<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/NCT04488042</url>
  </required_header>
  <id_info>
    <org_study_id>Stapler-less sleeve</org_study_id>
    <nct_id>NCT04488042</nct_id>
  </id_info>
  <brief_title>Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue</brief_title>
  <official_title>Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campania &quot;Luigi Vanvitelli&quot;</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>
      Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable&#xD;
      cost-effective alternative procedure. However, no pre-clinical data are currently available&#xD;
      on human tissue. We aimed to evaluate whether traditionally suturing without the use of&#xD;
      surgical stapling may produces a comparable bursting pressure on human gastric tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable&#xD;
      cost-effective alternative procedure. However, no pre-clinical data are currently available&#xD;
      on human tissue. We aimed to evaluate whether traditionally suturing without the use of&#xD;
      surgical stapling may produces a comparable bursting pressure on human gastric tissue.&#xD;
&#xD;
      A prospective cohort of consecutive patients underwent LSG was divided in two groups to&#xD;
      compare a barbed extramucosal running suture (stapler-less) versus a standard stapler line. A&#xD;
      burst pressure test was applied to the gastric specimen employing high-resolution manometric&#xD;
      catheter. Type, location and features of the leak were described.&#xD;
&#xD;
      In human ex-vivo model, traditional surgical suture (i.e. running hand-sewn) produced an&#xD;
      effective temporary closure, with superior resistance to increasing volume and pressure. How&#xD;
      this may impact on clinical LSG outcomes needs further evaluations and was not the object of&#xD;
      this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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 gastric specimen were immediately randomly allocated to the two groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Physicians who performed manometry were blinded from specimen allocation</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Gastric specimen tissue resistance</measure>
    <time_frame>During procedure</time_frame>
    <description>Evaluate the manometric burst pressure in the ex-vivo gastric specimen after hand-sewn running suture (group 1), and stapler suturing (group 2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastric specimen volume resistance</measure>
    <time_frame>During procedure</time_frame>
    <description>the saline volume needed to determine a gastric leak in the ex-vivo gastric specimen after hand-sewn running suture (group 1), and stapler suturing (group 2)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Obesity, Morbid</condition>
  <condition>Suture, Complication</condition>
  <condition>Suture Rupture</condition>
  <arm_group>
    <arm_group_label>Stapler-less</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>after the LSG stapler line removal by electrothermal bipolar-activated device (LigaSure Atlas™, Valleylab, Boulder, CO, USA), a stapler-less hand-sewn reconstruction was adopted. A single extra-mucosal running barbed suture (3/0 V-Loc™ suture; Covidien, Mansfield, MA, USA), incorporating sero- and submucosal gastric layers, closed the gastric tube.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Stapler</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>no reinforcement was performed, the stomach was re-sleeved along a 40F bougie with Echelon Flex Endopath 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH, USA) to reproduce standard volume of remnant LSG stomach and/or eliminating zig-zag shape of suture-line.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stapler-less gastrectomy</intervention_name>
    <description>After the LSG stapler line removal by electrothermal bipolar-activated device (LigaSure Atlas™, Valleylab, Boulder, CO, USA), a stapler-less hand-sewn reconstruction was adopted. A single extra-mucosal running barbed suture (3/0 V-Loc™ suture; Covidien, Mansfield, MA, USA), incorporating sero- and submucosal gastric layers, closed the gastric tube.</description>
    <arm_group_label>Stapler-less</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Suture</intervention_name>
    <description>No reinforcement was performed, the stomach was re-sleeved along a 40F bougie with Echelon Flex Endopath 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH, USA) to reproduce standard volume of remnant LSG stomach and/or eliminating zig-zag shape of suture-line.</description>
    <arm_group_label>Conventional Stapler</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Morbid obesity according to IFSO guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gastric specimen with injury and/or electrocoagulation signs at serosa&#xD;
&#xD;
          -  Presence of comorbidities capable of affecting specimen tissue resistance (i.e. type&#xD;
             II diabetes, gastric ulcer, connective tissue disease, systemic sclerosis,&#xD;
             polymyositis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gianmattia del Genio, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Claudio Gambardella</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
    <investigator_full_name>Claudio Gambardella</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>Sleeve gastrectomy</keyword>
  <keyword>stapler-less</keyword>
  <keyword>burst pressure</keyword>
  <keyword>leaks</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
    <mesh_term>Rupture</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/NCT04488042
org study id: Stapler-less sleeve
nct id: NCT04488042
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable
      cost-effective alternative procedure. However, no pre-clinical data are currently available
      on human tissue. We aimed to evaluate whether traditionally suturing without the use of
      surgical stapling may produces a comparable bursting pressure on human gastric tissue.
Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable
      cost-effective alternative procedure. However, no pre-clinical data are currently available
      on human tissue. We aimed to evaluate whether traditionally suturing without the use of
      surgical stapling may produces a comparable bursting pressure on human gastric tissue.

      A prospective cohort of consecutive patients underwent LSG was divided in two groups to
      compare a barbed extramucosal running suture (stapler-less) versus a standard stapler line. A
      burst pressure test was applied to the gastric specimen employing high-resolution manometric
      catheter. Type, location and features of the leak were described.

      In human ex-vivo model, traditional surgical suture (i.e. running hand-sewn) produced an
      effective temporary closure, with superior resistance to increasing volume and pressure. How
      this may impact on clinical LSG outcomes needs further evaluations and was not the object of
      this study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: the gastric specimen were immediately randomly allocated to the two groups
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: Physicians who performed manometry were blinded from specimen allocation
measure: Gastric specimen tissue resistance
time frame: During procedure
description: Evaluate the manometric burst pressure in the ex-vivo gastric specimen after hand-sewn running suture (group 1), and stapler suturing (group 2)
measure: Gastric specimen volume resistance
time frame: During procedure
description: the saline volume needed to determine a gastric leak in the ex-vivo gastric specimen after hand-sewn running suture (group 1), and stapler suturing (group 2)
arm group label: Stapler-less
arm group type: Experimental
description: after the LSG stapler line removal by electrothermal bipolar-activated device (LigaSure Atlas™, Valleylab, Boulder, CO, USA), a stapler-less hand-sewn reconstruction was adopted. A single extra-mucosal running barbed suture (3/0 V-Loc™ suture; Covidien, Mansfield, MA, USA), incorporating sero- and submucosal gastric layers, closed the gastric tube.
arm group label: Conventional Stapler
arm group type: Active Comparator
description: no reinforcement was performed, the stomach was re-sleeved along a 40F bougie with Echelon Flex Endopath 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH, USA) to reproduce standard volume of remnant LSG stomach and/or eliminating zig-zag shape of suture-line.
intervention type: Other
intervention name: Stapler-less gastrectomy
description: After the LSG stapler line removal by electrothermal bipolar-activated device (LigaSure Atlas™, Valleylab, Boulder, CO, USA), a stapler-less hand-sewn reconstruction was adopted. A single extra-mucosal running barbed suture (3/0 V-Loc™ suture; Covidien, Mansfield, MA, USA), incorporating sero- and submucosal gastric layers, closed the gastric tube.
arm group label: Stapler-less
intervention type: Other
intervention name: Suture
description: No reinforcement was performed, the stomach was re-sleeved along a 40F bougie with Echelon Flex Endopath 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH, USA) to reproduce standard volume of remnant LSG stomach and/or eliminating zig-zag shape of suture-line.
arm group label: Conventional Stapler
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Gianmattia del Genio, Prof
role: Principal Investigator
affiliation: University of Campania "Luigi Vanvitelli"
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Campania "Luigi Vanvitelli"
investigator full name: Claudio Gambardella
investigator title: Researcher
mesh term: Obesity, Morbid
mesh term: Rupture
sharing ipd: No