MIPE for Pilonidal Disease (NCT03772873) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MIPE for Pilonidal Disease
United States151 participantsStarted 2019-01-01
Plain-language 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.
Who can participate
Age range2 Years – 25 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Recurrent disease within 6 months of index surgery