<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/NCT02220530</url>
  </required_header>
  <id_info>
    <org_study_id>HSJD-1</org_study_id>
    <nct_id>NCT02220530</nct_id>
  </id_info>
  <brief_title>Sedation Effect on the Global Quality Colonoscopy</brief_title>
  <official_title>Sedation Effect on the Global Quality Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital San Juan de Dios Tenerife</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital San Juan de Dios Tenerife</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess the impact of the use of sedation on the overall quality of the&#xD;
      colonoscopy, therefore addressing each and every one of its dimensions, namely: scientific&#xD;
      and technical quality, perceived quality and safety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent decades there has been a notable increase in the use of a range of gastrointestinal&#xD;
      endoscopy procedures - colonoscopy particularly -, more so in recent years with the&#xD;
      implementation of colorectal cancer screening programs.&#xD;
&#xD;
      Colonoscopy can cause discomfort and even pain. In order to reduce these effects and&#xD;
      facilitate the procedure, patients are usually administered iv sedation.&#xD;
&#xD;
      Numerous studies have assessed the impact of sedation on patient discomfort and anxiety, on&#xD;
      the undesirable effects of the colonoscopy, and even on certain aspects relating to its&#xD;
      scientific and technical quality. There have not, however, been any studies evaluating the&#xD;
      effects of sedation on the overall quality of the procedure.&#xD;
&#xD;
      The overall quality of every medical act can be defined according to four dimensions:&#xD;
      accessibility, or how easily the patient can obtain the assistance required without physical&#xD;
      or bureaucratic barriers; scientific and technical quality, or the provision of the best&#xD;
      possible assistance with the most up-to-date knowledge and technical resources; perceived&#xD;
      quality, or the patient's degree of satisfaction with the care provided; and safety, or the&#xD;
      absence of undesirable side effects. Doctors have typically assessed the quality of a&#xD;
      procedure based on its scientific and technical quality and its safety. The investigators&#xD;
      have strived to conduct good, complication-free techniques based on cutting-edge scientific&#xD;
      knowledge, but have often overlooked the other dimensions.&#xD;
&#xD;
      This study aims to assess the impact of the use of sedation on the overall quality of the&#xD;
      colonoscopy, therefore addressing each and every one of its dimensions, namely: scientific&#xD;
      and technical quality, perceived quality and safety. Since sedation during the procedure has&#xD;
      no impact on accessibility, the study will not assess this dimension.&#xD;
&#xD;
      Subjects and Methods:&#xD;
&#xD;
      Prospective case-control study. The study will include consecutive ambulatory patients&#xD;
      referred to our Endoscopy Unit for a first-time colonoscopy. Patients will be excluded when&#xD;
      they have had previous colonoscopies, have an anesthetic risk above ASA III (American Society&#xD;
      of Anesthesia classifications) allergy to the drugs used or if they are undergoing&#xD;
      antiplatelet or anticoagulant therapy contraindicated for the procedure, pregnant woman and&#xD;
      patients unable to understand the questionnaires.&#xD;
&#xD;
      Prior to inclusion demographic data, clinical background and indication for the colonoscopy&#xD;
      will be collected on each patient.&#xD;
&#xD;
      Thereafter patients will be randomly assigned to colonoscopy without sedation or with&#xD;
      conscious sedation with iv midazolam and fentanyl dosed according to age, weight and baseline&#xD;
      conditions.&#xD;
&#xD;
      The procedures will be conducted by four endoscopists with ample experience in endoscopy and&#xD;
      sedation (over 7000 colonoscopies each).&#xD;
&#xD;
        1. Data collected during the endoscopy will include:&#xD;
&#xD;
             1. The degree of cleanliness of the colon according to the Boston scale; defined as&#xD;
                the adequate preparation of at least 2 points in each region of the colon);&#xD;
&#xD;
             2. Whether or not colonoscopy is completed up to the cecum;&#xD;
&#xD;
