<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/NCT03305523</url>
  </required_header>
  <id_info>
    <org_study_id>2011-KAEK-2 2017/2:52</org_study_id>
    <nct_id>NCT03305523</nct_id>
  </id_info>
  <brief_title>The Safety of Thermocautery Usage for Male Children's Circumcisions</brief_title>
  <acronym>MC</acronym>
  <official_title>The Safety of Thermocautery Usage for Male Children's Circumcisions</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since circumcision is a significant workload for surgeons working at the rural state&#xD;
      hospitals in Turkey, the use of circumcision techniques that are easy to implement and have&#xD;
      low complications is becoming widespread. This research will examine short and long-term&#xD;
      complications of male circumcisions using thermocautery technique in light of current&#xD;
      literature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who were circumcised between May 2014 and May 2016 at the Pediatric Surgery and&#xD;
      Urology Clinics at Yuksekova State Hospital were retrospectively analyzed through the&#xD;
      hospital registry system. Patients who underwent circumcision with thermocautery technique&#xD;
      were examined in terms of age, duration of circumcision and complication rates. Complications&#xD;
      were classified as perioperative (bleeding during the circumcision or under observation at&#xD;
      the hospital after circumcision that required knotting or cauterization, scrotum or penile&#xD;
      injury), early postoperative (first 10 days after being discharged) and long-term (late&#xD;
      postoperative = after 10 days) (skin-mucosal bridge, delayed wound healing, secondary&#xD;
      phimosis, meatitis).&#xD;
&#xD;
      Patients were discharged after being kept under observation for 1 hour after circumcision.&#xD;
      Patients were suggested to apply routine warm sitting bath, daily dressing and the patients&#xD;
      with phimosis opening were suggested to apply epithelizing cream. On the 10th postoperative&#xD;
      day, all patients were called for control. Patients who developed complications were included&#xD;
      in long-term follow-up. Complications were treated.&#xD;
&#xD;
      Statistical analysis: The data obtained from the study were transferred to a computer&#xD;
      environment and evaluated with the help of Statistical Package for Social Sciences Version&#xD;
      19.0. Chi-square test was used to evaluate categorical data and Mann-Whitney U test was used&#xD;
      to evaluate quantitative variables. P &lt; 0.05 was considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2014</start_date>
  <completion_date type="Actual">May 1, 2016</completion_date>
  <primary_completion_date type="Actual">May 1, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Short and long-term complications of male circumcisions using thermocautery was examined during 2 years period.&#xD;
Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term (late postoperative = after 10 days) (skin-mucosal bridge, delayed wound healing, secondary phimosis, meatitis).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complication rate</measure>
    <time_frame>perioperative (during circumcision) - 6 months after circumcision</time_frame>
    <description>On the 10th postoperative day, all patients were called for control. Patients who developed complications were included in long-term follow-up. Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term complications (10 days- 2 years).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical processing time</measure>
    <time_frame>4-15 minutes</time_frame>
    <description>Surgical processing times were analyzed retrospectively by using the hospital registry system</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1780</enrollment>
  <condition>Circumcision, Male</condition>
  <arm_group>
    <arm_group_label>Thermocautery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Circumcision with thermocautery technique was applied all participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thermocautery</intervention_name>
    <description>In the thermocautery method, a digital thermocautery device (Thermo-Med TM 802-B, Thermo Medical, Adana, Turkey) with 6 different temperature settings was used. Circumcision was performed in the same way as the surgical circumcision. Only cutting and bleeding intervention was done by using a thermocautery device. Cutting was performed by making the appropriate heat adjustment according to the age of the child and the thickness of the glans. Hemorrhage control was performed with a thermocautery device and then the skin-mucosa integrity was ensured by using a 5/0 absorbable suture</description>
    <arm_group_label>Thermocautery</arm_group_label>
    <other_name>Study group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who circumcised by Thermocautery device Patients without additional disease&#xD;
        between 2 weeks and 18 years included in the study Male gender&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other circumcision Techniques (Conventional surgical, Alis clamp, Tara, Mogen&#xD;
             clamp...)&#xD;
&#xD;
          -  Patients older than 18 years&#xD;
&#xD;
          -  The presence of additional diseases ( such as hematologic disease, diabetes...)&#xD;
&#xD;
          -  Patient with hypospadias&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>2 Weeks</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmet Ali Tuncer, Asst Prof Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Afyon Kocatepe University</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 8, 2017</last_update_submitted>
  <last_update_submitted_qc>October 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 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>circumcision; Thermocautery; Complication</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03305523
org study id: 2011-KAEK-2 2017/2:52
nct id: NCT03305523
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since circumcision is a significant workload for surgeons working at the rural state
      hospitals in Turkey, the use of circumcision techniques that are easy to implement and have
      low complications is becoming widespread. This research will examine short and long-term
      complications of male circumcisions using thermocautery technique in light of current
      literature.
