<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/NCT04473456</url>
  </required_header>
  <id_info>
    <org_study_id>2020-ECL-6-1</org_study_id>
    <nct_id>NCT04473456</nct_id>
  </id_info>
  <brief_title>Combined Simultaneous EGD-colonoscopy Trial (CoSi Endoscopy)</brief_title>
  <official_title>Combined Simultaneous EGD-colonoscopy (CoSi Endoscopy) Harmlessly Reduces Procedure Times: a Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>EmuraCenter LatinoAmerica</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad de la Sabana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>EmuraCenter LatinoAmerica</source>
  <oversight_info>
    <has_dmc>Yes</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 COVID -19 pandemic has reduced endoscopy services to an average of 83% producing a&#xD;
      significant economic impact on endoscopy units worldwide. Endoscopy as an aerosol-generating&#xD;
      procedure requires endoscopy units to allow 12 cycles of air exchange per hour, equivalent to&#xD;
      20 minutes, between patients, to reduce medical risk exposure. Planning strategies to&#xD;
      facilitate economic reactivation of endoscopy services in a responsible manner, maintaining&#xD;
      adequate security measures for both patients and healthcare personnel is currently a major&#xD;
      challenge. Serial endoscopic interventions as esophagogastroduodenoscopy (EGD) and&#xD;
      colonoscopy are commonly performed during the same sedation time. Estimated times for quality&#xD;
      inspection in the upper digestive tract and the colon, are 7 and 6 minutes, respectively. In&#xD;
      addition, time to reach the cecum and to set up the following procedure increase not only&#xD;
      procedure time but SARS-CoV-2 exposure to healthcare personnel. Performing these two&#xD;
      procedures simultaneously by two endoscopists would considerably reduce procedure time while&#xD;
      increasing the number of patients evaluated in one day, especially in the period of service&#xD;
      reactivation. There are no studies comparing simultaneous EGD and colonoscopy procedures and,&#xD;
      serial procedures. This study aims to determine differences in procedures times between&#xD;
      simultaneous EGD-colonoscopy and conventional serial EGD-colonoscopy as an alternative to&#xD;
      improve the number of procedures/hour/unit during the COVID-19 era.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study type:&#xD;
&#xD;
      This is a prospective controlled randomized study to determine differences in procedure times&#xD;
      of simultaneous EGD-colonoscopy and serial EGD-colonoscopy. Patients are randomized into two&#xD;
      groups: the serial group, where the EGD is performed first and thereafter the colonoscopy&#xD;
      and, the simultaneous group, where the two procedures are performed at the same time, each by&#xD;
      a trained gastroenterologist.&#xD;
&#xD;
      Patients:&#xD;
&#xD;
      Eligible patients are those consecutively scheduled for EGD and colonoscopy at EmuraCenter&#xD;
      LatinoAmerica, Bogota DC, Colombia between June and August, 2020. Indications for procedures&#xD;
      include among others abdominal pain, screening for digestive cancer, chronic anemia,&#xD;
      digestive bleeding, and chronic diarrhea. Exclusion criteria are inadequate bowel preparation&#xD;
      with Boston score with at least 1 point in any segment, residual gastric food, previous&#xD;
      digestive system surgery, and refusal to participate. Patients and their accompanying person&#xD;
      give written consent of the procedures and are asked to complete a telephone survey related&#xD;
      to COVID-19 symptoms 1 day before the procedure and 30 minutes before the procedure.&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      Endoscopists participating in the study are experts endoscopists. In both groups,&#xD;
      colonoscopies are performed by the same expert endoscopist. EGD in the serial group is&#xD;
      performed by the attending endoscopist responsible for procedures that day.&#xD;
&#xD;
      Outcomes:&#xD;
&#xD;
      Variables to be compared between groups include unit entry's time, time to completion of both&#xD;
      procedures, EGD time, EGD inspection time, colonoscopy time, time to teach the cecum,&#xD;
      withdrawal time, inter-procedure time, unit's exit time, the dose of sedation agent and&#xD;
      endoscopic findings. Oxygenation (pO2) and percutaneous pCo2 are evaluated 5 minutes before,&#xD;
      5, and 10 minutes during the procedure and 5 minutes after completing the last procedure. A&#xD;
      trained physician or anesthesiologist will administrate sedation to patients using Propofol.&#xD;
      Post-procedure symptoms will be assessed by written survey 30 minutes and 24 hours after the&#xD;
      procedure. This survey evaluates 6 symptoms, 3 of which are related to sedation: Nausea,&#xD;
      drowsiness, and dizziness. and, the other 3 symptoms are related to the endoscopic procedure:&#xD;
      abdominal pain, bloating, and pharyngeal pain. Each of the 6 symptoms will be scored from 1&#xD;
      to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).&#xD;
&#xD;
      Patient position and location of endoscopy systems:&#xD;
&#xD;
      All patients are positioned in the left lateral decubitus position. For simultaneous&#xD;
      procedures, the EGD tower is located to the left side and the colonoscopy tower at the right&#xD;
      side of the bedside at the level patient's head.&#xD;
&#xD;
