<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/NCT03042858</url>
  </required_header>
  <id_info>
    <org_study_id>16020156</org_study_id>
    <nct_id>NCT03042858</nct_id>
  </id_info>
  <brief_title>Natural History of Infants With Patent Processus Vaginalis</brief_title>
  <acronym>HxPPV</acronym>
  <official_title>Natural History of Infants With Patent Processus Vaginalis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>C.S. Mott Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>James Whitcomb Riley Hospital for Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Family Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital and Health System Foundation, Wisconsin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norton Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lurie Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Mercy Hospital Kansas City</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a multi-center prospective observational study of all patients who undergo&#xD;
      laparoscopic pyloromyotomy. Subjects who have PPV will be followed up to just before their&#xD;
      18th birthday through annual phone calls or emails to determine the incidence and timing of&#xD;
      subsequent inguinal hernia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be identified at the time the need for laparoscopic pyloromyotomy is determined&#xD;
      by the consulting surgeon. After informed permission is obtained, demographic information&#xD;
      will be collected on all subjects. Subjects who do not have PPV at the time of surgery will&#xD;
      have no further data collected and their study participation will be complete. Subjects who&#xD;
      have PPV will receive annual phone calls, emails, or other contact methods selected by the&#xD;
      family, for up to before their 18th birthday or until they report having surgical inguinal&#xD;
      hernia repair. Data will be recorded as noted on the master list and datasheet and entered&#xD;
      into a REDCap database. All participating institutions will upload data into REDCap along&#xD;
      with subject contact information so all follow up contact can be made by the coordinating&#xD;
      center. All identifiable information in REDCap will be accessible by the coordinating center.&#xD;
      Each enrolling center will have access to identifiers for their subjects only. Enrolling&#xD;
      centers will be contacted and asked to update the contact information in REDCap if the&#xD;
      coordinating center is not able to make contact with a subject. Subjects will also be given&#xD;
      contact information for the coordinating center so they can provide updated information&#xD;
      directly. Parents will be the main study contact for the duration of the study since no study&#xD;
      interventions other than the phone call/email are required.&#xD;
&#xD;
      During laparoscopy for pyloric stenosis, the surgeon will turn the camera downward to answer&#xD;
      the first question, whether the inguinal canal is patent or closed. Many surgeons routinely&#xD;
      perform this maneuver; it takes no more than 10 seconds to perform and adds no risk to the&#xD;
      operation. The study will include a quick estimate of width and depth of the PPV as outlined&#xD;
      in the datasheet to characterize the size of the opening. The first characterization will be&#xD;
      the presence of CO2 in the scrotum/labia upon insufflation, which clarifies that the PPV&#xD;
      provides wide continuity from the abdomen to beyond the inguinal canal. The second&#xD;
      characterization will be an estimate of the width of the opening in millimeters. The next&#xD;
      step will be to note whether the bottom of the defect is seen. This is, by definition, no if&#xD;
      the answer to the first question is yes and this no longer applies. Therefore the no answer&#xD;
      to this question will identify those with an open tunnel but no external insufflation.&#xD;
      Finally, if the bottom is seen then an estimate will be made in millimeters.&#xD;
&#xD;
      If there is no PPV, meaning the patient presents normal anatomy, the patient demographic data&#xD;
      will be recorded and this will terminate their participation.&#xD;
&#xD;
      If a PPV is present, the investigators will conduct annual phone calls, or other contact&#xD;
      method of the family's choice, to ask questions about whether the child has been diagnosed&#xD;
      with hernia, underwent hernia repair or currently has symptoms consistent with a hernia&#xD;
      (questionnaire attached). Subjects will be followed until hernia repair or as long as&#xD;
      possible, up to their 18th birthday.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2036</completion_date>
  <primary_completion_date type="Anticipated">December 2035</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of inguinal hernia</measure>
    <time_frame>18 years</time_frame>
    <description>frequency of the development of symptomatic inguinal hernia in infants who are found to have an opening in their inguinal canal during laparoscopy for pyloric stenosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to development of inguinal hernia</measure>
    <time_frame>18 years</time_frame>
