<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/NCT04410744</url>
  </required_header>
  <id_info>
    <org_study_id>TSIH INCIDENCE</org_study_id>
    <nct_id>NCT04410744</nct_id>
  </id_info>
  <brief_title>Incidence and Risk Factors for TSIH</brief_title>
  <acronym>TSIHi</acronym>
  <official_title>Incidence and Risk Factors for Trocar Site Incisional Hernia Detected by Clinical and Ultrasonographic Examination.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Mataró</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Mataró</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>
      Trocar site incisional hernia (TSIH) is the most frequent complication associated to&#xD;
      laparoscopic surgery. Few studies currently describes its real prevalence or risk factors.&#xD;
      The aim of this study is to determine the real incidence of TSIH and to identify risk factors&#xD;
      in the investigator's series of patients.&#xD;
&#xD;
      A cross sectional, prospective study is performed including consecutive patients who&#xD;
      underwent a laparoscopic procedure during a four months period. All the patients are assessed&#xD;
      both clinically (TSIHc) and by an ultrasonographic exam (TSIHu). Main variable studied is the&#xD;
      incidence of TSIH. A multivariate analysis is performed to identify risk factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Single-centre cross-sectional study based on prospective clinical and radiological assessment&#xD;
      and retrospective risk factor analyses performed at a single hospital.&#xD;
&#xD;
      All consecutive patients who underwent laparoscopic surgery (cholecystectomy, colon&#xD;
      resection, adrenalectomy, Nissen fundoplication and appendectomy) during a four months period&#xD;
      were included in the study. At least 30 months after hospital discharge, they were invited by&#xD;
      telephone to participate in the study. Detailed project information was provided, and those&#xD;
      who accepted received an appointment for an outpatient visit and a dynamic ultrasound.&#xD;
      Informed consent was obtained from all participants. In all patients, the umbilical trocar&#xD;
      wound was closed with an interrupted suture with synthetic braided absorbable 2/0 suture&#xD;
      (Novosyn® or Safil®). During the postoperative outpatient visit, clinical and&#xD;
      ultrasonographic examinations were performed. To increase study homogeneity, all clinical&#xD;
      examinations and ultrasounds were performed by a single surgeon and a single radiology&#xD;
      resident supervised by the same abdominal radiology consultant, respectively. Sonography was&#xD;
      performed with an Applio 500 equipment (Toshiba, Japan) with a 3.5MHz convex probe and a 7MHz&#xD;
      linear probe. The ultrasound diagnosis was based on the identification of an abdominal wall&#xD;
      defect with intraabdominal tissue protrusion. The main variables of the study were clinical&#xD;
      (TSIHc) and ultrasound (TSIHu) diagnosis of incisional hernia. All results and variables were&#xD;
      introduced in a previous specifically designed database (File MakerPro 11.0v3 © 1984-2011&#xD;
      FileMaker, Inc.). Data were collected from clinical interviews, physical and radiological&#xD;
      examinations and the electronic medical record. Statistical analyses were performed using the&#xD;
      SPSS statistical software (IBM SPSS® Statistics).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2015</start_date>
  <completion_date type="Actual">January 1, 2016</completion_date>
  <primary_completion_date type="Actual">January 1, 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>clinical TSIH incidence</measure>
    <time_frame>30 seconds</time_frame>
    <description>Presence / absence palpableTSIH (yes / not)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ultrasonographic TSIH incidence</measure>
    <time_frame>1 minute 30 seconds</time_frame>
    <description>Identification of an abdominal wall defect with intraabdominal tissue protrusion (yes /not) Caudal and cranial diameters of the abdominal wall's defect (cm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors for TSIH</measure>
    <time_frame>5 minutes</time_frame>
    <description>Risk factors for TSIH determination. Information obtained from the electronic medical record</description>
  </secondary_outcome>
  <enrollment type="Actual">76</enrollment>
  <condition>Incisional Hernia</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasonographic examination</intervention_name>
    <description>All clinical examinations (physical exam) and ultrasounds are performed by a single surgeon and a single radiology resident supervised by the same abdominal radiology consultant, respectively.</description>
    <other_name>Clinical examination</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients who underwent laparoscopic surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous laparoscopic surgery&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous umbilical hernia repair&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Informed consent not signed&#xD;
&#xD;
          -  Failure to attend the postoperative appointment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ana Ciscar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Mataró</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Mataró</investigator_affiliation>
    <investigator_full_name>Ana Ciscar</investigator_full_name>
    <investigator_title>General and digestive surgery specialist</investigator_title>
  </responsible_party>
  <keyword>Incisional hernia</keyword>
  <keyword>Port site</keyword>
  <keyword>Trocar site</keyword>
  <keyword>Risk factors</keyword>
  <keyword>Incidence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Incisional Hernia</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/NCT04410744
org study id: TSIH INCIDENCE
nct id: NCT04410744
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Trocar site incisional hernia (TSIH) is the most frequent complication associated to
      laparoscopic surgery. Few studies currently describes its real prevalence or risk factors.
