<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/NCT01723540</url>
  </required_header>
  <id_info>
    <org_study_id>KUH5204520</org_study_id>
    <nct_id>NCT01723540</nct_id>
  </id_info>
  <brief_title>A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy</brief_title>
  <acronym>MC-UsD</acronym>
  <official_title>A Comparison of Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy Versus Laparoscopic Cholecystectomy; a Randomised Two-center Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kuopio University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kuopio University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and&#xD;
      therefore we investigate here the contributions of UsD in early recovery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</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>Early recovery</measure>
    <time_frame>One month</time_frame>
    <description>Post operative pain, wound infections, bile leak, mean length of sick leave days, use of analgesics the success of day-surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peroperative outcome</measure>
    <time_frame>24 hours</time_frame>
    <description>Operative time, time at the operation theatre, bleeding, length of skin incision</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Minilaparotomy cholecystectomy with ultrasonic scissors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Minilaparotomy vs laparoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic cholecystectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Minilaparotomy vs laparoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Minilaparotomy vs laparoscopy</intervention_name>
    <description>MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy</description>
    <arm_group_label>Laparoscopic cholecystectomy</arm_group_label>
    <arm_group_label>Minilaparotomy cholecystectomy with ultrasonic scissors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:- Uncomplicted symptomatic cholelithiasis cholecystitis confirmed by&#xD;
        ultrasoud&#xD;
&#xD;
          -  ASA physical status 1-3&#xD;
&#xD;
          -  Body mass index 18-30&#xD;
&#xD;
          -  AGE 18 - 75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or lactating&#xD;
&#xD;
          -  common bile-duct stones&#xD;
&#xD;
          -  acute cholecystitis&#xD;
&#xD;
          -  previous upper abdominal operation&#xD;
&#xD;
          -  Chirrosis&#xD;
&#xD;
          -  Renal disease&#xD;
&#xD;
          -  Pancreatitis&#xD;
&#xD;
          -  ASA 4-5&#xD;
&#xD;
          -  Participation of any other clinical trial within 30 days before the start of the&#xD;
             screening period&#xD;
&#xD;
          -  History of uncontrolled cardiovascular, epileptic disorder, psychosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kuopio University Hospital</name>
      <address>
        <city>Kuopio</city>
        <zip>70211</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>November 6, 2012</last_update_submitted>
  <last_update_submitted_qc>November 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 8, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cholecystectomy,minilaparotomy,laparascopy,ultrasonic dissection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT01723540
org study id: KUH5204520
nct id: NCT01723540
lead sponsor: 
has dmc: No
Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and
      therefore we investigate here the contributions of UsD in early recovery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Early recovery
time frame: One month
description: Post operative pain, wound infections, bile leak, mean length of sick leave days, use of analgesics the success of day-surgery
measure: Peroperative outcome
time frame: 24 hours
description: Operative time, time at the operation theatre, bleeding, length of skin incision
arm group label: Minilaparotomy cholecystectomy with ultrasonic scissors
arm group type: Experimental
description: Minilaparotomy vs laparoscopy
arm group label: Laparoscopic cholecystectomy
arm group type: Active Comparator
description: Minilaparotomy vs laparoscopy
intervention type: Procedure
intervention name: Minilaparotomy vs laparoscopy
description: MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy
arm group label: Laparoscopic cholecystectomy
arm group label: Minilaparotomy cholecystectomy with ultrasonic scissors
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Pain, Postoperative