<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/NCT03750032</url>
  </required_header>
  <id_info>
    <org_study_id>FNO-CHIR-CAS</org_study_id>
    <nct_id>NCT03750032</nct_id>
  </id_info>
  <brief_title>Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy</brief_title>
  <acronym>CAS</acronym>
  <official_title>Technical Modifications of Appendicular Stump Closure During Laparoscopic Appendectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Ostrava</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Ostrava</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>
      Laparoscopic appendectomy (L-APPE) presents a golden standard in the treatment of acute&#xD;
      appendicitis nowadays. However, there are ongoing controversies regarding the ideal technique&#xD;
      of appendicular stump closure during L-APPE in the published literature. Several technical&#xD;
      modifications of appendicular stump closure are available at the present - closure using&#xD;
      endoloop, endostapler or Hem-o-lock clips. The aim of the proposed project (CAS study) is to&#xD;
      compare medical and economic outcomes of patients undergoing L-APPE with different methods of&#xD;
      appendicular stump closure (endostapler, endoloop and Hem-o-lock clips).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Acute appendicitis presents one of the most common surgical illnesses which affect&#xD;
      approximately 7% of the western population. In the Czech Republic, 11664 patients were&#xD;
      hospitalized and operated for the diagnosis of acute appendicitis (K35-K38) during 2016. It&#xD;
      might seem that the procedure of appendectomy will be guided by a clear algorithm for its&#xD;
      frequency, but it is not so. Because of acute appendicitis, appendectomy may be performed via&#xD;
      laparotomy or laparoscopy (minimally invasive surgery). During laparoscopic appendectomy&#xD;
      (L-APPE), there are no clear recommendations regarding trocar placement, methods of dividing&#xD;
      appendicular mesenteriolum, methods of appendicular stump closure or appendicular stump&#xD;
      sinking.&#xD;
&#xD;
      The proposed clinical study is focused on the issue of the appendicular base interruption&#xD;
      during L-APPE. At the present, there are several technical modifications of appendicular&#xD;
      stump closure - by means of endoloop (the suture loop from absorbable fiber), endostapler or&#xD;
      using Hem-o-lock clips. The performed literature search revealed that evidence-based medicine&#xD;
      data regarding the optimal way of appendicular stump closure are insufficient. That is why&#xD;
      the investigators have decided to conduct a prospective randomized single-center clinical&#xD;
      study aimed to compare different technical modifications of appendicular stump closure during&#xD;
      L-APPE. Within a study period, all patients undergoing L-APPE at the University Hospital&#xD;
      Ostrava will be randomized to one of the technical modifications of appendicular stump&#xD;
      closure.&#xD;
&#xD;
      The aim of the project (CAS study) is to compare medical and economic outcomes of patients&#xD;
      undergoing L-APPE with different methods of appendicular stump closure (endostapler, endoloop&#xD;
      and Hem-o-lock clips). The operative time, intraoperative and postoperative complications&#xD;
      will be the primary outcome measures of the study, economic outcomes will be the secondary&#xD;
      outcome measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</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>
    <intervention_model_description>The patients will be randomized into three groups of various appendicular stump closure.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking will be used in the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Operative time</measure>
    <time_frame>12 months</time_frame>
    <description>Operative time will be measured in minutes and analysed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of intraoperative and postoperative complications</measure>
    <time_frame>12 months</time_frame>
    <description>The incidence of intraoperative and postoperative complications will be analysed in all groups of study subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Costs of surgery</measure>
    <time_frame>12 months</time_frame>
    <description>Costs of surgery will be analysed for all groups of study subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs of hospitalization</measure>
    <time_frame>12 months</time_frame>
    <description>The overall costs of hospitalisation will be analysed for all groups of study subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs of treatment of complications</measure>
    <time_frame>12 months</time_frame>
    <description>Costs of treatment of complications will be analysed for all groups of study subjects.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Acute Appendicitis</condition>
  <arm_group>