             3. Time needed for insertion up to the cecum and for withdrawal;&#xD;
&#xD;
             4. The complications that might arise during the procedure and recovery period (early&#xD;
                complications). To this end, patients' oxygen saturation and heart rate will be&#xD;
                continuously monitored from the beginning of the procedure until their discharged&#xD;
                and their blood pressure will be taken every 5 minutes. Non-sedated patients will&#xD;
                be discharged from the Unit immediately after the procedure, and sedated patients&#xD;
                when they reach a score of 9 or 10 on the Aldrete scale.&#xD;
&#xD;
             5. Adenomas resected, based on pathology reports. All of the biopsies will be examined&#xD;
                by a pathologist specialized in gastrointestinal pathology.&#xD;
&#xD;
        2. Thirty days after the Endoscopy, patients will be interviewed by telephone by staff with&#xD;
           no involvement in the study (call center) and asked to respond to two questionnaires.&#xD;
&#xD;
             1. The ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction&#xD;
                survey (GHAA 9-me), previously translated into Spanish and validated by our team.&#xD;
&#xD;
             2. A survey on complications suffered in the 30 days following the procedure (late&#xD;
                complications), previously used in earlier studies.&#xD;
&#xD;
        3. Assessment of quality criteria:&#xD;
&#xD;
             1. Six indicators will be used to assess the scientific and technical quality of each&#xD;
                procedure. The first three will assess their technical aspects: percentage of&#xD;
                colonoscopies completed up to the cecum; time required to reach the cecum; and&#xD;
                withdrawal time. The remaining three are results indicators: percentage of patients&#xD;
                with adenomas; total number of adenomas per patient; and total number of advanced&#xD;
                adenomas. These indicators were previously validated in our setting.&#xD;
&#xD;
                Since the use or not of sedation during the procedure does not affect the&#xD;
                cleanliness of the colon, this indicator will be used as a control variable.&#xD;
&#xD;
             2. Perceived quality will be assessed using the ASGE (American Society of&#xD;
                Gastrointestinal Endoscopy) satisfaction survey, previously translated into Spanish&#xD;
                and adapted and validated. Total scores, scores for the procedure (item 7 on the&#xD;
                survey) and the number of patients rating the procedure &quot;excellent&quot; will be&#xD;
                analyzed.&#xD;
&#xD;
             3. Safety will be assessed following the same method used in previous research,&#xD;
                analyzing early complications (those occurring during the procedure and recovery&#xD;
                phase) and late complications (those occurring in the 30 days after the procedure).&#xD;
&#xD;
      Statistical Analyses:&#xD;
&#xD;
      Results will be expressed as mean ± standard deviation. Comparisons between groups will be&#xD;
      performed using the Chi-squared test for ordinal variables and Student's t-test for&#xD;
      quantitative variables. Results with a p value &lt;0.05 will be considered statistically&#xD;
      significant. Logistic regression will be used to determine the impact of sedation on the&#xD;
      quality indicators studied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">November 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>Percentage of colonoscopies completed up to the cecum.</measure>
    <time_frame>During colonoscopy</time_frame>
    <description>Colonoscopy in which the cecum is reached per hundred colonoscopy performed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time required to reach the cecum</measure>
    <time_frame>During colonoscopy</time_frame>
    <description>Time used to complete colonoscopy (in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Endoscopic withdrawal time</measure>
    <time_frame>During colonoscopy</time_frame>
    <description>Time used (in minutes) to endoscopic withdrawal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adenomas resected</measure>
    <time_frame>During colonoscopy</time_frame>
    <description>Number of adenomas resected</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived quality (patients satisfaction).</measure>
