<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/NCT02235623</url>
  </required_header>
  <id_info>
    <org_study_id>P00008033</org_study_id>
    <nct_id>NCT02235623</nct_id>
  </id_info>
  <brief_title>Orchidopexy Randomized Clinical Assessment</brief_title>
  <acronym>ORCA</acronym>
  <official_title>Randomized Trial of One Stage vs Two Stage Orchidopexy for Abdominal Undescended Testis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized trial designed to evaluate testicular outcomes after a single stage&#xD;
      versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in&#xD;
      the abdomen. Also to determine and compare the costs, surgical complications and the health&#xD;
      related quality of life for the two procedures. Testicular outcomes will be measured using a&#xD;
      scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for&#xD;
      those randomized to a 2 stage surgery).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the volume of the operated testis via ultrasound measurements.</measure>
    <time_frame>6-12 months after final FSO surgery</time_frame>
    <description>To evaluate the volume of the operated testis at 6-12 months after single-stage Fowler-Stephens orchidopexy (FSO) (6-12 months after two- stage FSO), as determined by ultrasound measurements. This will be compared to the intra-operative testicular measurements done during the laparoscopy.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Unilateral Cryptorchidism</condition>
  <arm_group>
    <arm_group_label>Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Stage 2 2 surgeries: 1st surgery-Clip vessels to testis. 2nd surgery done 6-12 months later, divide the spermatic vessels and bring the testis into the scrotum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single-stage Fowler-Stephens orchidopexy (FSO)</intervention_name>
    <arm_group_label>Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Two-stage Fowler-Stephens orchidopexy (FSO)</intervention_name>
    <arm_group_label>Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Boys age 4 months to 36 months&#xD;
&#xD;
          -  Undergoing diagnostic laparoscopy for unilateral non-palpable testis, who are found at&#xD;
             laparoscopy to have an abdominal undescended testis, in whom a Fowler-Stephens&#xD;
             Orchiopexy would be appropriate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 36 months&#xD;
&#xD;
          -  Age &lt; 4 months&#xD;
&#xD;
          -  Bilateral cryptorchidism&#xD;
&#xD;
          -  Solitary testis&#xD;
&#xD;
          -  Findings at laparoscopy for which Fowler-Stephens Orchiopexy would not be indicated&#xD;
&#xD;
          -  Intra-operative mobility of the intra-abdominal testis such that, with no (or minimal)&#xD;
             mobilization, the testis is able to reach the contralateral internal ring, without&#xD;
             dividing the spermatic vessels.&#xD;
&#xD;
          -  Assessment of whether a single stage primary orchidopexy will be performed, is&#xD;
             entirely at the discretion of the attending surgeon.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>4 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caleb P Nelson, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Badar Omar, BA</last_name>
    <phone>617-919-6352</phone>
    <email>Badar.Omar@childrens.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Saunders, BA</last_name>
      <phone>617-355-4720</phone>
      <email>Rachel.Saunders@childrens.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Caleb P Nelson, MD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Caleb Nelson</investigator_full_name>
    <investigator_title>Caleb Nelson, MD MPH</investigator_title>
  </responsible_party>
  <keyword>Laparoscopic Surgery</keyword>
  <keyword>Orchiopexy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cryptorchidism</mesh_term>
  </condition_browse>
  <!-- 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/NCT02235623
org study id: P00008033
nct id: NCT02235623
lead sponsor: 
has dmc: Yes
This is a randomized trial designed to evaluate testicular outcomes after a single stage
      versus a two-stage surgical procedure to fix an undescended, one-sided testicle located in
      the abdomen. Also to determine and compare the costs, surgical complications and the health
      related quality of life for the two procedures. Testicular outcomes will be measured using a
      scrotal ultrasound 6-12 months after the procedure (after the second stage procedure for
      those randomized to a 2 stage surgery).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate the volume of the operated testis via ultrasound measurements.
time frame: 6-12 months after final FSO surgery
description: To evaluate the volume of the operated testis at 6-12 months after single-stage Fowler-Stephens orchidopexy (FSO) (6-12 months after two- stage FSO), as determined by ultrasound measurements. This will be compared to the intra-operative testicular measurements done during the laparoscopy.
arm group label: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)
arm group type: Other
description: Stage 1 single surgery to clip the vessels to the testis, divide the spermatic vessels and bring the testis into the scrotum.
arm group label: Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)
arm group type: Other
description: Stage 2 2 surgeries: 1st surgery-Clip vessels to testis. 2nd surgery done 6-12 months later, divide the spermatic vessels and bring the testis into the scrotum.
intervention type: Procedure
intervention name: Single-stage Fowler-Stephens orchidopexy (FSO)
arm group label: Stage 1- Single-stage Fowler-Stephens orchidopexy (FSO)
intervention type: Procedure
intervention name: Two-stage Fowler-Stephens orchidopexy (FSO)
arm group label: Stage 2- Two-stage Fowler-Stephens orchidopexy (FSO)
criteria: 
gender: Male
minimum age: 4 Months
maximum age: 36 Months
healthy volunteers: No
last name: Caleb P Nelson, MD, MPH
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Badar Omar, BA
phone: 617-919-6352
email: Badar.Omar@childrens.harvard.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Caleb Nelson
investigator title: Caleb Nelson, MD MPH
mesh term: Cryptorchidism