    <arm_group_label>Stapler appendectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using a stapler.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endoloop</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using endoloop.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hem-O-Lock</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using Hem-O-Lock.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stapler appendectomy</intervention_name>
    <description>The patients randomised for this intervention will undergo stapler appendectomy.</description>
    <arm_group_label>Stapler appendectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoloop</intervention_name>
    <description>The patients randomised for this intervention will undergo appendicular stump closure using Endoloop.</description>
    <arm_group_label>Endoloop</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hem-O-Lock</intervention_name>
    <description>The patients randomised for this intervention will undergo appendicular stump closure using Hem-O-Lock.</description>
    <arm_group_label>Hem-O-Lock</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥18 years&#xD;
&#xD;
          -  acute appendicitis&#xD;
&#xD;
          -  laparoscopic approach&#xD;
&#xD;
          -  signed informed content&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - necrosis or advanced inflammatory changes in the area of appendicular stump&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Ihnát, Ass.Prof.,MD,PhD,MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Ostrava</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Ostrava</name>
      <address>
        <city>Ostrava</city>
        <state>Moravian-Silesian Region</state>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <reference>
    <citation>Mayir B, Bilecik T, Ensari CO, Oruc MT. Laparoscopic appendectomy with hand-made loop. Wideochir Inne Tech Maloinwazyjne. 2014 Jun;9(2):152-6. doi: 10.5114/wiitm.2014.41624. Epub 2014 Mar 24.</citation>
    <PMID>25097680</PMID>
  </reference>
  <reference>
    <citation>Matyja M, Strzalka M, Rembiasz K. Laparosocopic Appendectomy, Cost-Effectiveness of Three Different Techniques Used to Close the Appendix Stump. Pol Przegl Chir. 2015 Dec;87(12):634-7. doi: 10.1515/pjs-2016-0015.</citation>
    <PMID>26963058</PMID>
  </reference>
  <reference>
    <citation>Mayir B, Ensari CO, Bilecik T, Aslaner A, Oruc MT. Methods for closure of appendix stump during laparoscopic appendectomy procedure. Ulus Cerrahi Derg. 2015 Aug 18;31(4):229-31. doi: 10.5152/UCD.2015.2768. eCollection 2015.</citation>
    <PMID>26668532</PMID>
  </reference>
  <reference>
    <citation>Yildiz I, Koca S. Is There An Ideal Stump Closure Technique In Laparoscopic Appendectomy? Surg Technol Int. 2016 Apr;28:117-20.</citation>
    <PMID>27121413</PMID>
  </reference>
  <reference>
    <citation>Delibegovic S, Mehmedovic Z. Erratum to: The Influence of the Appendiceal Base Diameter on Appendix Stump Closure in Laparoscopic Appendectomy. World J Surg. 2016 Nov;40(11):2832. doi: 10.1007/s00268-016-3709-5. No abstract available.</citation>
    <PMID>27627887</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 2, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute appendicitis</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>closure of appendicular stump</keyword>
  <keyword>economical and medical outcomes</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>Undecided</sharing_ipd>
    <ipd_description>The investigators have not decided to make the individual participant data available to other researchers.</ipd_description>
  </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/NCT03750032
org study id: FNO-CHIR-CAS
nct id: NCT03750032
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Laparoscopic appendectomy (L-APPE) presents a golden standard in the treatment of acute
      appendicitis nowadays. However, there are ongoing controversies regarding the ideal technique
      of appendicular stump closure during L-APPE in the published literature. Several technical
      modifications of appendicular stump closure are available at the present - closure using
      endoloop, endostapler or Hem-o-lock clips. The aim of the proposed project (CAS study) is to
      compare medical and economic outcomes of patients undergoing L-APPE with different methods of
      appendicular stump closure (endostapler, endoloop and Hem-o-lock clips).
Acute appendicitis presents one of the most common surgical illnesses which affect
      approximately 7% of the western population. In the Czech Republic, 11664 patients were
      hospitalized and operated for the diagnosis of acute appendicitis (K35-K38) during 2016. It
      might seem that the procedure of appendectomy will be guided by a clear algorithm for its
      frequency, but it is not so. Because of acute appendicitis, appendectomy may be performed via
      laparotomy or laparoscopy (minimally invasive surgery). During laparoscopic appendectomy
      (L-APPE), there are no clear recommendations regarding trocar placement, methods of dividing
      appendicular mesenteriolum, methods of appendicular stump closure or appendicular stump
      sinking.

