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/NCT06016426</url>
    </required_header>
    <id_info>
      <org_study_id>36264PR286/8/23</org_study_id>
      <nct_id>NCT06016426</nct_id>
    </id_info>
    <brief_title>Mass Closure vs Layer by Layer Closure</brief_title>
    <official_title>Mass Closure vs Layer by Layer Closure of the Transverse Abdominal Laparotomy Incisions in Infants and Children: a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</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>
        to assess two different ways of closure of laparotomy in children and infants&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction:&#xD;
  &#xD;
        The technique of abdominal wall closure in infants subjected to abdominal transverse&#xD;
        laparotomy incision may have an impact not only on the development of a future incisional&#xD;
        hernia but also on the function of the anterior abdominal wall muscles.&#xD;
  &#xD;
        There are two ways to close this laparotomy incision. These ways are either closure in mass&#xD;
        or layer by layer closure. Neither of them is superior to the other.&#xD;
  &#xD;
        The main issue that minds the pediatric surgeons is a safe and successful repair of the&#xD;
        abdominal wall incision and the avoidance of the development of incisional hernia.&#xD;
  &#xD;
        The aim of this work is to randomly compare the two different techniques of the closure of&#xD;
        transverse laparotomy incision.&#xD;
  &#xD;
        Patients and methods:&#xD;
  &#xD;
        - Study design: The study was performed during the period from January 2020 to October 2024.&#xD;
        It is a randomized control trial.&#xD;
  &#xD;
        Inclusion criteria were infants younger than 3 years. We excluded infants with history of&#xD;
        prematurity, previous abdominal operations and infants with congenital abdominal wall&#xD;
        defects.&#xD;
  &#xD;
        An informed consent was obtained from the parents or the care giver of every participant.&#xD;
  &#xD;
        Randomization was obtained using closed envelop method. Patients were categorized into two&#xD;
        groups A and B. Group A included patients that their exploratory wound was closed with mass&#xD;
        closure method using Vicryl® 2/0 round needle. Group B included patients that their&#xD;
        exploratory wound was closed layer by layer using the same suture material.&#xD;
  &#xD;
        In both groups the ratio of the suture length to the wound was 3 to 1. - The measured&#xD;
        variables: The variables that were addressed were&#xD;
  &#xD;
          1. the mean operative time in minutes,&#xD;
  &#xD;
          2. the incidence of wound dehiscence,&#xD;
  &#xD;
          3. the occurrence of wound infection,&#xD;
  &#xD;
          4. The development of an incisional hernia&#xD;
  &#xD;
          5. Long term assessment of both abdominal wall structure and dynamics of abdominal muscles&#xD;
             at the site of incision.&#xD;
  &#xD;
               -  Follow up protocol:&#xD;
  &#xD;
        All patients were scheduled on a follow up regimen. They were examined weekly for one month&#xD;
        post-operative. Then monthly for one year. The anterior abdominal wall of these patients was&#xD;
        examined by ultrasound at the 6th and 12th moth postoperatively. This helped assessment of&#xD;
        the dynamics and structure of the muscles at the site of the incision.&#xD;
  &#xD;
        - Statistical analysis: Statistical analysis was conducted using SPSS ™ statistical package&#xD;
        ver. 21 (IBM SPSS, NY, USA). Numerical data were compared using an independent sample t-test,&#xD;
        whereas categorical data were compared using the chi-square test. Statistical significance&#xD;
        was set at p &lt;0.05.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2024</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>wound failure with the development of incisional hernia later in either group</measure>
      <time_frame>one year</time_frame>
      <description>the occurrence or development of the incisional hernia is the primary outcome. the incidence of the development of this hernia will be recorded in each group. this will help choose the more appropriate method of transverse laparotomy closure in infants and children</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>surgical site infections</measure>
      <time_frame>two weeks up to one month</time_frame>
      <description>the number of patients who will develop a surgical site infections in each group, the mean duration of hospital stay if this happened. the number of patients who will later develop an incisional hernia</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Abdominal Wall Wound</condition>
    <condition>Ventral Hernia</condition>
    <condition>Incisional Hernia</condition>
    <arm_group>
      <arm_group_label>mass closure</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>infants and children whose transverse laparotomy incisions will be closed in mass closure.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>layer by layer closure</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>infants and children whose transverse laparotomy incisions will be closed layer by layer.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.</intervention_name>
      <description>the transverse laparotomy incision in infants and children will be either closed as single layer included the peritoneum, posterior rectus sheath and anterior rectus sheath wit muscle sparing, or the laparotomy will be closed in layer by layer in which the peritoneum and posterior rectus sheath are closed as a layer and the anterior rectus sheath is closed as a seprate layer.</description>
      <arm_group_label>layer by layer closure</arm_group_label>
      <arm_group_label>mass closure</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  all infants and children with transverse laparotomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  previous abdominal operations&#xD;
  &#xD;
            -  children and infants with congenital abdominal wall defects&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Months</minimum_age>
      <maximum_age>1 Year</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tanta University Hospitals</name>
        <address>
          <city>Tanta</city>
          <state>Gharbia</state>
          <zip>31111</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nagi E eldessouki, professor</last_name>
        <phone>+20 201003546853</phone>
        <email>&quot;nagi2709Staff&quot; &lt;neldesoky@med.tanta.edu.eg&gt;</email>
      </contact>
      <investigator>
        <last_name>Suzan E Gado, professor</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nagi E ldessouki, professor</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Radwa M Elkholy, professor</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mazen O Kurdi, professor</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ahmed Moukhtar, specalist</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Mohammad Gharieb Mohammad Khirallah</investigator_full_name>
      <investigator_title>professor of pediatric surgery</investigator_title>
    </responsible_party>
    <keyword>transverse laparotomy</keyword>
    <keyword>incisional hernia</keyword>
    <keyword>mass closure</keyword>
    <keyword>layer by layer closure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hernia</mesh_term>
      <mesh_term>Hernia, Ventral</mesh_term>
      <mesh_term>Incisional Hernia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06016426
  org study id: 36264PR286/8/23
  nct id: NCT06016426
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  to assess two different ways of closure of laparotomy in children and infants
  Introduction:
  
