<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/NCT04433312</url>
  </required_header>
  <id_info>
    <org_study_id>SURG RES COL 2</org_study_id>
    <nct_id>NCT04433312</nct_id>
  </id_info>
  <brief_title>Impact of Cancellation of Non-urgent Surgical Cases on Patients During the COVID-19 Pandemic</brief_title>
  <official_title>Impact of Cancellation of Non-urgent Surgical Cases on Patients During the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      A questionnaire is developed based on the literature and clinical experience. Initial testing&#xD;
      will be performed on 20 patients. The first and second sectors include patient demographics&#xD;
      and patient clinical diagnosis/scheduled surgery, respectively. The following sectors examine&#xD;
      the process of delivering the cancellation/re-scheduling; care after cancellation and whether&#xD;
      the procedure conducted elsewhere or not; and the impact of cancellation on patient health,&#xD;
      career, and financial aspects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a cross-sectional survey of patients who were scheduled for elective surgical&#xD;
      procedures and their surgeries were cancelled or postponed during the first wave of COVID-19&#xD;
      pandemic. The survey consists of a semi-structured questionnaire that is provided in the&#xD;
      English language. A subsequent translation in patients' own Language will be provided based&#xD;
      on geographical distribution. The survey will be conducted online, via email, or via&#xD;
      telephone call based on the available and best method of participation according to involved&#xD;
      hospital. Participants will be aware of the nature of the study and informed that their&#xD;
      participation will be voluntary. Collected data will be confidential and anonymous.&#xD;
&#xD;
      The questionnaire is developed based on a literature review and clinical experience. Initial&#xD;
      testing of the questionnaire will be performed with 20 patients to assess the reliability and&#xD;
      inter-rater variations. Ambiguous questions and questions with a high rate of &quot;I do not know&quot;&#xD;
      the answer will be excluded. To ensure high compliance, the questionnaire included the least&#xD;
      possible number of questions. The questionnaire consists of closed questions except for two&#xD;
      open questions that explore patients' suggestions to decrease the insult of cancellation on&#xD;
      his life.&#xD;
&#xD;
      After initial testing, the final questionnaire will be formulated. The first sector of the&#xD;
      questionnaire includes patient demographics and baseline characteristics; the second sector&#xD;
      is regarding patient clinical condition, diagnosis, and scheduled surgery. The following&#xD;
      sector examines the process of delivering the cancellation to the patient and requirements&#xD;
      for re-scheduling. Patients will be classified into satisfied or dissatisfied according to&#xD;
      the responses in this sector. The following sector addresses the course of care after&#xD;
      cancellation and whether the patient conducted the surgery elsewhere or not. The last sector&#xD;
      explores the impact of cancellation on patient health, career, and financial aspects. The&#xD;
      impact of cancellation on patients' life will be classified into negative/positive/neutral&#xD;
      based on the answers to this sector.&#xD;
&#xD;
      Statistical analyses will be performed using SPSS v. 20. Data distribution will be tested for&#xD;
      normality using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. Categorical variables&#xD;
      will be expressed as group percentages and will be compared for independent samples using the&#xD;
      Chi-square test. Continuous data of the survey will be presented as medians with ranges or&#xD;
      means and standard deviations. A comparison of continuous data will be compared for&#xD;
      independent samples using the T-test or Mann-Whitney test according to the data distribution.&#xD;
      Spearman correlation coefficient will be used for further assessment of the strength of the&#xD;
      association between variables. The statistical significance level will be set at &lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Quality of Life of the patients</measure>
    <time_frame>During the COVID-19 pandemic 6 months (March-October 2020)</time_frame>
    <description>A questionnaire based on the literature review to access the quality of the life of the patients</description>
  </primary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Satisfaction, Patient</condition>
  <condition>Quality of Life</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>The questionnaire is developed based on a literature review and clinical experience. Initial testing of the questionnaire will be performed with 20 patients to assess the reliability and inter-rater variations. After initial testing, the final questionnaire will be formulated. The first sector of the questionnaire includes patient demographics and baseline characteristics; the second sector is regarding patient clinical condition, diagnosis, and scheduled surgery. The following sector examines the process of delivering the cancellation to the patient and requirements for re-scheduling. Patients will be classified into satisfied or dissatisfied according to the responses in this sector. The following sector addresses the course of care after cancellation and whether the patient conducted the surgery elsewhere or not. The last sector explores the impact of cancellation on patient health, career, and financial aspects.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Both sex&#xD;
&#xD;
          -  Patients their elective surgeries were cancelled or postponed due to COVID-19 pandemic&#xD;
&#xD;
          -  World wide&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both sex&#xD;
&#xD;
          -  Patients their elective surgeries were cancelled or postponed due to COVID-19 pandemic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients underwent surgery during COVID-19&#xD;
&#xD;
          -  Emergency Surgeries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Mostafa Shalaby, MD, MSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hosam Hamed, MD, MSc, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed M Elsheikh, MD,MBA,CMQOE</last_name>
    <role>Study Director</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mostafa M Shalaby, MD, MSc, PhD</last_name>
    <phone>00201001645917</phone>
    <email>mostafashalaby@mans.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hosam Hamed, MD, MSc, PhD</last_name>
    <phone>00201006178599</phone>
    <email>hosam-eldin@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mansoura Faculty of Medicine</name>
      <address>
        <city>Mansoura</city>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Mostafa Shalaby, MD, MSc, PhD</last_name>
      <phone>00201001645917</phone>
      <email>mostafashalaby@mans.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Mostafa shalaby, MD, MSc, PhD</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04433312
org study id: SURG RES COL 2
nct id: NCT04433312
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A questionnaire is developed based on the literature and clinical experience. Initial testing
      will be performed on 20 patients. The first and second sectors include patient demographics
      and patient clinical diagnosis/scheduled surgery, respectively. The following sectors examine
      the process of delivering the cancellation/re-scheduling; care after cancellation and whether
      the procedure conducted elsewhere or not; and the impact of cancellation on patient health,
      career, and financial aspects.
This study is a cross-sectional survey of patients who were scheduled for elective surgical
      procedures and their surgeries were cancelled or postponed during the first wave of COVID-19
      pandemic. The survey consists of a semi-structured questionnaire that is provided in the
      English language. A subsequent translation in patients' own Language will be provided based
      on geographical distribution. The survey will be conducted online, via email, or via
      telephone call based on the available and best method of participation according to involved
      hospital. Participants will be aware of the nature of the study and informed that their
      participation will be voluntary. Collected data will be confidential and anonymous.

