<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/NCT03783156</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT03783156</nct_id>
  </id_info>
  <brief_title>Polypectomy With Hot vs Cold Snare in Small Colonic Lesions</brief_title>
  <acronym>Polypech-c</acronym>
  <official_title>Polypectomy With Hot vs Cold Snare in Small Colonic Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital del Río Hortega</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital del Río Hortega</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>
      Colonoscopy is the technique of choice for the diagnosis and prevention of colorectal cancer&#xD;
      (CRC). The identification and extirpation of adenomas decreases the incidence of CRC by up to&#xD;
      76%. More than 70% of the excised lesions are less than 10 mm. There is controversy about the&#xD;
      technique to be used (resection with cold vs hot snare) in lesions of 5-9mm. Both use a&#xD;
      polypectomy snare. The cold snare cuts by friction, while the hot snare uses electrical&#xD;
      current. We propose a multicenter randomized clinical trial comparing both endoscopic&#xD;
      techniques. At least 394 injuries per group will be included, randomizing patients to whom a&#xD;
      diagnostic colonoscopy is requested for symptoms, screening or revision protocols.&#xD;
      Randomization will be performed stratified by center. The primary objective is the proportion&#xD;
      of incomplete polypectomies, which will be analyzed centrally from random biopsies of the&#xD;
      edges of the lesion. As secondary objectives, we will compare the proportion of immediate and&#xD;
      delayed hemorrhagic complications, the evolution of postprocedural abdominal pain and the&#xD;
      factors associated with incomplete excision in each group and the factors associated with a&#xD;
      failed cold polypectomy. The analysis of the primary objective will be carried out by means&#xD;
      of the z test of homogeneity without using the correction of Yates, estimating the confidence&#xD;
      interval of the difference between both groups. The analysis will be carried out by intention&#xD;
      to treat and per protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Introduction&#xD;
&#xD;
           Colorectal cancer (CRC) is a major cause of morbidity and mortality worldwide. It is&#xD;
           estimated that in 2008, 1233,000 new cases were diagnosed and more than 600,000 people&#xD;
           died for this reason throughout the world. Colonoscopy is the technique of choice for&#xD;
           both diagnosis and prevention, since the identification and removal of colonic adenomas&#xD;
           reduces the incidence of CRC by up to 76%.&#xD;
&#xD;
           Different endoscopic techniques have been developed for the removal of adenomas; The&#xD;
           choice of some over others is made according to the size, morphology and location of the&#xD;
           lesion.&#xD;
&#xD;
        2. Hypothesis&#xD;
&#xD;
           Conceptual hypothesis:&#xD;
&#xD;
           Cold snare polypectomy presents a proportion of incomplete polypectomies similar to&#xD;
           polypectomy with hot snare.&#xD;
&#xD;
           Operational hypothesis:&#xD;
&#xD;
           Two endoscopic techniques will be compared from two groups created by a random&#xD;
           assignment to one or another type of polypectomy, evaluating the proportion of&#xD;
           non-excised polypoid tissue after it. This will be done from random biopsies of the&#xD;
           edges of the lesion and possible macroscopic remnants&#xD;
&#xD;
        3. Objectives.&#xD;
&#xD;
           Primary objective:&#xD;
&#xD;
           To compare the proportion of incomplete polypectomies in both types of polypectomy (cold&#xD;
           snare vs. hot snare).&#xD;
&#xD;
           Secondary objectives:&#xD;
&#xD;
           Comparing the proportion of immediate and delayed bleeding complications, total and&#xD;
           according to the severity that they present according to the American Society of&#xD;
           Gastroenterology (ASGE) classification.&#xD;
&#xD;
           Comparing the evolution of abdominal pain in the 5 hours postprocedure between both&#xD;
           groups.&#xD;
&#xD;
           Evaluating factors associated with an incomplete extirpation in each group. Evaluating&#xD;
           factors associated with a failed cold polypectomy.&#xD;
&#xD;
        4. Design&#xD;
&#xD;
           Multicenter randomized clinical trial&#xD;
&#xD;
        5. Methods&#xD;
&#xD;
      Study population Patients scheduled to undergo a colonoscopy in a non-urgent setting.&#xD;
      Patients will be invited to participate before performing the colonoscopy.&#xD;
&#xD;
      Randomization It will be done once the patient agrees to participate in the work and the&#xD;
