<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/NCT03014817</url>
  </required_header>
  <id_info>
    <org_study_id>Ultrasonic scalpel trial</org_study_id>
    <nct_id>NCT03014817</nct_id>
  </id_info>
  <brief_title>Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis Trial</brief_title>
  <official_title>Ultrasonically Activated Scalpel Versus Electrocautery Based Dissection in Acute Cholecystitis. A Randomized, Double Blind, Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</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>
      The present study aims at analyzing whether ultrasonic tissue coagulation dissection&#xD;
      technique offers a smoother peri- and postoperative course and reduces the risk for&#xD;
      conversion from laparoscopic to open surgery in acute cholecystectomy patients as compared to&#xD;
      electrocautery in case of acute cholecystitis The study is performed as a double-blinded&#xD;
      study on patients undergoing laparoscopic surgery for acute cholecystitis. Patients included&#xD;
      in the study are randomized to surgery with either the traditional electrocautery based&#xD;
      technique or ultrasonic scalpel based dissection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Electrocautery is traditionally the method of choice for tissue dissection in laparoscopic&#xD;
      cholecystectomy. As an alternative to electrocautery, the ultrasonically activated scalpel&#xD;
      has proven to be an effective and safe instrument for the facilitation of dissection and to&#xD;
      minimize blood loss in both open and laparoscopic surgery. Whereas electrocautery coagulates&#xD;
      by burning at temperatures higher than 150ºC, the ultrasonic scalpel transforms the electric&#xD;
      power into mechanical longitudinal vibration of the working part of the instrument by a&#xD;
      piezoelectrical transducer. Accordingly, the former technique limits the heating- thermal&#xD;
      necrosis effect on the tissue to the area just adjacent to the cutting line.&#xD;
&#xD;
      Since the relative-potential benefit of the ultrasonic scalpel is high in technically&#xD;
      demanding surgery, the advantage may not be as pronounced in routine laparoscopic gallstone&#xD;
      surgery, which can usually be done more uneventfully whichever equipment is used.&#xD;
      Laparoscopic cholecystectomy for acute cholecystitis is, however, more demanding connected&#xD;
      with longer operative time, more postoperative complications, greater risk of conversion to&#xD;
      open cholecystectomy and longer postoperative stay. In addition, we know that operations for&#xD;
      acute cholecystitis are associated with a higher risk for severe complications such as bile&#xD;
      duct injury. The potential benefit from using the ultrasonic scalpel is thus even greater&#xD;
      when doing surgery for cholecystitis.&#xD;
&#xD;
      In addition to this there are numerous important aspects on the safety in the implementation&#xD;
      of the emergency cholecystectomy. Traditionally, most surgeons have chosen to operate these&#xD;
      patients with laparoscopic technique, with the use of a so-called electrocautery hook, which&#xD;
      usually allows tissue division with minimal blood loss. Further improvements in the&#xD;
      dissection technique followed the introduction of ultrasonic tissue coagulation. This&#xD;
      technique offers the option of performing these operations with even less blood loss, a more&#xD;
      gentle handling of the inflamed tissue and a sealing of the tissue sections while the tissue&#xD;
      is divided. Accordingly this ultrasonic tissue coagulation technique can theoretically be of&#xD;
      significant advantage not the least when dividing acutely inflamed tissue like in acute&#xD;
      cholecystitis with particular relevance for the dissection of the gallbladder from the liver&#xD;
      bed, where bleeding and bile leakage often occurs. Moreover if the surgeon instead chooses to&#xD;
      dissect the gallbladder from the doom and downwards, to the part that contains the cystic&#xD;
      duct and cystic artery (Calots triangle), unique options can be offered to not only simplify&#xD;
      the operation but also make it safer. This latter technique is called &quot;fundus first&quot;.&#xD;
&#xD;
      The present study aims at analyzing whether ultrasonic tissue coagulation dissection&#xD;
      technique combined with &quot;fundus first&quot; approach offers a smoother per and postoperative&#xD;
      course in acute cholecystectomy patients as compared to the traditional way of performing the&#xD;
      operation. Due to the lower risk of bleeding and better anatomical overview, the technique&#xD;
      may also reduce the risk of having to convert the procedure for laparoscopic cholecystectomy&#xD;
      to open cholecystectomy.&#xD;
&#xD;
      The study is performed as a double-blinded study on patients undergoing laparoscopic surgery&#xD;
      for acute cholecystitis. Patients included in the study are randomized to surgery with either&#xD;
      the traditional electrocautery based technique or ultrasonic scalpel based dissection with&#xD;
      the &quot;fundus first&quot; approach.&#xD;
&#xD;
      The choice of dissection approach is determined by the randomization procedure, whether it is&#xD;
      done from the triangle of Callot + electrocautery and upwards or from the gallbladder fundus&#xD;
      and downwards by the use of the ultrasonic scalpel. Peroperative cholangiography is done&#xD;
      routinely. The cystic duct is closed with a clip, not with the ultrasonic scalpel.&#xD;
&#xD;
      One month after surgery the patient is contacted by a telephone. In cases the questionnaires&#xD;
