xml: <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/NCT05987787</url>
    </required_header>
    <id_info>
      <org_study_id>8</org_study_id>
      <nct_id>NCT05987787</nct_id>
    </id_info>
    <brief_title>Suture Reinforcement to Reduce the Leak Rate After Sleeve Gastrectomy</brief_title>
    <official_title>Staple-line Suture Reinforcement: Could it Help Contain the Leak?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Foggia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Foggia</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Staple line reinforcement (SLR) has been suggested as a mean of reducing the risk of sleeve&#xD;
        leakage or bleeding. The aim of this study is to analyze if the suture reinforcement can be&#xD;
        used to reduce the leakage rate after sleeve gastrectomy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>the importance of staple line reinforcement</measure>
      <time_frame>1 year</time_frame>
      <description>reduction of the leak rate in the suture group</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the importance of staple line reinforcement</measure>
      <time_frame>During Surgery</time_frame>
      <description>the differences of operative time between two groups</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">33</enrollment>
    <condition>Bariatric Surgery Candidate</condition>
    <condition>Obesity, Morbid</condition>
    <condition>Leak, Anastomotic</condition>
    <condition>Bleeding</condition>
    <arm_group>
      <arm_group_label>Obese patients underwent laparoscopic sleeve gastrectomy with suture reinforcement</arm_group_label>
      <description>Laparoscopic sleeve gastrectomy running seromuscular stitches at the proximal third of the stapled line using unidirectional 2/0 barbed sutures to invaginate the staple line completely.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Obese patients underwent laparoscopic sleeve gastrectomy without suture reinforcement</arm_group_label>
      <description>Laparoscopic sleeve gastrectomy without staple line reinforcement.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>laparoscopic sleeve gastrectomy without suture reinforcement</intervention_name>
      <description>The procedure begins by dissecting the small branches of the gastroepiploic arch 6 cm from the pylorus. The dissection continues along the great curvature of the stomach, remaining very close to the gastric wall, up to the short gastric vessels which are also dissected. The stomach is then raised to expose its posterior wall and the adhesions are lysed. His angle is fully mobilized and the left diaphragmatic pillar exposed. The gastric tubule is created on the guide of a 40 F Bugie using mechanical suturing machines with charges of different thickness depending on the thickness of the gastric wall. At this point the bougie is removed and the resected stomach is extracted from the abdomen through the mesogastric access.</description>
      <arm_group_label>Obese patients underwent laparoscopic sleeve gastrectomy without suture reinforcement</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>laparoscopic sleeve gastrectomy with suture reinforcement</intervention_name>
      <description>The procedure begins by dissecting the small branches of the gastroepiploic arch 6 cm from the pylorus. The dissection continues along the great curvature of the stomach, remaining very close to the gastric wall, up to the short gastric vessels which are also dissected. The stomach is then raised to expose its posterior wall and the adhesions are lysed. His angle is fully mobilized and the left diaphragmatic pillar exposed. The gastric tubule is created on the guide of a 40 F Bugie using mechanical suturing machines with charges of different thickness depending on the thickness of the gastric wall. At this point the bougie is removed and the resected stomach is extracted from the abdomen through the mesogastric access. At this point, it is applied running seromuscular stitches at the proximal third of the stapled line using unidirectional 2/0 barbed sutures to invaginate the staple line completely.</description>
      <arm_group_label>Obese patients underwent laparoscopic sleeve gastrectomy with suture reinforcement</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or&#xD;
          BMI≥40kg/m2, age ≥ 18 years. Before surgery, patients underwent a standardized&#xD;
          psychological and physical evaluation which includes blood chemistry tests, chest x-rays,&#xD;
          electrocardiogram and cardiological examinations, nutritional evaluation,&#xD;
          esophagogastroduodenoscopy, spirometry and psychiatric evaluation .&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  BMI&gt;40 kg/m2&#xD;
  &#xD;
            -  BMI&gt;35 kg/m2with at least one associated major comorbidity&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  secondary obesity due to endocrine and psychological disorders&#xD;
  &#xD;
            -  patients under antiaggregant and anticoagulant therapy&#xD;
  &#xD;
            -  re-do surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>University of Foggia</name>
        <address>
          <city>Foggia</city>
          <zip>71122</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Foggia</investigator_affiliation>
      <investigator_full_name>Giovanna Pavone</investigator_full_name>
      <investigator_title>Medical doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity, Morbid</mesh_term>
      <mesh_term>Anastomotic Leak</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 2, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT05987787/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05987787
  org study id: 8
  nct id: NCT05987787
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Staple line reinforcement (SLR) has been suggested as a mean of reducing the risk of sleeve
        leakage or bleeding. The aim of this study is to analyze if the suture reinforcement can be
        used to reduce the leakage rate after sleeve gastrectomy.
  observational model: Cohort
  time perspective: Retrospective
  measure: the importance of staple line reinforcement
  time frame: 1 year
  description: reduction of the leak rate in the suture group
  measure: the importance of staple line reinforcement
  time frame: During Surgery
  description: the differences of operative time between two groups
  arm group label: Obese patients underwent laparoscopic sleeve gastrectomy with suture reinforcement
  description: Laparoscopic sleeve gastrectomy running seromuscular stitches at the proximal third of the stapled line using unidirectional 2/0 barbed sutures to invaginate the staple line completely.
  arm group label: Obese patients underwent laparoscopic sleeve gastrectomy without suture reinforcement
  description: Laparoscopic sleeve gastrectomy without staple line reinforcement.
  intervention type: Procedure
  intervention name: laparoscopic sleeve gastrectomy without suture reinforcement
  description: The procedure begins by dissecting the small branches of the gastroepiploic arch 6 cm from the pylorus. The dissection continues along the great curvature of the stomach, remaining very close to the gastric wall, up to the short gastric vessels which are also dissected. The stomach is then raised to expose its posterior wall and the adhesions are lysed. His angle is fully mobilized and the left diaphragmatic pillar exposed. The gastric tubule is created on the guide of a 40 F Bugie using mechanical suturing machines with charges of different thickness depending on the thickness of the gastric wall. At this point the bougie is removed and the resected stomach is extracted from the abdomen through the mesogastric access.
  arm group label: Obese patients underwent laparoscopic sleeve gastrectomy without suture reinforcement
  intervention type: Procedure
  intervention name: laparoscopic sleeve gastrectomy with suture reinforcement
  description: The procedure begins by dissecting the small branches of the gastroepiploic arch 6 cm from the pylorus. The dissection continues along the great curvature of the stomach, remaining very close to the gastric wall, up to the short gastric vessels which are also dissected. The stomach is then raised to expose its posterior wall and the adhesions are lysed. His angle is fully mobilized and the left diaphragmatic pillar exposed. The gastric tubule is created on the guide of a 40 F Bugie using mechanical suturing machines with charges of different thickness depending on the thickness of the gastric wall. At this point the bougie is removed and the resected stomach is extracted from the abdomen through the mesogastric access. At this point, it is applied running seromuscular stitches at the proximal third of the stapled line using unidirectional 2/0 barbed sutures to invaginate the staple line completely.
  arm group label: Obese patients underwent laparoscopic sleeve gastrectomy with suture reinforcement
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  facility: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: University of Foggia
  investigator full name: Giovanna Pavone
  investigator title: Medical doctor
  mesh term: Obesity, Morbid
  mesh term: Anastomotic Leak
  sharing ipd: No
  provided document: 