      first candidate polyp has been identified. Each patient will be randomized (regardless of the&#xD;
      number of lesions per patient) so all lesions of each patient will be removed in the same&#xD;
      way. It will be stratified by center.&#xD;
&#xD;
      Intervention Patients who meet the inclusion criteria and do not present any exclusion&#xD;
      criteria (pre-endoscopic) will be invited to participate in the study. The informed consent&#xD;
      will be completed according to the Spanish law 41/2002 of autonomy of the patient.&#xD;
&#xD;
        1. Endoscopic procedure The interventions will be carried out in each of the participating&#xD;
           centers. The examinations will be performed under sedation according to the protocols&#xD;
           established in each center. Once the first lesion is identified, the method of&#xD;
           extirpation of the lesion will be randomized.&#xD;
&#xD;
             -  Cold Group: polypectomy with a cold snare will be carried out according to the&#xD;
                usual standards recommended by international societies. The lesion should be placed&#xD;
                if possible in the position equivalent to 5 o'clock on the dial, the end of the&#xD;
                snare will be placed several millimeters from the lesion and the tip of the&#xD;
                catheter will be angled downwards, without aspiration at any time to avoid&#xD;
                entrapment of the submucosa.&#xD;
&#xD;
             -  Hot Group: polypectomy with snare connected to the electrosurgical unit according&#xD;
                to the standards recommended by international societies, using a mixed current&#xD;
                (cut-coagulation). Once the lesion is captured, the snare is pulled up to slightly&#xD;
                separate it from the surrounding mucosa before polypectomy. Elevation of the lesion&#xD;
                prior to polypectomy will not be performed.&#xD;
&#xD;
             -  Common evaluation: once the polypectomies are completed, the base of the&#xD;
                polypectomies will be evaluated, taking biopsies from any suggestive area and also&#xD;
                2 random biopsies at the base of the polypectomy.&#xD;
&#xD;
        2. Postendoscopic follow-up After a minimum of 21 days and a maximum of 28 days from the&#xD;
           endoscopic examination, the patient will be contacted by telephone to collect the form&#xD;
           about the evolution of the abdominal symptoms and to collect data about the appearance&#xD;
           of complications (questions will be asked about visits to the hospital and in a targeted&#xD;
           manner about the most frequent symptoms of the usual complications (fever, hemorrhage,&#xD;
           abdominal pain).&#xD;
&#xD;
        3. Histological analysis The analysis of the specimens of the polypectomies will be carried&#xD;
           out in each center according to their usual protocol. The analysis of the biopsies of&#xD;
           the base of the polyp will be carried out centrally by a pathologist with more than 5&#xD;
           years of experience in digestive pathology. Samples from the base of the polyp will be&#xD;
           sent periodically from each center to the Salamanca university hospital through a&#xD;
           messenger service. The pathologist will be blinded regarding the histological diagnosis&#xD;
           of the excised polyp and the type of polypectomy (although it is true that it is&#xD;
           difficult to blind this last point since the presence of heat artifacts in those removed&#xD;
           with a hot handle is very frequent). The samples sent for centralized analysis will not&#xD;
           be stored, but will be destroyed once the study is completed according to standard&#xD;
           protocols.&#xD;
&#xD;
      Sample size Assuming a proportion of incomplete polypectomies in both groups of 10% (using&#xD;
      the taking of biopsies as a diagnostic pattern) and setting an equivalence limit of 7%, a&#xD;
      total of 315 lesions per group are estimated to have an α risk of 5% and a power of 80%.&#xD;
      Assuming a proportion of losses (polyps not recovered for histological study, polypectomies&#xD;
      of the failed Cold group of 20%), an estimated 394 lesions per group are needed, with a total&#xD;
      of 788 lesions in total.&#xD;
&#xD;
      Data Collection All the variables concerning the characteristics of the endoscopist, the&#xD;
      patient and the injuries included will be collected in each center. The variables related to&#xD;
      the histological diagnosis will be collected in the same way in the respective center. The&#xD;
      variables concerning the follow-up will be collected in a centralized manner, through a&#xD;
      telephone call that will be made between 3 and 4 weeks from the procedure. The variable&#xD;