Patients who were circumcised between May 2014 and May 2016 at the Pediatric Surgery and
      Urology Clinics at Yuksekova State Hospital were retrospectively analyzed through the
      hospital registry system. Patients who underwent circumcision with thermocautery technique
      were examined in terms of age, duration of circumcision and complication rates. Complications
      were classified as perioperative (bleeding during the circumcision or under observation at
      the hospital after circumcision that required knotting or cauterization, scrotum or penile
      injury), early postoperative (first 10 days after being discharged) and long-term (late
      postoperative = after 10 days) (skin-mucosal bridge, delayed wound healing, secondary
      phimosis, meatitis).

      Patients were discharged after being kept under observation for 1 hour after circumcision.
      Patients were suggested to apply routine warm sitting bath, daily dressing and the patients
      with phimosis opening were suggested to apply epithelizing cream. On the 10th postoperative
      day, all patients were called for control. Patients who developed complications were included
      in long-term follow-up. Complications were treated.

      Statistical analysis: The data obtained from the study were transferred to a computer
      environment and evaluated with the help of Statistical Package for Social Sciences Version
      19.0. Chi-square test was used to evaluate categorical data and Mann-Whitney U test was used
      to evaluate quantitative variables. P < 0.05 was considered statistically significant.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Short and long-term complications of male circumcisions using thermocautery was examined during 2 years period.
Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term (late postoperative = after 10 days) (skin-mucosal bridge, delayed wound healing, secondary phimosis, meatitis).
primary purpose: Other
masking: None (Open Label)
measure: Complication rate
time frame: perioperative (during circumcision) - 6 months after circumcision
description: On the 10th postoperative day, all patients were called for control. Patients who developed complications were included in long-term follow-up. Complications were classified as perioperative (bleeding during the circumcision or under observation at the hospital after circumcision that required knotting or cauterization, scrotum or penile injury), early postoperative (first 10 days after being discharged) and long-term complications (10 days- 2 years).
measure: Surgical processing time
time frame: 4-15 minutes
description: Surgical processing times were analyzed retrospectively by using the hospital registry system
arm group label: Thermocautery
arm group type: Experimental
description: Circumcision with thermocautery technique was applied all participants
intervention type: Device
intervention name: Thermocautery
description: In the thermocautery method, a digital thermocautery device (Thermo-Med TM 802-B, Thermo Medical, Adana, Turkey) with 6 different temperature settings was used. Circumcision was performed in the same way as the surgical circumcision. Only cutting and bleeding intervention was done by using a thermocautery device. Cutting was performed by making the appropriate heat adjustment according to the age of the child and the thickness of the glans. Hemorrhage control was performed with a thermocautery device and then the skin-mucosa integrity was ensured by using a 5/0 absorbable suture
arm group label: Thermocautery
other name: Study group
criteria: 
gender: Male
minimum age: 2 Weeks
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmet Ali Tuncer, Asst Prof Dr
role: Principal Investigator
affiliation: Afyon Kocatepe University
responsible party type: Principal Investigator
investigator affiliation: Kocatepe University
investigator full name: Ahmet Ali Tuncer
investigator title: Asst Prof Dr
sharing ipd: Undecided