<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/NCT03830593</url>
  </required_header>
  <id_info>
    <org_study_id>OMU KAEK (2019/78)</org_study_id>
    <nct_id>NCT03830593</nct_id>
  </id_info>
  <brief_title>Laparoscopic Adrenalectomy for Large Adrenal Tumors.</brief_title>
  <official_title>Is There Anything New in the Field of Large Adrenal Tumors ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsun Liv Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ondokuz Mayıs University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Samsun Liv Hospital</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>
      Laparoscopic adrenalectomy is the treatment of choice for the benign tumor of less than 6 cm.&#xD;
      However, this is an ongoing debate that exact cut-off value of tumor size for LA. The aim of&#xD;
      this study was to assess whether the size of the adrenal tumor affects preoperative and&#xD;
      postoperative outcomes in patients undergoing laparoscopic transperitoneal adrenalectomy as&#xD;
      well as to evaluate the learning curve.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From April 2010 to October 2018, preoperative and postoperative data of 107 patients who&#xD;
      underwent LTA with adrenal mass were recorded prospectively and analyzed retrospectively.&#xD;
&#xD;
      The inclusion criteria were all hormonally active adrenal lesions, detection of increases in&#xD;
      size in &lt; 4 cm adrenal tumors on serial imaging, solitary adrenal metastases without evidence&#xD;
      of local invasion, tumors size ≥ 4 cm, patients between the age of 18 and 80, and American&#xD;
      Society of Anesthesiologists score (ASA) ≤ 3. The patients with adrenal masses that specified&#xD;
      suspicion of malignancy on imaging such as local invasion, irregular tumor margins were&#xD;
      evaluated as ineligible for LTA, and excluded in this study, were addressed to open surgery.&#xD;
      Retroperitoneoscopic and laparoscopic partial adrenalectomies were also excluded from the&#xD;
      study.&#xD;
&#xD;
      Totally 102 patients were included in the study. The patients were allocated according to&#xD;
      adrenal tumor size as &lt;6cm (group 1:76) and ≥ 6 cm (group 2: 26). The variables such as&#xD;
      demographics, tumor size, and laterality, operation time, blood loss, per-operative and&#xD;
      postoperative complications, length of hospital stay, final pathology result were compared&#xD;
      between the two groups. In order to evaluate the learning curve, the patients were also&#xD;
      classified into three consecutive groups including group A (1-25), group B (25-50), group C&#xD;
      (51-75) and group D (76-102) according to the chronological order of their surgery. Variables&#xD;
      including operation time, tumor size, blood loss, and hospital stay, and overall&#xD;
      complications were used to investigate the learning curve.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">July 5, 2019</completion_date>
  <primary_completion_date type="Actual">May 20, 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>Operation time</measure>
    <time_frame>intraoperative (minute)</time_frame>
    <description>time from onset to complete of operation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood loss</measure>
    <time_frame>intraoperative</time_frame>
    <description>amount of bleeding during surgery (milliliter)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hospitalization</measure>
    <time_frame>1 day</time_frame>
    <description>duration of postoperative hospital stay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complication</measure>
    <time_frame>1 day</time_frame>
    <description>abnormal conditions during or after surgery</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">102</enrollment>
  <condition>Adrenal Tumor</condition>
  <condition>Adrenal Adenoma</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>laparoscopic adrenalectomy group 1: tumor size as &lt; 6 (group1)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Laparoscopic adrenalectomy group2: tumor size ≥ 6 cm (group2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Learning Curve</arm_group_label>
    <description>The patients, underwent laparoscopic adrenalectomy, were also classified into group A (1-25), B (26-50), C (51-75), and D (76-102) according to the chronological order of their surgery in order to evaluate the learning curve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Adrenalectomy</intervention_name>
    <description>minimally invasive lateral transperitoneal adrenalectomy</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Learning Curve</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        From April 2010 to October 2018, preoperative and postoperative data of 107 patients who&#xD;
        underwent laparoscopic adrenalectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. all hormonally active adrenal lesions,&#xD;
&#xD;
          2. detection of increases in size in &lt; 4 cm adrenal tumors on serial imaging,&#xD;
&#xD;
          3. solitary adrenal metastases without evidence of local invasion,&#xD;
&#xD;
          4. tumors size ≥ 4 cm,&#xD;
&#xD;
          5. patients between the age of 18 and 80&#xD;
&#xD;
          6. American Society of Anesthesiologists score (ASA) ≤ 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. suspicion of malignancy on imaging such as local invasion, irregular tumor margins&#xD;
&#xD;
          2. Retroperitoneoscopic adrenalectomies&#xD;
&#xD;
          3. laparoscopic partial adrenalectomies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Şaban Sarıkaya, Prof. MD</last_name>
    <role>Study Chair</role>
    <affiliation>Ondokuz Mayıs University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsun Liv Hospital</name>
      <address>
        <city>Samsun</city>
        <zip>55020</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ondokuz Mayıs University</name>
      <address>
        <city>Samsun</city>
        <zip>55030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Huynh KT, Lee DY, Lau BJ, Flaherty DC, Lee J, Goldfarb M. Impact of Laparoscopic Adrenalectomy on Overall Survival in Patients with Nonmetastatic Adrenocortical Carcinoma. J Am Coll Surg. 2016 Sep;223(3):485-92. doi: 10.1016/j.jamcollsurg.2016.05.015. Epub 2016 May 26.</citation>
    <PMID>27238874</PMID>
  </reference>
  <results_reference>
    <citation>Conzo G, Gambardella C, Candela G, Sanguinetti A, Polistena A, Clarizia G, Patrone R, Di Capua F, Offi C, Musella M, Iorio S, Bellastella G, Pasquali D, De Bellis A, Sinisi A, Avenia N. Single center experience with laparoscopic adrenalectomy on a large clinical series. BMC Surg. 2018 Jan 11;18(1):2. doi: 10.1186/s12893-017-0333-8.</citation>
    <PMID>29325527</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>October 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsun Liv Hospital</investigator_affiliation>
    <investigator_full_name>Mehmet Necmettin Mercimek</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>endocrine surgery; laparoscopic adrenalectomy;</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Adrenal Gland Neoplasms</mesh_term>
    <mesh_term>Adrenocortical Adenoma</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/NCT03830593
org study id: OMU KAEK (2019/78)
nct id: NCT03830593
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Laparoscopic adrenalectomy is the treatment of choice for the benign tumor of less than 6 cm.
