<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/NCT03033381</url>
  </required_header>
  <id_info>
    <org_study_id>2015-KAEK-86/05-80</org_study_id>
    <nct_id>NCT03033381</nct_id>
  </id_info>
  <brief_title>A Comparison of Testicular Volume and Blood Flow in Patients With Inguinal Hernia, Hydrocele, and Cord Cyst</brief_title>
  <acronym>IHR</acronym>
  <official_title>A Comparison of Preoperative and Postoperative Testicular Volume and Blood Flow in Patients With Inguinal Hernia, Hydrocele, and Cord Cyst: A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocatepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocatepe University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Here, investigators aimed to evaluate the effect of inguinal operations performed with a&#xD;
      modified Ferguson technique upon testicular volume and blood flow. This study involved 23&#xD;
      patients receiving surgery for inguinal hernia, hydrocele, and cord cyst. The color Doppler&#xD;
      ultrasound (CDUS) was used to assess testicular volume and blood flow before and after a&#xD;
      modified Ferguson technique surgery. The pre- and postoperative testicular volume and blood&#xD;
      flow were compared with the contralateral testes. Statistical Package for the Social Sciences&#xD;
      (SPSS) software was used to statistically analyze the data arising; the Mann-Whitney U test&#xD;
      and Friedman test were used to compare samples, and P &lt; 0.05 was accepted as statistically&#xD;
      significant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients and Methods The study was performed prospectively with the approval of the Local&#xD;
      Human Ethics Committee. All procedures performed in studies involving human participants were&#xD;
      in accordance with the ethical standards of the institutional and/or national research&#xD;
      committee and with the 1964 Helsinki declaration and its later amendments or comparable&#xD;
      ethical standards. All patients included in the study were provided with a patient consent&#xD;
      form.&#xD;
&#xD;
      Study Group The analysis included male patients who were younger than 17 years and possessing&#xD;
      one-sided inguinal hernia, hydrocele, or cord cyst and who were otherwise healthy. The study&#xD;
      was performed prospectively between April 2016 and June 2016 in a medical faculty pediatric&#xD;
      surgery unit.&#xD;
&#xD;
      Study plan Following diagnosis, patients received a CDUS and testicular volume and blood flow&#xD;
      were measured preoperatively. All patients then received surgery with modified Ferguson&#xD;
      repair. Testicular volume and blood flow were then reassessed by CDUS on days 7 and 30&#xD;
      following surgery.&#xD;
&#xD;
      Radiological evaluation Radiological evaluation was performed by a single radiologist using&#xD;
      color doppler ultrasound (CDUS) preoperatively and on days 7 and 30 post-surgery.&#xD;
      Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the&#xD;
      testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 ×&#xD;
      D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse&#xD;
      diameters defined by CDUS) for both testicles in each patient [1]. Peak systolic velocity&#xD;
      (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.&#xD;
&#xD;
      Statistical analysis The SPSS 15.0 (Statistical Package for the Social Sciences) software&#xD;
      package was used for all statistical analysis. Testicular volumes and blood flow were&#xD;
      analyzed as mean±standard deviation. The Mann-Whitney U test was used to compare differences&#xD;
      in testicular volume and blood flow between the testis receiving surgery and the&#xD;
      contralateral testis. Differences in preoperative, early postoperative (7 days post-surgery),&#xD;
      and late postoperative (30 days post-surgery) testicular volume and blood flow of each&#xD;
      testicle were compared using the Friedman test and P &lt; 0.05 was accepted as statistically&#xD;
      significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>
    <intervention_model_description>operated and nonoperated side testis of each patient accepted two different group.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Statistician was masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of testicular volume</measure>
    <time_frame>Change of testicular volume from preoperative to postoperative 30 days</time_frame>
    <description>Radiological evaluation was performed by a single radiologist using CDUS preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of blood flow</measure>
    <time_frame>Change of blood flow from preoperative to postoperative 30 days</time_frame>
    <description>Radiological evaluation was performed by a single radiologist using CDUS preoperatively and on days 7 and 30 post-surgery. Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Inguinal Hernia Repair</condition>
  <arm_group>
    <arm_group_label>operated side testis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Operated side testis volume and blood flow will be evaluated with color doppler ultrasound before and after the surgery (Preoperative, 7 day and 30 day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contralateral testis</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Nonoperated side testis volume and blood flow will be evaluated with color doppler ultrasound before and after the surgery (Preoperative, 7 day and 30 day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Color Doppler Ultrasound</intervention_name>
    <description>Radiological evaluation was performed by a single radiologist using CDUS for operated side testis of each patient preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient . Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.</description>
    <arm_group_label>operated side testis</arm_group_label>
    <other_name>Operated side testis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Color Doppler Ultrasound</intervention_name>
    <description>Radiological evaluation was performed by a single radiologist using CDUS for nonoperated side testis of each patient preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient . Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.</description>
    <arm_group_label>Contralateral testis</arm_group_label>
    <other_name>Nonoperated side testis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Our analysis included boys who were younger than 17 years and possessing one-sided&#xD;
             inguinal hernia, hydrocele, or cord cyst and who were otherwise healthy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had bilaterally inguinal hernia, hydrocele, or cord cyst&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocatepe University</investigator_affiliation>
    <investigator_full_name>Ahmet Ali Tuncer</investigator_full_name>
    <investigator_title>Asst Prof Dr</investigator_title>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>Inguinal hernia</keyword>
  <keyword>Testis</keyword>
  <keyword>Doppler ultrasonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03033381
org study id: 2015-KAEK-86/05-80
nct id: NCT03033381
lead sponsor: 
has dmc: No
Here, investigators aimed to evaluate the effect of inguinal operations performed with a
      modified Ferguson technique upon testicular volume and blood flow. This study involved 23
      patients receiving surgery for inguinal hernia, hydrocele, and cord cyst. The color Doppler
      ultrasound (CDUS) was used to assess testicular volume and blood flow before and after a
      modified Ferguson technique surgery. The pre- and postoperative testicular volume and blood
      flow were compared with the contralateral testes. Statistical Package for the Social Sciences
      (SPSS) software was used to statistically analyze the data arising; the Mann-Whitney U test
      and Friedman test were used to compare samples, and P < 0.05 was accepted as statistically
      significant.
Patients and Methods The study was performed prospectively with the approval of the Local
      Human Ethics Committee. All procedures performed in studies involving human participants were
      in accordance with the ethical standards of the institutional and/or national research
      committee and with the 1964 Helsinki declaration and its later amendments or comparable
      ethical standards. All patients included in the study were provided with a patient consent
      form.

