<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/NCT04428229</url>
  </required_header>
  <id_info>
    <org_study_id>Medipol Hospital 14</org_study_id>
    <nct_id>NCT04428229</nct_id>
  </id_info>
  <brief_title>Optic Nerve Sheath Diameter in Laparoscopic Surgeries During Trendelenburg Position</brief_title>
  <official_title>The Evaluation of Optic Nerve Sheath Diameter in Patients Underwent Laparoscopic Colon and Gynecologic Surgeries During Trendelenburg Position.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medipol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medipol University</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>
      It is difficult to measure the several levels of intracranial pressure during abdominal&#xD;
      surgery, and direct monitoring with intracranial devices is often impossible. Measurement of&#xD;
      optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative&#xD;
      method for evaluating intracranial pressure. Increased intracranial pressure may cause in&#xD;
      expanding of the optic nerve sheath and may increase the diameter. Therefore, measuring the&#xD;
      diameter of the optic nerve sheath via ultrasonography is considered as a non-invasive,&#xD;
      easy-to-apply and reliable method to evaluate intracranial pressure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The peritoneum is inflated with carbon dioxide (insufflation) and head-down position is&#xD;
      performed (Trendelenburg) during laparoscopic colon and gynecologic surgeries. Intracranial&#xD;
      pressure (ICP) may be affected by positive intraabdominal pressure due to pneumoperitoneum.&#xD;
      The Trendelenburg position (usually at a degree of 25-400) causes increasing in the pressure&#xD;
      of cerebrospinal fluid during surgery. Therefore, cerebral edema and an increasing in ICP may&#xD;
      occur. It is difficult to measure the several levels of intracranial pressure during&#xD;
      abdominal surgery, and direct monitoring with intracranial devices is often impossible.&#xD;
      Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as&#xD;
      an alternative method for evaluating intracranial pressure. The optic nerve is an extension&#xD;
      of the central nervous system, surrounded by cerebrospinal fluid (CSF) and continues with the&#xD;
      nerve sheath. Increased intracranial pressure may cause in expanding of the optic nerve&#xD;
      sheath and may increase the diameter. Therefore, measuring the diameter of the optic nerve&#xD;
      sheath via ultrasonography is considered as a non-invasive, easy-to-apply and reliable method&#xD;
      to evaluate intracranial pressure.&#xD;
&#xD;
      In this study, we aimed to evaluate the changes of optic nerve sheath diameter in patients&#xD;
      who will undergo laparoscopic colon and gynecologic surgery during trendelenburg position.&#xD;
      Our primary goal is to compare the optic nerve sheath diameters via ultrasonography, and our&#xD;
      secondary aim is to evaluate the effect of this change on intracranial pressure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Optic nerve sheath diameter</measure>
    <time_frame>Change from baseline optic nerve sheath diameter at 10 mins and 60 mins after trendelenburg. And 10 minutes after the re-neutral position</time_frame>
    <description>Pre and post-trendelenburg diameters of optic nerve sheath</description>
  </primary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Colon Disease</condition>
  <condition>Gynecologic Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Optic nerve sheath diameter</intervention_name>
    <description>Pre and post-trendelenburg optic nerve sheath diameter will be measured</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Laparoscopic colon and gynecologic surgery patients aged between 18-75 years with ASA I and&#xD;
        ASA II status will be included in this randomized prospective study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) classification I-II&#xD;
&#xD;
          -  Scheduled for laparoscopic colon and gynecologic surgeries under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of beta blocker or diuretic drugs&#xD;
&#xD;
          -  severe heart failure&#xD;
&#xD;
          -  diabetes with ocular or neurologic complications&#xD;
&#xD;
          -  history of cardiac, eye, intracranial, and thoracic surgery&#xD;
&#xD;
          -  history of hydrocephalus, glocoma, intracranial tumor, cerebrovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medipol University Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Bagcilar</state>
        <zip>34070</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.</citation>
    <PMID>27956677</PMID>
  </reference>
  <reference>
    <citation>Chen K, Wang L, Wang Q, Liu X, Lu Y, Li Y, Wong GTC. Effects of pneumoperitoneum and steep Trendelenburg position on cerebral hemodynamics during robotic-assisted laparoscopic radical prostatectomy: A randomized controlled study. Medicine (Baltimore). 2019 May;98(21):e15794. doi: 10.1097/MD.0000000000015794.</citation>
    <PMID>31124975</PMID>
  </reference>