      related to the histological study of the base of the polyp will be collected in a centralized&#xD;
      manner by the pathologist in charge of the analysis of the samples.&#xD;
&#xD;
      6. Data management&#xD;
&#xD;
      Data from the data collection notebooks will be merged by the main researcher or&#xD;
      collaborating researchers anonymously, encrypted and dissociated from the clinical&#xD;
      information by means of a patient identification code (ID), in an online database. A copy of&#xD;
      the database will be used in each participating center, which will be merged after completing&#xD;
      the data collection. The responsible researcher will define an ID for each participant. The&#xD;
      data entered in the database will be anonymous and the database will be protected with a&#xD;
      password to which only the researchers will have access.&#xD;
&#xD;
      The unified file will be kept at the Río Hortega University Hospital and will be maintained&#xD;
      until the end of the study. Regarding the application of the Organic Law on Data Protection&#xD;
      15/1999 and 1720/2007 that develops it, it should be noted that the protocol defined in the&#xD;
      project oriented to epidemiological analysis, determines that the files will record&#xD;
      information completely anonymized&#xD;
&#xD;
      7. Statistical analysis&#xD;
&#xD;
      The Access program (Microsoft Corporation, Edmond, USA) will be used for the realization of&#xD;
      the database and the statistical analysis of them will be carried out through the STATA&#xD;
      program (StataCorp, 2013. Stata Statistical Software: Release 13. College Station, StataCorp&#xD;
      LP). In the quantitative variables, the arithmetic mean and the standard deviation will be&#xD;
      calculated (variables that do not follow a normal distribution according to the&#xD;
      Kolmogorov-Smirnov test will be described with median, minimum, maximum and interquartile&#xD;
      range), and the qualitative ones will be expressed as percentages and your 95% confidence&#xD;
      intervals.&#xD;
&#xD;
      The analysis of the primary objective, the proportion of incomplete polypectomies in both&#xD;
      groups will be compared by means of the z test of homogeneity without using the correction of&#xD;
      Yates.&#xD;
&#xD;
      The confidence interval of the difference between the two groups will also be estimated. The&#xD;
      analysis will be carried out by intention to treat, regardless of the type of polypectomy&#xD;
      performed and per protocol (assigning the lesions assigned to the group Cold that are&#xD;
      extirpated with hot snare to the Hot group). To evaluate possible confounding factors&#xD;
      (endoscopist, nurse, snare type, location ...), the STATA confound user command will be used,&#xD;
      defining as a significant change that which conditions a change in the odds ratio greater&#xD;
      than 10% with respect to the one obtained with the complete model. In case several models do&#xD;
      not present differences greater than 10%, the most parsimonious will be chosen.&#xD;
&#xD;
      Within the secondary objectives, the proportion of complications in both groups will be&#xD;
      verified by the de2 test. To evaluate the factors associated with incomplete polypectomies&#xD;
      and those associated with failed cold polypectomy, multivariate logistic regression&#xD;
      techniques will be used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with presence of adenomatous tissue al the base of polypectomy</measure>
    <time_frame>3 months</time_frame>
    <description>Number of patients with polypoid tissue at the base of polypectomy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Postpolypectomy Complications</measure>
    <time_frame>21-28 days</time_frame>
    <description>Clinical complications after polypectomy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Polyp of Colon</condition>
  <condition>Gastrointestinal Bleeding</condition>
  <condition>Colonic Adenoma</condition>
  <arm_group>
    <arm_group_label>hot snare</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>polypectomy with hot snare</description>
  </arm_group>
  <arm_group>
    <arm_group_label>cold snare</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>polypectomy with cold snare</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hot snare</intervention_name>
    <description>polypectomy with hot snare</description>
    <arm_group_label>hot snare</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cold snare</intervention_name>
    <description>polypectomy with cold snare</description>
    <arm_group_label>cold snare</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years scheduled to undergo a colonoscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of lesions of 5-9 mm.&#xD;
&#xD;
