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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 : September 11, 2020
Sponsor:
Collaborator:
Pediatric Surgical Research Collaborative
Information provided by (Responsible Party):
Charlotte Kvasnovsky, Northwell Health

Tracking Information
First Submitted Date December 4, 2018
First Posted Date December 11, 2018
Last Update Posted Date September 11, 2020
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 10, 2018)
  • 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
  • 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
  • Return to school or work post procedure [ Time Frame: 2 months ]
    Return to a full day of school or work following procedure
  • 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.
  • Requirement for hospital stay [ Time Frame: 1 week ]
    Any overnight stay following surgical procedure will be documented
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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.

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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children presenting to clinics with symptomatic pilonidal disease and recommended for surgery.
Condition
  • 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
Intervention Procedure: minimally invasive pilonidal excision
MIPE procedure with trephine excision of pits and sinuses
Other Name: Gips procedure
Study Groups/Cohorts
  • MIPE
    Patients undergoing minimally invasive pilonidal excision with trephination.
    Intervention: Procedure: minimally invasive pilonidal excision
  • Other
    Patients undergoing a different procedure for pilonidal disease.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 10, 2018)
140
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2025
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Charlotte Kvasnovsky, MD, PhD, MPH 443.690.2866 ckvasnovsky@northwell.edu
Contact: Aaron Lipskar, MD 718.470.5368 alipskar@northwell.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03772873
Other Study ID Numbers 18-0937-CCMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Discussing availability of IPD with participating sites.
Responsible Party Charlotte Kvasnovsky, Northwell Health
Study Sponsor Northwell Health
Collaborators Pediatric Surgical Research Collaborative
Investigators
Principal Investigator: Charlotte Kvasnovsky, MD, PhD, MPH Northwell Health
Study Director: Abdulraouf Lamoshi, MD Northwell Health
PRS Account Northwell Health
Verification Date September 2020