<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03772873</url>
  </required_header>
  <id_info>
    <org_study_id>18-0937-CCMC</org_study_id>
    <nct_id>NCT03772873</nct_id>
  </id_info>
  <brief_title>MIPE for Pilonidal Disease</brief_title>
  <official_title>Minimally Invasive Pilonidal Excision for the Treatment of Pilonidal Disease - A Multi-Center Non-Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pediatric Surgical Research Collaborative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilonidal disease often presents as a chronic, relapsing condition. A variety of procedures&#xD;
      are used in the management of pilonidal disease, with varying degrees of morbidity,&#xD;
      disease-free interval, and long-term success. In patients with new-onset or recurrent&#xD;
      pilonidal disease, the investigators aim to address how minimally invasive trephine excision&#xD;
      compares to other surgical procedures in terms of short- and long-term clinical outcomes and&#xD;
      patient satisfaction.&#xD;
&#xD;
      In the absence of a gold standard surgical procedure, surgeon preference will help dictate&#xD;
      the management of pilonidal disease. For many surgeons, this means a variation on open&#xD;
      excision for pilonidal disease failing conservative management. However, outcomes for&#xD;
      minimally invasive pilonidal excision (MIPE) as initially described by Gips and forthcoming&#xD;
      Lipskar et al., are likely to alter management of the disease (Gips, 2008). The investigators&#xD;
      wish to assess patient and surgeon satisfaction with MIPE, and short-term outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pilonidal disease is an inflammatory and infectious condition most often affecting young&#xD;
      adult males. Though the pathogenesis is still debated, it is thought that tears in hair&#xD;
      follicles of the natal cleft form small crevices where hairs and debris can collect. Over&#xD;
      time, constant friction and stretching from daily movement pulls the debris deeper into the&#xD;
      cavity creating a sinus. The patient is susceptible to recurrent infections because of the&#xD;
      constant warmth, humidity, and exposure to skin and gut flora in the affected area. The&#xD;
      clinical presentation of this condition may be acute or chronic and ranges from small,&#xD;
      asymptomatic pits in the skin, to large abscesses with purulent and blood drainage.&#xD;
&#xD;
      Initial treatments for pilonidal disease typically include trials of conservative treatments&#xD;
      such as improved personal hygiene with regular shaving or laser hair removal, before surgical&#xD;
      interventions are considered. Minimally invasive options include injection of phenol, fibrin&#xD;
      glue, cyanoacrylate into the affected areas. For patients failing conservative management, or&#xD;
      with extensive disease, surgical management has been the standard of care.&#xD;
&#xD;
      There are a wide variety of surgical techniques for refractory pilonidal disease. These&#xD;
      include excision with lay open or primary closure, incision and marsupialization, excision&#xD;
      with V-Y, W-, and Z-plasty flap. Other procedures described include rhomboid excision and&#xD;
      Limberg flap, and excision with off-midline closure. This lack of standardization suggests a&#xD;
      complex problem without optimal treatment. The MIPE procedure with trephine excision of pits&#xD;
      and sinuses provides an elegant solution for the majority of patients, maximizing clearance&#xD;
      of hair follicles and diseased tissue while minimizing morbidity.&#xD;
&#xD;
      Discrepancies in recurrence rates, lengths of hospital course, time to return to work, and&#xD;
      patients' aesthetic satisfaction between the various treatment options has led to great&#xD;
      controversy over the best approach. Among the surgical options, some studies have reported&#xD;
      shorter operative time, hospital stay, and time for wound healing with the excision with&#xD;
      primary closure method, whereas flap techniques generally have a lower incidence of&#xD;
      recurrence. However, other studies have shown shorter hospital duration and time to return to&#xD;
      work specifically for the Limberg flap in comparison to primary closure. Controversy aside,&#xD;
      the various surgical methods prioritize complete excision of diseased tissue at the expense&#xD;
      of dissatisfying wound aesthetics.&#xD;
&#xD;
      MIPE with trephination was introduced by Gips et al, as an alternative excision strategy that&#xD;
      allows for thorough pilonidal debridement while minimizing the need for general anesthesia,&#xD;
      inpatient post-operative care, and disfiguring wound healing. Though there is an increased&#xD;
      recurrence rate, this simple outpatient procedure allows for repeat excision at the onset of&#xD;
      disease recurrence.&#xD;
&#xD;
      The investigators aim to study the use of this procedure in children and young adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrent disease within 6 months of index surgery</measure>
    <time_frame>6 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrent disease within 24 months of index surgery</measure>
    <time_frame>24 months</time_frame>
    <description>Requirement for a second operative procedure of any kind for pilonidal disease within 24 months of initial procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrent disease within 5 years of index surgery</measure>
    <time_frame>5 years</time_frame>
    <description>Requirement for a second operative procedure of any kind for pilonidal disease within 5 years of initial procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to school or work post procedure</measure>
    <time_frame>2 months</time_frame>
    <description>Return to a full day of school or work following procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative surgical site infection</measure>
    <time_frame>2 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Requirement for hospital stay</measure>
    <time_frame>1 week</time_frame>
    <description>Any overnight stay following surgical procedure will be documented</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon satisfaction with procedure</measure>
    <time_frame>6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">151</enrollment>
  <condition>Pilonidal Disease</condition>
  <condition>Pilonidal Cyst/Fistula</condition>
  <condition>Pilonidal Sinus Without Abscess</condition>