      have not been returned yet, the patient is reminded about this. At the phone call the exact&#xD;
      number of days of sick leave postoperatively and any adverse events occurring after discharge&#xD;
      are recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2023</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>30 days</time_frame>
    <description>Postoperative complications registered according to Clavien-Dindo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>3 hours</time_frame>
    <description>Time required to complete surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of technical complexity</measure>
    <time_frame>3 hours</time_frame>
    <description>Level of technical complexity of the procedure as assessed by the surgeon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical performance</measure>
    <time_frame>3 hours</time_frame>
    <description>Perioperative technical performance assessed by an independent observer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative stay</measure>
    <time_frame>14 days</time_frame>
    <description>Time from surgery to duscharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sick leave</measure>
    <time_frame>30 days</time_frame>
    <description>Time from surgery to return to work</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conversion rate</measure>
    <time_frame>3 hours</time_frame>
    <description>Conversion from laparoscopic to open cholecystyectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>7 days</time_frame>
    <description>Daily assessments of pain on a visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative inflammatory activity</measure>
    <time_frame>7 days</time_frame>
    <description>Daily measurements of c-reactive protein and leukocyte particle concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conversion rate</measure>
    <time_frame>3 hours</time_frame>
    <description>Number of procedures converted to open cholecystectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct and indirect medical costs</measure>
    <time_frame>30 days</time_frame>
    <description>Analysis of health economics</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Cholecystitis, Acute</condition>
  <arm_group>
    <arm_group_label>Ultrasonically activated scalpel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dissection with ultrasonically activated scalpel. Direction of dissection undecided but by experience most naturally fundus first.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electrocautery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dissection with electrocautery. Direction of dissection undecided but by experience most naturally cystic duct first.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasonically activated scalpel</intervention_name>
    <description>Dissection with ultrasonically activated scalpel</description>
    <arm_group_label>Ultrasonically activated scalpel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrocautery</intervention_name>
    <description>Dissection with electrocautery</description>
    <arm_group_label>Electrocautery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Emergency laparoscopic cholecystectomy performed for cholecystitis&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to express themselves in Swedish&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previous open surgery in the upper abdomen&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score &gt;III&#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>Gabriel Sandblom, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>My Blohm, MD</last_name>
    <phone>+46702900521</phone>
    <email>My.Blohm@ltdalarna.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gabriel Sandblom, Assoc Prof</last_name>
    <phone>+46 70 415 82 18</phone>
    <email>gabriel.sandblom@ki.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Karolinska University Hospital, Center for Digestive Diseases</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriel Sandblom, Ass Prof</last_name>
      <phone>+46704158218</phone>
      <email>gabriel.sandblom@ki.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Gabriel Sandblom</investigator_full_name>
    <investigator_title>Associate 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/NCT03014817
org study id: Ultrasonic scalpel trial
nct id: NCT03014817
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study aims at analyzing whether ultrasonic tissue coagulation dissection
      technique offers a smoother peri- and postoperative course and reduces the risk for
      conversion from laparoscopic to open surgery in acute cholecystectomy patients as compared to
      electrocautery in case of acute cholecystitis The study is performed as a double-blinded
      study on patients undergoing laparoscopic surgery for acute cholecystitis. Patients included
      in the study are randomized to surgery with either the traditional electrocautery based
      technique or ultrasonic scalpel based dissection.
Electrocautery is traditionally the method of choice for tissue dissection in laparoscopic
      cholecystectomy. As an alternative to electrocautery, the ultrasonically activated scalpel
      has proven to be an effective and safe instrument for the facilitation of dissection and to
      minimize blood loss in both open and laparoscopic surgery. Whereas electrocautery coagulates
      by burning at temperatures higher than 150ºC, the ultrasonic scalpel transforms the electric
      power into mechanical longitudinal vibration of the working part of the instrument by a
      piezoelectrical transducer. Accordingly, the former technique limits the heating- thermal
      necrosis effect on the tissue to the area just adjacent to the cutting line.