    <description>Timeframe to develop a symptomatic inguinal hernia in infants who are found to have an opening in their inguinal canal during laparoscopy for pyloric stenosis.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Patent Processus Vaginalis</condition>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Infants with PPV</arm_group_label>
    <description>During laparoscopy for pyloric stenosis, the surgeon will turn the camera downward to answer the first question, whether the inguinal canal is patent or closed. If a PPV is present, the subject will be followed for up to 18 years of age.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infants without PPV</arm_group_label>
    <description>During laparoscopy for pyloric stenosis, the surgeon will turn the camera downward to answer the first question, whether the inguinal canal is patent or closed. If there is no PPV, meaning they have normal anatomy, the patient demographic data will be recorded and this will terminate their participation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infants with PPV</intervention_name>
    <description>Data will be collected for up to 18 years to monitor for inguinal hernia.</description>
    <arm_group_label>Infants with PPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infants without PPV</intervention_name>
    <description>Basic data will be collected regarding the surgery and the subject's study participation will be complete.</description>
    <arm_group_label>Infants without PPV</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infants undergoing laparoscopic pyloromyotomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients having laparoscopic surgery for pyloric stenosis. Subjects are&#xD;
             anticipated to be less than four months of age at the time of enrollment.&#xD;
&#xD;
          -  Enrollment inclusion dates: 08/2016 (upon IRB approval) to 7/31/2025&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are anticipated to have a hostile abdomen for visualizing the inguinal&#xD;
             rings (e.g. gastroschisis, necrotizing enterocolitis)&#xD;
&#xD;
          -  Patients who have unilateral or bilateral undescended testes&#xD;
&#xD;
          -  Patients undergoing open pyloromyotomy&#xD;
&#xD;
          -  Patients who have a known hernia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>4 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shawn D St. Peter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Mercy Hospital Kansas City</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shawn D St. Peter, MD</last_name>
    <phone>816-234-3575</phone>
    <email>sspeter@cmh.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yara K Duran, BSN</last_name>
    <phone>816-983-6852</phone>
    <email>ykduran@cmh.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shawn D St. Peter, MD</last_name>
      <phone>816-983-6479</phone>
      <email>sspeter@cmh.edu</email>
    </contact>
    <contact_backup>
      <last_name>Yara K Duran, RN</last_name>
      <phone>816 983 7852</phone>
      <email>ykduran@cmh.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Shawn D St. Peter, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>March 20, 2023</last_update_submitted>
  <last_update_submitted_qc>March 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Mercy Hospital Kansas City</investigator_affiliation>
    <investigator_full_name>Shawn St. Peter</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>PPV</keyword>
  <keyword>patent processus vaginalis</keyword>
  <keyword>inguinal hernia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Testicular Hydrocele</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data coordination site will have contact information for all subjects so that long-term follow-up can be done. Each contributing site will only have access to their own subjects' information.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>duration of study</ipd_time_frame>
    <ipd_access_criteria>REDCap</ipd_access_criteria>
  </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/NCT03042858
org study id: 16020156
nct id: NCT03042858
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This will be a multi-center prospective observational study of all patients who undergo
      laparoscopic pyloromyotomy. Subjects who have PPV will be followed up to just before their
      18th birthday through annual phone calls or emails to determine the incidence and timing of
      subsequent inguinal hernia.
Patients will be identified at the time the need for laparoscopic pyloromyotomy is determined
      by the consulting surgeon. After informed permission is obtained, demographic information
      will be collected on all subjects. Subjects who do not have PPV at the time of surgery will
      have no further data collected and their study participation will be complete. Subjects who
      have PPV will receive annual phone calls, emails, or other contact methods selected by the
      family, for up to before their 18th birthday or until they report having surgical inguinal
      hernia repair. Data will be recorded as noted on the master list and datasheet and entered
      into a REDCap database. All participating institutions will upload data into REDCap along
      with subject contact information so all follow up contact can be made by the coordinating
      center. All identifiable information in REDCap will be accessible by the coordinating center.
