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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 belowSelect...
I am scheduled for surgery to treat my pilonidal disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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
Find a Location
Who is running the clinical trial?
United States Naval Medical Center, PortsmouthLead Sponsor
31 Previous Clinical Trials
4,226 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for surgery to treat my pilonidal disease.I currently have an active infection with pus.I have had surgery for conditions other than pilonidal disease.
Research Study Groups:
This trial has the following groups:- Group 1: Open traditional pilonidal cystectomy
- Group 2: Minimal invasive pilonidal cystotomy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings available for participants in this experiment?
"As documented on clinicaltrials.gov, this medical trial is not accepting further participants at the moment; it was initially posted on November 1st 2010 and its most recent update took place on November 15th of the same year. Despite that, there are currently 4 other studies actively recruiting volunteers for their trials."
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