<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/NCT01726036</url>
  </required_header>
  <id_info>
    <org_study_id>H-11121</org_study_id>
    <nct_id>NCT01726036</nct_id>
  </id_info>
  <brief_title>Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial</brief_title>
  <acronym>GMRT</acronym>
  <official_title>Gomco Versus Mogen: Which is Best? A Randomized Controlled Trial: The GMRT Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TriHealth Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TriHealth Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare two commonly used circumcision clamps (Gomco and&#xD;
      Mogen) to see which results in less neonatal pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To compare pain levels assessed by salivary cortisol and standardized neonatal&#xD;
      pain scale among the two most common infant circumcision techniques in uncomplicated&#xD;
      pregnancies after a thorough resident-wide education curriculum under attending physician&#xD;
      supervision.&#xD;
&#xD;
      The secondary objectives are to assess the operative time, complication rates such as&#xD;
      infection and bleeding and short term outcomes including need for re-circumcision among&#xD;
      treatment groups.&#xD;
&#xD;
      Hypothesis: The Mogen technique of circumcision is less painful, faster, and associated with&#xD;
      less bleeding for newborns when compared to the Gomco technique after a resident circumcision&#xD;
      standard teaching curriculum.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neonatal Salivary Cortisol Level</measure>
    <time_frame>Approximately 2 hours before and 15 minutes after the procedure</time_frame>
    <description>Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool</measure>
    <time_frame>CRIES assessment completed prior to the procedure and post procedure.</time_frame>
    <description>The CRIES score assigns points for crying characteristics, oxygen requirements, change in vital signs, facial expressions, and the infant's sleep state. The minimum and maximum scores of CRIES is 0 to 10, respectively with the lower score associated with lower pain and the higher score associated with high amount of pain.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">274</enrollment>
  <condition>Circumcision, Male</condition>
  <arm_group>
    <arm_group_label>Gomco Circumcision Clamp</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gomco circumcision clamp used for neonatal circumcision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mogen Circumcision Clamp</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mogen circumcision clamp used for neonatal circumcision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Gomco Circumcision Clamp</intervention_name>
    <description>Neonatal male circumcision utilizing the Gomco Circumcision Clamp</description>
    <arm_group_label>Gomco Circumcision Clamp</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mogen Circumcision Clamp</intervention_name>
    <description>Neonatal male circumcision utilizing the Mogen Circumcision Clamp</description>
    <arm_group_label>Mogen Circumcision Clamp</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  term infants delivered by cesarean section or vaginal delivery at Good Samaritan&#xD;
             Hospital during the time period of the study&#xD;
&#xD;
          -  Infants with no blood drawn two hours prior to the circumcision&#xD;
&#xD;
          -  Singletons&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with congenital anomalies and/or known chromosomal syndromes&#xD;
&#xD;
          -  Preterm infants defined as less than 37 / 0 weeks gestation.&#xD;
&#xD;
          -  Delivery secondary to non-reassuring fetal heart tracing, defined by the delivering&#xD;
             physician&#xD;
&#xD;
          -  Infants of diabetic mothers.&#xD;
&#xD;
          -  Infants of preeclamptic mothers on magnesium sulfate within 48 hours of delivery.&#xD;
&#xD;
          -  Infants delivered by vacuum-assisted or forceps-assisted vaginal delivery.&#xD;
&#xD;
          -  Infants of mothers who took steroids for fetal lung maturity within 7 days of&#xD;
             delivery. (This may apply to term infants if the mother had no prenatal care and her&#xD;
             gestational age was not known on arrival).&#xD;
&#xD;
          -  Infants with a 5 minutes apgar score of less than 7&#xD;
&#xD;
          -  Infants born to mothers with a history of drug abuse during pregnancy, currently on&#xD;
             methadone, or with Hepatitis C or HIV.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>4 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mounira Habli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TriHealth Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TriHealth Good Samaritan Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <results_first_submitted>July 24, 2015</results_first_submitted>
  <results_first_submitted_qc>April 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 16, 2019</results_first_posted>
  <last_update_submitted>May 21, 2019</last_update_submitted>
  <last_update_submitted_qc>May 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neonatal circumcision</keyword>
  <keyword>neonatal surgical pain</keyword>
  <keyword>Mogen</keyword>
  <keyword>Gomco</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data will be shared by manuscript.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>274 infants were enrolled into the study from 10/2012 through 6/2013.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Gomco Circumcision Clamp</title>
          <description>Gomco circumcision clamp used for neonatal circumcision.&#xD;
Gomco Circumcision Clamp</description>
        </group>
        <group group_id="P2">
          <title>Mogen Circumcision Clamp</title>
          <description>Mogen circumcision clamp used for neonatal circumcision.&#xD;
Mogen Circumcision Clamp</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="137"/>
                <participants group_id="P2" count="137"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="121"/>
                <participants group_id="P2" count="130"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Male infants receiving circumcisions</population>
      <group_list>
        <group group_id="B1">
          <title>Gomco Circumcision Clamp</title>
          <description>Gomco circumcision clamp used for neonatal circumcision.&#xD;
Gomco Circumcision Clamp</description>
        </group>
        <group group_id="B2">
          <title>Mogen Circumcision Clamp</title>
          <description>Mogen circumcision clamp used for neonatal circumcision.&#xD;
Mogen Circumcision Clamp</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="137"/>
            <count group_id="B2" value="137"/>
            <count group_id="B3" value="274"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>Gestational Age (Weeks)</description>
          <population>The data of the patients who did not receive the allocated intervention were not included in the analysis.</population>
          <units>Weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Gestational Age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="121"/>
                    <count group_id="B2" value="130"/>
                    <count group_id="B3" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.44" spread="1.08"/>
