Status:
ACTIVE_NOT_RECRUITING
MIPE for Pilonidal Disease
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Pediatric Surgical Research Collaborative
Conditions:
Pilonidal Disease
Pilonidal Cyst/Fistula
Eligibility:
All Genders
2-25 years
Brief Summary
Pilonidal disease often presents as a chronic, relapsing condition. A variety of procedures are used in the management of pilonidal disease, with varying degrees of morbidity, disease-free interval, a...
Detailed Description
Pilonidal disease is an inflammatory and infectious condition most often affecting young adult males. Though the pathogenesis is still debated, it is thought that tears in hair follicles of the natal ...
Eligibility Criteria
Inclusion
- Patients under the age of 25 with pilonidal disease may be included in the study. Patients with primary pilonidal disease or recurrence of pilonidal disease after previous intervention may be included.
- Patients with acute pilonidal abscess or active infection may also be included in the study, provided they undergo a procedure more extensive than simple incision and drainage. At our institution, patients with acute abscess may undergo more extensive procedure at their initial operation, at surgeon discretion.
Exclusion
- Patients who undergo simple incision and drainage for pilonidal disease as their index procedure will be excluded from the study, as this is generally a temporizing measure. Patients who undergo wide local excision, or any more complex procedure will be included within the 'standard procedure' arm. Patients who had previously undergone a simple drainage procedure and present for definitive management will be included.
- Patients with significant medical comorbidities, such as cancer, diabetes mellitus, chronic steroid use, and use of immunosuppressant therapies, are excluded from the study. Any patient with an ASA III or IV will be excluded.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT03772873
Start Date
January 1 2019
End Date
June 1 2026
Last Update
November 17 2022
Active Locations (10)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
Advocate Health Center
Park Ridge, Illinois, United States, 60068
3
Maine Medical Center
Portland, Maine, United States, 04102
4
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201