Open Wide Excision Versus Minimal Surgery for Pilonidal Disease
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Purpose
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 | Intervention |
|---|---|
|
Pilonidal Disease |
Procedure: open wide-excision pilonidal cystectomy Procedure: minimal invasive pilonidal cystotomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Open Wide Excision Versus Minimal Surgery for Pilonidal Disease: A Randomized Control Trial Evaluating for Early Recurrence and Patient Satisfaction |
- 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
- 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.
| Estimated Enrollment: | 106 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Ellie Mentler, MD | 757-953-2454 | ellie.mentler@med.navy.mil |
| United States, Virginia | |
| Naval Medical Center Portsmouth | Recruiting |
| Portsmouth, Virginia, United States, 23708 | |
| Contact: Ellie Mentler, MD 757-953-2454 ellie.mentler@med.navy.mil | |
| Contact: Charles Morgan, PhD 757-953-5939 charles.morgan@med.navy.mil | |
| 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 | |
More Information
No publications provided
| Responsible Party: | LT Ellie Mentler, United States navy |
| ClinicalTrials.gov Identifier: | NCT01241136 History of Changes |
| Other Study ID Numbers: | CIP# 10.0041 |
| Study First Received: | November 15, 2010 |
| Last Updated: | November 15, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by United States Naval Medical Center, Portsmouth:
|
pilonidal disease, cystectomy, recurrence |
ClinicalTrials.gov processed this record on May 19, 2013