      The aim of this study is to determine the real incidence of TSIH and to identify risk factors
      in the investigator's series of patients.

      A cross sectional, prospective study is performed including consecutive patients who
      underwent a laparoscopic procedure during a four months period. All the patients are assessed
      both clinically (TSIHc) and by an ultrasonographic exam (TSIHu). Main variable studied is the
      incidence of TSIH. A multivariate analysis is performed to identify risk factors.
Single-centre cross-sectional study based on prospective clinical and radiological assessment
      and retrospective risk factor analyses performed at a single hospital.

      All consecutive patients who underwent laparoscopic surgery (cholecystectomy, colon
      resection, adrenalectomy, Nissen fundoplication and appendectomy) during a four months period
      were included in the study. At least 30 months after hospital discharge, they were invited by
      telephone to participate in the study. Detailed project information was provided, and those
      who accepted received an appointment for an outpatient visit and a dynamic ultrasound.
      Informed consent was obtained from all participants. In all patients, the umbilical trocar
      wound was closed with an interrupted suture with synthetic braided absorbable 2/0 suture
      (Novosyn® or Safil®). During the postoperative outpatient visit, clinical and
      ultrasonographic examinations were performed. To increase study homogeneity, all clinical
      examinations and ultrasounds were performed by a single surgeon and a single radiology
      resident supervised by the same abdominal radiology consultant, respectively. Sonography was
      performed with an Applio 500 equipment (Toshiba, Japan) with a 3.5MHz convex probe and a 7MHz
      linear probe. The ultrasound diagnosis was based on the identification of an abdominal wall
      defect with intraabdominal tissue protrusion. The main variables of the study were clinical
      (TSIHc) and ultrasound (TSIHu) diagnosis of incisional hernia. All results and variables were
      introduced in a previous specifically designed database (File MakerPro 11.0v3 © 1984-2011
      FileMaker, Inc.). Data were collected from clinical interviews, physical and radiological
      examinations and the electronic medical record. Statistical analyses were performed using the
      SPSS statistical software (IBM SPSS® Statistics).
observational model: Cohort
time perspective: Prospective
measure: clinical TSIH incidence
time frame: 30 seconds
description: Presence / absence palpableTSIH (yes / not)
measure: ultrasonographic TSIH incidence
time frame: 1 minute 30 seconds
description: Identification of an abdominal wall defect with intraabdominal tissue protrusion (yes /not) Caudal and cranial diameters of the abdominal wall's defect (cm)
measure: Risk factors for TSIH
time frame: 5 minutes
description: Risk factors for TSIH determination. Information obtained from the electronic medical record
intervention type: Diagnostic Test
intervention name: Ultrasonographic examination
description: All clinical examinations (physical exam) and ultrasounds are performed by a single surgeon and a single radiology resident supervised by the same abdominal radiology consultant, respectively.
other name: Clinical examination
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ana Ciscar
role: Principal Investigator
affiliation: Hospital de Mataró
responsible party type: Principal Investigator
investigator affiliation: Hospital de Mataró
investigator full name: Ana Ciscar
investigator title: General and digestive surgery specialist
mesh term: Hernia
mesh term: Incisional Hernia