    <time_frame>Thirty days after colonoscopy</time_frame>
    <description>ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction survery score (GHAA 9-me).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Early complications.</measure>
    <time_frame>During colonoscopy.</time_frame>
    <description>Complications occurring during the procedure and recovery phase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Late complications.</measure>
    <time_frame>Thirty days after colonoscopy</time_frame>
    <description>Complications occurring in the 30 days after the procedure).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">7000</enrollment>
  <condition>Ambulatory Patients Referred for a First-time Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Sedation group</arm_group_label>
    <description>Colonoscopies performed with conscious sedation with iv midazolam and fentanyl</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Colonoscopies performed without sedation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Conscious sedation with iv midazolam and fentanyl.</intervention_name>
    <description>Sedation group: Conscious sedation with iv midazolam and fentanyl dosed according to age, weight and baseline conditions of the patients.</description>
    <arm_group_label>Sedation group</arm_group_label>
    <other_name>Control group: Colonoscopies performed without sedation.</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prospective case-control study. The study will include . Patients will be excluded when&#xD;
        they have had previous colonoscopies, have an anesthetic risk above ASA III, allergy to the&#xD;
        drugs used or if they are undergoing antiplatelet or anticoagulant therapy contraindicated&#xD;
        for the procedure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive ambulatory patients referred to our Endoscopy Unit for a first-time&#xD;
             colonoscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous colonoscopies.&#xD;
&#xD;
          -  Patients with anesthetic risk above ASA III,&#xD;
&#xD;
          -  Patients with allergy to the drugs used.&#xD;
&#xD;
          -  Patients undergoing antiplatelet or anticoagulant therapy.&#xD;
&#xD;
          -  Pregnant woman.&#xD;
&#xD;
          -  Patients unable to understand the questionnaires.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Salvador Baudet, M. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital San Juan de Dios Tenerife</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Htal. Universitario Ntra. Sra. de Candelaria</name>
      <address>
        <city>Santa Cruz de Tenerife</city>
        <zip>38010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Gellad ZF, Weiss DG, Ahnen DJ, Lieberman DA, Jackson GL, Provenzale D. Colonoscopy withdrawal time and risk of neoplasia at 5 years: results from VA Cooperative Studies Program 380. Am J Gastroenterol. 2010 Aug;105(8):1746-52. doi: 10.1038/ajg.2010.107. Epub 2010 Mar 16.</citation>
    <PMID>20234348</PMID>
  </reference>
  <reference>
    <citation>Bannert C, Reinhart K, Dunkler D, Trauner M, Renner F, Knoflach P, Ferlitsch A, Weiss W, Ferlitsch M. Sedation in screening colonoscopy: impact on quality indicators and complications. Am J Gastroenterol. 2012 Dec;107(12):1837-48. doi: 10.1038/ajg.2012.347. Epub 2012 Nov 13.</citation>
    <PMID>23147522</PMID>
  </reference>
  <reference>
    <citation>Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for colonoscopy. Am J Gastroenterol. 2006 Apr;101(4):873-85. doi: 10.1111/j.1572-0241.2006.00673.x. No abstract available.</citation>
    <PMID>16635231</PMID>
  </reference>
  <reference>
    <citation>Rex DK. Quality in colonoscopy: cecal intubation first, then what? Am J Gastroenterol. 2006 Apr;101(4):732-4. doi: 10.1111/j.1572-0241.2006.00483.x.</citation>
    <PMID>16635220</PMID>
  </reference>
  <reference>
    <citation>Baudet JS, Aguirre-Jaime A. The sedation increases the acceptance of repeat colonoscopies. Eur J Gastroenterol Hepatol. 2012 Jul;24(7):775-80. doi: 10.1097/MEG.0b013e32835376a2.</citation>
    <PMID>22522140</PMID>
  </reference>
  <reference>
    <citation>Sanchez Del Rio A, Baudet JS, Naranjo Rodriguez A, Campo Fernandez de Los Rios R, Salces Franco I, Aparicio Tormo JR, Sanchez Munoz D, Llach J, Hervas Molina A, Parra-Blanco A, Diaz Acosta JA; los miembros del Grupo de Calidad en Endoscopia de la Asociacion Espanola de Gastroenterologia. [Development and validation of quality standards for colonoscopy]. Med Clin (Barc). 2010 Jan 30;134(2):49-56. doi: 10.1016/j.medcli.2009.07.047. Epub 2009 Nov 14. Spanish.</citation>