      However, this is an ongoing debate that exact cut-off value of tumor size for LA. The aim of
      this study was to assess whether the size of the adrenal tumor affects preoperative and
      postoperative outcomes in patients undergoing laparoscopic transperitoneal adrenalectomy as
      well as to evaluate the learning curve.
From April 2010 to October 2018, preoperative and postoperative data of 107 patients who
      underwent LTA with adrenal mass were recorded prospectively and analyzed retrospectively.

      The inclusion criteria were all hormonally active adrenal lesions, detection of increases in
      size in < 4 cm adrenal tumors on serial imaging, solitary adrenal metastases without evidence
      of local invasion, tumors size ≥ 4 cm, patients between the age of 18 and 80, and American
      Society of Anesthesiologists score (ASA) ≤ 3. The patients with adrenal masses that specified
      suspicion of malignancy on imaging such as local invasion, irregular tumor margins were
      evaluated as ineligible for LTA, and excluded in this study, were addressed to open surgery.
      Retroperitoneoscopic and laparoscopic partial adrenalectomies were also excluded from the
      study.

      Totally 102 patients were included in the study. The patients were allocated according to
      adrenal tumor size as <6cm (group 1:76) and ≥ 6 cm (group 2: 26). The variables such as
      demographics, tumor size, and laterality, operation time, blood loss, per-operative and
      postoperative complications, length of hospital stay, final pathology result were compared
      between the two groups. In order to evaluate the learning curve, the patients were also
      classified into three consecutive groups including group A (1-25), group B (25-50), group C
      (51-75) and group D (76-102) according to the chronological order of their surgery. Variables
      including operation time, tumor size, blood loss, and hospital stay, and overall
      complications were used to investigate the learning curve.
observational model: Cohort
time perspective: Retrospective
measure: Operation time
time frame: intraoperative (minute)
description: time from onset to complete of operation
measure: Blood loss
time frame: intraoperative
description: amount of bleeding during surgery (milliliter)
measure: hospitalization
time frame: 1 day
description: duration of postoperative hospital stay
measure: Complication
time frame: 1 day
description: abnormal conditions during or after surgery
arm group label: Group 1
description: laparoscopic adrenalectomy group 1: tumor size as < 6 (group1)
arm group label: Group 2
description: Laparoscopic adrenalectomy group2: tumor size ≥ 6 cm (group2)
arm group label: Learning Curve
description: The patients, underwent laparoscopic adrenalectomy, were also classified into group A (1-25), B (26-50), C (51-75), and D (76-102) according to the chronological order of their surgery in order to evaluate the learning curve.
intervention type: Procedure
intervention name: Laparoscopic Adrenalectomy
description: minimally invasive lateral transperitoneal adrenalectomy
arm group label: Group 1
arm group label: Group 2
arm group label: Learning Curve
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Şaban Sarıkaya, Prof. MD
role: Study Chair
affiliation: Ondokuz Mayıs University
facility: 
facility: 
country: Turkey
citation: Huynh KT, Lee DY, Lau BJ, Flaherty DC, Lee J, Goldfarb M. Impact of Laparoscopic Adrenalectomy on Overall Survival in Patients with Nonmetastatic Adrenocortical Carcinoma. J Am Coll Surg. 2016 Sep;223(3):485-92. doi: 10.1016/j.jamcollsurg.2016.05.015. Epub 2016 May 26.
PMID: 27238874
citation: Conzo G, Gambardella C, Candela G, Sanguinetti A, Polistena A, Clarizia G, Patrone R, Di Capua F, Offi C, Musella M, Iorio S, Bellastella G, Pasquali D, De Bellis A, Sinisi A, Avenia N. Single center experience with laparoscopic adrenalectomy on a large clinical series. BMC Surg. 2018 Jan 11;18(1):2. doi: 10.1186/s12893-017-0333-8.
PMID: 29325527
responsible party type: Principal Investigator
investigator affiliation: Samsun Liv Hospital
investigator full name: Mehmet Necmettin Mercimek
investigator title: MD
mesh term: Adenoma
mesh term: Adrenal Gland Neoplasms
mesh term: Adrenocortical Adenoma
sharing ipd: No