<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/NCT03833232</url>
  </required_header>
  <id_info>
    <org_study_id>110511</org_study_id>
    <nct_id>NCT03833232</nct_id>
  </id_info>
  <brief_title>Omentopexy With Glubran®2 for Reducing Complications After Sleeve Gastrectomy</brief_title>
  <official_title>Omentopexy With Glubran®2 for Reducing Complications After Laparoscopic Sleeve Gastrectomy: Results of a Prospective Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Salerno</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Salerno</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>
      BACKGROUND. Gastric fistulas, bleeding, and strictures are commonly reported after&#xD;
      laparoscopic sleeve gastrectomy (LSG), that increase morbidity and hospital stay and may put&#xD;
      the patient's life at risk. This trial reports our prospective evaluation of application of&#xD;
      synthetic sealant, a modified cyanoacrylate (Glubran®2), on suture rime, associated with&#xD;
      omentopexy, to identify results on LSG-related complications.&#xD;
&#xD;
      METHODS. Patients were enrolled for LSG by two Bariatric Centers, with high-level activity&#xD;
      volume. Intraoperative recorded parameters were: operative time, estimated intraoperative&#xD;
      bleeding, conversion rate. Presence of early complications after LSG during the follow up&#xD;
      period was evaluated. Overall complications were analyzed. Perioperative data and weight loss&#xD;
      were also evaluated. A control group was identified for the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prospective randomized trial is designed with the aim to verify the effectiveness of the&#xD;
      Glubran®2 used in its spray application, according to manufacturer's indications, to perform&#xD;
      the omentopexy of the staple line to prevent and reduce early complications after LSG.&#xD;
      single-blind randomization was explained: a single surgeon, in enrollment phase, assigned&#xD;
      patient to case or control group, after adequate communication of randomization to all&#xD;
      patients. The surgeon that performed procedure only knew if patient was randomized to case&#xD;
      group (LSG with omentopexy with Glubran®2) or to control group (LSG without omentopexy with&#xD;
      Glubran®2). Control group was identified for the study with simple randomization, considering&#xD;
      patients treated with LSG during same period. Patients of case and control groups were not&#xD;
      paired. Same recording was performed for both groups. Patients were enrolled for LSG by two&#xD;
      Bariatric Centers, with high-level activity volume, after multidisciplinary evaluation:&#xD;
      inclusion criteria, according with international guidelines, was body mass index (BMI) of&#xD;
      greater than 40 kg/m2 or &gt; 35 with at least one co-morbidity, such as hypertension,&#xD;
      dyslipidemia or diabetes, age ≥ 18 years old, medically unfit for surgical intervention,&#xD;
      absence of active gastric disease, of uncontrolled medical or psychiatric conditions, and&#xD;
      signed informed consent. Bariatric procedure was performed according with standardized&#xD;
      four-trocars technique. All surgeons involved had a proved experience for bariatric surgery,&#xD;
      and have completed learning curve.&#xD;
&#xD;
      The size of the boogie to be used for calibration ranged from 42 to 48 Fr, among two groups.&#xD;
      In case group, after gastric partition and confirming correct closure of mechanical section&#xD;
      (performed with Endo-Gia, varying depth of stapler, from 3.5 mm blue to 4.4 black charge,&#xD;
      according with gastric level), a layer of the synthetic sealant on all rime suture was&#xD;
      applied and an omentum flap to place was apposed. Absence of gastric rotation with omentum&#xD;
      flap, or any tension on the resected stomach was carefully controlled. In control group, we&#xD;
      reinforced staple line with buttressing (bovine pericardium) of mechanical stapler, or with&#xD;
      running suture of the rime alone, indifferently. A recording of type of reinforcing was&#xD;
      performed, also if not pertinent to study.&#xD;
&#xD;
      Anthropometric data recorded were: age, weight, BMI, presence of comorbidities.&#xD;
      Intraoperative recorded parameters were: operative time, estimated intraoperative bleeding&#xD;
      (in ml), conversion rate. We prospectively evaluated the presence of early complications&#xD;
      after LSG during the follow up period (30 days from intervention). Considered complications&#xD;
      were staple line leakage/gastric fistula, postoperative bleeding, intraabdominal abscess,&#xD;
      cardiopulmonary failure, and all other complications. In order to considering effects and&#xD;
      real impact of mentioned events, we also evaluated length of hospital stay, rate of&#xD;
      readmission, rate of reintervention, overall mortality at 30 days. Weight loss was recorded&#xD;
      at 15 and 30 days, as excess weight loss percent (EWL%) and as reduction of BMI.&#xD;
&#xD;
      The demographic data and perioperative data were compared using the student's t and Mann-&#xD;
      Whitney U tests for continuous variables. Fisher's exact test was used to determine any&#xD;
      statistical significance for the categorical variables. The continuous variables were&#xD;
      presented as mean ± standard deviation and the categorical variables were presented as the&#xD;
      number (%). The level of significance was set at 0.05.&#xD;
&#xD;
      All procedures involving human participants were in accordance with the Ethical standards of&#xD;
      the institutional research committee and with the 1964 Helsinki declaration and its later&#xD;
      amendments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">April 30, 2017</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fistulization rate</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>bleeding rate</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Obesity With BMI &gt;35</condition>
  <arm_group>
    <arm_group_label>omentopexy and cyanoacrilate glue</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Apposition of omentum with cyanoacrilate glue after gastric section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>gastrectomy without omentopexy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Gastric section without omentopexy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>omentopexy with cyanoacrilate glue</intervention_name>
    <description>apposition of omentum with cyanoacrilate glue on gastric section</description>
    <arm_group_label>omentopexy and cyanoacrilate glue</arm_group_label>
    <other_name>omentopexy with Glubran 2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  body mass index (BMI) of greater than 40 kg/m2 or &gt; 35 with at least one co-morbidity,&#xD;
             such as hypertension, dyslipidemia or diabetes,&#xD;
&#xD;
          -  age ≥ 18 years old,&#xD;
&#xD;
          -  medically unfit for surgical&#xD;
&#xD;
          -  absence of active gastric disease, of uncontrolled medical or psychiatric conditions,&#xD;
&#xD;
          -  signed informed consent.&#xD;
&#xD;
        Exlusion criteria&#xD;
&#xD;
        - patient not suitable for bariatric surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Salerno</investigator_affiliation>
    <investigator_full_name>SALVATORE TRAMONTANO</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <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/NCT03833232
org study id: 110511
nct id: NCT03833232
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
BACKGROUND. Gastric fistulas, bleeding, and strictures are commonly reported after
      laparoscopic sleeve gastrectomy (LSG), that increase morbidity and hospital stay and may put
      the patient's life at risk. This trial reports our prospective evaluation of application of
      synthetic sealant, a modified cyanoacrylate (Glubran®2), on suture rime, associated with
      omentopexy, to identify results on LSG-related complications.