                    <measurement group_id="B2" value="39.29" spread="1.14"/>
                    <measurement group_id="B3" value="39.36" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="137"/>
                    <count group_id="B2" value="137"/>
                    <count group_id="B3" value="274"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="137"/>
                    <measurement group_id="B2" value="137"/>
                    <measurement group_id="B3" value="274"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Neonatal Salivary Cortisol Level</title>
        <description>Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure</description>
        <time_frame>Approximately 2 hours before and 15 minutes after the procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gomco Circumcision Clamp</title>
            <description>Gomco circumcision clamp used for neonatal circumcision.&#xD;
Gomco Circumcision Clamp</description>
          </group>
          <group group_id="O2">
            <title>Mogen Circumcision Clamp</title>
            <description>Mogen circumcision clamp used for neonatal circumcision.&#xD;
Mogen Circumcision Clamp</description>
          </group>
        </group_list>
        <measure>
          <title>Neonatal Salivary Cortisol Level</title>
          <description>Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure</description>
          <units>mcg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-op Salivary Cortisol Level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="0.59"/>
                    <measurement group_id="O2" value="0.72" spread="0.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-op Salivary Cortisol Level</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" spread="0.80"/>
                    <measurement group_id="O2" value="1.08" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool</title>
        <description>The CRIES score assigns points for crying characteristics, oxygen requirements, change in vital signs, facial expressions, and the infant's sleep state. The minimum and maximum scores of CRIES is 0 to 10, respectively with the lower score associated with lower pain and the higher score associated with high amount of pain.</description>
        <time_frame>CRIES assessment completed prior to the procedure and post procedure.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Gomco Circumcision Clamp</title>
            <description>Gomco circumcision clamp used for neonatal circumcision.&#xD;
Gomco Circumcision Clamp</description>
          </group>
          <group group_id="O2">
            <title>Mogen Circumcision Clamp</title>
            <description>Mogen circumcision clamp used for neonatal circumcision.&#xD;
Mogen Circumcision Clamp</description>
          </group>
        </group_list>
        <measure>
          <title>Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool</title>
          <description>The CRIES score assigns points for crying characteristics, oxygen requirements, change in vital signs, facial expressions, and the infant's sleep state. The minimum and maximum scores of CRIES is 0 to 10, respectively with the lower score associated with lower pain and the higher score associated with high amount of pain.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
                <count group_id="O2" value="117"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.457</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected during the infant's hospital stay and at 4-6 weeks after discharge.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Gomco Circumcision Clamp</title>
          <description>Gomco circumcision clamp used for neonatal circumcision.&#xD;
Gomco Circumcision Clamp</description>
        </group>
        <group group_id="E2">
          <title>Mogen Circumcision Clamp</title>
          <description>Mogen circumcision clamp used for neonatal circumcision.&#xD;
Mogen Circumcision Clamp</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>Physician</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Adhesion at 2 months</sub_title>
                <description>Adhesion</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
              </event>
              <event>
                <sub_title>Pustule at head of penis - self resolved</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="99"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="117"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Rachel G. Sinkey MD - PI</name_or_title>
      <organization>TriHealth</organization>
      <phone>513-862-6918</phone>
      <email>pam_plummer@trihealth.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01726036
org study id: H-11121
nct id: NCT01726036
lead sponsor: 
has dmc: No
The purpose of this study is to compare two commonly used circumcision clamps (Gomco and
      Mogen) to see which results in less neonatal pain.
Objective: To compare pain levels assessed by salivary cortisol and standardized neonatal
      pain scale among the two most common infant circumcision techniques in uncomplicated
      pregnancies after a thorough resident-wide education curriculum under attending physician
      supervision.

      The secondary objectives are to assess the operative time, complication rates such as
      infection and bleeding and short term outcomes including need for re-circumcision among
      treatment groups.

      Hypothesis: The Mogen technique of circumcision is less painful, faster, and associated with
      less bleeding for newborns when compared to the Gomco technique after a resident circumcision
      standard teaching curriculum.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Neonatal Salivary Cortisol Level
time frame: Approximately 2 hours before and 15 minutes after the procedure
description: Neonatal pain will be assessed by change in salivary cortisol, measured in mcg/dL., level pre and post procedure
measure: Post-procedure Neonatal Pain Score Using the CRIES Neonatal Pain Measurement Tool
time frame: CRIES assessment completed prior to the procedure and post procedure.
description: The CRIES score assigns points for crying characteristics, oxygen requirements, change in vital signs, facial expressions, and the infant's sleep state. The minimum and maximum scores of CRIES is 0 to 10, respectively with the lower score associated with lower pain and the higher score associated with high amount of pain.
arm group label: Gomco Circumcision Clamp
arm group type: Active Comparator
description: Gomco circumcision clamp used for neonatal circumcision.
arm group label: Mogen Circumcision Clamp
arm group type: Active Comparator
description: Mogen circumcision clamp used for neonatal circumcision.
intervention type: Device
intervention name: Gomco Circumcision Clamp
description: Neonatal male circumcision utilizing the Gomco Circumcision Clamp
arm group label: Gomco Circumcision Clamp
intervention type: Device
intervention name: Mogen Circumcision Clamp
description: Neonatal male circumcision utilizing the Mogen Circumcision Clamp
arm group label: Mogen Circumcision Clamp
criteria: 
gender: Male
minimum age: N/A
maximum age: 4 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Mounira Habli, MD
role: Principal Investigator
affiliation: TriHealth Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The data will be shared by manuscript.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 