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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
  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

Further study details as provided by United States Naval Medical Center, Portsmouth:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241136

Contacts
Contact: Ellie Mentler, MD 757-953-2454 ellie.mentler@med.navy.mil

Locations
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

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 November 25, 2014