<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/NCT03755219</url>
  </required_header>
  <id_info>
    <org_study_id>Bengan III</org_study_id>
    <nct_id>NCT03755219</nct_id>
  </id_info>
  <brief_title>Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery</brief_title>
  <official_title>Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bengt Novik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swedish Hernia Registry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Skaraborg Hospital Research &amp; Development Center, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study attempts to quantify the relative risks for recurrence depending on complex&#xD;
      combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and&#xD;
      hernia type.&#xD;
&#xD;
      For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open cohort study design where the investigators will analyze existing data that&#xD;
      have been prospectively collected in the Swedish Hernia Registry (SHR), which covers &gt; 95% of&#xD;
      all groin hernia repairs in Sweden. The very large cohort of more than 38,000 TEP (totally&#xD;
      extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enables assessment of the&#xD;
      relative risks for recurrence depending on complex combinations of plausible risk factors, in&#xD;
      particular mesh, mesh fixation, hernia size and hernia type, with fulfilling statistical&#xD;
      power.&#xD;
&#xD;
      Each participant was entered at the date of surgery, when demographic and intraoperative data&#xD;
      were registered. Reoperations were registered in the SHR in the same manner as index repairs,&#xD;
      and were used as endpoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2005</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>14 Years</target_duration>
  <primary_outcome>
    <measure>Reoperation for recurrence</measure>
    <time_frame>Assessment at Dec 31, 2018</time_frame>
    <description>The date of the recurrent surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>Assessment at Dec 31, 2018</time_frame>
    <description>The date of death</description>
  </primary_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Actual">38450</enrollment>
  <condition>Hernia, Inguinal</condition>
  <condition>Surgical Mesh</condition>
  <condition>Laparoscopy</condition>
  <condition>Hernia</condition>
  <condition>Hernia, Femoral</condition>
  <condition>Surgical Procedures, Minimally Invasive</condition>
  <condition>Surgical Staplers</condition>
  <condition>Recurrence</condition>
  <condition>Fixation Device; Complications</condition>
  <arm_group>
    <arm_group_label>StdPPM</arm_group_label>
    <description>Standard pure polypropylene mesh.&#xD;
&quot;Standard&quot; is defined in SHR by weight ≥ 50 g/square meter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LWM</arm_group_label>
    <description>Lightweight mesh: Either a pure polypropylene mesh, or a polypropylene-based composite mesh.&#xD;
The study uses SHR's classification of &quot;light-weight&quot; = &lt;50 g/square meter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tacks, metal</arm_group_label>
    <description>Metal staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tacks, absorbable</arm_group_label>
    <description>Absorbable synthetic staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tacks, uncategorized</arm_group_label>
    <description>Staples or tacks were in SHR 2005-2011 not further categorized.&#xD;
This category also includes staples/tacks registered from 2012 and forth, not being specified as either metal or absorbable.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fibrin glue</arm_group_label>
    <description>Biologic glue/sealant produced from human donor blood</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-fixation</arm_group_label>
    <description>Mesh is deployed without fixation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3D Mesh</arm_group_label>
    <description>Mesh categorized by anatomical shaped, rather than material or weight. Therefore, this category will be excluded in the original study. Depending on the volume of casess found, the 3D mesh category may eventually be analyzed separately in another study..</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TEP</intervention_name>
    <description>By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device</description>
    <arm_group_label>3D Mesh</arm_group_label>
    <arm_group_label>Fibrin glue</arm_group_label>
    <arm_group_label>LWM</arm_group_label>
    <arm_group_label>Non-fixation</arm_group_label>
    <arm_group_label>StdPPM</arm_group_label>
    <arm_group_label>Tacks, absorbable</arm_group_label>
    <arm_group_label>Tacks, metal</arm_group_label>
    <arm_group_label>Tacks, uncategorized</arm_group_label>
