Open Wide Excision Versus Minimal Surgery for Pilonidal Disease

Pilonidal Disease Clinical Trial

Official title:

Open Wide Excision Versus Minimal Surgery for Pilonidal Disease: A Randomized Control Trial Evaluating for Early Recurrence and Patient Satisfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241136
• Other study ID #: CIP# 10.0041
• Status: Completed
• Phase: N/A
• Start date: February 19, 2010
• Est. completion date: November 25, 2014

Study information

• Verified date: May 2024
• Source: United States Naval Medical Center, Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 25, 2014
• Est. primary completion date: November 25, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pilonidal Disease

Intervention

Procedure:
• open wide-excision pilonidal cystectomy
traditional open wide-excisional pilonidal cystectomy
• minimal invasive pilonidal cystotomy
unroofing the cyst cavity and curettage the cyst

Locations

Country	Name	City	State
United States	Naval Medical Center Portsmouth	Portsmouth	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, Portsmouth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of early recurrence	After surgical interventions, to see after 2 years the rate of recurrence of pilonidal disease	2 years
Secondary	Tolerance of the procedure	Determine wound healing times and amount of convalescence associated with each procedure	30 days
Secondary	Patient satisfaction	Determine patient satisfaction factors using the quality of life survey and the post-operative visual analog pain scale.	30 days