        The technique of abdominal wall closure in infants subjected to abdominal transverse
        laparotomy incision may have an impact not only on the development of a future incisional
        hernia but also on the function of the anterior abdominal wall muscles.
  
        There are two ways to close this laparotomy incision. These ways are either closure in mass
        or layer by layer closure. Neither of them is superior to the other.
  
        The main issue that minds the pediatric surgeons is a safe and successful repair of the
        abdominal wall incision and the avoidance of the development of incisional hernia.
  
        The aim of this work is to randomly compare the two different techniques of the closure of
        transverse laparotomy incision.
  
        Patients and methods:
  
        - Study design: The study was performed during the period from January 2020 to October 2024.
        It is a randomized control trial.
  
        Inclusion criteria were infants younger than 3 years. We excluded infants with history of
        prematurity, previous abdominal operations and infants with congenital abdominal wall
        defects.
  
        An informed consent was obtained from the parents or the care giver of every participant.
  
        Randomization was obtained using closed envelop method. Patients were categorized into two
        groups A and B. Group A included patients that their exploratory wound was closed with mass
        closure method using Vicryl® 2/0 round needle. Group B included patients that their
        exploratory wound was closed layer by layer using the same suture material.
  
        In both groups the ratio of the suture length to the wound was 3 to 1. - The measured
        variables: The variables that were addressed were
  
          1. the mean operative time in minutes,
  
          2. the incidence of wound dehiscence,
  
          3. the occurrence of wound infection,
  
          4. The development of an incisional hernia
  
          5. Long term assessment of both abdominal wall structure and dynamics of abdominal muscles
             at the site of incision.
  
               -  Follow up protocol:
  
        All patients were scheduled on a follow up regimen. They were examined weekly for one month
        post-operative. Then monthly for one year. The anterior abdominal wall of these patients was
        examined by ultrasound at the 6th and 12th moth postoperatively. This helped assessment of
        the dynamics and structure of the muscles at the site of the incision.
  
        - Statistical analysis: Statistical analysis was conducted using SPSS ™ statistical package
        ver. 21 (IBM SPSS, NY, USA). Numerical data were compared using an independent sample t-test,
        whereas categorical data were compared using the chi-square test. Statistical significance
        was set at p <0.05.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: wound failure with the development of incisional hernia later in either group
  time frame: one year
  description: the occurrence or development of the incisional hernia is the primary outcome. the incidence of the development of this hernia will be recorded in each group. this will help choose the more appropriate method of transverse laparotomy closure in infants and children
  measure: surgical site infections
  time frame: two weeks up to one month
  description: the number of patients who will develop a surgical site infections in each group, the mean duration of hospital stay if this happened. the number of patients who will later develop an incisional hernia
  arm group label: mass closure
  arm group type: Active Comparator
  description: infants and children whose transverse laparotomy incisions will be closed in mass closure.
  arm group label: layer by layer closure
  arm group type: Active Comparator
  description: infants and children whose transverse laparotomy incisions will be closed layer by layer.
  intervention type: Other
  intervention name: Mass closure vs layer by layer closure of transverse laparotomy incisions in children and infants.
  description: the transverse laparotomy incision in infants and children will be either closed as single layer included the peritoneum, posterior rectus sheath and anterior rectus sheath wit muscle sparing, or the laparotomy will be closed in layer by layer in which the peritoneum and posterior rectus sheath are closed as a layer and the anterior rectus sheath is closed as a seprate layer.
  arm group label: layer by layer closure
  arm group label: mass closure
  criteria: 
  gender: All
  minimum age: 3 Months
  maximum age: 1 Year
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Mohammad Gharieb Mohammad Khirallah
  investigator title: professor of pediatric surgery
  mesh term: Hernia
  mesh term: Hernia, Ventral
  mesh term: Incisional Hernia
  sharing ipd: Undecided