<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/NCT01670851</url>
  </required_header>
  <id_info>
    <org_study_id>ISIS.11.01.06.BS/SC</org_study_id>
    <nct_id>NCT01670851</nct_id>
  </id_info>
  <brief_title>Perineal Reconstruction Following eLAPE and Simultaneous Stoma Sublay Reinforcement</brief_title>
  <acronym>PRESSUR</acronym>
  <official_title>Perineal Reconstruction Following Extralevator Abdominoperineal Excision of Rectum and Simultaneous Stoma Sublay Reinforcement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals, Leicester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Slagelse Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospitals, Leicester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multicenter, single arm, observational pilot study to assess the&#xD;
      clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction&#xD;
      following eLAPE and simultaneous stoma reinforcement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      About 40 subjects will be enrolled from 4 centers over approx 24 months. Subjects will all be&#xD;
      undergoing extralevator abdominoperineal excision with concomitant ostomy creation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Perineal wound healing</measure>
    <time_frame>12 months</time_frame>
    <description>Perineal wound healing will be assessed using the Southamptom Wound Scoring System and perineal pain assessed using a visual analogue scale (VAS) daily during hospital stay and then POD 7, 30 and months 3, 6 and 12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of perineal herniation</measure>
    <time_frame>24 months</time_frame>
    <description>Incidence of perineal hernia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of parastomal hernia</measure>
    <time_frame>24 months</time_frame>
    <description>Stoma will be assessed for herniation at Months 3, 6, 12 and 24</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>Strattice</arm_group_label>
    <description>eLAPE</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Strattice</intervention_name>
    <description>Perineal reconstruction and stoma reinforcement with Strattice</description>
    <arm_group_label>Strattice</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with low rectal carcinoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary cancers undergoing curative surgery (R0)&#xD;
&#xD;
          -  Life expectancy &gt; 2 yrs&#xD;
&#xD;
          -  Neoadjuvant radiotherapy with or without chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pelvic extenteration or extended resections&#xD;
&#xD;
          -  Previously irradiated patients (i.e. radiation therapy for a previous cancer)&#xD;
&#xD;
          -  Co-morbidities of: systemic infection, chronic liver failure, chronic renal failure,&#xD;
             HIV, Hepatitis C, other advanced/metastatic cancer, collagen disorder&#xD;
&#xD;
          -  sensitivity to porcine derived products or polysorbate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baljit Singh, FRCS, FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Leicester, UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sanjay Chaudhri, FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Leicester, UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Per J Nilsson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre J Maina, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Slagelse Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>W Bemelman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academic Medical Center, Amsterdam, Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Slagelse Hospital</name>
      <address>
        <city>Slagelse</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Leicester</name>
      <address>
        <city>Leicester</city>
        <zip>LE5 4PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Netherlands</country>
  </removed_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>December 7, 2015</last_update_submitted>
  <last_update_submitted_qc>December 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>eLAPE,</keyword>
  <keyword>perineum,</keyword>
  <keyword>pelvic floor reconstruction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</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/NCT01670851
org study id: ISIS.11.01.06.BS/SC
nct id: NCT01670851
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This is a prospective, multicenter, single arm, observational pilot study to assess the
      clinical outcomes of Strattice Reconstructive Tissue Matrix for perineal reconstruction
      following eLAPE and simultaneous stoma reinforcement.
About 40 subjects will be enrolled from 4 centers over approx 24 months. Subjects will all be
      undergoing extralevator abdominoperineal excision with concomitant ostomy creation.
observational model: Cohort
time perspective: Prospective
measure: Perineal wound healing
time frame: 12 months
description: Perineal wound healing will be assessed using the Southamptom Wound Scoring System and perineal pain assessed using a visual analogue scale (VAS) daily during hospital stay and then POD 7, 30 and months 3, 6 and 12.
measure: Incidence of perineal herniation
time frame: 24 months
description: Incidence of perineal hernia
measure: Incidence of parastomal hernia
time frame: 24 months
description: Stoma will be assessed for herniation at Months 3, 6, 12 and 24
arm group label: Strattice
description: eLAPE
intervention type: Device
intervention name: Strattice
description: Perineal reconstruction and stoma reinforcement with Strattice
arm group label: Strattice
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Baljit Singh, FRCS, FACS
role: Principal Investigator
affiliation: University Hospital Leicester, UK
last name: Sanjay Chaudhri, FRCS
role: Principal Investigator
affiliation: University Hospital Leicester, UK
last name: Per J Nilsson, MD
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Pierre J Maina, MD
role: Principal Investigator
affiliation: Slagelse Hospital, Denmark
last name: W Bemelman, MD
role: Principal Investigator
affiliation: Academic Medical Center, Amsterdam, Netherlands
facility: 
facility: 
facility: 
country: Denmark
country: Sweden
country: United Kingdom
country: Netherlands
responsible party type: Sponsor
mesh term: Rectal Neoplasms