MIPE for Pilonidal Disease

Status unconfirmed

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT03772873
Run by: Northwell Health
People needed: 151
Starts: 2019-01-01
Expected to finish: 2026-06-01
Last updated by the study team: 2022-11-17

Who can join

Age: 2 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
Advocate Health Center — Park Ridge, Illinois, United States
Maine Medical Center — Portland, Maine, United States
University of Maryland Medical Center — Baltimore, Maryland, United States
Cohen Children's Medical Center — New Hyde Park, New York, United States
Dayton Children's Hospital — Dayton, Ohio, United States
Lehigh Valley Reilly Children's Hospital — Allentown, Pennsylvania, United States
LeBonheur Children's Hospital — Memphis, Tennessee, United States
Children's Medical Center Dallas — Dallas, Texas, United States
Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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