<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/NCT02972944</url>
  </required_header>
  <id_info>
    <org_study_id>326/2016</org_study_id>
    <nct_id>NCT02972944</nct_id>
  </id_info>
  <brief_title>Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients</brief_title>
  <official_title>Acute Cholecystitis in the Elderly: Comparative Randomized and Cohort Study of Laparoscopic Cholecystectomy vs. Conservative Treatment With Antibiotics Alone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kuopio University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tampere University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oulu University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mikkeli Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North Karelia Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jyväskylä Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Päijänne Tavastia Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central Hospital of Hämeenlinna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central Hospital of Jorvi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kuopio University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cholecystectomy is the only curative treatment for gallstone disease of acute calculous&#xD;
      cholecystitis.The purpose of this study is to find the most effective treatment (laparoscopic&#xD;
      cholecystectomy vs. conservative) for elderly patients with acute cholecystitis. Therefore a&#xD;
      randomized multi-centre study of 200 elderly patients suffering from acute cholecystitis is&#xD;
      performed with additional cohort of all elderly patients with acute cholecystitis in the&#xD;
      study hospitals during study period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The increasing age is one of the main risk factors for developing complicated gallstone&#xD;
      disease. Currently, there is lack of good quality studies comparing risks and benefits of&#xD;
      early laparoscopic cholecystectomy in the elderly patients. Cholecystectomy is the only&#xD;
      curative treatment for gallstone disease of acute calculous cholecystitis.&#xD;
&#xD;
      Aim: The purpose is to find out the most effective treatment (laparoscopic cholecystectomy&#xD;
      vs. conservative) with the least morbidity for elderly patients with acute cholecystitis.&#xD;
&#xD;
      Study design: multicenter randomized controlled trial (RCT) and additional cohort of all&#xD;
      elderly patients (&gt;75 years old) with acute cholecystitis.&#xD;
&#xD;
      Patient allocation: Elderly patients with diagnosis of acute cholecystitis will be randomly&#xD;
      allocated to either early laparoscopic cholecystectomy or treatment with antibiotics.&#xD;
      Reasonably healthy elderly patients (ASA 2-3) are included in this study, excluding the&#xD;
      patients with ASA-class above 4.&#xD;
&#xD;
      Interventions: The study group of patients will undergo early laparoscopic cholecystectomy&#xD;
      within 48 hours after hospitalization. The control group will be managed conservatively with&#xD;
      intravenous antibiotics and elective cholecystectomy will not be scheduled later.&#xD;
&#xD;
      Primary outcome: Assessment of morbidities related to acute cholecystitis and individual&#xD;
      quality of life. Secondary outcomes include number of hospital admissions, length of&#xD;
      hospitalization, pain, complications, mortality and cost analysis.&#xD;
&#xD;
      Sample size and data-analysis: Based on data of previous studies the recruitment of 200&#xD;
      patients in total is expected. Follow-up will be for 12 months.&#xD;
&#xD;
      In addition of RCT, we decided to record and analyze all acute cholecystitis of elderly&#xD;
      patients in study hospitals during the study period. We will present these results in the&#xD;
      connection of RCT analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">December 2021</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>Specific Morbidity Index Scores</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>The primary outcome is morbidity, all complications will be scored (according to &quot;morbidity-index&quot; -chart) (ref: Gutt et al: Ann Surg 2013;258:385-393)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life RAND-36 scores</measure>
    <time_frame>pre-operatively and 1 year postoperatively</time_frame>
    <description>Quality of life according to RAND-36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores (0-100)</measure>
    <time_frame>pre-operatively, 1 week, 1 month and 1 year postoperatively</time_frame>
    <description>Pain (VAS, range 0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with failure of antibiotic therapy</measure>
    <time_frame>1 week, 1 month and 1 year postoperatively</time_frame>
    <description>Recurrent cholecystitis after antibiotic therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of hospitalization (days)</measure>
    <time_frame>1 month</time_frame>
    <description>Length of time at hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality (number of patients)</measure>
    <time_frame>1 month</time_frame>
    <description>Death within 30 d</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with complications</measure>
    <time_frame>1 week, 1 month and 1 year postoperatively</time_frame>
    <description>Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost analysis in euros</measure>
    <time_frame>1 week, 1 month and 1 year postoperatively</time_frame>
    <description>cost analysis comparison between groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cholecystitis, Acute</condition>
  <arm_group>
    <arm_group_label>Cholecystectomy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-operative group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic cholecystectomy</intervention_name>
    <arm_group_label>Cholecystectomy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-operative treatment</intervention_name>
    <arm_group_label>Non-operative group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Radiologically confirmed acute cholecystitis&#xD;
&#xD;
          -  Age over 75 yrs&#xD;
&#xD;
          -  American Association of Anesthesiologists Classification class 2-3&#xD;
&#xD;
          -  Duration of symptoms &lt; 5 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Association of Anesthesiologists Classification class 4-5&#xD;
&#xD;
          -  Age under 75 yrs&#xD;
&#xD;
          -  Peritonitis&#xD;
&#xD;
          -  Sepsis or septic shock&#xD;
&#xD;
          -  Duration of symptoms over 6 days&#xD;
&#xD;
          -  Cholestasis or diagnosed stone at common biliary duct.&#xD;
&#xD;
          -  Acute Pancreatitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hannu Paajanen, Professor</last_name>
    <phone>17 173 311</phone>
    <phone_ext>+358</phone_ext>
    <email>Hannu.Paajanen@kuh.fi</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Antti Kivivuori, MD</last_name>
    <phone>443516698</phone>
    <phone_ext>+358</phone_ext>
    <email>Antti.Kivivuori@esshp.fi</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kuopio University Hospital</name>
      <address>
        <city>Kuopio</city>
        <state>Pohjois-Savo</state>
        <zip>70200</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tuomo Rantanen, Professor</last_name>
      <phone>17 173 311</phone>
      <phone_ext>+358</phone_ext>
      <email>Tuomo.Rantanen@kuh.fi</email>
    </contact>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>October 13, 2021</last_update_submitted>
  <last_update_submitted_qc>October 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kuopio University Hospital</investigator_affiliation>
    <investigator_full_name>Hannu Paajanen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Acalculous Cholecystitis</mesh_term>
    <mesh_term>Cholecystitis, Acute</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/NCT02972944
org study id: 326/2016
nct id: NCT02972944
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Cholecystectomy is the only curative treatment for gallstone disease of acute calculous
      cholecystitis.The purpose of this study is to find the most effective treatment (laparoscopic
      cholecystectomy vs. conservative) for elderly patients with acute cholecystitis. Therefore a
      randomized multi-centre study of 200 elderly patients suffering from acute cholecystitis is
      performed with additional cohort of all elderly patients with acute cholecystitis in the
      study hospitals during study period.
The increasing age is one of the main risk factors for developing complicated gallstone
      disease. Currently, there is lack of good quality studies comparing risks and benefits of
      early laparoscopic cholecystectomy in the elderly patients. Cholecystectomy is the only
      curative treatment for gallstone disease of acute calculous cholecystitis.