          -  Contraindication for polypectomy (anticoagulant treatment, treatment with clopidogrel,&#xD;
             coagulopathy or severe thrombocytopenia)&#xD;
&#xD;
          -  Loss of polypectomy specimen&#xD;
&#xD;
          -  Refusal to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marina de Benito, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Río Hortega</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Rio Hortega</name>
      <address>
        <city>Valladolid</city>
        <zip>47012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28.</citation>
    <PMID>28970290</PMID>
  </reference>
  <reference>
    <citation>Noda H, Ogasawara N, Sugiyama T, Yoshimine T, Tamura Y, Izawa S, Kondo Y, Ebi M, Funaki Y, Sasaki M, Kasugai K. The Influence of Snare Size on the Utility and Safety of Cold Snare Polypectomy for the Removal of Colonic Polyps in Japanese Patients. J Clin Med Res. 2016 Sep;8(9):662-6. doi: 10.14740/jocmr2646w. Epub 2016 Jul 30.</citation>
    <PMID>27540440</PMID>
  </reference>
  <reference>
    <citation>Din S, Ball AJ, Riley SA, Kitsanta P, Johal S. A randomized comparison of cold snare polypectomy versus a suction pseudopolyp technique. Endoscopy. 2015 Nov;47(11):1005-10. doi: 10.1055/s-0034-1392533. Epub 2015 Jul 10.</citation>
    <PMID>26165735</PMID>
  </reference>
  <reference>
    <citation>Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.</citation>
    <PMID>24042189</PMID>
  </reference>
  <reference>
    <citation>Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25. Erratum In: Gastroenterology. 2021 Oct;161(4):1347.</citation>
    <PMID>23022496</PMID>
  </reference>
  <reference>
    <citation>Pattullo V, Bourke MJ, Tran KL, McLeod D, Williams SJ, Bailey AA, Alexander S, Mishra A, Co J. The suction pseudopolyp technique: a novel method for the removal of small flat nonpolypoid lesions of the colon and rectum. Endoscopy. 2009 Dec;41(12):1032-7. doi: 10.1055/s-0029-1215294. Epub 2009 Nov 6.</citation>
    <PMID>19899034</PMID>
  </reference>
  <reference>
    <citation>Ichise Y, Horiuchi A, Nakayama Y, Tanaka N. Prospective randomized comparison of cold snare polypectomy and conventional polypectomy for small colorectal polyps. Digestion. 2011;84(1):78-81. doi: 10.1159/000323959. Epub 2011 Apr 14.</citation>
    <PMID>21494037</PMID>
  </reference>
  <reference>
    <citation>Aslan F, Camci M, Alper E, Akpinar Z, Arabul M, Celik M, Unsal B. Cold snare polypectomy versus hot snare polypectomy in endoscopic treatment of small polyps. Turk J Gastroenterol. 2014 Jun;25(3):279-83. doi: 10.5152/tjg.2014.5085.</citation>
    <PMID>25141316</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>May 12, 2020</last_update_submitted>
  <last_update_submitted_qc>May 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital del Río Hortega</investigator_affiliation>
    <investigator_full_name>Marina de Benito Sanz</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>polypectomy snare</keyword>
  <keyword>polypectomy complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Colonic Polyps</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03783156/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03783156
org study id: 001
nct id: NCT03783156
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colonoscopy is the technique of choice for the diagnosis and prevention of colorectal cancer
      (CRC). The identification and extirpation of adenomas decreases the incidence of CRC by up to
      76%. More than 70% of the excised lesions are less than 10 mm. There is controversy about the
      technique to be used (resection with cold vs hot snare) in lesions of 5-9mm. Both use a
      polypectomy snare. The cold snare cuts by friction, while the hot snare uses electrical
      current. We propose a multicenter randomized clinical trial comparing both endoscopic
      techniques. At least 394 injuries per group will be included, randomizing patients to whom a
      diagnostic colonoscopy is requested for symptoms, screening or revision protocols.
      Randomization will be performed stratified by center. The primary objective is the proportion
      of incomplete polypectomies, which will be analyzed centrally from random biopsies of the
      edges of the lesion. As secondary objectives, we will compare the proportion of immediate and
      delayed hemorrhagic complications, the evolution of postprocedural abdominal pain and the
      factors associated with incomplete excision in each group and the factors associated with a
      failed cold polypectomy. The analysis of the primary objective will be carried out by means
      of the z test of homogeneity without using the correction of Yates, estimating the confidence
      interval of the difference between both groups. The analysis will be carried out by intention
      to treat and per protocol.
1. Introduction

