xml: <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/NCT05999019</url>
    </required_header>
    <id_info>
      <org_study_id>RGiAE-01</org_study_id>
      <nct_id>NCT05999019</nct_id>
    </id_info>
    <brief_title>Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer</brief_title>
    <official_title>Appraisal of Surgical Outcomes and Oncological Efficiency of Intraoperative Adverse Events in Robotic Radical Gastrectomy for Gastric Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fujian Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fujian Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Surgical quality control is a crucial determinant of evaluating the tumor efficacy. We assess&#xD;
        the ClassIntra grade for quality control and oncological outcomes of robotic radical surgery&#xD;
        for gastric cancer (GC).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Gastric cancer (GC) is the fifth most common malignant tumor worldwide and the fourth leading&#xD;
        cause of cancer-related deaths. Surgery remains the cornerstone of GC treatment, and there is&#xD;
        a significant lack of research on iAE compared with postoperative complications. Owing to the&#xD;
        influence of reporting and cultural acceptance, there have been issues of inadequate&#xD;
        reporting and non-standardized practices regarding iAE reporting.&#xD;
  &#xD;
        The previously reported laparoscopic results showed that the ClassIntra grade is an effective&#xD;
        prognostic and surgical quality control index for laparoscopic radical surgery for gastric&#xD;
        cancer therefore it could be included in routine hospital care and surgical quality control.&#xD;
        (DOI: 10.1097/SLA.0000000000005727). Here, iAEs in patients who underwent robotic radical&#xD;
        gastrectomy significantly correlated with the occurrence of postoperative complications and a&#xD;
        poor long-term prognosis. Therefore, utilization and inclusion of ClassIntra grading as a&#xD;
        crucial surgical quality control and prognostic indicator in the routine surgical quality&#xD;
        evaluation system are recommended.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2016</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">September 30, 2019</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>ClassIntra grade</measure>
      <time_frame>1 months</time_frame>
      <description>Patients who experienced iAE were classified into the iAE group using ClassIntra grading (version 1.0). The iAEs were further classified into five sublevels (ranging from I to V according to severity) based on the ClassIntra grade</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective Structured Assessment of Technical Skill (OSATS)</measure>
      <time_frame>1 months</time_frame>
      <description>Surgical performance was assessed using the Objective Structured Assessment of Technical Skill (OSATS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3-year overall survival</measure>
      <time_frame>36 months</time_frame>
      <description>Overall survival (OS) was calculated from the date of surgery to death from any cause or the last follow-up.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>3-year disease-free survival</measure>
      <time_frame>36 months</time_frame>
      <description>Disease-free survival (DFS) was calculated from the date of surgery to recurrence (locoregional and systemic), death from any cause, or the last follow-up.</description>
    </secondary_outcome>
    <enrollment type="Actual">366</enrollment>
    <condition>Gastric Cancer</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>robotic surgery</intervention_name>
      <description>robotic surgery</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study included 366 patients who underwent robotic gastrectomy at the Department of&#xD;
          Gastrointestinal Surgery, Fujian Medical University Union Hospital, between August 2016 and&#xD;
          September 2019, where over 800 gastrectomies were performed annually for patients with GC.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients diagnosed with gastric adenocarcinoma through pathology;&#xD;
  &#xD;
            -  Preoperative chest radiograph, abdominal ultrasonogram, and full abdominal CT&#xD;
               examination showed no distant metastasis to the liver, lungs, or abdominal cavity;&#xD;
  &#xD;
            -  Patients who underwent robotic radical gastrectomy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intraoperatively existing distant metastases&#xD;
  &#xD;
            -  Neoadjuvant chemotherapy&#xD;
  &#xD;
            -  Missing general and video data.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fujian Medical University</investigator_affiliation>
      <investigator_full_name>Chang-Ming Huang, Prof.</investigator_full_name>
      <investigator_title>Director of gastric surgery</investigator_title>
    </responsible_party>
    <keyword>gastric cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999019
  org study id: RGiAE-01
  nct id: NCT05999019
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Surgical quality control is a crucial determinant of evaluating the tumor efficacy. We assess
        the ClassIntra grade for quality control and oncological outcomes of robotic radical surgery
        for gastric cancer (GC).
  Gastric cancer (GC) is the fifth most common malignant tumor worldwide and the fourth leading
        cause of cancer-related deaths. Surgery remains the cornerstone of GC treatment, and there is
        a significant lack of research on iAE compared with postoperative complications. Owing to the
        influence of reporting and cultural acceptance, there have been issues of inadequate
        reporting and non-standardized practices regarding iAE reporting.
  
        The previously reported laparoscopic results showed that the ClassIntra grade is an effective
        prognostic and surgical quality control index for laparoscopic radical surgery for gastric
        cancer therefore it could be included in routine hospital care and surgical quality control.
        (DOI: 10.1097/SLA.0000000000005727). Here, iAEs in patients who underwent robotic radical
        gastrectomy significantly correlated with the occurrence of postoperative complications and a
        poor long-term prognosis. Therefore, utilization and inclusion of ClassIntra grading as a
        crucial surgical quality control and prognostic indicator in the routine surgical quality
        evaluation system are recommended.
  observational model: Cohort
  time perspective: Retrospective
  measure: ClassIntra grade
  time frame: 1 months
  description: Patients who experienced iAE were classified into the iAE group using ClassIntra grading (version 1.0). The iAEs were further classified into five sublevels (ranging from I to V according to severity) based on the ClassIntra grade
  measure: Objective Structured Assessment of Technical Skill (OSATS)
  time frame: 1 months
  description: Surgical performance was assessed using the Objective Structured Assessment of Technical Skill (OSATS)
  measure: 3-year overall survival
  time frame: 36 months
  description: Overall survival (OS) was calculated from the date of surgery to death from any cause or the last follow-up.
  measure: 3-year disease-free survival
  time frame: 36 months
  description: Disease-free survival (DFS) was calculated from the date of surgery to recurrence (locoregional and systemic), death from any cause, or the last follow-up.
  intervention type: Procedure
  intervention name: robotic surgery
  description: robotic surgery
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Fujian Medical University
  investigator full name: Chang-Ming Huang, Prof.
  investigator title: Director of gastric surgery
  mesh term: Stomach Neoplasms