    <other_name>Laparoscopic totally extraperitoneal mesh repair</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAPP</intervention_name>
    <description>By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device</description>
    <arm_group_label>3D Mesh</arm_group_label>
    <arm_group_label>Fibrin glue</arm_group_label>
    <arm_group_label>LWM</arm_group_label>
    <arm_group_label>Non-fixation</arm_group_label>
    <arm_group_label>StdPPM</arm_group_label>
    <arm_group_label>Tacks, absorbable</arm_group_label>
    <arm_group_label>Tacks, metal</arm_group_label>
    <arm_group_label>Tacks, uncategorized</arm_group_label>
    <other_name>Laparoscopic transabdominal preperitoneal mesh repair</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population consists of all laparoscopic TEP and TAPP repairs that have been&#xD;
        registered in the SHR from September 1, 2005 until December 31, 2017.&#xD;
&#xD;
        The database is the SHR, which was launched in 1992 and prospectively records groin&#xD;
        (lateral, medial and femoral) hernia repairs, including both public and private hospitals.&#xD;
&#xD;
        The source population are all residents in Sweden from the age of 15 years, having a&#xD;
        state-assigned personal identity number.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All laparoscopic (mainly TEP and TAPP) repairs that have been registered in the SHR&#xD;
             from January 1, 2005 until December 31, 2018.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open repairs.&#xD;
&#xD;
          -  Hernioplasties that were converted from laparoscopic to open surgery.&#xD;
&#xD;
          -  Age &lt; 15 years.&#xD;
&#xD;
          -  Patients not having a 10-digit state-assigned Patient Identification Number.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bengt Novik</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm</affiliation>
  </overall_official>
  <reference>
    <citation>Novik B, Nordin P, Skullman S, Dalenback J, Enochsson L. More recurrences after hernia mesh fixation with short-term absorbable sutures: A registry study of 82 015 Lichtenstein repairs. Arch Surg. 2011 Jan;146(1):12-7. doi: 10.1001/archsurg.2010.302.</citation>
    <PMID>21242440</PMID>
  </reference>
  <reference>
    <citation>Novik B, Hagedorn S, Mork UB, Dahlin K, Skullman S, Dalenback J. Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair: a study with a 40-month prospective follow-up period. Surg Endosc. 2006 Mar;20(3):462-7. doi: 10.1007/s00464-005-0391-3. Epub 2006 Jan 19. Erratum In: Surg Endosc. 2022 May;36(5):3675.</citation>
    <PMID>16424986</PMID>
  </reference>
  <results_reference>
    <citation>Novik B, et al. Mesh and mesh fixation in laparoscopic groin hernia repairs. A study of 25,189 TEP and TAPP in the Swedish Hernia Registry [congress abstract]. Hernia 2019; 23 (Suppl 2):S251-S252. https://doi.org/10.1007/s10029-019-02013-8</citation>
  </results_reference>
  <results_reference>
    <citation>Novik B, Sandblom G, Ansorge C, Thorell A. Association of Mesh and Fixation Options with Reoperation Risk after Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study of 25,190 Totally Extraperitoneal and Transabdominal Preperitoneal Repairs. J Am Coll Surg. 2022 Mar 1;234(3):311-325. doi: 10.1097/XCS.0000000000000060.</citation>
    <PMID>35213495</PMID>
  </results_reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 30, 2022</last_update_submitted>
  <last_update_submitted_qc>November 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Bengt Novik</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Totally extraperitoneal</keyword>
  <keyword>Transabdominal preperitoneal</keyword>
  <keyword>Fibrin glue</keyword>
  <keyword>Fibrin sealant</keyword>
  <keyword>Mesh fixation</keyword>
  <keyword>Fixation devices</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
    <mesh_term>Hernia, Femoral</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/NCT03755219
org study id: Bengan III
nct id: NCT03755219
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study attempts to quantify the relative risks for recurrence depending on complex
      combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and
      hernia type.

      For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR).
This is an open cohort study design where the investigators will analyze existing data that
      have been prospectively collected in the Swedish Hernia Registry (SHR), which covers > 95% of
      all groin hernia repairs in Sweden. The very large cohort of more than 38,000 TEP (totally
      extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enables assessment of the
      relative risks for recurrence depending on complex combinations of plausible risk factors, in
      particular mesh, mesh fixation, hernia size and hernia type, with fulfilling statistical
      power.