           Colorectal cancer (CRC) is a major cause of morbidity and mortality worldwide. It is
           estimated that in 2008, 1233,000 new cases were diagnosed and more than 600,000 people
           died for this reason throughout the world. Colonoscopy is the technique of choice for
           both diagnosis and prevention, since the identification and removal of colonic adenomas
           reduces the incidence of CRC by up to 76%.

           Different endoscopic techniques have been developed for the removal of adenomas; The
           choice of some over others is made according to the size, morphology and location of the
           lesion.

        2. Hypothesis

           Conceptual hypothesis:

           Cold snare polypectomy presents a proportion of incomplete polypectomies similar to
           polypectomy with hot snare.

           Operational hypothesis:

           Two endoscopic techniques will be compared from two groups created by a random
           assignment to one or another type of polypectomy, evaluating the proportion of
           non-excised polypoid tissue after it. This will be done from random biopsies of the
           edges of the lesion and possible macroscopic remnants

        3. Objectives.

           Primary objective:

           To compare the proportion of incomplete polypectomies in both types of polypectomy (cold
           snare vs. hot snare).

           Secondary objectives:

           Comparing the proportion of immediate and delayed bleeding complications, total and
           according to the severity that they present according to the American Society of
           Gastroenterology (ASGE) classification.

           Comparing the evolution of abdominal pain in the 5 hours postprocedure between both
           groups.

           Evaluating factors associated with an incomplete extirpation in each group. Evaluating
           factors associated with a failed cold polypectomy.

        4. Design

           Multicenter randomized clinical trial

        5. Methods

      Study population Patients scheduled to undergo a colonoscopy in a non-urgent setting.
      Patients will be invited to participate before performing the colonoscopy.

      Randomization It will be done once the patient agrees to participate in the work and the
      first candidate polyp has been identified. Each patient will be randomized (regardless of the
      number of lesions per patient) so all lesions of each patient will be removed in the same
      way. It will be stratified by center.

      Intervention Patients who meet the inclusion criteria and do not present any exclusion
      criteria (pre-endoscopic) will be invited to participate in the study. The informed consent
      will be completed according to the Spanish law 41/2002 of autonomy of the patient.

        1. Endoscopic procedure The interventions will be carried out in each of the participating
           centers. The examinations will be performed under sedation according to the protocols
           established in each center. Once the first lesion is identified, the method of
           extirpation of the lesion will be randomized.

             -  Cold Group: polypectomy with a cold snare will be carried out according to the
                usual standards recommended by international societies. The lesion should be placed
                if possible in the position equivalent to 5 o'clock on the dial, the end of the
                snare will be placed several millimeters from the lesion and the tip of the
                catheter will be angled downwards, without aspiration at any time to avoid
                entrapment of the submucosa.

             -  Hot Group: polypectomy with snare connected to the electrosurgical unit according
                to the standards recommended by international societies, using a mixed current
                (cut-coagulation). Once the lesion is captured, the snare is pulled up to slightly
                separate it from the surrounding mucosa before polypectomy. Elevation of the lesion
                prior to polypectomy will not be performed.

             -  Common evaluation: once the polypectomies are completed, the base of the
                polypectomies will be evaluated, taking biopsies from any suggestive area and also
                2 random biopsies at the base of the polypectomy.

        2. Postendoscopic follow-up After a minimum of 21 days and a maximum of 28 days from the
           endoscopic examination, the patient will be contacted by telephone to collect the form
           about the evolution of the abdominal symptoms and to collect data about the appearance
           of complications (questions will be asked about visits to the hospital and in a targeted
           manner about the most frequent symptoms of the usual complications (fever, hemorrhage,
           abdominal pain).

        3. Histological analysis The analysis of the specimens of the polypectomies will be carried
           out in each center according to their usual protocol. The analysis of the biopsies of
           the base of the polyp will be carried out centrally by a pathologist with more than 5
           years of experience in digestive pathology. Samples from the base of the polyp will be
           sent periodically from each center to the Salamanca university hospital through a
           messenger service. The pathologist will be blinded regarding the histological diagnosis
           of the excised polyp and the type of polypectomy (although it is true that it is
           difficult to blind this last point since the presence of heat artifacts in those removed
           with a hot handle is very frequent). The samples sent for centralized analysis will not
           be stored, but will be destroyed once the study is completed according to standard
           protocols.

      Sample size Assuming a proportion of incomplete polypectomies in both groups of 10% (using
      the taking of biopsies as a diagnostic pattern) and setting an equivalence limit of 7%, a
      total of 315 lesions per group are estimated to have an α risk of 5% and a power of 80%.
      Assuming a proportion of losses (polyps not recovered for histological study, polypectomies
      of the failed Cold group of 20%), an estimated 394 lesions per group are needed, with a total
      of 788 lesions in total.

      Data Collection All the variables concerning the characteristics of the endoscopist, the
      patient and the injuries included will be collected in each center. The variables related to
      the histological diagnosis will be collected in the same way in the respective center. The
      variables concerning the follow-up will be collected in a centralized manner, through a
      telephone call that will be made between 3 and 4 weeks from the procedure. The variable
      related to the histological study of the base of the polyp will be collected in a centralized
      manner by the pathologist in charge of the analysis of the samples.

