xml: <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/NCT06035627</url>
    </required_header>
    <id_info>
      <org_study_id>PYILMAZEKER</org_study_id>
      <nct_id>NCT06035627</nct_id>
    </id_info>
    <brief_title>The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.</brief_title>
    <official_title>Uncontrolled Inadvertent Perioperative Hypothermia as a Risk Factor for Surgical Site Infection in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cumhuriyet University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cumhuriyet 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>
        There are conflicting results in the literature explaining the relationship between surgical&#xD;
        site infection (SSI) and inadvertent perioperative hypothermia (IPH). Although it is thought&#xD;
        that the risk of IPH is lower in laparoscopic surgery types due to the short duration of the&#xD;
        surgical procedure, these conflicting results raise doubts as to whether there is a&#xD;
        relationship between IPH and SSI in laparoscopic surgery patients. A randomized controlled&#xD;
        study will be planned in the future to examine the effect of IPH on SSI in patients who will&#xD;
        undergo laparoscopic cholecystectomies. The study will be conducted in the general surgery&#xD;
        clinic and operating room of a university hospital. It will be completed with a total of 100&#xD;
        patients, 50 of whom will be in the case group, and 50 will be in the control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: This study was conducted to examine the effect of inadvertent perioperative&#xD;
        hypothermia (IPH) on Surgical Site Infection (SSI) in patients undergoing laparoscopic&#xD;
        cholecystectomy.&#xD;
  &#xD;
        Summary of Background Data: There are conflicting results in the literature explaining the&#xD;
        relationship between SSI and IPH. Although the risk of IPH is thought to be lower in&#xD;
        laparoscopic surgery types due to the short duration of the surgical procedure, these&#xD;
        conflicting results raise doubts about the existence of a relationship between IPH and SSI in&#xD;
        laparoscopic surgery patients.&#xD;
  &#xD;
        Methods: This study will be a quasi-experimental and randomized controlled study in the&#xD;
        future. The study will be conducted with patients who will have undergone laparoscopic&#xD;
        cholecystectomy in the general surgery clinic and operating room of a university hospital.&#xD;
        The study will be completed with a total of 100 patients, 50 in the case group, and 50 in the&#xD;
        control group. During the study, preoperative, intraoperative, and postoperative body&#xD;
        temperatures, as well as biomarkers of the patients, will be monitored using a form developed&#xD;
        by the researchers. Additionally, patients will be followed up postoperatively to evaluate&#xD;
        the potential impact of IPH on SSI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 15, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 15, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Prevention of inadvertent perioperative hypothermia</measure>
      <time_frame>September 15, 2022- September 15, 2023</time_frame>
      <description>This study aims to evaluate whether inadvertent perioperative hypothermia has an effect on surgical site infection. For this, applications to prevent hypothermia will be applied to the patients in the experimental group</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Following surgical site infection</measure>
      <time_frame>16 September 16, 2023 - October 25, 2023</time_frame>
      <description>After the applications for preventing hypothermia in the experimental group and the patients in the experimental and control groups will be examined for surgical site infection.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Surgical Site Infection</condition>
    <condition>Perioperative Complication</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <description>The population of the study consisted of patients who were being treated in the general surgery clinic of the hospital, who met the sampling criteria, who were to undergo laparoscopic cholecystectomy, and who agreed to participate in the study. The sample size of the study was determined by the G*Power 3.1.9.7 program. In the power analysis, when α =0.05, β=0.10, and 1-β =0.90, the sample size was determined as 50 people per group and a total of 100 people.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>The population of the study consisted of patients who were being treated in the general surgery clinic of the hospital, who met the sampling criteria, who were to undergo laparoscopic cholecystectomy, and who agreed to participate in the study. The sample size of the study was determined by the G*Power 3.1.9.7 program. In the power analysis, when α =0.05, β=0.10, and 1-β =0.90, the sample size was determined as 50 people per group and a total of 100 people.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Prevention hypothermia</intervention_name>
      <description>Hypothermia was prevented by warming the case group. control group remained stable. As a result, the presence of surgical site infection was followed.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          laparoscopic cholecystectomy patients who met the inclusion and exclusion criteria&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being aged 18-65 years old,&#xD;