    <PMID>19913837</PMID>
  </reference>
  <reference>
    <citation>Baudet JS, Borque P, Borja E, Alarcon-Fernandez O, Sanchez-del-Rio A, Campo R, Aviles J. Use of sedation in gastrointestinal endoscopy: a nationwide survey in Spain. Eur J Gastroenterol Hepatol. 2009 Aug;21(8):882-8. doi: 10.1097/MEG.0b013e328314b7ca.</citation>
    <PMID>19352194</PMID>
  </reference>
  <reference>
    <citation>Baudet JS, Diaz-Bethencourt D, Aviles J, Aguirre-Jaime A. Minor adverse events of colonoscopy on ambulatory patients: the impact of moderate sedation. Eur J Gastroenterol Hepatol. 2009 Jun;21(6):656-61. doi: 10.1097/MEG.0b013e328314b7e3.</citation>
    <PMID>19300274</PMID>
  </reference>
  <reference>
    <citation>Del Rio AS, Baudet JS, Fernandez OA, Morales I, Socas Mdel R. Evaluation of patient satisfaction in gastrointestinal endoscopy. Eur J Gastroenterol Hepatol. 2007 Oct;19(10):896-900. doi: 10.1097/MEG.0b013e3281532bae.</citation>
    <PMID>17873615</PMID>
  </reference>
  <reference>
    <citation>Sanchez del Rio A, Alarcon Fernandez O, Baudet JS, Sainz Menendez Z, Socas Mendez M. Reliability of the Spanish version of a brief questionnaire on patient satisfaction with gastrointestinal endoscopy. Rev Esp Enferm Dig. 2005 Aug;97(8):554-61. doi: 10.4321/s1130-01082005000800003. English, Spanish.</citation>
    <PMID>16266222</PMID>
  </reference>
  <reference>
    <citation>Kahi CJ, Ballard D, Shah AS, Mears R, Johnson CS. Impact of a quarterly report card on colonoscopy quality measures. Gastrointest Endosc. 2013 Jun;77(6):925-31. doi: 10.1016/j.gie.2013.01.012. Epub 2013 Mar 6.</citation>
    <PMID>23472996</PMID>
  </reference>
  <reference>
    <citation>Valori R, Rey JF, Atkin WS, Bretthauer M, Senore C, Hoff G, Kuipers EJ, Altenhofen L, Lambert R, Minoli G; International Agency for Research on Cancer. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition--Quality assurance in endoscopy in colorectal cancer screening and diagnosis. Endoscopy. 2012 Sep;44 Suppl 3:SE88-105. doi: 10.1055/s-0032-1309795. Epub 2012 Sep 25.</citation>
    <PMID>23012124</PMID>
  </reference>
  <reference>
    <citation>Williams JE, Holub JL, Faigel DO. Polypectomy rate is a valid quality measure for colonoscopy: results from a national endoscopy database. Gastrointest Endosc. 2012 Mar;75(3):576-82. doi: 10.1016/j.gie.2011.12.012.</citation>
    <PMID>22341104</PMID>
  </reference>
  <reference>
    <citation>Lee TJ, Rutter MD, Blanks RG, Moss SM, Goddard AF, Chilton A, Nickerson C, McNally RJ, Patnick J, Rees CJ. Colonoscopy quality measures: experience from the NHS Bowel Cancer Screening Programme. Gut. 2012 Jul;61(7):1050-7. doi: 10.1136/gutjnl-2011-300651. Epub 2011 Sep 22.</citation>
    <PMID>21940723</PMID>
  </reference>
  <reference>
    <citation>Imperiali G, Minoli G, Meucci GM, Spinzi G, Strocchi E, Terruzzi V, Radaelli F. Effectiveness of a continuous quality improvement program on colonoscopy practice. Endoscopy. 2007 Apr;39(4):314-8. doi: 10.1055/s-2006-945196. Epub 2007 Feb 1.</citation>
    <PMID>17273959</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>April 7, 2013</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital San Juan de Dios Tenerife</investigator_affiliation>
    <investigator_full_name>Juan Salvador Baudet</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Sedation.</keyword>
  <keyword>Colonoscopy quality.</keyword>
  <keyword>Scientific and technical quality.</keyword>
  <keyword>Perceived quality (patient's satisfaction).</keyword>
  <keyword>Safety</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Midazolam</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02220530
org study id: HSJD-1
nct id: NCT02220530
lead sponsor: 
has dmc: Yes
This study aims to assess the impact of the use of sedation on the overall quality of the
      colonoscopy, therefore addressing each and every one of its dimensions, namely: scientific
      and technical quality, perceived quality and safety.
In recent decades there has been a notable increase in the use of a range of gastrointestinal
      endoscopy procedures - colonoscopy particularly -, more so in recent years with the
      implementation of colorectal cancer screening programs.

