<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/NCT03252860</url>
  </required_header>
  <id_info>
    <org_study_id>WHO SSC Compliance Uganda</org_study_id>
    <nct_id>NCT03252860</nct_id>
  </id_info>
  <brief_title>WHO SSC : Compliance and Associated Surgical Outcomes in Uganda's Referral Hospitals</brief_title>
  <official_title>World Health Organization Surgical Safety Checklist: Compliance and Associated Surgical Outcomes in Uganda's Referral Hospitals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makerere University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makerere University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators set out to determine the extent of compliance with the World Health&#xD;
      Organization Surgical Safety Checklist and the association of this compliance with&#xD;
      perioperative surgical outcomes in five of Uganda's referral hospitals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multicentre prospective cohort study in five of Uganda's referral Hospitals in Uganda&#xD;
      including the referral private not for profit (PNFPs) hospitals.&#xD;
&#xD;
      Target population: Patients undergoing surgery in Uganda's referral hospitals.&#xD;
&#xD;
      Study population: Surgical operations being performed in Uganda's referral hospitals over a&#xD;
      4-month period.&#xD;
&#xD;
      Sampling method&#xD;
&#xD;
      Purposive sampling of the hospitals was done based on their geographical location, their&#xD;
      influence in the areas where they are situated and the presence of an anaesthesiologist in&#xD;
      the hospital. The surgeries were enrolled into the study by probability proportional to the&#xD;
      size sampling. The sampling unit was surgical operations done in the eligible hospitals.&#xD;
      Surgical operations were enrolled into the study systematically during the study period.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      Primary objective: To determine the extent of compliance to the WHO surgical safety checklist&#xD;
      among Uganda's referral hospitals.&#xD;
&#xD;
      The sample size for this objective was calculated using the Modified Kish &amp; Leslie method&#xD;
      (1965)&#xD;
&#xD;
      N= [Z² p (1-p)] / d² where;&#xD;
&#xD;
      Z= is a percentile of the standard normal value determined by the 95% confidence level&#xD;
      (1.96).&#xD;
&#xD;
      N= minimum required sample size&#xD;
&#xD;
      d= desired precision for the study = 0.05&#xD;
&#xD;
      p= is the estimated proportion of hospitals that had poor compliance to SSC = 50%&#xD;
&#xD;
      The proportion used to compute the sample size was the proportion of hospitals which had poor&#xD;
      compliance to the SSC. This proportion was obtained from the WHO recommendation when no&#xD;
      previous proportions are available = 50% n= 384 participants, since the study was done in&#xD;
      several hospitals, adjustment for clustering was done by applying a cluster effect of 2.&#xD;
&#xD;
      Sample size = 768&#xD;
&#xD;
      Adjusting for a 10% loss to follow up, N = n (100+10)/100&#xD;
&#xD;
      Sample size = 845&#xD;
&#xD;
      Variables:&#xD;
&#xD;
      The categorical variables included patient demographics, urgency of the surgery, actual use&#xD;
      of the WHO SSC, qualification of staff and the team leader present in the operating room&#xD;
      during the use of the checklist, the team member who initiated the checklist, timing of the&#xD;
      performance of the different domains and post-operative complications within a 24 hour period&#xD;
      after the surgery and daily until discharge or 30 days of in hospital stay, while the ordinal&#xD;
      variables included percentage of items checked among the 19 parameters and 3 broad domains of&#xD;
      the WHO SSC. These variables were ticked off the questionnaire by the research assistant as&#xD;
      they observed the surgery. Compliance was expressed as the percentage of items that has been&#xD;
      completed per checklist.&#xD;
&#xD;
      Data collection&#xD;
&#xD;
      Data was collected using standardized sheets and stored safely using waterproof boxes and&#xD;
      treated with utmost confidence. All patients undergoing surgical operations were recruited&#xD;
      into the study regardless of their age, surgical specialty and the urgency of the surgical&#xD;
      operation provided consent to participate in the study was given. The research assistant&#xD;
      present in the operating room observed the activities in the room and completed a structured&#xD;
      questionnaire regarding demographics, the 19 parameters and 3 domains of the WHO SSC, near&#xD;
      misses, qualification of the staff present in the operating room, and intraoperative&#xD;
      variables. Technical and intraoperative complications were recorded as well. The patients&#xD;
      were followed up and questioned on the occurrence of complications at 24 hours and daily&#xD;
      until discharge or 30 days post-surgery whichever came first. The nurses on the ward reported&#xD;
      any immediate post-operative complications.&#xD;
&#xD;
      The complications were recorded as defined by the American College of Surgeons National&#xD;
      Surgical Quality Improvement Program database ; Bleeding: overt frank bleeding from the&#xD;
      surgical site, heavy soiling of the surgical site dressing with blood or need to change&#xD;
      dressing within the first 24 hours due to soiling with blood, respiratory complications;&#xD;
      acute airway obstruction, inability to saturate above 92% off oxygen therapy within the first&#xD;
      24 hours after surgery with absence of previous hypoxemia on room air and prolonged&#xD;
      intubation, post-operative nausea and vomiting, loss of consciousness or altered&#xD;
      consciousness within the first 24 hours after surgery based on GCS scores before and after&#xD;
      the surgery, cardiac and hemodynamic complications such as hypotension which were defined as&#xD;
      a blood pressure of less than 90/60 mmHg, need for unanticipated blood transfusion&#xD;
      intraoperatively and 24 hours postoperatively cardiac arrest, pain and death. The patients&#xD;
      were then followed prospectively for any other complications in the perioperative period. Any&#xD;
      other occurrences that the ward nurses considered complications attributed to the&#xD;
      perioperative period were reported to the research assistants and this was recorded in the&#xD;