      EGD:&#xD;
&#xD;
      The systematic complete photodocumentation approach proposed by Emura et al will be carried&#xD;
      out to inspect the upper GI tract mucosa using a Fuji 7000 video processor and a Fuji Lasereo&#xD;
      EG-760 gastroscope. BLI-bright digital chromoendoscopy will be performed to observe the&#xD;
      hypopharynx, the esophagus, and the esophagogastric junction and, the LCI mode for evaluation&#xD;
      of the stomach and duodenal mucosa. Low CO2 insufflation will be used using the Fuji GW-100&#xD;
      insufflator.&#xD;
&#xD;
      Colonoscopy in the serial group:&#xD;
&#xD;
      A Fuji Lasereo 7000 equipment and an EC-760ZP-V / L colonoscope will be used. The CO2&#xD;
      insufflation will be carried out with Fuji GW-100 equipment.&#xD;
&#xD;
      Colonoscopy in the parallel-group:&#xD;
&#xD;
      An Olympus Evis Exera II equipment and an H-180-AI colonoscope will be used. An Olympus UCR&#xD;
      insufflator will be used for CO2 insufflation.&#xD;
&#xD;
      Transcutaneous measurement of pCo2:&#xD;
&#xD;
      The pCO2 measurements will be performed using a Tosca TCM kit (XLab Solutions). This&#xD;
      equipment uses a transducer (ts sensor 54) that is positioned on the patient's arm and&#xD;
      measures pCO2 non-invasively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2020</start_date>
  <completion_date type="Actual">September 23, 2020</completion_date>
  <primary_completion_date type="Actual">September 22, 2020</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>
    <intervention_model_description>Patients are randomly assigned to non-intervention and intervention (simultaneous EGD and colonoscopy) arms</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>Participants, care providers, and outcomes evaluator are masked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Procedures time</measure>
    <time_frame>Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.</time_frame>
    <description>Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interprocedure time</measure>
    <time_frame>Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)</time_frame>
    <description>Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Upper GI inspection time</measure>
    <time_frame>Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.</time_frame>
    <description>Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Colonoscopy withdrawal time</measure>
    <time_frame>Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa</time_frame>
    <description>Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Colonoscopy insertion time</measure>
    <time_frame>Time elapsed in minutes to reach the cecum</time_frame>
    <description>Time elapsed in minutes to reach the cecum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EGD time</measure>
    <time_frame>Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth</time_frame>
    <description>Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Colonoscopy time</measure>
    <time_frame>Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum</time_frame>
    <description>Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Propofol used in EGD</measure>
    <time_frame>Amount in mg of Propofol used during EGD</time_frame>
    <description>Amount in mg of Propofol used during EGD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Propofol used in colonoscopy</measure>
    <time_frame>Amount in mg of Propofol used during colonoscopy</time_frame>
    <description>Amount in mg of Propofol used during colonoscopy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Propofol used in EGD and colonoscopy</measure>
    <time_frame>Amount of Propofol in mg used fro procedures in the simultaneous arm</time_frame>
    <description>Amount of Propofol in mg used fro procedures in the simultaneous arm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>percutaneous pCO2</measure>
    <time_frame>Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.</time_frame>
    <description>Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>percutaneous pO2</measure>
    <time_frame>Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.</time_frame>
    <description>Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Position change 1</measure>
    <time_frame>During colonoscopy</time_frame>
    <description>Change of patient's position during colonoscopy. Yes or No answer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Position change 2</measure>
    <time_frame>During olonoscopy</time_frame>
    <description>If occurred, how many times the position changed. Numerical variable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post procedure symptoms survey related to colonoscopy</measure>
    <time_frame>20 minutes after the last procedure and after 24 hours</time_frame>
    <description>Nausea, drowsiness, and dizziness are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post procedure symptoms survey related to sedation</measure>
    <time_frame>20 minutes after the last procedure and after 24 hours</time_frame>
    <description>Abdominal pain, bloating, and pharyngeal pain are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Procedure Time</condition>
  <arm_group>
    <arm_group_label>Serial arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the serial group, all colonoscopies will be performed by the same endoscopist. EGDs are performed by the attending endoscopist on the day of the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simultaneous arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the simultaneous group, all colonoscopies will be performed by the same endoscopist. EGDs are performed by the attending endoscopist on the day of the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Simultaneous EGD and colonoscopy</intervention_name>
