<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/NCT04440514</url>
  </required_header>
  <id_info>
    <org_study_id>137157</org_study_id>
    <nct_id>NCT04440514</nct_id>
  </id_info>
  <brief_title>Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)</brief_title>
  <acronym>ePauli</acronym>
  <official_title>Endoscopic Preperitoneal Parastomal Hernia Repair (ePauli Repair)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sykehuset Innlandet HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sykehuset Innlandet HF</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>
      Observational study on laparoscopic and robotic extraperitoneal mesh repair of parastomal&#xD;
      hernia, employing TAR.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endoscopic trans-abdominal preperitoneal plasty (TAPP) for parastomal hernia employing&#xD;
      transversus abdominis release component separation (TAR) and reinforcement with mesh after&#xD;
      the Sugarbaker principle, but placing mesh extraabdominally, anteriorly to the transversalis&#xD;
      fascia. Laparoscopic and robotic procedures. Repair of concomitant midline hernia with&#xD;
      endoscopic enhanced-view Rives-Stoppa technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 2035</completion_date>
  <primary_completion_date type="Anticipated">June 2035</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>3 Years</target_duration>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>1 month</time_frame>
    <description>Per- and post-operative complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Late complications</measure>
    <time_frame>2 years</time_frame>
    <description>Stoma function, pain, mesh complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of hernia</measure>
    <time_frame>2 years</time_frame>
    <description>Hernia recurrence</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Parastomal Hernia</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>endoscopic preperitoneal repair of parastomal hernia</intervention_name>
    <description>repair of parastomal hernia after the Sugarbaker principle with TAR and preperitoneal mesh reinforcement</description>
    <other_name>ePauli</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with permanent ostomy and parastomal hernia in need of repair&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parastomal hernia with need of repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jan r lambrecht, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sykehuset Innlandet Hospital Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>jan r lambrecht, PhD</last_name>
    <phone>99703962</phone>
    <email>jan@lambrecht.no</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sykehuset Innlandet Hospital Trust</name>
      <address>
        <city>Brumunddal</city>
        <zip>2380</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Enrolling by invitation</status>
  </location>
  <location>
    <facility>
      <name>Sykehuset Innlandet HF</name>
      <address>
        <city>Hamar</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>jan r lambrecht, md, phd</last_name>
    </contact>
    <contact_backup>
      <last_name>lars martin rekkedal, md</last_name>
    </contact_backup>
    <investigator>
      <last_name>lambrecht</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Gavigan T, Stewart T, Matthews B, Reinke C. Patients Undergoing Parastomal Hernia Repair Using the Americas Hernia Society Quality Collaborative: A Prospective Cohort Study. J Am Coll Surg. 2018 Oct;227(4):393-403.e1. doi: 10.1016/j.jamcollsurg.2018.07.658. Epub 2018 Aug 4.</citation>
    <PMID>30081081</PMID>
  </reference>
  <reference>
    <citation>Nasvall P, Rutegard J, Dahlberg M, Gunnarsson U, Strigard K. Parastomal Hernia Repair with Intraperitoneal Mesh. Surg Res Pract. 2017;2017:8597463. doi: 10.1155/2017/8597463. Epub 2017 Oct 24.</citation>
    <PMID>29204515</PMID>
  </reference>
  <reference>
    <citation>Hansson BM, Slater NJ, van der Velden AS, Groenewoud HM, Buyne OR, de Hingh IH, Bleichrodt RP. Surgical techniques for parastomal hernia repair: a systematic review of the literature. Ann Surg. 2012 Apr;255(4):685-95. doi: 10.1097/SLA.0b013e31824b44b1.</citation>
    <PMID>22418006</PMID>
  </reference>
  <reference>
    <citation>DeAsis FJ, Lapin B, Gitelis ME, Ujiki MB. Current state of laparoscopic parastomal hernia repair: A meta-analysis. World J Gastroenterol. 2015 Jul 28;21(28):8670-7. doi: 10.3748/wjg.v21.i28.8670.</citation>
    <PMID>26229409</PMID>
  </reference>
  <reference>
    <citation>Pauli EM, Juza RM, Winder JS. How I do it: novel parastomal herniorrhaphy utilizing transversus abdominis release. Hernia. 2016 Aug;20(4):547-52. doi: 10.1007/s10029-016-1489-3. Epub 2016 Mar 29.</citation>