      questionnaire. The patients exited the study at discharge or at 30 days of in hospital stay.&#xD;
&#xD;
      Checklist compliance was defined as &quot;non compliance&quot; (none of the 19 items checked off),&#xD;
      &quot;partial compliance&quot; (at least 1 to 9 items checked off) and &quot;high compliance&quot; (10 to 19&#xD;
      items checked off) and was expressed as a percentage of the number of the expected checked&#xD;
      off items.&#xD;
&#xD;
      Data safety&#xD;
&#xD;
      Raw data sources were received from the different hospitals and stored in safe waterproof&#xD;
      boxes. An electronic data entry tool was formulated and used to store the data on multiple&#xD;
      storage devices.&#xD;
&#xD;
      Data management&#xD;
&#xD;
      Data were double-entered in an entry tool created using Epidata software version 3.1. This&#xD;
      had in-built checks. The data were validated and inconsistencies cleared accordingly. The&#xD;
      data were backed up and a copy was sent to the data analysis program.&#xD;
&#xD;
      Data analysis&#xD;
&#xD;
      Data were analysed using STATA version 13 (StataCorp.2013.Stata Statistical Software: Release&#xD;
      13. College Station, TX: StataCorp LP)&#xD;
&#xD;
      Descriptives: Descriptives were summarised using means and standard deviations for the&#xD;
      parametric continuous data. Categorical data were summarised using proportions and&#xD;
      percentages.&#xD;
&#xD;
      Comparisons: Comparisons for variables between participants with poor and good surgical&#xD;
      outcomes were made. For the parametric continuous data, the student t test was used and for&#xD;
      the non-parametric data, Mann-Whitney- U test was employed. For the categorical data, the&#xD;
      Chi-Square test of Fisher's exact test was used.&#xD;
&#xD;
      Prevalence of compliance was calculated as follows; the numerator was the number of checked&#xD;
      off items on the checklist. The denominator was the total number of expected checked off&#xD;
      items. We expressed compliance as a percentage completion of the items comprising the&#xD;
      checklist. There is a total of 19 items in the checklist, therefore high compliance involved&#xD;
      adhering to at least 10 of them while non-compliance involved not adhering to any of the&#xD;
      items. We assigned each of the items of the checklist a score of 1 then calculated a&#xD;
      percentage of the compliance by dividing the score attained out the 19 which is the expected&#xD;
      score. We presented the mean percentage compliances with their corresponding 95% confidence&#xD;
      intervals.&#xD;
&#xD;
      Bivariate analysis: Binary logistic regression model was used to assess for association of&#xD;
      each of the predictors with mortality while a linear regression model was used to asses for&#xD;
      the association with the length of hospital stay&#xD;
&#xD;
      Multivariate analysis: All factors with p value of 0.2 or less at bivariate analysis were&#xD;
      simultaneously entered in multivariate linear and logistic regression models respectively.&#xD;
      Confounding was assessed for at a 10% or more difference between the unadjusted and adjusted&#xD;
      models. Statistical significance was defined as p &lt; 0.05&#xD;
&#xD;
      Analysed data were presented in figures, tables and text. Results of the linear regression&#xD;
      were expressed as coefficient and the ones of logistic regression expressed as OR with a&#xD;
      confidence interval of 95%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">August 12, 2016</completion_date>
  <primary_completion_date type="Actual">July 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance with the WHO surgical safety checklist</measure>
    <time_frame>immediate</time_frame>
    <description>number of parameters on the surgical safety checklist actually performed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>perioperative adverse events</measure>
    <time_frame>time to discharge or 30 days of in hospital stay whichever came first</time_frame>
    <description>The participants were followed up daily and perioperative adverse events as defined by the American College of Surgeons National Quality Improvement Program. The participants were followed up until discharge or 30 days of in hospital stay and the secondary outcome measures entered into a questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>time to discharge or 30 days of in hospital stay whichever came first</time_frame>
    <description>The participants were followed up daily until discharge or 30 days of in patient stay and the length of stay recorded in a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>all cause mortality</measure>
    <time_frame>from date of recruitment until date of death from any cause assessed up to 3 months of in hospital stay</time_frame>
    <description>The participants were followed up daily and deaths and the time of their occurrence were recorded in a questionnaire</description>
  </secondary_outcome>
  <enrollment type="Actual">850</enrollment>
  <condition>Surgical Safety Checklist Compliance</condition>
  <condition>Perioperative Surgical Adverse Events</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation of compliance with the World Health Organisation Surgical Safety Checklist</intervention_name>
    <description>Observation of use and compliance with the surgical safety checklist and associated perioperative surgical outcomes</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing surgical operations in 5 of Uganda's referral hospitals over a&#xD;
        4-month period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgical operations being performed in the participating hospitals whose directors&#xD;
             consented to be part of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgical operations performed in hospitals whose directors declined to consent to be&#xD;
             part of study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03252860
org study id: WHO SSC Compliance Uganda
nct id: NCT03252860
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators set out to determine the extent of compliance with the World Health
      Organization Surgical Safety Checklist and the association of this compliance with
      perioperative surgical outcomes in five of Uganda's referral hospitals.
Multicentre prospective cohort study in five of Uganda's referral Hospitals in Uganda
      including the referral private not for profit (PNFPs) hospitals.

