<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/NCT03293628</url>
  </required_header>
  <id_info>
    <org_study_id>826/2014</org_study_id>
    <nct_id>NCT03293628</nct_id>
  </id_info>
  <brief_title>Comparing Two Techniques of Haemostasis After Cervical Conization</brief_title>
  <official_title>Randomized Clinical Trial Comparing Two Techniques of Haemostasis After Cervical Conization With High Frequency Surgery</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The LEEP conization is commonly used for cervical pathologies treatment. The techniques for&#xD;
      hemostasis usually used are: cautery, Monsel's solution and vaginal pack. Actually, there is&#xD;
      no consensus about the best technique and there is not much information that validates the&#xD;
      use of some of that. To compare the use or not of vaginal pack as methods of hemostasis after&#xD;
      LEEP conization for management of cervical lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized clinical trial was conducted at Gynecology Oncology Department/Barretos Cancer&#xD;
      Hospital for patients with indication of LEEP conization. After local IRB approval, patients&#xD;
      were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with&#xD;
      vaginal pack (group 2 - GP2). The Monsel's solution was used in all patients. Intraoperative&#xD;
      and postoperative outcomes will be evaluated: operative time, intraoperative and&#xD;
      postoperative bleeding, hormonal status, age, parity and cone specimens' characteristics as&#xD;
      well as short-term outcome were recorded and compared using Chi-square test, Fisher exact&#xD;
      test and t-test where appropriate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">January 30, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2015</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>
    <intervention_model_description>Patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2).Randomization was generated through a computer program creating a random entry list in the study, separating in group 1 (local application of Monsel's solution without intra-vaginal gauze buffer) and group 2 (application of Monsel's solution with intra-vaginal gauze). In this way, all patients had an equal chance of being included in both groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The allocation of patients to one group or another was only known moments before the surgical procedure was started.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Vaginal bleeding until 30 days after surgery</measure>
    <time_frame>Until 30 days after surgery</time_frame>
    <description>Bleeding was assessed by the need for reintervention.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Cervical Intraepithelial Neoplasia</condition>
  <condition>Cervix Neoplasm</condition>
  <arm_group>
    <arm_group_label>Conization With Vaginal Packing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conization Without Vaginal Packing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Haemostasis at the end of the procedure using only Monsel's solution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vaginal Packing</intervention_name>
    <description>This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique</description>
    <arm_group_label>Conization With Vaginal Packing</arm_group_label>
    <arm_group_label>Conization Without Vaginal Packing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication of cervical conization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We excluded patients who were not treated by our department physicians or if the&#xD;
             patient did not return for follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo D Reis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital do Câncer de Barretos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital do Câncer de Barretos</name>
      <address>
        <city>Barretos</city>
        <state>SP</state>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</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>cervical intraepithelial neoplasia</keyword>
  <keyword>haemostasis</keyword>
  <keyword>vaginal pack</keyword>
  <keyword>Loop electrical excision procedure</keyword>
  <keyword>randomized clinical trials</keyword>
  <keyword>uterine cervical neoplasm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Uterine Cervical Dysplasia</mesh_term>
    <mesh_term>Uterine Cervical Neoplasms</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/NCT03293628
org study id: 826/2014
nct id: NCT03293628
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The LEEP conization is commonly used for cervical pathologies treatment. The techniques for
      hemostasis usually used are: cautery, Monsel's solution and vaginal pack. Actually, there is
      no consensus about the best technique and there is not much information that validates the
      use of some of that. To compare the use or not of vaginal pack as methods of hemostasis after
      LEEP conization for management of cervical lesions.
A randomized clinical trial was conducted at Gynecology Oncology Department/Barretos Cancer
      Hospital for patients with indication of LEEP conization. After local IRB approval, patients
      were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with
      vaginal pack (group 2 - GP2). The Monsel's solution was used in all patients. Intraoperative
      and postoperative outcomes will be evaluated: operative time, intraoperative and
      postoperative bleeding, hormonal status, age, parity and cone specimens' characteristics as
      well as short-term outcome were recorded and compared using Chi-square test, Fisher exact
      test and t-test where appropriate.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2).Randomization was generated through a computer program creating a random entry list in the study, separating in group 1 (local application of Monsel's solution without intra-vaginal gauze buffer) and group 2 (application of Monsel's solution with intra-vaginal gauze). In this way, all patients had an equal chance of being included in both groups.
primary purpose: Treatment
masking: Single (Participant)
masking description: The allocation of patients to one group or another was only known moments before the surgical procedure was started.
measure: Vaginal bleeding until 30 days after surgery
time frame: Until 30 days after surgery
description: Bleeding was assessed by the need for reintervention.
arm group label: Conization With Vaginal Packing
arm group type: Experimental
description: Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.
arm group label: Conization Without Vaginal Packing
arm group type: Active Comparator
description: Haemostasis at the end of the procedure using only Monsel's solution.
intervention type: Procedure
intervention name: Vaginal Packing
description: This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique
arm group label: Conization With Vaginal Packing
arm group label: Conization Without Vaginal Packing
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 68 Years
healthy volunteers: No
last name: Ricardo D Reis, MD
role: Principal Investigator
affiliation: Hospital do Câncer de Barretos
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: Neoplasms
mesh term: Uterine Cervical Dysplasia
mesh term: Uterine Cervical Neoplasms