Open Wide Excision Versus Minimal Surgery for Pilonidal Disease

NCT01241136 | Withdrawn DMC

• 1 other identifier: CIP# 10.0041
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pilonidal Disease

Keywords

pilonidal disease, cystectomy, recurrence

Outcome Measures

Primary Outcomes (1)

• Rate of early recurrence

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

  2 years

Secondary Outcomes (2)

• Tolerance of the procedure

  30 days

• Patient satisfaction

  30 days

Study Arms (2)

Open traditional pilonidal cystectomy

PLACEBO COMPARATOR

traditional complete wide-excision pilonidal cystectomy

Procedure: open wide-excision pilonidal cystectomy

Minimal invasive pilonidal cystotomy

EXPERIMENTAL

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

Procedure: minimal invasive pilonidal cystotomy

Interventions

open wide-excision pilonidal cystectomy PROCEDURE

traditional open wide-excisional pilonidal cystectomy

Open traditional pilonidal cystectomy

minimal invasive pilonidal cystotomy PROCEDURE

unroofing the cyst cavity and curettage the cyst

Minimal invasive pilonidal cystotomy

Eligibility Criteria

• Age: 17 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 16, 2010
• Study Start: February 19, 2010
• Primary Completion: November 25, 2014
• Study Completion: July 16, 2025
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)