<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/NCT01676025</url>
  </required_header>
  <id_info>
    <org_study_id>Kyu.eun.lee-001</org_study_id>
    <nct_id>NCT01676025</nct_id>
  </id_info>
  <brief_title>Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy</brief_title>
  <acronym>PRA</acronym>
  <official_title>Randomized Controlled Trial Between PRA(Posterior Retroperitoneoscopic Adrenalectomy) and LA(Laparoscopic Adrenalectomy)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare two surgical methods of adrenalectomy. One is called&#xD;
      PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at&#xD;
      patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through&#xD;
      patient's abdominal cavity after making 3 or 4 holes in the abdomen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since 1992, transabdominal LA(laparoscopic adrenalectomy) has been a standard method of&#xD;
      adrenalectomy. This traditional method has been used widely because this procedure provides&#xD;
      wide view of the whole abdomen which is familiar to surgeons. But due to its unique location&#xD;
      at retroperitoneum, adrenal is still not easy to approach. So various retroperitoneal&#xD;
      approaches were designed and adjusted. Among those, PRA(posterior retroperitoneal&#xD;
      adrenalectomy) has showed good outcomes in many institutes. PRA facilitates direct approach&#xD;
      to kidney and adrenal gland, and so operative time can be shortened. But there has been no&#xD;
      randomized controlled trial between these two methods.&#xD;
&#xD;
      Therefore, as experienced surgeons in both methods, we want to practice this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 28, 2016</completion_date>
  <primary_completion_date type="Actual">February 28, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operation time</measure>
    <time_frame>Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks</time_frame>
    <description>operation time will be measured by attending nerse</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain sensation after surgery</measure>
    <time_frame>Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks</time_frame>
    <description>Pain score will be described daily during hospitalization, and also at out patient clinic after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery of bowel movement</measure>
    <time_frame>Participants will be followed the duration of hospital stay, an expected average of 5 days</time_frame>
    <description>Gas out is regarded as a recovery of bowel movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound complication</measure>
    <time_frame>Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood loss during operation</measure>
    <time_frame>Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-operative hemodynamic status</measure>
    <time_frame>Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks</time_frame>
    <description>Events as below will be recorded and compared severe hypertension(systolic BP&gt;200mmHg), severe hypotension(systolic BP&lt;90mmHg), Tachycardia(HR&gt;110/min), Bradycardia(HR&lt;50/min)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Adrenal Disease</condition>
  <arm_group>
    <arm_group_label>PRA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Persons who get PRA surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Persons who get LA surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PRA</intervention_name>
    <arm_group_label>PRA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LA</intervention_name>
    <arm_group_label>LA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are expected to have benign adrenal disease at preoperative exams&#xD;
&#xD;
          -  Patients who have pheochromocytoma measured less than 5cm, and the other benign&#xD;
             adrenal tumors less than 7cm in diameter in preoperative CT scan&#xD;
&#xD;
          -  Patients who do not have previous surgery history at the interested quadrant&#xD;
&#xD;
          -  Patients who is I or II grade in ASA classification(American society of&#xD;
             anesthesiologists' physical status classification)&#xD;
&#xD;
          -  Patients who has tolerable liver function and renal function(bilirubin&lt;2.0mg/dl and&#xD;
             AST, ALT, serum creatinine within twice of upper normal range, coagulation panel :&#xD;
             within normal limit)&#xD;
&#xD;
          -  Patients whose BMI(body mass index) is less than 35&#xD;
&#xD;
          -  Patients who are supposed to have normal cognitive function&#xD;
&#xD;
          -  Patients who signed the consent paper.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are expected to have malignant or metastatic adrenal tumor at&#xD;
             preoperative exams&#xD;
&#xD;
          -  Patients who have bilateral adrenal tumors&#xD;
&#xD;
          -  Patients who have condition to undergo the other operation at the abdomen together&#xD;
             with adrenalectomy&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients who have active or uncontrolled infection&#xD;
&#xD;
          -  Patients who have medical problems as below&#xD;
&#xD;
          -  Uncontrollable hypertension with medication(Systolic BP&gt;150 or diastolic BP&gt;100)&#xD;
&#xD;
          -  Angina, congestive heart failure, acute myocardial infection&#xD;
&#xD;
          -  History of coronary angioplasty or Coronary artery bypass graft surgery&#xD;
&#xD;
          -  History of stroke, transient ischemic attack with sequela&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyueun Lee, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Kyu Eun Lee</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Surgery, Seoul National University College of Medicine, Seoul, Korea</investigator_title>
  </responsible_party>
  <keyword>pheochromocytoma</keyword>
  <keyword>aldosteronism</keyword>
  <keyword>cushing's syndrome</keyword>
  <keyword>adrenal incidentaloma</keyword>
  <keyword>Conn's syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adrenal Gland Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT01676025
org study id: Kyu.eun.lee-001
nct id: NCT01676025
lead sponsor: 
has dmc: No
The purpose of this study is to compare two surgical methods of adrenalectomy. One is called
      PRA(posterior retroperitoneal adrenalectomy), which is performed through 3 or 4 holes at
      patient's back. The other is LA(laparoscopic adrenalectomy) which is performed through
      patient's abdominal cavity after making 3 or 4 holes in the abdomen.
Since 1992, transabdominal LA(laparoscopic adrenalectomy) has been a standard method of
      adrenalectomy. This traditional method has been used widely because this procedure provides
      wide view of the whole abdomen which is familiar to surgeons. But due to its unique location
      at retroperitoneum, adrenal is still not easy to approach. So various retroperitoneal
      approaches were designed and adjusted. Among those, PRA(posterior retroperitoneal
      adrenalectomy) has showed good outcomes in many institutes. PRA facilitates direct approach
      to kidney and adrenal gland, and so operative time can be shortened. But there has been no
      randomized controlled trial between these two methods.

      Therefore, as experienced surgeons in both methods, we want to practice this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Operation time
time frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
description: operation time will be measured by attending nerse
measure: Pain sensation after surgery
time frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
description: Pain score will be described daily during hospitalization, and also at out patient clinic after discharge
measure: Recovery of bowel movement
time frame: Participants will be followed the duration of hospital stay, an expected average of 5 days
description: Gas out is regarded as a recovery of bowel movement
measure: Wound complication
time frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
measure: Blood loss during operation
time frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
measure: Intra-operative hemodynamic status
time frame: Participants will be followed until the first visit of out patients clinic after discharge, an expected average of 3 weeks
description: Events as below will be recorded and compared severe hypertension(systolic BP>200mmHg), severe hypotension(systolic BP<90mmHg), Tachycardia(HR>110/min), Bradycardia(HR<50/min)
arm group label: PRA
arm group type: Experimental
description: Persons who get PRA surgery.
arm group label: LA
arm group type: Experimental
description: Persons who get LA surgery.
intervention type: Procedure
intervention name: PRA
arm group label: PRA
intervention type: Procedure
intervention name: LA
arm group label: LA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Kyueun Lee, Ph.D
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Kyu Eun Lee
investigator title: Assistant Professor, Department of Surgery, Seoul National University College of Medicine, Seoul, Korea
mesh term: Adrenal Gland Diseases