      Target population: Patients undergoing surgery in Uganda's referral hospitals.

      Study population: Surgical operations being performed in Uganda's referral hospitals over a
      4-month period.

      Sampling method

      Purposive sampling of the hospitals was done based on their geographical location, their
      influence in the areas where they are situated and the presence of an anaesthesiologist in
      the hospital. The surgeries were enrolled into the study by probability proportional to the
      size sampling. The sampling unit was surgical operations done in the eligible hospitals.
      Surgical operations were enrolled into the study systematically during the study period.

      Sample size:

      Primary objective: To determine the extent of compliance to the WHO surgical safety checklist
      among Uganda's referral hospitals.

      The sample size for this objective was calculated using the Modified Kish & Leslie method
      (1965)

      N= [Z² p (1-p)] / d² where;

      Z= is a percentile of the standard normal value determined by the 95% confidence level
      (1.96).

      N= minimum required sample size

      d= desired precision for the study = 0.05

      p= is the estimated proportion of hospitals that had poor compliance to SSC = 50%

      The proportion used to compute the sample size was the proportion of hospitals which had poor
      compliance to the SSC. This proportion was obtained from the WHO recommendation when no
      previous proportions are available = 50% n= 384 participants, since the study was done in
      several hospitals, adjustment for clustering was done by applying a cluster effect of 2.

      Sample size = 768

      Adjusting for a 10% loss to follow up, N = n (100+10)/100

      Sample size = 845

      Variables:

      The categorical variables included patient demographics, urgency of the surgery, actual use
      of the WHO SSC, qualification of staff and the team leader present in the operating room
      during the use of the checklist, the team member who initiated the checklist, timing of the
      performance of the different domains and post-operative complications within a 24 hour period
      after the surgery and daily until discharge or 30 days of in hospital stay, while the ordinal
      variables included percentage of items checked among the 19 parameters and 3 broad domains of
      the WHO SSC. These variables were ticked off the questionnaire by the research assistant as
      they observed the surgery. Compliance was expressed as the percentage of items that has been
      completed per checklist.

      Data collection

      Data was collected using standardized sheets and stored safely using waterproof boxes and
      treated with utmost confidence. All patients undergoing surgical operations were recruited
      into the study regardless of their age, surgical specialty and the urgency of the surgical
      operation provided consent to participate in the study was given. The research assistant
      present in the operating room observed the activities in the room and completed a structured
      questionnaire regarding demographics, the 19 parameters and 3 domains of the WHO SSC, near
      misses, qualification of the staff present in the operating room, and intraoperative
      variables. Technical and intraoperative complications were recorded as well. The patients
      were followed up and questioned on the occurrence of complications at 24 hours and daily
      until discharge or 30 days post-surgery whichever came first. The nurses on the ward reported
      any immediate post-operative complications.

