<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/NCT02184975</url>
  </required_header>
  <id_info>
    <org_study_id>Conization1</org_study_id>
    <nct_id>NCT02184975</nct_id>
  </id_info>
  <brief_title>Cold Knife Conization With and Without Lateral Hemostatic Sutures</brief_title>
  <official_title>Randomized Clinical Trial Comparing Cold Knife Conization of the Cervix With and Without Lateral Hemostatic Sutures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barretos Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Barretos Cancer Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The treatment of high grade Cervical Intraepithelial Neoplasia (CIN) 2, 3 is defined&#xD;
      according to the colposcopic evaluation of the patient. In case colposcopy findings are&#xD;
      satisfactory (visible squamocolumnar junction), both ablative and excisional methods are&#xD;
      adequate. In the middle of the 20th century, lateral hemostatic sutures were added to the&#xD;
      cold knife conization surgical technique to reduce blood loss. Some authors recommend that&#xD;
      these branches should be ligated, but it remains unclear whether these sutures are actually&#xD;
      effective in reducing bleeding.This study compared blood loss during cold knife conization of&#xD;
      the cervix with and without lateral hemostatic sutures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a study that will evaluate two groups of patients undergoing cold-knife conization&#xD;
      for cervical intraepithelial neoplasia high grade where 50% will undergo hemostatic sutures&#xD;
      in the lateral cervical and 50% of patients will not be subjected to these sutures. The main&#xD;
      objective of the study is to evaluate the amount of intraoperative bleeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <phase>Phase 2</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperatory vaginal bleeding</measure>
    <time_frame>Intraoperatory</time_frame>
    <description>The intraoperatory bleeding will be measure by weigh the gauze in grams (g).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cervical Intraepithelial Neoplasia</condition>
  <condition>Cervix Neoplasms</condition>
  <arm_group>
    <arm_group_label>Stitches</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cold Knife Conization with stitches</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No stitches</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cold Knife Conization without stitches</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold Knife Conization with stitches</intervention_name>
    <description>In the research arm patients who underwent cold-knife conization of the cervix underwent hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. These sutures were held prior to the onset of cold conization of the cervix.</description>
    <arm_group_label>Stitches</arm_group_label>
    <other_name>Cold Knife conization with sutures</other_name>
    <other_name>Cervix hemostatic sutures</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold knife Conization without stitches</intervention_name>
    <description>In the research arm patients who underwent cold-knife conization of the cervix have not undergone hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. After patient anesthesia and routine antisepsis was performed, cold knife conization of the cervix was performed.</description>
    <arm_group_label>No stitches</arm_group_label>
    <other_name>Cervix conization without hemostatic sutures</other_name>
    <other_name>Cold knife conization without lateral sutures</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  indication of cold knife conization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  conization using techniques other than the cold knife;&#xD;
&#xD;
          -  previous cervical conization using any other technique;&#xD;
&#xD;
          -  previous pelvic radiotherapy;&#xD;
&#xD;
          -  pregnancy; and&#xD;
&#xD;
          -  refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo D Reis, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital de Clinicas de Porto Alegre-Brazil</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 5, 2014</last_update_submitted>
  <last_update_submitted_qc>July 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Barretos Cancer Hospital</investigator_affiliation>
    <investigator_full_name>Ricardo dos Reis</investigator_full_name>
    <investigator_title>Medical doctor</investigator_title>
  </responsible_party>
  <keyword>cold knife conization</keyword>
  <keyword>lateral hemostatic sutures</keyword>
  <keyword>cervix</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatics</mesh_term>
  </intervention_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/NCT02184975
org study id: Conization1
nct id: NCT02184975
lead sponsor: 
has dmc: No
The treatment of high grade Cervical Intraepithelial Neoplasia (CIN) 2, 3 is defined
      according to the colposcopic evaluation of the patient. In case colposcopy findings are
      satisfactory (visible squamocolumnar junction), both ablative and excisional methods are
      adequate. In the middle of the 20th century, lateral hemostatic sutures were added to the
      cold knife conization surgical technique to reduce blood loss. Some authors recommend that
      these branches should be ligated, but it remains unclear whether these sutures are actually
      effective in reducing bleeding.This study compared blood loss during cold knife conization of
      the cervix with and without lateral hemostatic sutures.
This is a study that will evaluate two groups of patients undergoing cold-knife conization
      for cervical intraepithelial neoplasia high grade where 50% will undergo hemostatic sutures
      in the lateral cervical and 50% of patients will not be subjected to these sutures. The main
      objective of the study is to evaluate the amount of intraoperative bleeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Intraoperatory vaginal bleeding
time frame: Intraoperatory
description: The intraoperatory bleeding will be measure by weigh the gauze in grams (g).
arm group label: Stitches
arm group type: Experimental
description: Cold Knife Conization with stitches
arm group label: No stitches
arm group type: Active Comparator
description: Cold Knife Conization without stitches
intervention type: Procedure
intervention name: Cold Knife Conization with stitches
description: In the research arm patients who underwent cold-knife conization of the cervix underwent hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. These sutures were held prior to the onset of cold conization of the cervix.
arm group label: Stitches
other name: Cold Knife conization with sutures
other name: Cervix hemostatic sutures
intervention type: Procedure
intervention name: Cold knife Conization without stitches
description: In the research arm patients who underwent cold-knife conization of the cervix have not undergone hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. After patient anesthesia and routine antisepsis was performed, cold knife conization of the cervix was performed.
arm group label: No stitches
other name: Cervix conization without hemostatic sutures
other name: Cold knife conization without lateral sutures
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ricardo D Reis, MD
role: Study Chair
affiliation: Hospital de Clinicas de Porto Alegre-Brazil
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Barretos Cancer Hospital
investigator full name: Ricardo dos Reis
investigator title: Medical doctor
mesh term: Uterine Cervical Dysplasia
mesh term: Uterine Cervical Neoplasms
mesh term: Hemostatics