      The questionnaire is developed based on a literature review and clinical experience. Initial
      testing of the questionnaire will be performed with 20 patients to assess the reliability and
      inter-rater variations. Ambiguous questions and questions with a high rate of "I do not know"
      the answer will be excluded. To ensure high compliance, the questionnaire included the least
      possible number of questions. The questionnaire consists of closed questions except for two
      open questions that explore patients' suggestions to decrease the insult of cancellation on
      his life.

      After initial testing, the final questionnaire will be formulated. The first sector of the
      questionnaire includes patient demographics and baseline characteristics; the second sector
      is regarding patient clinical condition, diagnosis, and scheduled surgery. The following
      sector examines the process of delivering the cancellation to the patient and requirements
      for re-scheduling. Patients will be classified into satisfied or dissatisfied according to
      the responses in this sector. The following sector addresses the course of care after
      cancellation and whether the patient conducted the surgery elsewhere or not. The last sector
      explores the impact of cancellation on patient health, career, and financial aspects. The
      impact of cancellation on patients' life will be classified into negative/positive/neutral
      based on the answers to this sector.

      Statistical analyses will be performed using SPSS v. 20. Data distribution will be tested for
      normality using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. Categorical variables
      will be expressed as group percentages and will be compared for independent samples using the
      Chi-square test. Continuous data of the survey will be presented as medians with ranges or
      means and standard deviations. A comparison of continuous data will be compared for
      independent samples using the T-test or Mann-Whitney test according to the data distribution.
      Spearman correlation coefficient will be used for further assessment of the strength of the
      association between variables. The statistical significance level will be set at <0.05.
observational model: Other
time perspective: Cross-Sectional
measure: Quality of Life of the patients
time frame: During the COVID-19 pandemic 6 months (March-October 2020)
description: A questionnaire based on the literature review to access the quality of the life of the patients
intervention type: Other
intervention name: Questionnaire
description: The questionnaire is developed based on a literature review and clinical experience. Initial testing of the questionnaire will be performed with 20 patients to assess the reliability and inter-rater variations. After initial testing, the final questionnaire will be formulated. The first sector of the questionnaire includes patient demographics and baseline characteristics; the second sector is regarding patient clinical condition, diagnosis, and scheduled surgery. The following sector examines the process of delivering the cancellation to the patient and requirements for re-scheduling. Patients will be classified into satisfied or dissatisfied according to the responses in this sector. The following sector addresses the course of care after cancellation and whether the patient conducted the surgery elsewhere or not. The last sector explores the impact of cancellation on patient health, career, and financial aspects.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Mostafa Shalaby, MD, MSc, PhD
role: Principal Investigator
affiliation: Mansoura University
last name: Hosam Hamed, MD, MSc, PhD
role: Study Chair
affiliation: Mansoura University
last name: Ahmed M Elsheikh, MD,MBA,CMQOE
role: Study Director
affiliation: Mansoura University
last name: Mostafa M Shalaby, MD, MSc, PhD
phone: 00201001645917
email: mostafashalaby@mans.edu.eg
last name: Hosam Hamed, MD, MSc, PhD
phone: 00201006178599
email: hosam-eldin@hotmail.com
facility: 
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Mostafa shalaby, MD, MSc, PhD
investigator title: Dr
mesh term: COVID-19
sharing ipd: No