      Study Group The analysis included male patients who were younger than 17 years and possessing
      one-sided inguinal hernia, hydrocele, or cord cyst and who were otherwise healthy. The study
      was performed prospectively between April 2016 and June 2016 in a medical faculty pediatric
      surgery unit.

      Study plan Following diagnosis, patients received a CDUS and testicular volume and blood flow
      were measured preoperatively. All patients then received surgery with modified Ferguson
      repair. Testicular volume and blood flow were then reassessed by CDUS on days 7 and 30
      following surgery.

      Radiological evaluation Radiological evaluation was performed by a single radiologist using
      color doppler ultrasound (CDUS) preoperatively and on days 7 and 30 post-surgery.
      Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the
      testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 ×
      D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse
      diameters defined by CDUS) for both testicles in each patient [1]. Peak systolic velocity
      (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.

      Statistical analysis The SPSS 15.0 (Statistical Package for the Social Sciences) software
      package was used for all statistical analysis. Testicular volumes and blood flow were
      analyzed as mean±standard deviation. The Mann-Whitney U test was used to compare differences
      in testicular volume and blood flow between the testis receiving surgery and the
      contralateral testis. Differences in preoperative, early postoperative (7 days post-surgery),
      and late postoperative (30 days post-surgery) testicular volume and blood flow of each
      testicle were compared using the Friedman test and P < 0.05 was accepted as statistically
      significant.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: operated and nonoperated side testis of each patient accepted two different group.
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
masking description: Statistician was masking
measure: Change of testicular volume
time frame: Change of testicular volume from preoperative to postoperative 30 days
description: Radiological evaluation was performed by a single radiologist using CDUS preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient
measure: Change of blood flow
time frame: Change of blood flow from preoperative to postoperative 30 days
description: Radiological evaluation was performed by a single radiologist using CDUS preoperatively and on days 7 and 30 post-surgery. Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.
arm group label: operated side testis
arm group type: Active Comparator
description: Operated side testis volume and blood flow will be evaluated with color doppler ultrasound before and after the surgery (Preoperative, 7 day and 30 day)
arm group label: Contralateral testis
arm group type: Sham Comparator
description: Nonoperated side testis volume and blood flow will be evaluated with color doppler ultrasound before and after the surgery (Preoperative, 7 day and 30 day)
intervention type: Device
intervention name: Color Doppler Ultrasound
description: Radiological evaluation was performed by a single radiologist using CDUS for operated side testis of each patient preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient . Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.
arm group label: operated side testis
other name: Operated side testis
intervention type: Device
intervention name: Color Doppler Ultrasound
description: Radiological evaluation was performed by a single radiologist using CDUS for nonoperated side testis of each patient preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient . Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.
arm group label: Contralateral testis
other name: Nonoperated side testis
criteria: 
gender: Male
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Kocatepe University
investigator full name: Ahmet Ali Tuncer
investigator title: Asst Prof Dr
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: No