<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/NCT04451512</url>
  </required_header>
  <id_info>
    <org_study_id>20200615</org_study_id>
    <nct_id>NCT04451512</nct_id>
  </id_info>
  <brief_title>Comparison of Cold and Hot Snare Resection for Colorectal Polyps Sized 10-19mm.</brief_title>
  <official_title>A Prospective Observational Study of Cold and Hot Snare Resection for Colorectal Polyps Sized 10-19mm.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital of Xi'an Jiaotong University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or&#xD;
      hot snare were included in the study, signed by endoscopic treatment written informed consent&#xD;
      for surgery, patients with detailed tracking and record the basic information and information&#xD;
      related to the operation, postoperative lack of region and edge endoscopic observation&#xD;
      carefully no residue, additional excision may be took if necessary，after resection specimen&#xD;
      inspection, and in 6 months review colonoscopy, assess whether there is residual or&#xD;
      recurrence of polyps.Main outcome: technical success rate (no other auxiliary resection),&#xD;
      complete resection rate, secondary outcome: intraoperative and postoperative complications,&#xD;
      polypectomy time and related costs, influential factors of incomplete resection.Research&#xD;
      significance: The effectiveness, safety and cost-effectiveness of cold and hot snare&#xD;
      resection of 10-19mm colorectal polyps were compared, and the influencing factors of&#xD;
      incomplete polyps resection were analyzed, so as to provide evidence for the decision on the&#xD;
      best method of medium-size polyps resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Technical success rate</measure>
    <time_frame>2020.07.31</time_frame>
    <description>(without other auxiliary resection)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete resection rate</measure>
    <time_frame>2021.01.31</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative and postoperative complications</measure>
    <time_frame>2021.01.31</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Polypectomy time</measure>
    <time_frame>2021.01.31</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>related costs of treatment</measure>
    <time_frame>2021.01.31</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Colonic Polyps/Colonoscopy/Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>CSP</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>HSP</arm_group_label>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Colorectal polyps after resection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or&#xD;
        hot snare were included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. colorectal polyps sized 10≤ diameter ≤19 mm;&#xD;
&#xD;
          2. Boston bowel prepare score: 5-9;&#xD;
&#xD;
          3. The patients all signed the informed consent of endoscopic treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Complicated with inflammatory bowel disease, P-J syndrome or familial polyposis;&#xD;
&#xD;
          2. Complicated with malignant tumors;&#xD;
&#xD;
          3. polyp size is uncertain;&#xD;
&#xD;
          4. Currently taking aspirin, warfarin or other anticoagulants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The second affiliated hospital of xi'an jiaotong university</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Polyps</mesh_term>
    <mesh_term>Colonic Polyps</mesh_term>
  </condition_browse>
  <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/NCT04451512
org study id: 20200615
nct id: NCT04451512
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients who met the criteria for removal of 10-19mm colorectal polyps using cold snare or
      hot snare were included in the study, signed by endoscopic treatment written informed consent
      for surgery, patients with detailed tracking and record the basic information and information
      related to the operation, postoperative lack of region and edge endoscopic observation
      carefully no residue, additional excision may be took if necessary，after resection specimen
      inspection, and in 6 months review colonoscopy, assess whether there is residual or
      recurrence of polyps.Main outcome: technical success rate (no other auxiliary resection),
      complete resection rate, secondary outcome: intraoperative and postoperative complications,
      polypectomy time and related costs, influential factors of incomplete resection.Research
      significance: The effectiveness, safety and cost-effectiveness of cold and hot snare
      resection of 10-19mm colorectal polyps were compared, and the influencing factors of
      incomplete polyps resection were analyzed, so as to provide evidence for the decision on the
      best method of medium-size polyps resection.
observational model: Cohort
time perspective: Prospective
measure: Technical success rate
time frame: 2020.07.31
description: (without other auxiliary resection)
measure: Complete resection rate
time frame: 2021.01.31
measure: Intraoperative and postoperative complications
time frame: 2021.01.31
measure: Polypectomy time
time frame: 2021.01.31
measure: related costs of treatment
time frame: 2021.01.31
arm group label: CSP
arm group label: HSP
Colorectal polyps after resection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Polyps
mesh term: Colonic Polyps
sharing ipd: Undecided