<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/NCT03792802</url>
  </required_header>
  <id_info>
    <org_study_id>ANIL ERGIN..</org_study_id>
    <nct_id>NCT03792802</nct_id>
  </id_info>
  <brief_title>EFFECT OF USING SAME DERMATOME LİNE FOR ALL PORT SİTES IN LAPAROSCOPIC APPENDECTOMY IN ACUTE APANDICITIS</brief_title>
  <acronym>DERMATOME</acronym>
  <official_title>EFFECT OF USING SAME DERMATOME LİNE FOR ALL PORT SİTES IN LAPAROSCOPIC APPENDECTOMY IN ACUTE APANDICITIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fatih Sultan Mehmet Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fatih Sultan Mehmet Training and Research 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>
      Acute apandicitis is the one of most common cause of abdominal pain.Most of center still use&#xD;
      open appendectomy(OA) technic for acute apandisitis.But Semm was defined Laparoskopic&#xD;
      appendectomy(LA) with 3 ports in 1983.Today surgeons skill and experience ara increasing&#xD;
      about LA day by day. Because of advantages of LA , this technical tend to be gold standart in&#xD;
      acute apandisitis. In LA , all of centers use same technic as 3 ports for the surgery. Port&#xD;
      sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent in this&#xD;
      surgery. But 3 dermatome lines have been effected in this style of location .This 3 points&#xD;
      causes more pain postoperatively.In our study we will define the port locations into the same&#xD;
      dermatome line (T10) . Purpose of this research is incerasing the postoperative pain score&#xD;
      ,decreasing postoperative need of analgesia and develop the patient satisfy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most of surgeon use 3 port sites for the Laparoscopic appendectomy in acute apandisitis. One&#xD;
      of them places to infraumbilical region.,The other ports place to 1 right lower quadrant and&#xD;
      1 left lower quadrent routinly. In this study we will define T10 dermatome lregion in 40&#xD;
      patients who are planing to Laparoscopic appendectomy because of acute apandisitis older than&#xD;
      18 years old , before the surgery . All of LA port sites will put in this region .One of the&#xD;
      port will put in infraumbilical site and the other ones will put 10 cm right and left side&#xD;
      from infraumbilical port. In control group classic LA port sites will be used in the surgery&#xD;
      for 40 patients.These two groups will compare after the surgery by Visual Analog Scala (VAS)&#xD;
      Postoperative pain quantity will save by using VAS. Measurements will save in 1 hour,2 hour ,&#xD;
      6 hour ,12 hour and 24 hour. All patients will take the same pain relief medication&#xD;
      peroperatively and postoperatively. If the pain score would be more than 3 in VAS , all&#xD;
      patient will take additional analgesic doses.Patients and VAS researcher will not know the&#xD;
      patients group .Study will do as double blind.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Model 1: Single dermatome laparoscopic appendectomy Model 2: Standard laparoscopic appendectomy</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Care provider, participant and investigator did not know which type of surgery has applicated.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>compare of same dermatome trochar sites and different dermatomes trokar sites methods for postoperative pain relief by VAS (Visual Analog Scala)</measure>
    <time_frame>24 hours</time_frame>
    <description>pain scores of the participants will be followed at postoperative 1,2,4,6,12,24 hour (up to 24 hours).&#xD;
(VAS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Appendicitis</condition>
  <arm_group>
    <arm_group_label>classic port sites</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>. Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>same dermatome port sites</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One of the port will put in infraumbilical site and the other ones will put 10 cm right and left side from infraumbilical port.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic appendectomy port sites</intervention_name>
    <description>one group will have classic port sites ;.Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent . one group will have same dermatome port sites ; One of the port will put in infraumbilical site and the other ones will put 10 cm right and left side from infraumbilical port</description>
    <arm_group_label>classic port sites</arm_group_label>
    <arm_group_label>same dermatome port sites</arm_group_label>
    <other_name>port sites in the same dermatome T10</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients who will undergo to Laparoscopic Appendectomy for Acute Apandisitis older&#xD;
             than 18 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Perforated apandisitis&#xD;
&#xD;
          -  Plastrone apndisitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fatih Sultan Mehmet Research and Training Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34734</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fatih Sultan Mehmet Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>ANIL ERGIN</investigator_full_name>
    <investigator_title>asistant doctor</investigator_title>
  </responsible_party>
  <keyword>dermatome</keyword>
  <keyword>laparoscopic appendectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</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/NCT03792802
org study id: ANIL ERGIN..
nct id: NCT03792802
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute apandicitis is the one of most common cause of abdominal pain.Most of center still use
      open appendectomy(OA) technic for acute apandisitis.But Semm was defined Laparoskopic
      appendectomy(LA) with 3 ports in 1983.Today surgeons skill and experience ara increasing
      about LA day by day. Because of advantages of LA , this technical tend to be gold standart in
      acute apandisitis. In LA , all of centers use same technic as 3 ports for the surgery. Port
      sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent in this
      surgery. But 3 dermatome lines have been effected in this style of location .This 3 points
      causes more pain postoperatively.In our study we will define the port locations into the same
      dermatome line (T10) . Purpose of this research is incerasing the postoperative pain score
      ,decreasing postoperative need of analgesia and develop the patient satisfy.
Most of surgeon use 3 port sites for the Laparoscopic appendectomy in acute apandisitis. One
      of them places to infraumbilical region.,The other ports place to 1 right lower quadrant and
      1 left lower quadrent routinly. In this study we will define T10 dermatome lregion in 40
      patients who are planing to Laparoscopic appendectomy because of acute apandisitis older than
      18 years old , before the surgery . All of LA port sites will put in this region .One of the
      port will put in infraumbilical site and the other ones will put 10 cm right and left side
      from infraumbilical port. In control group classic LA port sites will be used in the surgery
      for 40 patients.These two groups will compare after the surgery by Visual Analog Scala (VAS)
      Postoperative pain quantity will save by using VAS. Measurements will save in 1 hour,2 hour ,
      6 hour ,12 hour and 24 hour. All patients will take the same pain relief medication
      peroperatively and postoperatively. If the pain score would be more than 3 in VAS , all
      patient will take additional analgesic doses.Patients and VAS researcher will not know the
      patients group .Study will do as double blind.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Model 1: Single dermatome laparoscopic appendectomy Model 2: Standard laparoscopic appendectomy
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Care provider, participant and investigator did not know which type of surgery has applicated.
measure: compare of same dermatome trochar sites and different dermatomes trokar sites methods for postoperative pain relief by VAS (Visual Analog Scala)
time frame: 24 hours
description: pain scores of the participants will be followed at postoperative 1,2,4,6,12,24 hour (up to 24 hours).
(VAS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
arm group label: classic port sites
arm group type: Active Comparator
description: . Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent
arm group label: same dermatome port sites
arm group type: Active Comparator
description: One of the port will put in infraumbilical site and the other ones will put 10 cm right and left side from infraumbilical port.
intervention type: Procedure
intervention name: laparoscopic appendectomy port sites
description: one group will have classic port sites ;.Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent . one group will have same dermatome port sites ; One of the port will put in infraumbilical site and the other ones will put 10 cm right and left side from infraumbilical port
arm group label: classic port sites
arm group label: same dermatome port sites
other name: port sites in the same dermatome T10
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Fatih Sultan Mehmet Training and Research Hospital
investigator full name: ANIL ERGIN
investigator title: asistant doctor
mesh term: Appendicitis
sharing ipd: No