  <condition>Pilonidal Cyst Without Abscess</condition>
  <condition>Pilonidal Cyst and Sinus Without Abscess</condition>
  <condition>Pilonidal Abscess</condition>
  <condition>Pilonidal Sinus With Abscess</condition>
  <condition>Pilonidal Dimple With Abscess</condition>
  <condition>Pilonidal Fistula With Abscess</condition>
  <condition>Pilonidal Sinus Infected</condition>
  <condition>Pilonidal Cyst With Sinus</condition>
  <condition>Pilonidal Cyst and Sinus With Abscess</condition>
  <condition>Pilonidal Disease of Natal Cleft Abscess</condition>
  <arm_group>
    <arm_group_label>MIPE</arm_group_label>
    <description>Patients undergoing minimally invasive pilonidal excision with trephination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other</arm_group_label>
    <description>Patients undergoing a different procedure for pilonidal disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>minimally invasive pilonidal excision</intervention_name>
    <description>MIPE procedure with trephine excision of pits and sinuses</description>
    <arm_group_label>MIPE</arm_group_label>
    <other_name>Gips procedure</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children presenting to clinics with symptomatic pilonidal disease and recommended for&#xD;
        surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 25 with pilonidal disease may be included in the study.&#xD;
             Patients with primary pilonidal disease or recurrence of pilonidal disease after&#xD;
             previous intervention may be included.&#xD;
&#xD;
        Patients with acute pilonidal abscess or active infection may also be included in the&#xD;
        study, provided they undergo a procedure more extensive than simple incision and drainage.&#xD;
        At our institution, patients with acute abscess may undergo more extensive procedure at&#xD;
        their initial operation, at surgeon discretion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who undergo simple incision and drainage for pilonidal disease as their index&#xD;
             procedure will be excluded from the study, as this is generally a temporizing measure.&#xD;
             Patients who undergo wide local excision, or any more complex procedure will be&#xD;
             included within the 'standard procedure' arm. Patients who had previously undergone a&#xD;
             simple drainage procedure and present for definitive management will be included.&#xD;
&#xD;
        Patients with significant medical comorbidities, such as cancer, diabetes mellitus, chronic&#xD;
        steroid use, and use of immunosuppressant therapies, are excluded from the study. Any&#xD;
        patient with an ASA III or IV will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charlotte Kvasnovsky, MD, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Abdulraouf Lamoshi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Health Center</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cohen Children's Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Children's Hospital</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Reilly Children's Hospital</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LeBonheur Children's Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Medical Center Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>26975846</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28366559</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18516645</PMID>
  </reference>
  <reference>
    <citation>Holmebakk T, Nesbakken A. Surgery for pilonidal disease. Scand J Surg. 2005;94(1):43-6. doi: 10.1177/145749690509400111.</citation>
    <PMID>15865116</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>November 14, 2022</last_update_submitted>
  <last_update_submitted_qc>November 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abscess</mesh_term>
    <mesh_term>Cysts</mesh_term>
    <mesh_term>Pilonidal Sinus</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Discussing availability of IPD with participating sites.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03772873
org study id: 18-0937-CCMC
nct id: NCT03772873
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: Recurrent disease within 6 months of index surgery
time frame: 6 months
description: 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
measure: Recurrent disease within 24 months of index surgery
time frame: 24 months
description: Requirement for a second operative procedure of any kind for pilonidal disease within 24 months of initial procedure
measure: Recurrent disease within 5 years of index surgery
time frame: 5 years
description: Requirement for a second operative procedure of any kind for pilonidal disease within 5 years of initial procedure
measure: Return to school or work post procedure
time frame: 2 months
description: Return to a full day of school or work following procedure
measure: Post operative surgical site infection
time frame: 2 months
description: 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.
measure: Requirement for hospital stay
time frame: 1 week
description: Any overnight stay following surgical procedure will be documented
measure: Surgeon satisfaction with procedure
time frame: 6 months
description: 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.
arm group label: MIPE
description: Patients undergoing minimally invasive pilonidal excision with trephination.
arm group label: Other
description: Patients undergoing a different procedure for pilonidal disease.
intervention type: Procedure
intervention name: minimally invasive pilonidal excision
description: MIPE procedure with trephine excision of pits and sinuses
arm group label: MIPE
other name: Gips procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Charlotte Kvasnovsky, MD, PhD, MPH
role: Principal Investigator
affiliation: Northwell Health
last name: Abdulraouf Lamoshi, MD
role: Study Director
affiliation: Northwell Health
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: 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.
PMID: 26975846
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.
PMID: 28366559
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.
PMID: 18516645
citation: Holmebakk T, Nesbakken A. Surgery for pilonidal disease. Scand J Surg. 2005;94(1):43-6. doi: 10.1177/145749690509400111.
PMID: 15865116
responsible party type: Sponsor
mesh term: Abscess
mesh term: Cysts
mesh term: Pilonidal Sinus
mesh term: Fistula
sharing ipd: Undecided
ipd description: Discussing availability of IPD with participating sites.