MIPE for Pilonidal Disease

NCT03772873 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 151

Last updated 2022-11-17

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03772873 on ClinicalTrials.gov