    <PMID>27023876</PMID>
  </reference>
  <reference>
    <citation>Jones CM, Winder JS, Potochny JD, Pauli EM. Posterior Component Separation with Transversus Abdominis Release: Technique, Utility, and Outcomes in Complex Abdominal Wall Reconstruction. Plast Reconstr Surg. 2016 Feb;137(2):636-646. doi: 10.1097/01.prs.0000475778.45783.e2.</citation>
    <PMID>26818302</PMID>
  </reference>
  <reference>
    <citation>Tastaldi L, Haskins IN, Perez AJ, Prabhu AS, Rosenblatt S, Rosen MJ. Single center experience with the modified retromuscular Sugarbaker technique for parastomal hernia repair. Hernia. 2017 Dec;21(6):941-949. doi: 10.1007/s10029-017-1644-5. Epub 2017 Aug 24.</citation>
    <PMID>28840354</PMID>
  </reference>
  <reference>
    <citation>Antoniou SA, Agresta F, Garcia Alamino JM, Berger D, Berrevoet F, Brandsma HT, Bury K, Conze J, Cuccurullo D, Dietz UA, Fortelny RH, Frei-Lanter C, Hansson B, Helgstrand F, Hotouras A, Janes A, Kroese LF, Lambrecht JR, Kyle-Leinhase I, Lopez-Cano M, Maggiori L, Mandala V, Miserez M, Montgomery A, Morales-Conde S, Prudhomme M, Rautio T, Smart N, Smietanski M, Szczepkowski M, Stabilini C, Muysoms FE. European Hernia Society guidelines on prevention and treatment of parastomal hernias. Hernia. 2018 Feb;22(1):183-198. doi: 10.1007/s10029-017-1697-5. Epub 2017 Nov 13.</citation>
    <PMID>29134456</PMID>
  </reference>
  <reference>
    <citation>Belyansky I, Reza Zahiri H, Sanford Z, Weltz AS, Park A. Early operative outcomes of endoscopic (eTEP access) robotic-assisted retromuscular abdominal wall hernia repair. Hernia. 2018 Oct;22(5):837-847. doi: 10.1007/s10029-018-1795-z. Epub 2018 Jul 4.</citation>
    <PMID>29974283</PMID>
  </reference>
  <reference>
    <citation>Imamura K, Takada M, Umemoto K, Furukawa S, Ambo Y, Nakamura F. Laparoscopic parastomal herniorrhaphy utilizing transversus abdominis release and a modified Sugarbaker technique: A case report. Asian J Endosc Surg. 2021 Jan;14(1):106-108. doi: 10.1111/ases.12804. Epub 2020 Jun 3.</citation>
    <PMID>32495518</PMID>
  </reference>
  <reference>
    <citation>Zolin SJ, Fafaj A, Krpata DM. Transversus abdominis release (TAR): what are the real indications and where is the limit? Hernia. 2020 Apr;24(2):333-340. doi: 10.1007/s10029-020-02150-5. Epub 2020 Mar 9.</citation>
    <PMID>32152808</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hernia</keyword>
  <keyword>parastomal</keyword>
  <keyword>robotic</keyword>
  <keyword>laparoscopic</keyword>
  <keyword>transversus abdominis release</keyword>
  <keyword>repair</keyword>
  <keyword>incisional</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No sharing</ipd_description>
  </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>June 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT04440514/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT04440514/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04440514
org study id: 137157
nct id: NCT04440514
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational study on laparoscopic and robotic extraperitoneal mesh repair of parastomal
      hernia, employing TAR.
Endoscopic trans-abdominal preperitoneal plasty (TAPP) for parastomal hernia employing
      transversus abdominis release component separation (TAR) and reinforcement with mesh after
      the Sugarbaker principle, but placing mesh extraabdominally, anteriorly to the transversalis
      fascia. Laparoscopic and robotic procedures. Repair of concomitant midline hernia with
      endoscopic enhanced-view Rives-Stoppa technique.
observational model: Cohort
time perspective: Prospective
measure: Adverse events
time frame: 1 month
description: Per- and post-operative complications
measure: Late complications
time frame: 2 years
description: Stoma function, pain, mesh complications
measure: Recurrence of hernia
time frame: 2 years
description: Hernia recurrence
intervention type: Procedure
intervention name: endoscopic preperitoneal repair of parastomal hernia
description: repair of parastomal hernia after the Sugarbaker principle with TAR and preperitoneal mesh reinforcement
other name: ePauli
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: jan r lambrecht, PhD
role: Principal Investigator
affiliation: Sykehuset Innlandet Hospital Trust
last name: jan r lambrecht, PhD
phone: 99703962
email: jan@lambrecht.no
facility: 
status: Enrolling by invitation
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Norway
citation: Gavigan T, Stewart T, Matthews B, Reinke C. Patients Undergoing Parastomal Hernia Repair Using the Americas Hernia Society Quality Collaborative: A Prospective Cohort Study. J Am Coll Surg. 2018 Oct;227(4):393-403.e1. doi: 10.1016/j.jamcollsurg.2018.07.658. Epub 2018 Aug 4.
