<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/NCT03806439</url>
  </required_header>
  <id_info>
    <org_study_id>16/71(8/2/2017)</org_study_id>
    <nct_id>NCT03806439</nct_id>
  </id_info>
  <brief_title>Post-surgical Delirium in Patients Undergoing Radical Cystectomy.</brief_title>
  <official_title>Post-surgical Delirium in Patients Undergoing Radical Cystectomy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alexandria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alexandria</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>
      Post-surgical delirium in patients undergoing radical cystectomy. Introduction Delirium&#xD;
      occurs after major abdominal surgery may reach about 15% of the patients.(1)&#xD;
&#xD;
      Aim The aim of this study is to determine the incidence of delirium after radical cystectomy&#xD;
      surgery and the associated risk factors in Alexandria University hospital.&#xD;
&#xD;
      Patients and Methods After approval of local ethical committee and patient consent, the study&#xD;
      will be done on patients undergoing radical cystectomy surgery in Alexandria University&#xD;
      hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test&#xD;
      (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3&#xD;
      days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-surgical delirium in patients undergoing radical cystectomy. Introduction Delirium&#xD;
      occurs after major abdominal surgery may reach about 15% of the patients.(1)&#xD;
&#xD;
      Aim The aim of this study is to determine the incidence of delirium after radical cystectomy&#xD;
      surgery and the associated risk factors in Alexandria University hospital.&#xD;
&#xD;
      Patients and Methods After approval of local ethical committee and patient consent, the study&#xD;
      will be done on patients undergoing radical cystectomy surgery in Alexandria University&#xD;
      hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test&#xD;
      (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3&#xD;
      days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after&#xD;
      surgery.&#xD;
&#xD;
      Results Results will be collected in tables and graphs. Appropriate statistical analysis will&#xD;
      be done.&#xD;
&#xD;
      Discussion Results of the study will be discussed compared to other studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 25, 2021</start_date>
  <completion_date type="Anticipated">October 24, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 24, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Delirium</measure>
    <time_frame>1 year</time_frame>
    <description>Post-surgical delirium in patients undergoing radical cystectomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Mortality in patients undergoing radical cystectomy.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Delirium</condition>
  <condition>Radical Cystectomy</condition>
  <arm_group>
    <arm_group_label>Patients undergoing radical cystectomy.</arm_group_label>
    <description>After approval of local ethical committee and patient consent, the study will be done on patients undergoing radical cystectomy surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Radical cystectomy.</intervention_name>
    <description>Adult patients undergoing radical cystectomy.</description>
    <arm_group_label>Patients undergoing radical cystectomy.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients undergoing radical cystectomy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:Adult patients undergoing radical cystectomy. -&#xD;
&#xD;
        Exclusion Criteria: Patient refusal.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammad Hazem I Ahmad Sabry, MB,ChB MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohammad Hazem I Ahmad Sabry, MB,ChB</last_name>
    <phone>01062718827</phone>
    <email>mohammad_hazem@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohammad Hazem I Sabry</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Alexandria Faculty of Medicine</name>
      <address>
        <city>Alexandria</city>
        <zip>21111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad Hazem I Ahmad Sabry, MB,ChB MD</last_name>
      <phone>+2034842236</phone>
      <email>mohammad_hazem@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Raats JW, van Eijsden WA, Crolla RM, Steyerberg EW, van der Laan L. Risk Factors and Outcomes for Postoperative Delirium after Major Surgery in Elderly Patients. PLoS One. 2015 Aug 20;10(8):e0136071. doi: 10.1371/journal.pone.0136071. eCollection 2015.</citation>
    <PMID>26291459</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 5, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>September 25, 2021</last_update_submitted>
  <last_update_submitted_qc>September 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Mohammad Hazem I. Ahmad Sabry</investigator_full_name>
    <investigator_title>Lecturer of Anesthesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03806439
org study id: 16/71(8/2/2017)
nct id: NCT03806439
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Post-surgical delirium in patients undergoing radical cystectomy. Introduction Delirium
      occurs after major abdominal surgery may reach about 15% of the patients.(1)

      Aim The aim of this study is to determine the incidence of delirium after radical cystectomy
      surgery and the associated risk factors in Alexandria University hospital.

      Patients and Methods After approval of local ethical committee and patient consent, the study
      will be done on patients undergoing radical cystectomy surgery in Alexandria University
      hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test
      (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3
      days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after
      surgery.
Post-surgical delirium in patients undergoing radical cystectomy. Introduction Delirium
      occurs after major abdominal surgery may reach about 15% of the patients.(1)

      Aim The aim of this study is to determine the incidence of delirium after radical cystectomy
      surgery and the associated risk factors in Alexandria University hospital.

      Patients and Methods After approval of local ethical committee and patient consent, the study
      will be done on patients undergoing radical cystectomy surgery in Alexandria University
      hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test
      (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3
      days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after
      surgery.

      Results Results will be collected in tables and graphs. Appropriate statistical analysis will
      be done.

      Discussion Results of the study will be discussed compared to other studies.
observational model: Cohort
time perspective: Cross-Sectional
measure: Delirium
time frame: 1 year
description: Post-surgical delirium in patients undergoing radical cystectomy.
measure: Mortality
time frame: 1 year
description: Mortality in patients undergoing radical cystectomy.
arm group label: Patients undergoing radical cystectomy.
description: After approval of local ethical committee and patient consent, the study will be done on patients undergoing radical cystectomy surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6, 9 and 12 months after surgery.
intervention type: Other
intervention name: Radical cystectomy.
description: Adult patients undergoing radical cystectomy.
arm group label: Patients undergoing radical cystectomy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Mohammad Hazem I Ahmad Sabry, MB,ChB MD
role: Principal Investigator
affiliation: Alexandria University
last name: Mohammad Hazem I Ahmad Sabry, MB,ChB
phone: 01062718827
email: mohammad_hazem@yahoo.com
last name: Mohammad Hazem I Sabry
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Raats JW, van Eijsden WA, Crolla RM, Steyerberg EW, van der Laan L. Risk Factors and Outcomes for Postoperative Delirium after Major Surgery in Elderly Patients. PLoS One. 2015 Aug 20;10(8):e0136071. doi: 10.1371/journal.pone.0136071. eCollection 2015.
PMID: 26291459
responsible party type: Principal Investigator
investigator affiliation: University of Alexandria
investigator full name: Mohammad Hazem I. Ahmad Sabry
investigator title: Lecturer of Anesthesia
mesh term: Delirium
sharing ipd: No