Purpose:
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.
Study summary:
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 cleft form small crevices where hairs and debris can collect. Over
time, constant friction and stretching from daily movement pulls the debris deeper into the
cavity creating a sinus. The patient is susceptible to recurrent infections because of the
constant warmth, humidity, and exposure to skin and gut flora in the affected area. The
clinical presentation of this condition may be acute or chronic and ranges from small,
asymptomatic pits in the skin, to large abscesses with purulent and blood drainage.
Initial treatments for pilonidal disease typically include trials of conservative treatments
such as improved personal hygiene with regular shaving or laser hair removal, before surgical
interventions are considered. Minimally invasive options include injection of phenol, fibrin
glue, cyanoacrylate into the affected areas. For patients failing conservative management, or
with extensive disease, surgical management has been the standard of care.
There are a wide variety of surgical techniques for refractory pilonidal disease. These
include excision with lay open or primary closure, incision and marsupialization, excision
with V-Y, W-, and Z-plasty flap. Other procedures described include rhomboid excision and
Limberg flap, and excision with off-midline closure. This lack of standardization suggests a
complex problem without optimal treatment. The MIPE procedure with trephine excision of pits
and sinuses provides an elegant solution for the majority of patients, maximizing clearance
of hair follicles and diseased tissue while minimizing morbidity.
Discrepancies in recurrence rates, lengths of hospital course, time to return to work, and
patients' aesthetic satisfaction between the various treatment options has led to great
controversy over the best approach. Among the surgical options, some studies have reported
shorter operative time, hospital stay, and time for wound healing with the excision with
primary closure method, whereas flap techniques generally have a lower incidence of
recurrence. However, other studies have shown shorter hospital duration and time to return to
work specifically for the Limberg flap in comparison to primary closure. Controversy aside,
the various surgical methods prioritize complete excision of diseased tissue at the expense
of dissatisfying wound aesthetics.
MIPE with trephination was introduced by Gips et al, as an alternative excision strategy that
allows for thorough pilonidal debridement while minimizing the need for general anesthesia,
inpatient post-operative care, and disfiguring wound healing. Though there is an increased
recurrence rate, this simple outpatient procedure allows for repeat excision at the onset of
disease recurrence.
The investigators aim to study the use of this procedure in children and young adults.
Criteria:
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.
Brief Title:
MIPE for Pilonidal Disease
Official Title:
Minimally Invasive Pilonidal Excision for the Treatment of Pilonidal Disease - A Multi-Center Non-Randomized Controlled Trial
Oversight Authority:
There was an error processing this request
Overall Contact Information
| Official Name: | Charlotte Kvasnovsky, MD, PhD, MPH
Principal Investigator
Northwell Health
|
Study Links
There are no available Study Links