    <description>Patients are examined simultaneously by EGD and colonoscopy</description>
    <arm_group_label>Simultaneous arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible patients are those scheduled for EGD and colonoscopy at EmuraCenter&#xD;
             Latinoamerica, Bogota DC, Colombia between June and August 2020. Procedure&#xD;
             indications: abdominal pain, chronic anemia, chronic diarrhea, cancer screening,&#xD;
             gastrointestinal bleeding.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria are inadequate bowel preparation with Boston score with at least 1&#xD;
             point in any segment, residual gastric food, previous surgery of the digestive tract,&#xD;
             and refusal to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>FABIAN EMURA, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>EmuraCenter LatinoAmerica</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>EmuraCenter LatinoAmerica</name>
      <address>
        <city>Bogota</city>
        <state>Cundinamarca</state>
        <zip>110121</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <reference>
    <citation>Emura F, Sharma P, Arantes V, Cerisoli C, Parra-Blanco A, Sumiyama K, Araya R, Sobrino S, Chiu P, Matsuda K, Gonzalez R, Fujishiro M, Tajiri H. Principles and practice to facilitate complete photodocumentation of the upper gastrointestinal tract: World Endoscopy Organization position statement. Dig Endosc. 2020 Jan;32(2):168-179. doi: 10.1111/den.13530. Epub 2019 Nov 6.</citation>
    <PMID>31529547</PMID>
  </reference>
  <reference>
    <citation>Parasa S, Reddy N, Faigel DO, Repici A, Emura F, Sharma P. Global Impact of the COVID-19 Pandemic on Endoscopy: An International Survey of 252 Centers From 55 Countries. Gastroenterology. 2020 Oct;159(4):1579-1581.e5. doi: 10.1053/j.gastro.2020.06.009. Epub 2020 Jun 11. No abstract available.</citation>
    <PMID>32534934</PMID>
  </reference>
  <reference>
    <citation>Guda NM, Emura F, Reddy DN, Rey JF, Seo DW, Gyokeres T, Tajiri H, Faigel D. Recommendations for the Operation of Endoscopy Centers in the setting of the COVID-19 pandemic - World Endoscopy Organization guidance document. Dig Endosc. 2020 Sep;32(6):844-850. doi: 10.1111/den.13777. Epub 2020 Aug 12.</citation>
    <PMID>32569438</PMID>
  </reference>
  <reference>
    <citation>Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2016 Sep;48(9):843-64. doi: 10.1055/s-0042-113128. Epub 2016 Aug 22. No abstract available.</citation>
    <PMID>27548885</PMID>
  </reference>
  <reference>
    <citation>Trencheva K, Dhar P, Sonoda T, Lee S, Samuels J, Stein B, Milsom J. Physiologic effects of simultaneous carbon dioxide insufflation by laparoscopy and colonoscopy: prospective evaluation. Surg Endosc. 2011 Oct;25(10):3279-85. doi: 10.1007/s00464-011-1705-2. Epub 2011 May 24.</citation>
    <PMID>21607827</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>December 6, 2020</last_update_submitted>
  <last_update_submitted_qc>December 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Combined simultaneous (CoSi) endoscopy</keyword>
  <keyword>EGD</keyword>
  <keyword>Colonoscopy</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>There is s plan to share IPD with other researchers</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>December 1, 2020, for 1 month</ipd_time_frame>
    <ipd_access_criteria>free access</ipd_access_criteria>
    <ipd_url>http://emuracenter.org</ipd_url>
  </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/NCT04473456
org study id: 2020-ECL-6-1
nct id: NCT04473456
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The COVID -19 pandemic has reduced endoscopy services to an average of 83% producing a
      significant economic impact on endoscopy units worldwide. Endoscopy as an aerosol-generating
      procedure requires endoscopy units to allow 12 cycles of air exchange per hour, equivalent to
      20 minutes, between patients, to reduce medical risk exposure. Planning strategies to
      facilitate economic reactivation of endoscopy services in a responsible manner, maintaining
      adequate security measures for both patients and healthcare personnel is currently a major
      challenge. Serial endoscopic interventions as esophagogastroduodenoscopy (EGD) and
      colonoscopy are commonly performed during the same sedation time. Estimated times for quality
      inspection in the upper digestive tract and the colon, are 7 and 6 minutes, respectively. In
      addition, time to reach the cecum and to set up the following procedure increase not only
      procedure time but SARS-CoV-2 exposure to healthcare personnel. Performing these two
      procedures simultaneously by two endoscopists would considerably reduce procedure time while
      increasing the number of patients evaluated in one day, especially in the period of service
      reactivation. There are no studies comparing simultaneous EGD and colonoscopy procedures and,
      serial procedures. This study aims to determine differences in procedures times between
      simultaneous EGD-colonoscopy and conventional serial EGD-colonoscopy as an alternative to
      improve the number of procedures/hour/unit during the COVID-19 era.
Study type:

      This is a prospective controlled randomized study to determine differences in procedure times
      of simultaneous EGD-colonoscopy and serial EGD-colonoscopy. Patients are randomized into two
      groups: the serial group, where the EGD is performed first and thereafter the colonoscopy
      and, the simultaneous group, where the two procedures are performed at the same time, each by
      a trained gastroenterologist.

      Patients:

      Eligible patients are those consecutively scheduled for EGD and colonoscopy at EmuraCenter
      LatinoAmerica, Bogota DC, Colombia between June and August, 2020. Indications for procedures
      include among others abdominal pain, screening for digestive cancer, chronic anemia,
      digestive bleeding, and chronic diarrhea. Exclusion criteria are inadequate bowel preparation
      with Boston score with at least 1 point in any segment, residual gastric food, previous
      digestive system surgery, and refusal to participate. Patients and their accompanying person
      give written consent of the procedures and are asked to complete a telephone survey related
      to COVID-19 symptoms 1 day before the procedure and 30 minutes before the procedure.

      Randomization:

      Endoscopists participating in the study are experts endoscopists. In both groups,
      colonoscopies are performed by the same expert endoscopist. EGD in the serial group is
      performed by the attending endoscopist responsible for procedures that day.

      Outcomes:

      Variables to be compared between groups include unit entry's time, time to completion of both
      procedures, EGD time, EGD inspection time, colonoscopy time, time to teach the cecum,
      withdrawal time, inter-procedure time, unit's exit time, the dose of sedation agent and
      endoscopic findings. Oxygenation (pO2) and percutaneous pCo2 are evaluated 5 minutes before,
      5, and 10 minutes during the procedure and 5 minutes after completing the last procedure. A
      trained physician or anesthesiologist will administrate sedation to patients using Propofol.
      Post-procedure symptoms will be assessed by written survey 30 minutes and 24 hours after the
      procedure. This survey evaluates 6 symptoms, 3 of which are related to sedation: Nausea,
      drowsiness, and dizziness. and, the other 3 symptoms are related to the endoscopic procedure:
      abdominal pain, bloating, and pharyngeal pain. Each of the 6 symptoms will be scored from 1
      to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).

      Patient position and location of endoscopy systems:

      All patients are positioned in the left lateral decubitus position. For simultaneous
      procedures, the EGD tower is located to the left side and the colonoscopy tower at the right
      side of the bedside at the level patient's head.

      EGD:

      The systematic complete photodocumentation approach proposed by Emura et al will be carried
      out to inspect the upper GI tract mucosa using a Fuji 7000 video processor and a Fuji Lasereo
      EG-760 gastroscope. BLI-bright digital chromoendoscopy will be performed to observe the
      hypopharynx, the esophagus, and the esophagogastric junction and, the LCI mode for evaluation
      of the stomach and duodenal mucosa. Low CO2 insufflation will be used using the Fuji GW-100
      insufflator.

      Colonoscopy in the serial group:

      A Fuji Lasereo 7000 equipment and an EC-760ZP-V / L colonoscope will be used. The CO2
      insufflation will be carried out with Fuji GW-100 equipment.

      Colonoscopy in the parallel-group:

      An Olympus Evis Exera II equipment and an H-180-AI colonoscope will be used. An Olympus UCR
      insufflator will be used for CO2 insufflation.