  <reference>
    <citation>Colombo R, Agarossi A, Borghi B, Ottolina D, Bergomi P, Ballone E, Minari C, Della Porta V, Menozzi E, Figini S, Fossali T, Catena E. The effect of prolonged steep head-down laparoscopy on the optical nerve sheath diameter. J Clin Monit Comput. 2020 Dec;34(6):1295-1302. doi: 10.1007/s10877-019-00418-5. Epub 2019 Nov 5.</citation>
    <PMID>31691148</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>May 19, 2021</last_update_submitted>
  <last_update_submitted_qc>May 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medipol University</investigator_affiliation>
    <investigator_full_name>Bahadir Ciftci</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Trendelenburg position</keyword>
  <keyword>Optic nerve sheath diameter</keyword>
  <keyword>Colon surgery</keyword>
  <keyword>Gynecologic surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Diseases</mesh_term>
    <mesh_term>Genital Diseases, Female</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We will not plan to share IPD data</ipd_description>
  </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/NCT04428229
org study id: Medipol Hospital 14
nct id: NCT04428229
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is difficult to measure the several levels of intracranial pressure during abdominal
      surgery, and direct monitoring with intracranial devices is often impossible. Measurement of
      optic nerve sheath diameter (ONSD) via ultrasonography has been developed as an alternative
      method for evaluating intracranial pressure. Increased intracranial pressure may cause in
      expanding of the optic nerve sheath and may increase the diameter. Therefore, measuring the
      diameter of the optic nerve sheath via ultrasonography is considered as a non-invasive,
      easy-to-apply and reliable method to evaluate intracranial pressure.
The peritoneum is inflated with carbon dioxide (insufflation) and head-down position is
      performed (Trendelenburg) during laparoscopic colon and gynecologic surgeries. Intracranial
      pressure (ICP) may be affected by positive intraabdominal pressure due to pneumoperitoneum.
      The Trendelenburg position (usually at a degree of 25-400) causes increasing in the pressure
      of cerebrospinal fluid during surgery. Therefore, cerebral edema and an increasing in ICP may
      occur. It is difficult to measure the several levels of intracranial pressure during
      abdominal surgery, and direct monitoring with intracranial devices is often impossible.
      Measurement of optic nerve sheath diameter (ONSD) via ultrasonography has been developed as
      an alternative method for evaluating intracranial pressure. The optic nerve is an extension
      of the central nervous system, surrounded by cerebrospinal fluid (CSF) and continues with the
      nerve sheath. Increased intracranial pressure may cause in expanding of the optic nerve
      sheath and may increase the diameter. Therefore, measuring the diameter of the optic nerve
      sheath via ultrasonography is considered as a non-invasive, easy-to-apply and reliable method
      to evaluate intracranial pressure.

      In this study, we aimed to evaluate the changes of optic nerve sheath diameter in patients
      who will undergo laparoscopic colon and gynecologic surgery during trendelenburg position.
      Our primary goal is to compare the optic nerve sheath diameters via ultrasonography, and our
      secondary aim is to evaluate the effect of this change on intracranial pressure.
observational model: Case-Only
time perspective: Prospective
measure: Optic nerve sheath diameter
time frame: Change from baseline optic nerve sheath diameter at 10 mins and 60 mins after trendelenburg. And 10 minutes after the re-neutral position
description: Pre and post-trendelenburg diameters of optic nerve sheath
intervention type: Other
intervention name: Optic nerve sheath diameter
description: Pre and post-trendelenburg optic nerve sheath diameter will be measured
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
facility: 
country: Turkey
citation: Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.
PMID: 27956677
citation: Chen K, Wang L, Wang Q, Liu X, Lu Y, Li Y, Wong GTC. Effects of pneumoperitoneum and steep Trendelenburg position on cerebral hemodynamics during robotic-assisted laparoscopic radical prostatectomy: A randomized controlled study. Medicine (Baltimore). 2019 May;98(21):e15794. doi: 10.1097/MD.0000000000015794.
PMID: 31124975
citation: Colombo R, Agarossi A, Borghi B, Ottolina D, Bergomi P, Ballone E, Minari C, Della Porta V, Menozzi E, Figini S, Fossali T, Catena E. The effect of prolonged steep head-down laparoscopy on the optical nerve sheath diameter. J Clin Monit Comput. 2020 Dec;34(6):1295-1302. doi: 10.1007/s10877-019-00418-5. Epub 2019 Nov 5.
PMID: 31691148
responsible party type: Principal Investigator
investigator affiliation: Medipol University
investigator full name: Bahadir Ciftci
investigator title: Principal Investigator
mesh term: Colonic Diseases
mesh term: Genital Diseases, Female
sharing ipd: No
ipd description: We will not plan to share IPD data