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WithdrawnNCT01241136Updated Oct 9, 2025

Open Wide Excision Versus Minimal Surgery for Pilonidal Disease

An interventional study of open wide-excision pilonidal cystectomy and minimal invasive pilonidal cystotomy in Pilonidal Disease, sponsored by United States Naval Medical Center, Portsmouth. Withdrawn at 1 site in United States. Open to participants aged 17 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-10-09.

Sponsored by United States Naval Medical Center, Portsmouth · Not applicable, Interventional, and Other

Why this study was withdrawn
No recruitment occurred and the PI stopped the study.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Feb 2010, registered Nov 2010).
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
17 Years to 99 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Pilonidal Disease

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Keywords

  • pilonidal disease, cystectomy, recurrence
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

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Lead sponsor

United States Naval Medical Center, Portsmouth is the lead sponsor of 18 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Open traditional pilonidal cystectomy

    traditional complete wide-excision pilonidal cystectomy

    Procedure: open wide-excision pilonidal cystectomy

  • Experimental
    Minimal invasive pilonidal cystotomy

    Using only Keyes Trephines to unroof and curette the pilonidal cyst cavity

    Procedure: minimal invasive pilonidal cystotomy

Interventions

  • Procedureopen wide-excision pilonidal cystectomy

    traditional open wide-excisional pilonidal cystectomy

  • Procedureminimal invasive pilonidal cystotomy

    unroofing the cyst cavity and curettage the cyst

06

What researchers measure

Primary outcomes

  1. Rate of early recurrence

    After surgical interventions, to see after 2 years the rate of recurrence of pilonidal disease

    Time frame: 2 years

Secondary outcomes

  1. Tolerance of the procedure

    Determine wound healing times and amount of convalescence associated with each procedure

    Time frame: 30 days

  2. Patient satisfaction

    Determine patient satisfaction factors using the quality of life survey and the post-operative visual analog pain scale.

    Time frame: 30 days

07

Study locations

1 site
  • Naval Medical Center Portsmouth
    Portsmouth, Virginia 23708, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01241136
Lead sponsor
United States Naval Medical Center, Portsmouth
Responsible party
Sponsor
First posted
Nov 16, 2010
Start date
Feb 19, 2010
Primary completion
Nov 25, 2014
Completion
Jul 16, 2025
Last update
Oct 9, 2025

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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