      The complications were recorded as defined by the American College of Surgeons National
      Surgical Quality Improvement Program database ; Bleeding: overt frank bleeding from the
      surgical site, heavy soiling of the surgical site dressing with blood or need to change
      dressing within the first 24 hours due to soiling with blood, respiratory complications;
      acute airway obstruction, inability to saturate above 92% off oxygen therapy within the first
      24 hours after surgery with absence of previous hypoxemia on room air and prolonged
      intubation, post-operative nausea and vomiting, loss of consciousness or altered
      consciousness within the first 24 hours after surgery based on GCS scores before and after
      the surgery, cardiac and hemodynamic complications such as hypotension which were defined as
      a blood pressure of less than 90/60 mmHg, need for unanticipated blood transfusion
      intraoperatively and 24 hours postoperatively cardiac arrest, pain and death. The patients
      were then followed prospectively for any other complications in the perioperative period. Any
      other occurrences that the ward nurses considered complications attributed to the
      perioperative period were reported to the research assistants and this was recorded in the
      questionnaire. The patients exited the study at discharge or at 30 days of in hospital stay.

      Checklist compliance was defined as "non compliance" (none of the 19 items checked off),
      "partial compliance" (at least 1 to 9 items checked off) and "high compliance" (10 to 19
      items checked off) and was expressed as a percentage of the number of the expected checked
      off items.

      Data safety

      Raw data sources were received from the different hospitals and stored in safe waterproof
      boxes. An electronic data entry tool was formulated and used to store the data on multiple
      storage devices.

      Data management

      Data were double-entered in an entry tool created using Epidata software version 3.1. This
      had in-built checks. The data were validated and inconsistencies cleared accordingly. The
      data were backed up and a copy was sent to the data analysis program.

      Data analysis

      Data were analysed using STATA version 13 (StataCorp.2013.Stata Statistical Software: Release
      13. College Station, TX: StataCorp LP)

      Descriptives: Descriptives were summarised using means and standard deviations for the
      parametric continuous data. Categorical data were summarised using proportions and
      percentages.

      Comparisons: Comparisons for variables between participants with poor and good surgical
      outcomes were made. For the parametric continuous data, the student t test was used and for
      the non-parametric data, Mann-Whitney- U test was employed. For the categorical data, the
      Chi-Square test of Fisher's exact test was used.

      Prevalence of compliance was calculated as follows; the numerator was the number of checked
      off items on the checklist. The denominator was the total number of expected checked off
      items. We expressed compliance as a percentage completion of the items comprising the
      checklist. There is a total of 19 items in the checklist, therefore high compliance involved
      adhering to at least 10 of them while non-compliance involved not adhering to any of the
      items. We assigned each of the items of the checklist a score of 1 then calculated a
      percentage of the compliance by dividing the score attained out the 19 which is the expected
      score. We presented the mean percentage compliances with their corresponding 95% confidence
      intervals.

      Bivariate analysis: Binary logistic regression model was used to assess for association of
      each of the predictors with mortality while a linear regression model was used to asses for
      the association with the length of hospital stay

      Multivariate analysis: All factors with p value of 0.2 or less at bivariate analysis were
      simultaneously entered in multivariate linear and logistic regression models respectively.
      Confounding was assessed for at a 10% or more difference between the unadjusted and adjusted
      models. Statistical significance was defined as p < 0.05

      Analysed data were presented in figures, tables and text. Results of the linear regression
      were expressed as coefficient and the ones of logistic regression expressed as OR with a
      confidence interval of 95%.
observational model: Cohort
time perspective: Prospective
measure: Compliance with the WHO surgical safety checklist
time frame: immediate
description: number of parameters on the surgical safety checklist actually performed
measure: perioperative adverse events
time frame: time to discharge or 30 days of in hospital stay whichever came first
description: The participants were followed up daily and perioperative adverse events as defined by the American College of Surgeons National Quality Improvement Program. The participants were followed up until discharge or 30 days of in hospital stay and the secondary outcome measures entered into a questionnaire.
measure: length of hospital stay
time frame: time to discharge or 30 days of in hospital stay whichever came first
description: The participants were followed up daily until discharge or 30 days of in patient stay and the length of stay recorded in a questionnaire
measure: all cause mortality
time frame: from date of recruitment until date of death from any cause assessed up to 3 months of in hospital stay
description: The participants were followed up daily and deaths and the time of their occurrence were recorded in a questionnaire
intervention type: Other
intervention name: Observation of compliance with the World Health Organisation Surgical Safety Checklist
description: Observation of use and compliance with the surgical safety checklist and associated perioperative surgical outcomes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 100 Years
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No