      Since the relative-potential benefit of the ultrasonic scalpel is high in technically
      demanding surgery, the advantage may not be as pronounced in routine laparoscopic gallstone
      surgery, which can usually be done more uneventfully whichever equipment is used.
      Laparoscopic cholecystectomy for acute cholecystitis is, however, more demanding connected
      with longer operative time, more postoperative complications, greater risk of conversion to
      open cholecystectomy and longer postoperative stay. In addition, we know that operations for
      acute cholecystitis are associated with a higher risk for severe complications such as bile
      duct injury. The potential benefit from using the ultrasonic scalpel is thus even greater
      when doing surgery for cholecystitis.

      In addition to this there are numerous important aspects on the safety in the implementation
      of the emergency cholecystectomy. Traditionally, most surgeons have chosen to operate these
      patients with laparoscopic technique, with the use of a so-called electrocautery hook, which
      usually allows tissue division with minimal blood loss. Further improvements in the
      dissection technique followed the introduction of ultrasonic tissue coagulation. This
      technique offers the option of performing these operations with even less blood loss, a more
      gentle handling of the inflamed tissue and a sealing of the tissue sections while the tissue
      is divided. Accordingly this ultrasonic tissue coagulation technique can theoretically be of
      significant advantage not the least when dividing acutely inflamed tissue like in acute
      cholecystitis with particular relevance for the dissection of the gallbladder from the liver
      bed, where bleeding and bile leakage often occurs. Moreover if the surgeon instead chooses to
      dissect the gallbladder from the doom and downwards, to the part that contains the cystic
      duct and cystic artery (Calots triangle), unique options can be offered to not only simplify
      the operation but also make it safer. This latter technique is called "fundus first".

      The present study aims at analyzing whether ultrasonic tissue coagulation dissection
      technique combined with "fundus first" approach offers a smoother per and postoperative
      course in acute cholecystectomy patients as compared to the traditional way of performing the
      operation. Due to the lower risk of bleeding and better anatomical overview, the technique
      may also reduce the risk of having to convert the procedure for laparoscopic cholecystectomy
      to open cholecystectomy.

      The study is performed as a double-blinded study on patients undergoing laparoscopic surgery
      for acute cholecystitis. Patients included in the study are randomized to surgery with either
      the traditional electrocautery based technique or ultrasonic scalpel based dissection with
      the "fundus first" approach.

      The choice of dissection approach is determined by the randomization procedure, whether it is
      done from the triangle of Callot + electrocautery and upwards or from the gallbladder fundus
      and downwards by the use of the ultrasonic scalpel. Peroperative cholangiography is done
      routinely. The cystic duct is closed with a clip, not with the ultrasonic scalpel.

      One month after surgery the patient is contacted by a telephone. In cases the questionnaires
      have not been returned yet, the patient is reminded about this. At the phone call the exact
      number of days of sick leave postoperatively and any adverse events occurring after discharge
      are recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Postoperative complications
time frame: 30 days
description: Postoperative complications registered according to Clavien-Dindo
measure: Operative time
time frame: 3 hours
description: Time required to complete surgery
measure: Level of technical complexity
time frame: 3 hours
description: Level of technical complexity of the procedure as assessed by the surgeon
measure: Technical performance
time frame: 3 hours
description: Perioperative technical performance assessed by an independent observer
measure: Postoperative stay
time frame: 14 days
description: Time from surgery to duscharge
measure: Sick leave
time frame: 30 days
description: Time from surgery to return to work
measure: Conversion rate
time frame: 3 hours
description: Conversion from laparoscopic to open cholecystyectomy
measure: Postoperative pain
time frame: 7 days
description: Daily assessments of pain on a visual analogue scale
measure: Postoperative inflammatory activity
time frame: 7 days
description: Daily measurements of c-reactive protein and leukocyte particle concentration
measure: Conversion rate
time frame: 3 hours
description: Number of procedures converted to open cholecystectomy
measure: Direct and indirect medical costs
time frame: 30 days
description: Analysis of health economics
arm group label: Ultrasonically activated scalpel
arm group type: Experimental
description: Dissection with ultrasonically activated scalpel. Direction of dissection undecided but by experience most naturally fundus first.
arm group label: Electrocautery
arm group type: Active Comparator
description: Dissection with electrocautery. Direction of dissection undecided but by experience most naturally cystic duct first.
intervention type: Procedure
intervention name: Ultrasonically activated scalpel
description: Dissection with ultrasonically activated scalpel
arm group label: Ultrasonically activated scalpel
intervention type: Procedure
intervention name: Electrocautery
description: Dissection with electrocautery
arm group label: Electrocautery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Gabriel Sandblom, Assoc Prof
role: Principal Investigator
affiliation: Karolinska Institutet
last name: My Blohm, MD
phone: +46702900521
email: My.Blohm@ltdalarna.se
last name: Gabriel Sandblom, Assoc Prof
phone: +46 70 415 82 18
email: gabriel.sandblom@ki.se
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Gabriel Sandblom
investigator title: Associate Professor
mesh term: Cholecystitis
mesh term: Acalculous Cholecystitis
mesh term: Cholecystitis, Acute
sharing ipd: No