      Each participant was entered at the date of surgery, when demographic and intraoperative data
      were registered. Reoperations were registered in the SHR in the same manner as index repairs,
      and were used as endpoints.
observational model: Cohort
time perspective: Prospective
measure: Reoperation for recurrence
time frame: Assessment at Dec 31, 2018
description: The date of the recurrent surgery
measure: Death
time frame: Assessment at Dec 31, 2018
description: The date of death
arm group label: StdPPM
description: Standard pure polypropylene mesh.
"Standard" is defined in SHR by weight ≥ 50 g/square meter.
arm group label: LWM
description: Lightweight mesh: Either a pure polypropylene mesh, or a polypropylene-based composite mesh.
The study uses SHR's classification of "light-weight" = <50 g/square meter.
arm group label: Tacks, metal
description: Metal staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.
arm group label: Tacks, absorbable
description: Absorbable synthetic staples or tacks. Material specification of staples/tacks was introduced in SHR 2012.
arm group label: Tacks, uncategorized
description: Staples or tacks were in SHR 2005-2011 not further categorized.
This category also includes staples/tacks registered from 2012 and forth, not being specified as either metal or absorbable.
arm group label: Fibrin glue
description: Biologic glue/sealant produced from human donor blood
arm group label: Non-fixation
description: Mesh is deployed without fixation
arm group label: 3D Mesh
description: Mesh categorized by anatomical shaped, rather than material or weight. Therefore, this category will be excluded in the original study. Depending on the volume of casess found, the 3D mesh category may eventually be analyzed separately in another study..
intervention type: Procedure
intervention name: TEP
description: By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device
arm group label: 3D Mesh
arm group label: Fibrin glue
arm group label: LWM
arm group label: Non-fixation
arm group label: StdPPM
arm group label: Tacks, absorbable
arm group label: Tacks, metal
arm group label: Tacks, uncategorized
other name: Laparoscopic totally extraperitoneal mesh repair
intervention type: Procedure
intervention name: TAPP
description: By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device
arm group label: 3D Mesh
arm group label: Fibrin glue
arm group label: LWM
arm group label: Non-fixation
arm group label: StdPPM
arm group label: Tacks, absorbable
arm group label: Tacks, metal
arm group label: Tacks, uncategorized
other name: Laparoscopic transabdominal preperitoneal mesh repair
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Bengt Novik
role: Principal Investigator
affiliation: Dept of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, Stockholm
citation: Novik B, Nordin P, Skullman S, Dalenback J, Enochsson L. More recurrences after hernia mesh fixation with short-term absorbable sutures: A registry study of 82 015 Lichtenstein repairs. Arch Surg. 2011 Jan;146(1):12-7. doi: 10.1001/archsurg.2010.302.
PMID: 21242440
citation: Novik B, Hagedorn S, Mork UB, Dahlin K, Skullman S, Dalenback J. Fibrin glue for securing the mesh in laparoscopic totally extraperitoneal inguinal hernia repair: a study with a 40-month prospective follow-up period. Surg Endosc. 2006 Mar;20(3):462-7. doi: 10.1007/s00464-005-0391-3. Epub 2006 Jan 19. Erratum In: Surg Endosc. 2022 May;36(5):3675.
PMID: 16424986
citation: Novik B, et al. Mesh and mesh fixation in laparoscopic groin hernia repairs. A study of 25,189 TEP and TAPP in the Swedish Hernia Registry [congress abstract]. Hernia 2019; 23 (Suppl 2):S251-S252. https://doi.org/10.1007/s10029-019-02013-8
citation: Novik B, Sandblom G, Ansorge C, Thorell A. Association of Mesh and Fixation Options with Reoperation Risk after Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study of 25,190 Totally Extraperitoneal and Transabdominal Preperitoneal Repairs. J Am Coll Surg. 2022 Mar 1;234(3):311-325. doi: 10.1097/XCS.0000000000000060.
PMID: 35213495
responsible party type: Sponsor-Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Bengt Novik
investigator title: Principal Investigator
mesh term: Hernia
mesh term: Recurrence
mesh term: Hernia, Inguinal
mesh term: Hernia, Femoral
sharing ipd: No