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Open Wide Excision Versus Minimal Surgery for Pilonidal Disease

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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
Information provided by:

Study Description
Brief Summary:

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
Pilonidal Disease Procedure: open wide-excision pilonidal cystectomy Procedure: minimal invasive pilonidal cystotomy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : November 2010
Estimated Primary Completion Date : December 2014
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Rate of early recurrence [ Time Frame: 2 years ]
    After surgical interventions, to see after 2 years the rate of recurrence of pilonidal disease

Secondary Outcome Measures :
  1. Tolerance of the procedure [ Time Frame: 30 days ]
    Determine wound healing times and amount of convalescence associated with each procedure

  2. Patient satisfaction [ Time Frame: 30 days ]
    Determine patient satisfaction factors using the quality of life survey and the post-operative visual analog pain scale.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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, 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         
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
More Information

Responsible Party: LT Ellie Mentler, United States navy
ClinicalTrials.gov Identifier: NCT01241136     History of Changes
Other Study ID Numbers: CIP# 10.0041
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: November 16, 2010
Last Verified: November 2010

Keywords provided by United States Naval Medical Center, Portsmouth:
pilonidal disease, cystectomy, recurrence