      Colonoscopy can cause discomfort and even pain. In order to reduce these effects and
      facilitate the procedure, patients are usually administered iv sedation.

      Numerous studies have assessed the impact of sedation on patient discomfort and anxiety, on
      the undesirable effects of the colonoscopy, and even on certain aspects relating to its
      scientific and technical quality. There have not, however, been any studies evaluating the
      effects of sedation on the overall quality of the procedure.

      The overall quality of every medical act can be defined according to four dimensions:
      accessibility, or how easily the patient can obtain the assistance required without physical
      or bureaucratic barriers; scientific and technical quality, or the provision of the best
      possible assistance with the most up-to-date knowledge and technical resources; perceived
      quality, or the patient's degree of satisfaction with the care provided; and safety, or the
      absence of undesirable side effects. Doctors have typically assessed the quality of a
      procedure based on its scientific and technical quality and its safety. The investigators
      have strived to conduct good, complication-free techniques based on cutting-edge scientific
      knowledge, but have often overlooked the other dimensions.

      This study aims to assess the impact of the use of sedation on the overall quality of the
      colonoscopy, therefore addressing each and every one of its dimensions, namely: scientific
      and technical quality, perceived quality and safety. Since sedation during the procedure has
      no impact on accessibility, the study will not assess this dimension.

      Subjects and Methods:

      Prospective case-control study. The study will include consecutive ambulatory patients
      referred to our Endoscopy Unit for a first-time colonoscopy. Patients will be excluded when
      they have had previous colonoscopies, have an anesthetic risk above ASA III (American Society
      of Anesthesia classifications) allergy to the drugs used or if they are undergoing
      antiplatelet or anticoagulant therapy contraindicated for the procedure, pregnant woman and
      patients unable to understand the questionnaires.

      Prior to inclusion demographic data, clinical background and indication for the colonoscopy
      will be collected on each patient.

      Thereafter patients will be randomly assigned to colonoscopy without sedation or with
      conscious sedation with iv midazolam and fentanyl dosed according to age, weight and baseline
      conditions.

      The procedures will be conducted by four endoscopists with ample experience in endoscopy and
      sedation (over 7000 colonoscopies each).

        1. Data collected during the endoscopy will include:

             1. The degree of cleanliness of the colon according to the Boston scale; defined as
                the adequate preparation of at least 2 points in each region of the colon);

             2. Whether or not colonoscopy is completed up to the cecum;

             3. Time needed for insertion up to the cecum and for withdrawal;

             4. The complications that might arise during the procedure and recovery period (early
                complications). To this end, patients' oxygen saturation and heart rate will be
                continuously monitored from the beginning of the procedure until their discharged
                and their blood pressure will be taken every 5 minutes. Non-sedated patients will
                be discharged from the Unit immediately after the procedure, and sedated patients
                when they reach a score of 9 or 10 on the Aldrete scale.