  &#xD;
            -  Having an ASA score of I-II,&#xD;
  &#xD;
            -  Remaining in the hospital for at least 24 hours in the postoperative period,&#xD;
  &#xD;
            -  Undergoing laparoscopic cholecystectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being under 18 or over 65,&#xD;
  &#xD;
            -  Having an ASA score above III,&#xD;
  &#xD;
            -  Requiring emergency surgery&#xD;
  &#xD;
            -  Having a neurological, psychiatric, or neuromuscular disease,&#xD;
  &#xD;
            -  Being addicted to alcohol and/or other toxic substances,&#xD;
  &#xD;
            -  Being pregnant or having a suspected pregnancy,&#xD;
  &#xD;
            -  Undergoing open surgery, or being converted to an open procedure during surgery,&#xD;
  &#xD;
            -  Having symptoms of fever&#xD;
  &#xD;
            -  Having an active infection excluding cholecystitis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pınar YILMAZ EKER, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>corresponding researcher</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pınar YILMAZ EKER, Ph.D.</last_name>
      <phone>+905309468919</phone>
      <email>yilmazpinar20@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cumhuriyet University</name>
        <address>
          <city>Sivas</city>
          <state>Suşehri</state>
          <zip>58140</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pınar YILMAZ EKER, Ph.D.</last_name>
        <phone>+905309468919</phone>
        <email>yilmazpinar20@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sivas Cumhuriyet University</name>
        <address>
          <city>Sivas</city>
          <zip>58140</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pınar YILMAZ EKER, Ph.D.</last_name>
        <phone>+905309468919</phone>
        <email>yilmazpinar20@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Connelly L, Cramer E, DeMott Q, Piperno J, Coyne B, Winfield C, Swanberg M. The Optimal Time and Method for Surgical Prewarming: A Comprehensive Review of the Literature. J Perianesth Nurs. 2017 Jun;32(3):199-209. doi: 10.1016/j.jopan.2015.11.010. Epub 2016 Sep 1.</citation>
      <PMID>28527547</PMID>
    </reference>
    <reference>
      <citation>Horn EP, Bein B, Broch O, Iden T, Bohm R, Latz SK, Hocker J. Warming before and after epidural block before general anaesthesia for major abdominal surgery prevents perioperative hypothermia: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):334-40. doi: 10.1097/EJA.0000000000000369.</citation>
      <PMID>26555870</PMID>
    </reference>
    <reference>
      <citation>Scott AV, Stonemetz JL, Wasey JO, Johnson DJ, Rivers RJ, Koch CG, Frank SM. Compliance with Surgical Care Improvement Project for Body Temperature Management (SCIP Inf-10) Is Associated with Improved Clinical Outcomes. Anesthesiology. 2015 Jul;123(1):116-25. doi: 10.1097/ALN.0000000000000681.</citation>
      <PMID>25909970</PMID>
    </reference>
    <reference>
      <citation>Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.</citation>
      <PMID>26775126</PMID>
    </reference>
    <reference>
      <citation>Ryczek E, White J, Poole RL, Reeves NL, Torkington J, Carolan-Rees G. Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 20;8(12):e14533. doi: 10.2196/14533.</citation>
      <PMID>31859685</PMID>
    </reference>
    <reference>
      <citation>Chen HY, Su LJ, Wu HZ, Zou H, Yang R, Zhu YX. Risk factors for inadvertent intraoperative hypothermia in patients undergoing laparoscopic surgery: A prospective cohort study. PLoS One. 2021 Sep 23;16(9):e0257816. doi: 10.1371/journal.pone.0257816. eCollection 2021.</citation>
      <PMID>34555101</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cumhuriyet University</investigator_affiliation>
      <investigator_full_name>Pınar YILMAZ EKER</investigator_full_name>
      <investigator_title>Asst. Prof</investigator_title>
    </responsible_party>
    <keyword>inadvertent perioperative hypothermia</keyword>
    <keyword>surgical site infection</keyword>
    <keyword>laparoscopic cholecystectomies</keyword>
    <keyword>perioperative nursing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Surgical Wound Infection</mesh_term>
      <mesh_term>Hypothermia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035627
  org study id: PYILMAZEKER
  nct id: NCT06035627
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  There are conflicting results in the literature explaining the relationship between surgical
        site infection (SSI) and inadvertent perioperative hypothermia (IPH). Although it is thought
        that the risk of IPH is lower in laparoscopic surgery types due to the short duration of the
        surgical procedure, these conflicting results raise doubts as to whether there is a
        relationship between IPH and SSI in laparoscopic surgery patients. A randomized controlled
        study will be planned in the future to examine the effect of IPH on SSI in patients who will
        undergo laparoscopic cholecystectomies. The study will be conducted in the general surgery
        clinic and operating room of a university hospital. It will be completed with a total of 100
        patients, 50 of whom will be in the case group, and 50 will be in the control group.
  Objective: This study was conducted to examine the effect of inadvertent perioperative
        hypothermia (IPH) on Surgical Site Infection (SSI) in patients undergoing laparoscopic
        cholecystectomy.