      The proposed clinical study is focused on the issue of the appendicular base interruption
      during L-APPE. At the present, there are several technical modifications of appendicular
      stump closure - by means of endoloop (the suture loop from absorbable fiber), endostapler or
      using Hem-o-lock clips. The performed literature search revealed that evidence-based medicine
      data regarding the optimal way of appendicular stump closure are insufficient. That is why
      the investigators have decided to conduct a prospective randomized single-center clinical
      study aimed to compare different technical modifications of appendicular stump closure during
      L-APPE. Within a study period, all patients undergoing L-APPE at the University Hospital
      Ostrava will be randomized to one of the technical modifications of appendicular stump
      closure.

      The aim of the project (CAS study) is to compare medical and economic outcomes of patients
      undergoing L-APPE with different methods of appendicular stump closure (endostapler, endoloop
      and Hem-o-lock clips). The operative time, intraoperative and postoperative complications
      will be the primary outcome measures of the study, economic outcomes will be the secondary
      outcome measures.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The patients will be randomized into three groups of various appendicular stump closure.
primary purpose: Treatment
masking: None (Open Label)
masking description: No masking will be used in the study.
measure: Operative time
time frame: 12 months
description: Operative time will be measured in minutes and analysed.
measure: Incidence of intraoperative and postoperative complications
time frame: 12 months
description: The incidence of intraoperative and postoperative complications will be analysed in all groups of study subjects.
measure: Costs of surgery
time frame: 12 months
description: Costs of surgery will be analysed for all groups of study subjects.
measure: Costs of hospitalization
time frame: 12 months
description: The overall costs of hospitalisation will be analysed for all groups of study subjects.
measure: Costs of treatment of complications
time frame: 12 months
description: Costs of treatment of complications will be analysed for all groups of study subjects.
arm group label: Stapler appendectomy
arm group type: Experimental
description: A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using a stapler.
arm group label: Endoloop
arm group type: Experimental
description: A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using endoloop.
arm group label: Hem-O-Lock
arm group type: Experimental
description: A total of 40 study subjects undergoing appendectomy will be randomized into the group with appendicular stump closure using Hem-O-Lock.
intervention type: Procedure
intervention name: Stapler appendectomy
description: The patients randomised for this intervention will undergo stapler appendectomy.
arm group label: Stapler appendectomy
intervention type: Procedure
intervention name: Endoloop
description: The patients randomised for this intervention will undergo appendicular stump closure using Endoloop.
arm group label: Endoloop
intervention type: Procedure
intervention name: Hem-O-Lock
description: The patients randomised for this intervention will undergo appendicular stump closure using Hem-O-Lock.
arm group label: Hem-O-Lock
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Ihnát, Ass.Prof.,MD,PhD,MBA
role: Principal Investigator
affiliation: University Hospital Ostrava
facility: 
country: Czechia
citation: Mayir B, Bilecik T, Ensari CO, Oruc MT. Laparoscopic appendectomy with hand-made loop. Wideochir Inne Tech Maloinwazyjne. 2014 Jun;9(2):152-6. doi: 10.5114/wiitm.2014.41624. Epub 2014 Mar 24.
PMID: 25097680
citation: Matyja M, Strzalka M, Rembiasz K. Laparosocopic Appendectomy, Cost-Effectiveness of Three Different Techniques Used to Close the Appendix Stump. Pol Przegl Chir. 2015 Dec;87(12):634-7. doi: 10.1515/pjs-2016-0015.
PMID: 26963058
citation: Mayir B, Ensari CO, Bilecik T, Aslaner A, Oruc MT. Methods for closure of appendix stump during laparoscopic appendectomy procedure. Ulus Cerrahi Derg. 2015 Aug 18;31(4):229-31. doi: 10.5152/UCD.2015.2768. eCollection 2015.
PMID: 26668532
citation: Yildiz I, Koca S. Is There An Ideal Stump Closure Technique In Laparoscopic Appendectomy? Surg Technol Int. 2016 Apr;28:117-20.
PMID: 27121413
citation: Delibegovic S, Mehmedovic Z. Erratum to: The Influence of the Appendiceal Base Diameter on Appendix Stump Closure in Laparoscopic Appendectomy. World J Surg. 2016 Nov;40(11):2832. doi: 10.1007/s00268-016-3709-5. No abstract available.
PMID: 27627887
responsible party type: Sponsor
mesh term: Appendicitis
sharing ipd: Undecided
ipd description: The investigators have not decided to make the individual participant data available to other researchers.