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MIPE for Pilonidal Disease

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ClinicalTrials.gov Identifier: NCT03772873
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
Pediatric Surgical Research Collaborative
Information provided by (Responsible Party):
Charlotte Kvasnovsky, Northwell Health

Brief 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.


Condition or disease Intervention/treatment
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 Procedure: minimally invasive pilonidal excision

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Minimally Invasive Pilonidal Excision for the Treatment of Pilonidal Disease - A Multi-Center Non-Randomized Controlled Trial
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : November 2025

Group/Cohort Intervention/treatment
MIPE
Patients undergoing minimally invasive pilonidal excision with trephination.
Procedure: minimally invasive pilonidal excision
MIPE procedure with trephine excision of pits and sinuses
Other Name: Gips procedure

Other
Patients undergoing a different procedure for pilonidal disease.



Primary Outcome Measures :
  1. Recurrent disease within 6 months of index surgery [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Recurrent disease within 24 months of index surgery [ Time Frame: 24 months ]
    Requirement for a second operative procedure of any kind for pilonidal disease within 24 months of initial procedure

  2. Recurrent disease within 5 years of index surgery [ Time Frame: 5 years ]
    Requirement for a second operative procedure of any kind for pilonidal disease within 5 years of initial procedure

  3. Return to school or work post procedure [ Time Frame: 2 months ]
    Return to a full day of school or work following procedure

  4. Post operative surgical site infection [ Time Frame: 2 months ]
    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.

  5. Requirement for hospital stay [ Time Frame: 1 week ]
    Any overnight stay following surgical procedure will be documented

  6. Surgeon satisfaction with procedure [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   2 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children presenting to clinics with symptomatic pilonidal disease and recommended for surgery.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772873


Contacts
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Contact: Charlotte Kvasnovsky, MD, PhD, MPH 443.690.2866 ckvasnovsky@northwell.edu
Contact: Aaron Lipskar, MD 718.470.5368 alipskar@northwell.edu

Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Julia Grabowski, MD    312-227-4210      
Contact: Benjamin Many         
Advocate Health Center Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Bethany Slater, MD    847-318-9330      
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Chris Turner, MD    207-662-5555      
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Kimberly Lumpkins, MD    410-328-6366      
United States, New York
Cohen Children's Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Charlotte Kvasnovsky, MD         
Contact: Aaron Lipskar, MD         
Sub-Investigator: Barrie Rich, MD         
United States, Ohio
Dayton Children's Hospital Recruiting
Dayton, Ohio, United States, 45404
Contact: Arturo Aranda, MD    937-641-3000      
Contact: Karen Herzing, BSN, RN    937-641-3799      
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Sara Fallon, MD    832-822-3135      
Contact: Sohail Shah, MD    8328223135      
Sub-Investigator: Matthew Lahey         
Sponsors and Collaborators
Northwell Health
Pediatric Surgical Research Collaborative
Investigators
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Principal Investigator: Charlotte Kvasnovsky, MD, PhD, MPH Northwell Health

Publications:
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Responsible Party: Charlotte Kvasnovsky, Clinical Research Fellow, Northwell Health
ClinicalTrials.gov Identifier: NCT03772873     History of Changes
Other Study ID Numbers: 18-0937-CCMC
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Discussing availability of IPD with participating sites.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Abscess
Cysts
Pilonidal Sinus
Fistula
Pathological Conditions, Anatomical
Suppuration
Infection
Inflammation
Pathologic Processes
Neoplasms