<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/NCT01720082</url>
  </required_header>
  <id_info>
    <org_study_id>ACOI - SICE</org_study_id>
    <nct_id>NCT01720082</nct_id>
  </id_info>
  <brief_title>Laparoscopic Appendectomy by Multi-port vs Single Port.</brief_title>
  <acronym>AMUSING</acronym>
  <official_title>Randomized Controlled Trial Comparing Single Incision Laparoscopic Appendectomy Versus Standard Three Port Appendectomy in a Selected Cohort of Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Associazione Chirurghi Ospedalieri Italiani</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Società Italiana di Chirurgia Endoscopica e nuove tecnologie (SICE)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Associazione Chirurghi Ospedalieri Italiani</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women&#xD;
      affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this&#xD;
      subgroup is high. Since the dissemination of single access surgery (no-scars surgery)&#xD;
      ameliorated outcome has been supposed in these patients regarding post-operative pain,&#xD;
      hospital stay and cosmetics results, and keeping the same safety as LA. This randomized&#xD;
      controlled study is supposed to give answers to these questions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>March 2013</start_date>
  <completion_date type="Anticipated">February 2014</completion_date>
  <primary_completion_date type="Anticipated">August 2013</primary_completion_date>
  <phase>Phase 3</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>Morbidity and mortality</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain score</measure>
    <time_frame>3 days</time_frame>
    <description>Visual Analogic Scale (VAS scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmetic result</measure>
    <time_frame>6 months</time_frame>
    <description>VAS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative hospital stay</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incision related morbidity</measure>
    <time_frame>6 months</time_frame>
    <description>during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Acute Appendicitis</condition>
  <arm_group>
    <arm_group_label>Single incision laparoscopic appendectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acute appendicitis with surgical indication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiport Laparoscopic appendectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acute appendicitis with surgical indication</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single incision laparoscopic appendectomy</intervention_name>
    <description>A multiport device will be introducted through a 2-2.5 transumbilical incision. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.</description>
    <arm_group_label>Single incision laparoscopic appendectomy</arm_group_label>
    <other_name>SILA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Multiport laparoscopic appendectomy</intervention_name>
    <description>Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.</description>
    <arm_group_label>Multiport Laparoscopic appendectomy</arm_group_label>
    <other_name>LA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: 14-60&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score: I-III&#xD;
&#xD;
          -  absence of non-correctable coagulopathy (international normalized ratio &gt;1,5, or&#xD;
             platelet count &lt;90 × 109/l).&#xD;
&#xD;
          -  diagnosis: acute appendicitis with surgical indication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complicated appendicitis after exploration or previously diagnosed (CT)&#xD;
&#xD;
          -  Psychical inability&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nereo Vettoretto, MD</last_name>
    <role>Study Chair</role>
    <affiliation>ACOI - SICE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ferdinando Agresta, MD</last_name>
    <role>Study Chair</role>
    <affiliation>ACOI - SICE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luigi Boni, MD, FACS</last_name>
    <role>Study Chair</role>
    <affiliation>SICE</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nereo Vettoretto, MD</last_name>
    <phone>00393492237383</phone>
    <email>nereovet@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>M.Mellini Hospital</name>
      <address>
        <city>Chiari</city>
        <state>BS</state>
        <zip>25032</zip>
        <country>Italy</country>
      </address>
    </facility>
    <investigator>
      <last_name>Nereo Vettoretto, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>November 2, 2012</last_update_submitted>
  <last_update_submitted_qc>November 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Associazione Chirurghi Ospedalieri Italiani</investigator_affiliation>
    <investigator_full_name>Nereo Vettoretto</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</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/NCT01720082
org study id: ACOI - SICE
nct id: NCT01720082
lead sponsor: 
collaborator: 
has dmc: No
Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women
      affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this
      subgroup is high. Since the dissemination of single access surgery (no-scars surgery)
      ameliorated outcome has been supposed in these patients regarding post-operative pain,
      hospital stay and cosmetics results, and keeping the same safety as LA. This randomized
      controlled study is supposed to give answers to these questions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Morbidity and mortality
time frame: 30 days
measure: Post-operative pain score
time frame: 3 days
description: Visual Analogic Scale (VAS scale)
measure: Operative time
time frame: 1 day
measure: Cosmetic result
time frame: 6 months
description: VAS scale
measure: Post-operative hospital stay
time frame: 7 days
measure: Incision related morbidity
time frame: 6 months
description: during hospital stay (7days): infectious morbidity during follow-up (6 months): incisional hernias
measure: Quality of life
time frame: 6 months
description: Gastro Intestinal Quality of Life Index (GIQLI) score at discharge and at 6 months follow-up
arm group label: Single incision laparoscopic appendectomy
arm group type: Active Comparator
description: Acute appendicitis with surgical indication
arm group label: Multiport Laparoscopic appendectomy
arm group type: Active Comparator
description: Acute appendicitis with surgical indication
intervention type: Procedure
intervention name: Single incision laparoscopic appendectomy
description: A multiport device will be introducted through a 2-2.5 transumbilical incision. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.
arm group label: Single incision laparoscopic appendectomy
other name: SILA
intervention type: Procedure
intervention name: Multiport laparoscopic appendectomy
description: Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.
arm group label: Multiport Laparoscopic appendectomy
other name: LA
criteria: 
gender: Female
minimum age: 14 Years
maximum age: 60 Years
healthy volunteers: No
last name: Nereo Vettoretto, MD
role: Study Chair
affiliation: ACOI - SICE
last name: Ferdinando Agresta, MD
role: Study Chair
affiliation: ACOI - SICE
last name: Luigi Boni, MD, FACS
role: Study Chair
affiliation: SICE
last name: Nereo Vettoretto, MD
phone: 00393492237383
email: nereovet@gmail.com
facility: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Associazione Chirurghi Ospedalieri Italiani
investigator full name: Nereo Vettoretto
investigator title: MD
mesh term: Appendicitis