  
        Summary of Background Data: There are conflicting results in the literature explaining the
        relationship between SSI and IPH. Although the risk of IPH is thought to be lower in
        laparoscopic surgery types due to the short duration of the surgical procedure, these
        conflicting results raise doubts about the existence of a relationship between IPH and SSI in
        laparoscopic surgery patients.
  
        Methods: This study will be a quasi-experimental and randomized controlled study in the
        future. The study will be conducted with patients who will have undergone laparoscopic
        cholecystectomy in the general surgery clinic and operating room of a university hospital.
        The study will be completed with a total of 100 patients, 50 in the case group, and 50 in the
        control group. During the study, preoperative, intraoperative, and postoperative body
        temperatures, as well as biomarkers of the patients, will be monitored using a form developed
        by the researchers. Additionally, patients will be followed up postoperatively to evaluate
        the potential impact of IPH on SSI.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Prevention of inadvertent perioperative hypothermia
  time frame: September 15, 2022- September 15, 2023
  description: This study aims to evaluate whether inadvertent perioperative hypothermia has an effect on surgical site infection. For this, applications to prevent hypothermia will be applied to the patients in the experimental group
  measure: Following surgical site infection
  time frame: 16 September 16, 2023 - October 25, 2023
  description: After the applications for preventing hypothermia in the experimental group and the patients in the experimental and control groups will be examined for surgical site infection.
  arm group label: Experimental group
  description: The population of the study consisted of patients who were being treated in the general surgery clinic of the hospital, who met the sampling criteria, who were to undergo laparoscopic cholecystectomy, and who agreed to participate in the study. The sample size of the study was determined by the G*Power 3.1.9.7 program. In the power analysis, when α =0.05, β=0.10, and 1-β =0.90, the sample size was determined as 50 people per group and a total of 100 people.
  arm group label: Control group
  description: The population of the study consisted of patients who were being treated in the general surgery clinic of the hospital, who met the sampling criteria, who were to undergo laparoscopic cholecystectomy, and who agreed to participate in the study. The sample size of the study was determined by the G*Power 3.1.9.7 program. In the power analysis, when α =0.05, β=0.10, and 1-β =0.90, the sample size was determined as 50 people per group and a total of 100 people.
  intervention type: Other
  intervention name: Prevention hypothermia
  description: Hypothermia was prevented by warming the case group. control group remained stable. As a result, the presence of surgical site infection was followed.
  arm group label: Experimental group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pınar YILMAZ EKER, Ph.D
  role: Principal Investigator
  affiliation: corresponding researcher
  last name: Pınar YILMAZ EKER, Ph.D.
  phone: +905309468919
  email: yilmazpinar20@gmail.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Connelly L, Cramer E, DeMott Q, Piperno J, Coyne B, Winfield C, Swanberg M. The Optimal Time and Method for Surgical Prewarming: A Comprehensive Review of the Literature. J Perianesth Nurs. 2017 Jun;32(3):199-209. doi: 10.1016/j.jopan.2015.11.010. Epub 2016 Sep 1.
  PMID: 28527547
  citation: Horn EP, Bein B, Broch O, Iden T, Bohm R, Latz SK, Hocker J. Warming before and after epidural block before general anaesthesia for major abdominal surgery prevents perioperative hypothermia: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):334-40. doi: 10.1097/EJA.0000000000000369.
  PMID: 26555870
  citation: Scott AV, Stonemetz JL, Wasey JO, Johnson DJ, Rivers RJ, Koch CG, Frank SM. Compliance with Surgical Care Improvement Project for Body Temperature Management (SCIP Inf-10) Is Associated with Improved Clinical Outcomes. Anesthesiology. 2015 Jul;123(1):116-25. doi: 10.1097/ALN.0000000000000681.
  PMID: 25909970
  citation: Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
  PMID: 26775126
  citation: Ryczek E, White J, Poole RL, Reeves NL, Torkington J, Carolan-Rees G. Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 20;8(12):e14533. doi: 10.2196/14533.
  PMID: 31859685
  citation: Chen HY, Su LJ, Wu HZ, Zou H, Yang R, Zhu YX. Risk factors for inadvertent intraoperative hypothermia in patients undergoing laparoscopic surgery: A prospective cohort study. PLoS One. 2021 Sep 23;16(9):e0257816. doi: 10.1371/journal.pone.0257816. eCollection 2021.
  PMID: 34555101
  responsible party type: Principal Investigator
  investigator affiliation: Cumhuriyet University
  investigator full name: Pınar YILMAZ EKER
  investigator title: Asst. Prof
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Surgical Wound Infection
  mesh term: Hypothermia