             5. Adenomas resected, based on pathology reports. All of the biopsies will be examined
                by a pathologist specialized in gastrointestinal pathology.

        2. Thirty days after the Endoscopy, patients will be interviewed by telephone by staff with
           no involvement in the study (call center) and asked to respond to two questionnaires.

             1. The ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction
                survey (GHAA 9-me), previously translated into Spanish and validated by our team.

             2. A survey on complications suffered in the 30 days following the procedure (late
                complications), previously used in earlier studies.

        3. Assessment of quality criteria:

             1. Six indicators will be used to assess the scientific and technical quality of each
                procedure. The first three will assess their technical aspects: percentage of
                colonoscopies completed up to the cecum; time required to reach the cecum; and
                withdrawal time. The remaining three are results indicators: percentage of patients
                with adenomas; total number of adenomas per patient; and total number of advanced
                adenomas. These indicators were previously validated in our setting.

                Since the use or not of sedation during the procedure does not affect the
                cleanliness of the colon, this indicator will be used as a control variable.

             2. Perceived quality will be assessed using the ASGE (American Society of
                Gastrointestinal Endoscopy) satisfaction survey, previously translated into Spanish
                and adapted and validated. Total scores, scores for the procedure (item 7 on the
                survey) and the number of patients rating the procedure "excellent" will be
                analyzed.

             3. Safety will be assessed following the same method used in previous research,
                analyzing early complications (those occurring during the procedure and recovery
                phase) and late complications (those occurring in the 30 days after the procedure).

      Statistical Analyses:

      Results will be expressed as mean ± standard deviation. Comparisons between groups will be
      performed using the Chi-squared test for ordinal variables and Student's t-test for
      quantitative variables. Results with a p value <0.05 will be considered statistically
      significant. Logistic regression will be used to determine the impact of sedation on the
      quality indicators studied.
observational model: Case-Control
time perspective: Prospective
measure: Percentage of colonoscopies completed up to the cecum.
time frame: During colonoscopy
description: Colonoscopy in which the cecum is reached per hundred colonoscopy performed
measure: Time required to reach the cecum
time frame: During colonoscopy
description: Time used to complete colonoscopy (in minutes)
measure: Endoscopic withdrawal time
time frame: During colonoscopy
description: Time used (in minutes) to endoscopic withdrawal.
measure: Adenomas resected
time frame: During colonoscopy
description: Number of adenomas resected
measure: Perceived quality (patients satisfaction).
time frame: Thirty days after colonoscopy
description: ASGE (American Society of Gastrointestinal Endoscopy) endoscopy satisfaction survery score (GHAA 9-me).
measure: Early complications.
time frame: During colonoscopy.
description: Complications occurring during the procedure and recovery phase.
measure: Late complications.
time frame: Thirty days after colonoscopy
description: Complications occurring in the 30 days after the procedure).
arm group label: Sedation group
description: Colonoscopies performed with conscious sedation with iv midazolam and fentanyl
arm group label: Control group
description: Colonoscopies performed without sedation.
intervention type: Drug
intervention name: Conscious sedation with iv midazolam and fentanyl.
description: Sedation group: Conscious sedation with iv midazolam and fentanyl dosed according to age, weight and baseline conditions of the patients.
arm group label: Sedation group
other name: Control group: Colonoscopies performed without sedation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Juan Salvador Baudet, M. D.
role: Principal Investigator
affiliation: Hospital San Juan de Dios Tenerife
facility: 
country: Spain
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PMID: 17873615
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PMID: 23012124
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PMID: 17273959
responsible party type: Principal Investigator
investigator affiliation: Hospital San Juan de Dios Tenerife
investigator full name: Juan Salvador Baudet
investigator title: Medical Doctor
mesh term: Fentanyl
mesh term: Midazolam