      6. Data management

      Data from the data collection notebooks will be merged by the main researcher or
      collaborating researchers anonymously, encrypted and dissociated from the clinical
      information by means of a patient identification code (ID), in an online database. A copy of
      the database will be used in each participating center, which will be merged after completing
      the data collection. The responsible researcher will define an ID for each participant. The
      data entered in the database will be anonymous and the database will be protected with a
      password to which only the researchers will have access.

      The unified file will be kept at the Río Hortega University Hospital and will be maintained
      until the end of the study. Regarding the application of the Organic Law on Data Protection
      15/1999 and 1720/2007 that develops it, it should be noted that the protocol defined in the
      project oriented to epidemiological analysis, determines that the files will record
      information completely anonymized

      7. Statistical analysis

      The Access program (Microsoft Corporation, Edmond, USA) will be used for the realization of
      the database and the statistical analysis of them will be carried out through the STATA
      program (StataCorp, 2013. Stata Statistical Software: Release 13. College Station, StataCorp
      LP). In the quantitative variables, the arithmetic mean and the standard deviation will be
      calculated (variables that do not follow a normal distribution according to the
      Kolmogorov-Smirnov test will be described with median, minimum, maximum and interquartile
      range), and the qualitative ones will be expressed as percentages and your 95% confidence
      intervals.

      The analysis of the primary objective, the proportion of incomplete polypectomies in both
      groups will be compared by means of the z test of homogeneity without using the correction of
      Yates.

      The confidence interval of the difference between the two groups will also be estimated. The
      analysis will be carried out by intention to treat, regardless of the type of polypectomy
      performed and per protocol (assigning the lesions assigned to the group Cold that are
      extirpated with hot snare to the Hot group). To evaluate possible confounding factors
      (endoscopist, nurse, snare type, location ...), the STATA confound user command will be used,
      defining as a significant change that which conditions a change in the odds ratio greater
      than 10% with respect to the one obtained with the complete model. In case several models do
      not present differences greater than 10%, the most parsimonious will be chosen.

      Within the secondary objectives, the proportion of complications in both groups will be
      verified by the de2 test. To evaluate the factors associated with incomplete polypectomies
      and those associated with failed cold polypectomy, multivariate logistic regression
      techniques will be used.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of participants with presence of adenomatous tissue al the base of polypectomy
time frame: 3 months
description: Number of patients with polypoid tissue at the base of polypectomy
measure: Number of participants with Postpolypectomy Complications
time frame: 21-28 days
description: Clinical complications after polypectomy
arm group label: hot snare
arm group type: Other
description: polypectomy with hot snare
arm group label: cold snare
arm group type: Other
description: polypectomy with cold snare
intervention type: Procedure
intervention name: hot snare
description: polypectomy with hot snare
arm group label: hot snare
intervention type: Procedure
intervention name: cold snare
description: polypectomy with cold snare
arm group label: cold snare
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marina de Benito, MD
role: Principal Investigator
affiliation: Hospital Río Hortega
facility: 
country: Spain
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PMID: 27540440
citation: Din S, Ball AJ, Riley SA, Kitsanta P, Johal S. A randomized comparison of cold snare polypectomy versus a suction pseudopolyp technique. Endoscopy. 2015 Nov;47(11):1005-10. doi: 10.1055/s-0034-1392533. Epub 2015 Jul 10.
PMID: 26165735
citation: Lee CK, Shim JJ, Jang JY. Cold snare polypectomy vs. Cold forceps polypectomy using double-biopsy technique for removal of diminutive colorectal polyps: a prospective randomized study. Am J Gastroenterol. 2013 Oct;108(10):1593-600. doi: 10.1038/ajg.2013.302. Epub 2013 Sep 17.
PMID: 24042189
citation: Pohl H, Srivastava A, Bensen SP, Anderson P, Rothstein RI, Gordon SR, Levy LC, Toor A, Mackenzie TA, Rosch T, Robertson DJ. Incomplete polyp resection during colonoscopy-results of the complete adenoma resection (CARE) study. Gastroenterology. 2013 Jan;144(1):74-80.e1. doi: 10.1053/j.gastro.2012.09.043. Epub 2012 Sep 25. Erratum In: Gastroenterology. 2021 Oct;161(4):1347.
PMID: 23022496
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PMID: 19899034
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PMID: 21494037
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PMID: 25141316
responsible party type: Principal Investigator
investigator affiliation: Hospital del Río Hortega
investigator full name: Marina de Benito Sanz
investigator title: Principal investigator
mesh term: Adenoma
mesh term: Gastrointestinal Hemorrhage
mesh term: Colonic Polyps
sharing ipd: No
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