      Aim: The purpose is to find out the most effective treatment (laparoscopic cholecystectomy
      vs. conservative) with the least morbidity for elderly patients with acute cholecystitis.

      Study design: multicenter randomized controlled trial (RCT) and additional cohort of all
      elderly patients (>75 years old) with acute cholecystitis.

      Patient allocation: Elderly patients with diagnosis of acute cholecystitis will be randomly
      allocated to either early laparoscopic cholecystectomy or treatment with antibiotics.
      Reasonably healthy elderly patients (ASA 2-3) are included in this study, excluding the
      patients with ASA-class above 4.

      Interventions: The study group of patients will undergo early laparoscopic cholecystectomy
      within 48 hours after hospitalization. The control group will be managed conservatively with
      intravenous antibiotics and elective cholecystectomy will not be scheduled later.

      Primary outcome: Assessment of morbidities related to acute cholecystitis and individual
      quality of life. Secondary outcomes include number of hospital admissions, length of
      hospitalization, pain, complications, mortality and cost analysis.

      Sample size and data-analysis: Based on data of previous studies the recruitment of 200
      patients in total is expected. Follow-up will be for 12 months.

      In addition of RCT, we decided to record and analyze all acute cholecystitis of elderly
      patients in study hospitals during the study period. We will present these results in the
      connection of RCT analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Specific Morbidity Index Scores
time frame: 1 year postoperatively
description: The primary outcome is morbidity, all complications will be scored (according to "morbidity-index" -chart) (ref: Gutt et al: Ann Surg 2013;258:385-393)
measure: Quality of life RAND-36 scores
time frame: pre-operatively and 1 year postoperatively
description: Quality of life according to RAND-36
measure: Pain scores (0-100)
time frame: pre-operatively, 1 week, 1 month and 1 year postoperatively
description: Pain (VAS, range 0-100)
measure: Number of patients with failure of antibiotic therapy
time frame: 1 week, 1 month and 1 year postoperatively
description: Recurrent cholecystitis after antibiotic therapy
measure: Time of hospitalization (days)
time frame: 1 month
description: Length of time at hospital
measure: Mortality (number of patients)
time frame: 1 month
description: Death within 30 d
measure: Number of patients with complications
time frame: 1 week, 1 month and 1 year postoperatively
description: Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc.
measure: Cost analysis in euros
time frame: 1 week, 1 month and 1 year postoperatively
description: cost analysis comparison between groups
arm group label: Cholecystectomy group
arm group type: Experimental
description: Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.
arm group label: Non-operative group
arm group type: Active Comparator
description: Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged.
intervention type: Procedure
intervention name: Laparoscopic cholecystectomy
arm group label: Cholecystectomy group
intervention type: Procedure
intervention name: Non-operative treatment
arm group label: Non-operative group
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hannu Paajanen, Professor
phone: 17 173 311
phone ext: +358
email: Hannu.Paajanen@kuh.fi
last name: Antti Kivivuori, MD
phone: 443516698
phone ext: +358
email: Antti.Kivivuori@esshp.fi
facility: 
status: Recruiting
contact: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Kuopio University Hospital
investigator full name: Hannu Paajanen
investigator title: Professor
mesh term: Cholecystitis
mesh term: Acalculous Cholecystitis
mesh term: Cholecystitis, Acute
sharing ipd: No