MIPE for Pilonidal Disease

Pilonidal Disease Clinical Trial

Official title:

Minimally Invasive Pilonidal Excision for the Treatment of Pilonidal Disease - A Multi-Center Non-Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03772873
• Other study ID #: 18-0937-CCMC
• Status: Active, not recruiting
• Start date: January 1, 2019
• Est. completion date: June 1, 2026

Study information

• Verified date: November 2022
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 151
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abscess
• Cysts
• Fistula
• Pilonidal Abscess
• Pilonidal Cyst and Sinus With Abscess
• Pilonidal Cyst and Sinus Without Abscess
• Pilonidal Cyst With Sinus
• Pilonidal Cyst Without Abscess
• Pilonidal Cyst/Fistula
• Pilonidal Dimple With Abscess
• Pilonidal Disease
• Pilonidal Disease of Natal Cleft Abscess
• Pilonidal Fistula With Abscess
• Pilonidal Sinus
• Pilonidal Sinus Infected
• Pilonidal Sinus With Abscess
• Pilonidal Sinus Without Abscess

Intervention

Procedure:
• minimally invasive pilonidal excision
MIPE procedure with trephine excision of pits and sinuses

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Pediatric Surgical Research Collaborative

Country where clinical trial is conducted

United States, 

References & Publications (4)

Elalfy K, Emile S, Lotfy A, Youssef M, Elfeki H. Bilateral gluteal advancement flap for treatment of recurrent sacrococcygeal pilonidal disease: A prospective cohort study. Int J Surg. 2016 May;29:1-8. doi: 10.1016/j.ijsu.2016.03.006. Epub 2016 Mar 11. — View Citation

Gips M, Melki Y, Salem L, Weil R, Sulkes J. Minimal surgery for pilonidal disease using trephines: description of a new technique and long-term outcomes in 1,358 patients. Dis Colon Rectum. 2008 Nov;51(11):1656-62; discussion 1662-3. doi: 10.1007/s10350-008-9329-x. Epub 2008 May 31. — View Citation

Hølmebakk T, Nesbakken A. Surgery for pilonidal disease. Scand J Surg. 2005;94(1):43-6. — View Citation

Speter C, Zmora O, Nadler R, Shinhar D, Bilik R. Minimal incision as a promising technique for resection of pilonidal sinus in children. J Pediatr Surg. 2017 Sep;52(9):1484-1487. doi: 10.1016/j.jpedsurg.2017.03.040. Epub 2017 Mar 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent disease within 6 months of index surgery	The primary end-point will be the requirement for a second operative procedure of any kind for pilonidal disease within 6 months of initial procedure	6 months
Secondary	Recurrent disease within 24 months of index surgery	Requirement for a second operative procedure of any kind for pilonidal disease within 24 months of initial procedure	24 months
Secondary	Recurrent disease within 5 years of index surgery	Requirement for a second operative procedure of any kind for pilonidal disease within 5 years of initial procedure	5 years
Secondary	Return to school or work post procedure	Return to a full day of school or work following procedure	2 months
Secondary	Post operative surgical site infection	Need for antibiotic therapy. While subjective this at least suggests a concern on the part of a healthcare provider, absent the need for objective measures such as WBC and fever.	2 months
Secondary	Requirement for hospital stay	Any overnight stay following surgical procedure will be documented	1 week
Secondary	Surgeon satisfaction with procedure	Surgeon questionnaire at beginning and end of enrollment on experience with procedure. Satisfaction will be measured qualitatively through a questionnaire designed for the study, detailing what procedure(s) the surgeon has performed in the past for pilonidal disease, his/her rationale for that procedure, and interest in MIPE.	6 months