      METHODS. Patients were enrolled for LSG by two Bariatric Centers, with high-level activity
      volume. Intraoperative recorded parameters were: operative time, estimated intraoperative
      bleeding, conversion rate. Presence of early complications after LSG during the follow up
      period was evaluated. Overall complications were analyzed. Perioperative data and weight loss
      were also evaluated. A control group was identified for the study.
The prospective randomized trial is designed with the aim to verify the effectiveness of the
      Glubran®2 used in its spray application, according to manufacturer's indications, to perform
      the omentopexy of the staple line to prevent and reduce early complications after LSG.
      single-blind randomization was explained: a single surgeon, in enrollment phase, assigned
      patient to case or control group, after adequate communication of randomization to all
      patients. The surgeon that performed procedure only knew if patient was randomized to case
      group (LSG with omentopexy with Glubran®2) or to control group (LSG without omentopexy with
      Glubran®2). Control group was identified for the study with simple randomization, considering
      patients treated with LSG during same period. Patients of case and control groups were not
      paired. Same recording was performed for both groups. Patients were enrolled for LSG by two
      Bariatric Centers, with high-level activity volume, after multidisciplinary evaluation:
      inclusion criteria, according with international guidelines, was body mass index (BMI) of
      greater than 40 kg/m2 or > 35 with at least one co-morbidity, such as hypertension,
      dyslipidemia or diabetes, age ≥ 18 years old, medically unfit for surgical intervention,
      absence of active gastric disease, of uncontrolled medical or psychiatric conditions, and
      signed informed consent. Bariatric procedure was performed according with standardized
      four-trocars technique. All surgeons involved had a proved experience for bariatric surgery,
      and have completed learning curve.

      The size of the boogie to be used for calibration ranged from 42 to 48 Fr, among two groups.
      In case group, after gastric partition and confirming correct closure of mechanical section
      (performed with Endo-Gia, varying depth of stapler, from 3.5 mm blue to 4.4 black charge,
      according with gastric level), a layer of the synthetic sealant on all rime suture was
      applied and an omentum flap to place was apposed. Absence of gastric rotation with omentum
      flap, or any tension on the resected stomach was carefully controlled. In control group, we
      reinforced staple line with buttressing (bovine pericardium) of mechanical stapler, or with
      running suture of the rime alone, indifferently. A recording of type of reinforcing was
      performed, also if not pertinent to study.

      Anthropometric data recorded were: age, weight, BMI, presence of comorbidities.
      Intraoperative recorded parameters were: operative time, estimated intraoperative bleeding
      (in ml), conversion rate. We prospectively evaluated the presence of early complications
      after LSG during the follow up period (30 days from intervention). Considered complications
      were staple line leakage/gastric fistula, postoperative bleeding, intraabdominal abscess,
      cardiopulmonary failure, and all other complications. In order to considering effects and
      real impact of mentioned events, we also evaluated length of hospital stay, rate of
      readmission, rate of reintervention, overall mortality at 30 days. Weight loss was recorded
      at 15 and 30 days, as excess weight loss percent (EWL%) and as reduction of BMI.

      The demographic data and perioperative data were compared using the student's t and Mann-
      Whitney U tests for continuous variables. Fisher's exact test was used to determine any
      statistical significance for the categorical variables. The continuous variables were
      presented as mean ± standard deviation and the categorical variables were presented as the
      number (%). The level of significance was set at 0.05.

      All procedures involving human participants were in accordance with the Ethical standards of
      the institutional research committee and with the 1964 Helsinki declaration and its later
      amendments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: fistulization rate
time frame: 12 months
measure: bleeding rate
time frame: 12 months
arm group label: omentopexy and cyanoacrilate glue
arm group type: Experimental
description: Apposition of omentum with cyanoacrilate glue after gastric section
arm group label: gastrectomy without omentopexy
arm group type: No Intervention
description: Gastric section without omentopexy
intervention type: Device
intervention name: omentopexy with cyanoacrilate glue
description: apposition of omentum with cyanoacrilate glue on gastric section
arm group label: omentopexy and cyanoacrilate glue
other name: omentopexy with Glubran 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Salerno
investigator full name: SALVATORE TRAMONTANO
investigator title: Clinical Professor
sharing ipd: No