010
Last Update Posted : November 16, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Pilonidal Disease||Procedure: open wide-excision pilonidal cystectomy Procedure: minimal invasive pilonidal cystotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Open Wide Excision Versus Minimal Surgery for Pilonidal Disease: A Randomized Control Trial Evaluating for Early Recurrence and Patient Satisfaction|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||December 2014|
Placebo Comparator: Open traditional pilonidal cystectomy
traditional complete wide-excision pilonidal cystectomy
Procedure: open wide-excision pilonidal cystectomy
traditional open wide-excisional pilonidal cystectomy
Experimental: Minimal invasive pilonidal cystotomy
Using only Keyes Trephines to unroof and curette the pilonidal cyst cavity
Procedure: minimal invasive pilonidal cystotomy
unroofing the cyst cavity and curettage the cyst
- Rate of early recurrence [ Time Frame: 2 years ]After surgical interventions, to see after 2 years the rate of recurrence of pilonidal disease
- Tolerance of the procedure [ Time Frame: 30 days ]Determine wound healing times and amount of convalescence associated with each procedure
- Patient satisfaction [ Time Frame: 30 days ]Determine patient satisfaction factors using the quality of life survey and the post-operative visual analog pain scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241136
|Contact: Ellie Mentler, MDfirstname.lastname@example.org|
|United States, Virginia|
|Naval Medical Center Portsmouth||Recruiting|
|Portsmouth, Virginia, United States, 23708|
|Contact: Ellie Mentler, MD 757-953-2454 email@example.com|
|Contact: Charles Morgan, PhD 757-953-5939 firstname.lastname@example.org|
|Sub-Investigator: Cade Cinnamond, DO|
|Sub-Investigator: Ralph Butler, MD|
|Sub-Investigator: Beth Jaklic, MD|
|Sub-Investigator: Christian Corwin, MD|
|Sub-Investigator: Zsolt Stockinger, MD|