<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/NCT04485247</url>
  </required_header>
  <id_info>
    <org_study_id>Myongji Surgery</org_study_id>
    <nct_id>NCT04485247</nct_id>
  </id_info>
  <brief_title>Transumbilical Laparoscopy-assisted Appendectomy</brief_title>
  <official_title>Is Transumbilical Laparoscopy-assisted Appendectomy in the Pediatric Acute Uncomplicated Appendicitis Superior to Conventional 3 Port Laparoscopic Appendectomy?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Myongji Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Myongji 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>
      transumbilical laparoscopic-assisted appendectomy (TULAA) was reported that the operation&#xD;
      time was shorter and the postoperative frequency of complications was not high compared to&#xD;
      conventional laparoscopic appendectomy (CLA) with three conventional ports in retrospective&#xD;
      studies. The purpose of this study is to evaluate the outcomes of transumbilical&#xD;
      laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single port appendectomy can be considered as the better option than conventional&#xD;
      laparoscopic appendectomy (CLA) for pediatric patients with uncomplicated acute appendicitis&#xD;
      in cosmetic aspect. However, this technique has not gained popularity because it has been&#xD;
      regarded as a tricky and time-consuming procedure. Recently, the frequency of implementation&#xD;
      of transumbilical laparoscopy-assisted appendectomy (TULAA) is increasing in pediatric&#xD;
      patients with uncomplicated appendicitis. The reason that this operation is possible in&#xD;
      children, is that the length between umbilicus and appendix is shorter than that of an adult,&#xD;
      and the abdominal wall is flexible, so that the appendix can be extracted through umbilical&#xD;
      incision. It was reported that the operation time was shorter and the postoperative frequency&#xD;
      of complications was not high compared to the laparoscopic appendectomy with three&#xD;
      conventional ports. The purpose of this study is to evaluate the outcomes of transumbilical&#xD;
      laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 3, 2020</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>1 day</time_frame>
    <description>Time from skin incision to skin closure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complication rate</measure>
    <time_frame>1 month</time_frame>
    <description>Rate of 30 day complication or in-hospital complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative hospital stay</measure>
    <time_frame>1 month</time_frame>
    <description>postoperative hospital stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">78</enrollment>
  <condition>Appendicitis Acute</condition>
  <arm_group>
    <arm_group_label>Conventional group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional laparoscopic appendectomy with 3-ports</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TULAA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An operator extracts and ligates appendix through umbilical port.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Transumbilical Laparoscopic-Assisted Appendectomy</intervention_name>
    <description>appendectomy performed extracorporeally through umbilical port</description>
    <arm_group_label>TULAA group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>3-port laparoscopic appendectomy</intervention_name>
    <description>appendectomy performed intracorporeally with 3-port</description>
    <arm_group_label>Conventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with clinically diagnosed as acute appendicitis&#xD;
&#xD;
          -  Age 18 or under&#xD;
&#xD;
          -  Lab tests Hemoglobin ≥ 10g/dl White blood cell count ≥ 4,000/mm3 Platelet count ≥&#xD;
             100,000/mm3 Creatinine ≤ 1.5 mg/dl Aspartate aminotransferase ≤ 100 IU/L Alanine&#xD;
             aminotransferase ≤ 100 IU/L&#xD;
&#xD;
          -  no significant dysfunction in the heart, lungs, kidneys.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous abdominal operation&#xD;
&#xD;
          -  Generalized peritonitis&#xD;
&#xD;
          -  Anticipated extended resection&#xD;
&#xD;
          -  Periappendiceal abscess on preoperative exam&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyung-Goo Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Myongji Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kyung-Goo Lee, MD</last_name>
    <phone>+82-31-810-5445</phone>
    <email>hashimot@naver.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Myongji Hospital, Hanyang university college of medicine</name>
      <address>
        <city>Goyang</city>
        <state>Gyeonggi-do</state>
        <zip>412-826</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kyung-Goo Lee, MD</last_name>
      <phone>+82-31-810-5445</phone>
      <email>hashimot@naver.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Sekioka A, Takahashi T, Yamoto M, Miyake H, Fukumoto K, Nakaya K, Nomura A, Yamada Y, Urushihara N. Outcomes of Transumbilical Laparoscopic-Assisted Appendectomy and Conventional Laparoscopic Appendectomy for Acute Pediatric Appendicitis in a Single Institution. J Laparoendosc Adv Surg Tech A. 2018 Dec;28(12):1548-1552. doi: 10.1089/lap.2018.0306. Epub 2018 Aug 8.</citation>
    <PMID>30088968</PMID>
  </reference>
  <results_reference>
    <citation>Dubbers M, Nikolaou E, Fuchs H, Fischer J, Alakus H, Leers J, Bruns C, Cernaianu G. Update on Transumbilical Single-Incision Laparoscopic Assisted Appendectomy (TULAA) - Which Children Benefit and What are the Complications? Klin Padiatr. 2018 Jul;230(4):194-199. doi: 10.1055/s-0044-101622. Epub 2018 Mar 15.</citation>
    <PMID>29544230</PMID>
  </results_reference>
  <results_reference>
    <citation>Shekherdimian S, DeUgarte D. Transumbilical laparoscopic-assisted appendectomy: an extracorporeal single-incision alternative to conventional laparoscopic techniques. Am Surg. 2011 May;77(5):557-60. doi: 10.1177/000313481107700513.</citation>
    <PMID>21679587</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Myongji Hospital</investigator_affiliation>
    <investigator_full_name>Kyung-Goo Lee</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all individual participant data that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>starting 6 months after publication</ipd_time_frame>
    <ipd_access_criteria>all individual participant data that underlie results in a publication</ipd_access_criteria>
  </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/NCT04485247
org study id: Myongji Surgery
nct id: NCT04485247
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
transumbilical laparoscopic-assisted appendectomy (TULAA) was reported that the operation
      time was shorter and the postoperative frequency of complications was not high compared to
      conventional laparoscopic appendectomy (CLA) with three conventional ports in retrospective
      studies. The purpose of this study is to evaluate the outcomes of transumbilical
      laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.