PMID: 30081081
citation: Nasvall P, Rutegard J, Dahlberg M, Gunnarsson U, Strigard K. Parastomal Hernia Repair with Intraperitoneal Mesh. Surg Res Pract. 2017;2017:8597463. doi: 10.1155/2017/8597463. Epub 2017 Oct 24.
PMID: 29204515
citation: Hansson BM, Slater NJ, van der Velden AS, Groenewoud HM, Buyne OR, de Hingh IH, Bleichrodt RP. Surgical techniques for parastomal hernia repair: a systematic review of the literature. Ann Surg. 2012 Apr;255(4):685-95. doi: 10.1097/SLA.0b013e31824b44b1.
PMID: 22418006
citation: DeAsis FJ, Lapin B, Gitelis ME, Ujiki MB. Current state of laparoscopic parastomal hernia repair: A meta-analysis. World J Gastroenterol. 2015 Jul 28;21(28):8670-7. doi: 10.3748/wjg.v21.i28.8670.
PMID: 26229409
citation: Pauli EM, Juza RM, Winder JS. How I do it: novel parastomal herniorrhaphy utilizing transversus abdominis release. Hernia. 2016 Aug;20(4):547-52. doi: 10.1007/s10029-016-1489-3. Epub 2016 Mar 29.
PMID: 27023876
citation: Jones CM, Winder JS, Potochny JD, Pauli EM. Posterior Component Separation with Transversus Abdominis Release: Technique, Utility, and Outcomes in Complex Abdominal Wall Reconstruction. Plast Reconstr Surg. 2016 Feb;137(2):636-646. doi: 10.1097/01.prs.0000475778.45783.e2.
PMID: 26818302
citation: Tastaldi L, Haskins IN, Perez AJ, Prabhu AS, Rosenblatt S, Rosen MJ. Single center experience with the modified retromuscular Sugarbaker technique for parastomal hernia repair. Hernia. 2017 Dec;21(6):941-949. doi: 10.1007/s10029-017-1644-5. Epub 2017 Aug 24.
PMID: 28840354
citation: Antoniou SA, Agresta F, Garcia Alamino JM, Berger D, Berrevoet F, Brandsma HT, Bury K, Conze J, Cuccurullo D, Dietz UA, Fortelny RH, Frei-Lanter C, Hansson B, Helgstrand F, Hotouras A, Janes A, Kroese LF, Lambrecht JR, Kyle-Leinhase I, Lopez-Cano M, Maggiori L, Mandala V, Miserez M, Montgomery A, Morales-Conde S, Prudhomme M, Rautio T, Smart N, Smietanski M, Szczepkowski M, Stabilini C, Muysoms FE. European Hernia Society guidelines on prevention and treatment of parastomal hernias. Hernia. 2018 Feb;22(1):183-198. doi: 10.1007/s10029-017-1697-5. Epub 2017 Nov 13.
PMID: 29134456
citation: Belyansky I, Reza Zahiri H, Sanford Z, Weltz AS, Park A. Early operative outcomes of endoscopic (eTEP access) robotic-assisted retromuscular abdominal wall hernia repair. Hernia. 2018 Oct;22(5):837-847. doi: 10.1007/s10029-018-1795-z. Epub 2018 Jul 4.
PMID: 29974283
citation: Imamura K, Takada M, Umemoto K, Furukawa S, Ambo Y, Nakamura F. Laparoscopic parastomal herniorrhaphy utilizing transversus abdominis release and a modified Sugarbaker technique: A case report. Asian J Endosc Surg. 2021 Jan;14(1):106-108. doi: 10.1111/ases.12804. Epub 2020 Jun 3.
PMID: 32495518
citation: Zolin SJ, Fafaj A, Krpata DM. Transversus abdominis release (TAR): what are the real indications and where is the limit? Hernia. 2020 Apr;24(2):333-340. doi: 10.1007/s10029-020-02150-5. Epub 2020 Mar 9.
PMID: 32152808
responsible party type: Sponsor
mesh term: Hernia
sharing ipd: No
ipd description: No sharing
provided document: 
provided document: 