MIPE for Pilonidal Disease
NCT03772873 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 151
Last updated 2022-11-17
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, and long-term success. In patients with new-onset or recurrent pilonidal disease, the investigators aim to address how minimally invasive trephine excision compares to other surgical procedures in terms of short- and long-term clinical outcomes and patient satisfaction.
In the absence of a gold standard surgical procedure, surgeon preference will help dictate the management of pilonidal disease. For many surgeons, this means a variation on open excision for pilonidal disease failing conservative management. However, outcomes for minimally invasive pilonidal excision (MIPE) as initially described by Gips and forthcoming Lipskar et al., are likely to alter management of the disease (Gips, 2008). The investigators wish to assess patient and surgeon satisfaction with MIPE, and short-term outcomes.
Conditions
- Pilonidal Disease
- Pilonidal Cyst/Fistula
- Pilonidal Sinus Without Abscess
- Pilonidal Cyst Without Abscess
- Pilonidal Cyst and Sinus Without Abscess
- Pilonidal Abscess
- Pilonidal Sinus With Abscess
- Pilonidal Dimple With Abscess
- Pilonidal Fistula With Abscess
- Pilonidal Sinus Infected
- Pilonidal Cyst With Sinus
- Pilonidal Cyst and Sinus With Abscess
- Pilonidal Disease of Natal Cleft Abscess
Interventions
- PROCEDURE
-
minimally invasive pilonidal excision
MIPE procedure with trephine excision of pits and sinuses
Sponsors & Collaborators
-
Pediatric Surgical Research Collaborative
collaborator UNKNOWN -
Northwell Health
lead OTHER
Principal Investigators
-
Charlotte Kvasnovsky, MD, PhD, MPH · Northwell Health
-
Abdulraouf Lamoshi, MD · Northwell Health
Eligibility
- Min Age
- 2 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-01-01
- Primary Completion
- 2026-06-01
- Completion
- 2026-06-01
Countries
- United States
Study Locations
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