      Transcutaneous measurement of pCo2:

      The pCO2 measurements will be performed using a Tosca TCM kit (XLab Solutions). This
      equipment uses a transducer (ts sensor 54) that is positioned on the patient's arm and
      measures pCO2 non-invasively.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients are randomly assigned to non-intervention and intervention (simultaneous EGD and colonoscopy) arms
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: Participants, care providers, and outcomes evaluator are masked.
measure: Procedures time
time frame: Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.
description: Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.
measure: Interprocedure time
time frame: Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)
description: Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)
measure: Upper GI inspection time
time frame: Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.
description: Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.
measure: Colonoscopy withdrawal time
time frame: Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa
description: Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa
measure: Colonoscopy insertion time
time frame: Time elapsed in minutes to reach the cecum
description: Time elapsed in minutes to reach the cecum
measure: EGD time
time frame: Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth
description: Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth
measure: Colonoscopy time
time frame: Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum
description: Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum
measure: Propofol used in EGD
time frame: Amount in mg of Propofol used during EGD
description: Amount in mg of Propofol used during EGD
measure: Propofol used in colonoscopy
time frame: Amount in mg of Propofol used during colonoscopy
description: Amount in mg of Propofol used during colonoscopy
measure: Propofol used in EGD and colonoscopy
time frame: Amount of Propofol in mg used fro procedures in the simultaneous arm
description: Amount of Propofol in mg used fro procedures in the simultaneous arm.
measure: percutaneous pCO2
time frame: Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
description: Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
measure: percutaneous pO2
time frame: Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
description: Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
measure: Position change 1
time frame: During colonoscopy
description: Change of patient's position during colonoscopy. Yes or No answer
measure: Position change 2
time frame: During olonoscopy
description: If occurred, how many times the position changed. Numerical variable.
measure: Post procedure symptoms survey related to colonoscopy
time frame: 20 minutes after the last procedure and after 24 hours
description: Nausea, drowsiness, and dizziness are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).
measure: Post procedure symptoms survey related to sedation
time frame: 20 minutes after the last procedure and after 24 hours
description: Abdominal pain, bloating, and pharyngeal pain are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).
arm group label: Serial arm
arm group type: No Intervention
description: In the serial group, all colonoscopies will be performed by the same endoscopist. EGDs are performed by the attending endoscopist on the day of the procedure.
arm group label: Simultaneous arm
arm group type: Active Comparator
description: In the simultaneous group, all colonoscopies will be performed by the same endoscopist. EGDs are performed by the attending endoscopist on the day of the procedure.
intervention type: Procedure
intervention name: Simultaneous EGD and colonoscopy
description: Patients are examined simultaneously by EGD and colonoscopy
arm group label: Simultaneous arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: FABIAN EMURA, PhD
role: Principal Investigator
affiliation: EmuraCenter LatinoAmerica
facility: 
country: Colombia
citation: Emura F, Sharma P, Arantes V, Cerisoli C, Parra-Blanco A, Sumiyama K, Araya R, Sobrino S, Chiu P, Matsuda K, Gonzalez R, Fujishiro M, Tajiri H. Principles and practice to facilitate complete photodocumentation of the upper gastrointestinal tract: World Endoscopy Organization position statement. Dig Endosc. 2020 Jan;32(2):168-179. doi: 10.1111/den.13530. Epub 2019 Nov 6.
PMID: 31529547
citation: Parasa S, Reddy N, Faigel DO, Repici A, Emura F, Sharma P. Global Impact of the COVID-19 Pandemic on Endoscopy: An International Survey of 252 Centers From 55 Countries. Gastroenterology. 2020 Oct;159(4):1579-1581.e5. doi: 10.1053/j.gastro.2020.06.009. Epub 2020 Jun 11. No abstract available.
PMID: 32534934
citation: Guda NM, Emura F, Reddy DN, Rey JF, Seo DW, Gyokeres T, Tajiri H, Faigel D. Recommendations for the Operation of Endoscopy Centers in the setting of the COVID-19 pandemic - World Endoscopy Organization guidance document. Dig Endosc. 2020 Sep;32(6):844-850. doi: 10.1111/den.13777. Epub 2020 Aug 12.
PMID: 32569438
citation: Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2016 Sep;48(9):843-64. doi: 10.1055/s-0042-113128. Epub 2016 Aug 22. No abstract available.
PMID: 27548885
citation: Trencheva K, Dhar P, Sonoda T, Lee S, Samuels J, Stein B, Milsom J. Physiologic effects of simultaneous carbon dioxide insufflation by laparoscopy and colonoscopy: prospective evaluation. Surg Endosc. 2011 Oct;25(10):3279-85. doi: 10.1007/s00464-011-1705-2. Epub 2011 May 24.
PMID: 21607827
responsible party type: Sponsor
sharing ipd: Yes
ipd description: There is s plan to share IPD with other researchers
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: December 1, 2020, for 1 month
ipd access criteria: free access
ipd url: http://emuracenter.org