<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/NCT04435171</url>
  </required_header>
  <id_info>
    <org_study_id>Renal Transplantation</org_study_id>
    <nct_id>NCT04435171</nct_id>
  </id_info>
  <brief_title>Comparison of Postoperative Early Period Quality of Life of Patients With Open and Robot Assisted Kidney Transplantation</brief_title>
  <official_title>Comparison of Postoperative Early Period Quality of Life of Patients With Open and Robot Assisted Kidney Transplantation: a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</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 aimed to investigate the quality of life in patients with end-stage renal&#xD;
      disease who underwent open or robot-assisted renal transplantation. Also, the investigators&#xD;
      sought to determine the parameters which can affect the quality of life in these patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who underwent open or robot-assisted renal transplantation at Bakirkoy Sadi Konuk&#xD;
      Training and Research Hospital between June 2016 and December 2018 constituted the target&#xD;
      population of this study. After application of the inclusion and exclusion criteria, the&#xD;
      patient group was divided into two groups as per the surgical technique (i.e., open vs.&#xD;
      robot-assisted). Demographic data, preoperative and postoperative data of all patients were&#xD;
      collected prospectively. The quality of life of the patients was assessed preoperatively and&#xD;
      on the postoperative 30th day&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2016</start_date>
  <completion_date type="Actual">May 20, 2020</completion_date>
  <primary_completion_date type="Actual">December 15, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>Percentage of change for Quality of Life (measure : Short Form 36) after open and robot assisted renal transplantation</measure>
    <time_frame>From just before the treatment and up to 30 days after the surgery was performed</time_frame>
    <description>Percentage of change for quality of life (measure : Short Form 36) for patients who performed open and robot assisted renal transplantation due to end stage renal disease. Scores of the Short Form-36 Health Survey vary between 0 and 100, a score of 0 corresponds to the lowest quality, while 100 indicates the highest quality.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">129</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Open renal transplantation</arm_group_label>
    <description>Patients who were performed open renal transplantation due to end stage renal disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>robot assisted renal transplantation</arm_group_label>
    <description>Patients who were performed robot assisted renal transplantation due to end stage renal disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Renal transplantation</intervention_name>
    <description>Open or robot assisted renal transplantation</description>
    <arm_group_label>Open renal transplantation</arm_group_label>
    <arm_group_label>robot assisted renal transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who were performed open or robot assisted renal transplantation due to End Stage&#xD;
        Renal Disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged between 18 and 75&#xD;
&#xD;
          -  Who were diagnosed with End Stage Renal Disease (i.e., estimated glomerular filtration&#xD;
             rate loer than 20 ml/minute or symptomatic uremia or dialysis requirement)&#xD;
&#xD;
          -  Received a kidney from a live donor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with mental retardation, dementia, and psychotic or cognitive disorders,&#xD;
             including delirium&#xD;
&#xD;
          -  Patients who underwent deceased renal transplantation and who underwent simple&#xD;
             bilateral nephrectomy or any other surgical procedure concurrent with Open renal&#xD;
             transplantation&#xD;
&#xD;
          -  Patients who died or had graft failure during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mithat Ekşi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bakırkoy Dr. Sadi Konuk Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bakirkoy Dr Sadi Konuk Training and Research Hospital, Department of Urology</name>
      <address>
        <city>Istanbul</city>
        <zip>34275</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>End Stage Renal Disease</keyword>
  <keyword>Renal Transplantation</keyword>
  <keyword>Quality of Life</keyword>
  <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/NCT04435171
org study id: Renal Transplantation
nct id: NCT04435171
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aimed to investigate the quality of life in patients with end-stage renal
      disease who underwent open or robot-assisted renal transplantation. Also, the investigators
      sought to determine the parameters which can affect the quality of life in these patients
Patients who underwent open or robot-assisted renal transplantation at Bakirkoy Sadi Konuk
      Training and Research Hospital between June 2016 and December 2018 constituted the target
      population of this study. After application of the inclusion and exclusion criteria, the
      patient group was divided into two groups as per the surgical technique (i.e., open vs.
      robot-assisted). Demographic data, preoperative and postoperative data of all patients were
      collected prospectively. The quality of life of the patients was assessed preoperatively and
      on the postoperative 30th day
observational model: Cohort
time perspective: Prospective
measure: Percentage of change for Quality of Life (measure : Short Form 36) after open and robot assisted renal transplantation
time frame: From just before the treatment and up to 30 days after the surgery was performed
description: Percentage of change for quality of life (measure : Short Form 36) for patients who performed open and robot assisted renal transplantation due to end stage renal disease. Scores of the Short Form-36 Health Survey vary between 0 and 100, a score of 0 corresponds to the lowest quality, while 100 indicates the highest quality.
arm group label: Open renal transplantation
description: Patients who were performed open renal transplantation due to end stage renal disease.
arm group label: robot assisted renal transplantation
description: Patients who were performed robot assisted renal transplantation due to end stage renal disease
intervention type: Procedure
intervention name: Renal transplantation
description: Open or robot assisted renal transplantation
arm group label: Open renal transplantation
arm group label: robot assisted renal transplantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mithat Ekşi
role: Principal Investigator
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
facility: 
country: Turkey
responsible party type: Sponsor
sharing ipd: No