      Each enrolling center will have access to identifiers for their subjects only. Enrolling
      centers will be contacted and asked to update the contact information in REDCap if the
      coordinating center is not able to make contact with a subject. Subjects will also be given
      contact information for the coordinating center so they can provide updated information
      directly. Parents will be the main study contact for the duration of the study since no study
      interventions other than the phone call/email are required.

      During laparoscopy for pyloric stenosis, the surgeon will turn the camera downward to answer
      the first question, whether the inguinal canal is patent or closed. Many surgeons routinely
      perform this maneuver; it takes no more than 10 seconds to perform and adds no risk to the
      operation. The study will include a quick estimate of width and depth of the PPV as outlined
      in the datasheet to characterize the size of the opening. The first characterization will be
      the presence of CO2 in the scrotum/labia upon insufflation, which clarifies that the PPV
      provides wide continuity from the abdomen to beyond the inguinal canal. The second
      characterization will be an estimate of the width of the opening in millimeters. The next
      step will be to note whether the bottom of the defect is seen. This is, by definition, no if
      the answer to the first question is yes and this no longer applies. Therefore the no answer
      to this question will identify those with an open tunnel but no external insufflation.
      Finally, if the bottom is seen then an estimate will be made in millimeters.

      If there is no PPV, meaning the patient presents normal anatomy, the patient demographic data
      will be recorded and this will terminate their participation.

      If a PPV is present, the investigators will conduct annual phone calls, or other contact
      method of the family's choice, to ask questions about whether the child has been diagnosed
      with hernia, underwent hernia repair or currently has symptoms consistent with a hernia
      (questionnaire attached). Subjects will be followed until hernia repair or as long as
      possible, up to their 18th birthday.
observational model: Cohort
time perspective: Prospective
measure: Incidence of inguinal hernia
time frame: 18 years
description: frequency of the development of symptomatic inguinal hernia in infants who are found to have an opening in their inguinal canal during laparoscopy for pyloric stenosis
measure: Time to development of inguinal hernia
time frame: 18 years
description: Timeframe to develop a symptomatic inguinal hernia in infants who are found to have an opening in their inguinal canal during laparoscopy for pyloric stenosis.
arm group label: Infants with PPV
description: During laparoscopy for pyloric stenosis, the surgeon will turn the camera downward to answer the first question, whether the inguinal canal is patent or closed. If a PPV is present, the subject will be followed for up to 18 years of age.
arm group label: Infants without PPV
description: During laparoscopy for pyloric stenosis, the surgeon will turn the camera downward to answer the first question, whether the inguinal canal is patent or closed. If there is no PPV, meaning they have normal anatomy, the patient demographic data will be recorded and this will terminate their participation.
intervention type: Other
intervention name: Infants with PPV
description: Data will be collected for up to 18 years to monitor for inguinal hernia.
arm group label: Infants with PPV
intervention type: Other
intervention name: Infants without PPV
description: Basic data will be collected regarding the surgery and the subject's study participation will be complete.
arm group label: Infants without PPV
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 4 Months
healthy volunteers: No
last name: Shawn D St. Peter, MD
role: Principal Investigator
affiliation: Children's Mercy Hospital Kansas City
last name: Shawn D St. Peter, MD
phone: 816-234-3575
email: sspeter@cmh.edu
last name: Yara K Duran, BSN
phone: 816-983-6852
email: ykduran@cmh.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Mercy Hospital Kansas City
investigator full name: Shawn St. Peter
investigator title: MD
mesh term: Testicular Hydrocele
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: Yes
ipd description: The data coordination site will have contact information for all subjects so that long-term follow-up can be done. Each contributing site will only have access to their own subjects' information.
ipd info type: Study Protocol
ipd info type: Analytic Code
ipd time frame: duration of study
ipd access criteria: REDCap