Single port appendectomy can be considered as the better option than conventional
      laparoscopic appendectomy (CLA) for pediatric patients with uncomplicated acute appendicitis
      in cosmetic aspect. However, this technique has not gained popularity because it has been
      regarded as a tricky and time-consuming procedure. Recently, the frequency of implementation
      of transumbilical laparoscopy-assisted appendectomy (TULAA) is increasing in pediatric
      patients with uncomplicated appendicitis. The reason that this operation is possible in
      children, is that the length between umbilicus and appendix is shorter than that of an adult,
      and the abdominal wall is flexible, so that the appendix can be extracted through umbilical
      incision. It was reported that the operation time was shorter and the postoperative frequency
      of complications was not high compared to the laparoscopic appendectomy with three
      conventional ports. The purpose of this study is to evaluate the outcomes of transumbilical
      laparoscopic-assisted appendectomy (TULAA) and to compare them to the outcomes of CLA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Operation time
time frame: 1 day
description: Time from skin incision to skin closure
measure: Postoperative complication rate
time frame: 1 month
description: Rate of 30 day complication or in-hospital complication
measure: postoperative hospital stay
time frame: 1 month
description: postoperative hospital stay
arm group label: Conventional group
arm group type: Active Comparator
description: conventional laparoscopic appendectomy with 3-ports
arm group label: TULAA group
arm group type: Experimental
description: An operator extracts and ligates appendix through umbilical port.
intervention type: Procedure
intervention name: Transumbilical Laparoscopic-Assisted Appendectomy
description: appendectomy performed extracorporeally through umbilical port
arm group label: TULAA group
intervention type: Procedure
intervention name: 3-port laparoscopic appendectomy
description: appendectomy performed intracorporeally with 3-port
arm group label: Conventional group
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Kyung-Goo Lee, MD
role: Principal Investigator
affiliation: Myongji Hospital
last name: Kyung-Goo Lee, MD
phone: +82-31-810-5445
email: hashimot@naver.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
citation: Sekioka A, Takahashi T, Yamoto M, Miyake H, Fukumoto K, Nakaya K, Nomura A, Yamada Y, Urushihara N. Outcomes of Transumbilical Laparoscopic-Assisted Appendectomy and Conventional Laparoscopic Appendectomy for Acute Pediatric Appendicitis in a Single Institution. J Laparoendosc Adv Surg Tech A. 2018 Dec;28(12):1548-1552. doi: 10.1089/lap.2018.0306. Epub 2018 Aug 8.
PMID: 30088968
citation: Dubbers M, Nikolaou E, Fuchs H, Fischer J, Alakus H, Leers J, Bruns C, Cernaianu G. Update on Transumbilical Single-Incision Laparoscopic Assisted Appendectomy (TULAA) - Which Children Benefit and What are the Complications? Klin Padiatr. 2018 Jul;230(4):194-199. doi: 10.1055/s-0044-101622. Epub 2018 Mar 15.
PMID: 29544230
citation: Shekherdimian S, DeUgarte D. Transumbilical laparoscopic-assisted appendectomy: an extracorporeal single-incision alternative to conventional laparoscopic techniques. Am Surg. 2011 May;77(5):557-60. doi: 10.1177/000313481107700513.
PMID: 21679587
responsible party type: Principal Investigator
investigator affiliation: Myongji Hospital
investigator full name: Kyung-Goo Lee
investigator title: Assistant professor
mesh term: Appendicitis
sharing ipd: Yes
ipd description: all individual participant data that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: starting 6 months after publication
ipd access criteria: all individual participant data that underlie results in a publication