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Open vs Minimal Surgery for Pilonidal Disease

N/A
Waitlist Available
Research Sponsored by United States Naval Medical Center, Portsmouth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients who are scheduled for elective surgical treatment for their pilonidal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will help to compare the early recurrence rates of pilonidal disease and overall patient satisfaction between procedures involving minimal and wide open excisions.

Who is the study for?
This trial is for individuals scheduled for elective surgery to treat pilonidal disease, a chronic infection near the tailbone. It's not open to those with an active pus-filled infection or who've had previous surgical interventions beyond abscess drainage.Check my eligibility
What is being tested?
The study compares two surgeries: wide excision (removing a large area of diseased tissue) versus minimal invasive excision (using small instruments to remove infected areas). Patients will be randomly assigned one of these treatments and followed up for satisfaction and recurrence rates.See study design
What are the potential side effects?
Potential side effects may include pain at the surgery site, risk of infection, scarring, and possible recurrence of pilonidal disease. The extent of side effects could vary based on the type of surgical procedure performed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for surgery to treat my pilonidal disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of early recurrence
Secondary outcome measures
Patient satisfaction
Tolerance of the procedure

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Minimal invasive pilonidal cystotomyExperimental Treatment1 Intervention
Using only Keyes Trephines to unroof and curette the pilonidal cyst cavity
Group II: Open traditional pilonidal cystectomyPlacebo Group1 Intervention
traditional complete wide-excision pilonidal cystectomy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
minimal invasive pilonidal cystotomy
2010
N/A
~20

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, PortsmouthLead Sponsor
32 Previous Clinical Trials
3,704 Total Patients Enrolled

Media Library

Minimal Surgery Clinical Trial Eligibility Overview. Trial Name: NCT01241136 — N/A
Pilonidal Disease Research Study Groups: Open traditional pilonidal cystectomy, Minimal invasive pilonidal cystotomy
Pilonidal Disease Clinical Trial 2023: Minimal Surgery Highlights & Side Effects. Trial Name: NCT01241136 — N/A
Minimal Surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT01241136 — N/A
~1 spots leftby Jun 2025
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