<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/NCT02233465</url>
  </required_header>
  <id_info>
    <org_study_id>09-021M</org_study_id>
    <nct_id>NCT02233465</nct_id>
  </id_info>
  <brief_title>Treating Parastomal Hernia With a Mesh</brief_title>
  <official_title>Mesh-repair With Inraperitoneal On-lay Mesh (IPOM) for Parastomal Hernia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norrbottens Lans Landsting</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norrbottens Lans Landsting</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parastomal herniation is difficult to treat. Several different treatment has been tested but&#xD;
      still none has revealed to be superior. The use of a mesh has been shown to be a promising&#xD;
      way of treating. In this study the investigators will evaluate safety and hernia recurrence&#xD;
      rate with a mesh tailored to treat parastomal hernias &quot;Parastomal hernia mesh BARD&quot; in&#xD;
      patients with parastomal hernia requiring surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parastomal hernia is a common complication in patients with a stoma and may cause the patient&#xD;
      difficulties with stomal dressing and leakage of stomal content, as well as pain and risk for&#xD;
      incarceration. The exact hernia incidence is not known, it depends on the definition of&#xD;
      whether a bulge is considered a hernia or not, as well as the duration of follow-up. The&#xD;
      reported incidence ranges between 0 and 52%. The majority of parastomal hernias develop&#xD;
      within a few years after the index operation, but can appear as late as 20 years after&#xD;
      surgery.&#xD;
&#xD;
      There is no superior treatment for an existing parastomal hernia. Several methods have been&#xD;
      tested and used such as stoma relocation, sutures to narrow the opening in the fascia and&#xD;
      abdominal wall and fixation and closure of the lateral space but none has proven to prevent&#xD;
      from recurrence of herniation. Mesh repair has been shown to give a lower recurrence rate&#xD;
      0-33%. No technical factor, such as site of stoma formation (through or lateral to rectus&#xD;
      abdominis muscle), related to the construction of the stoma was proven to prevent hernia&#xD;
      formation.&#xD;
&#xD;
      To find a way to prevent the occurrence of parastomal hernia is an important issue. Today&#xD;
      there are reports proposing a mesh in sublay position at the index operation would prevent&#xD;
      hernia formation. Although the results are promising these studies are small and they do not&#xD;
      meet the issue late complications according to the mesh implant.&#xD;
&#xD;
      The use of intraperitoneal on-lay mesh (IPOM) is widely used to treat incisional hernia. A&#xD;
      new mesh (Parastomal hernia mesh BARD) has been tailored to treat parastomal hernia. To&#xD;
      evaluate safety and hernia recurrence rate using the BARD-mesh for treating parastomal hernia&#xD;
      a prospective multicentre non-randomised study is performed. The aim is to include 50&#xD;
      patients in the study.&#xD;
&#xD;
      Patients with parastomal hernia requiring surgery due to leakage, problems with stoma&#xD;
      dressing, bulging, incarceration and other problems related to the hernia will be offered&#xD;
      enrollment in the study after informed consent. The preoperative examination include clinical&#xD;
      examination, three dimensional ultrasonography (3D) and or computed tomography (CT) of the&#xD;
      abdomen.&#xD;
&#xD;
      Surgery at the four hospitals will be performed by experienced colorectal surgeons with a&#xD;
      special interest in parastomal hernias. Postoperatively the patients will be allowed to&#xD;
      mobilize according to each hospital postoperative routines. Follow-up visits at one month,&#xD;
      one year and three year are scheduled. Early complications like infections, ileus, myocardial&#xD;
      infarction, pneumonia, urinary infection and thrombosis are evaluated at one-month follow-up&#xD;
      by clinical examination. At one and three year follow-up late complications and possible&#xD;
      recurrence of parastomal hernias will be searched for. CT will be performed one year&#xD;
      postoperatively. At the three year follow-up CT and or 3D will be performed.&#xD;
&#xD;
      Important outcome measures are complications and recurrence of parastomal hernia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parastomal recurrence rate</measure>
    <time_frame>One year and three year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>three months, one year and three year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Parastomal Hernia</condition>
  <arm_group>
    <arm_group_label>IPOM Mesh-repair parastomal hernia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mesh-repair of para-stomal hernia. Patients with para-stomal hernia requiring surgery are offererd enrollment in the study. Preoperatively a CT-scan of the abdomen and or a 3D ultrasonography of the stoma is performed. All patients in the stydy are operated with IPOM-mesh designed for treatment of parastomal hernia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No mesh-repair</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients not attending the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IPOM Mesh-repair parastomal hernia</intervention_name>
    <description>Safety study for mesh-repair of parastomal hernia</description>
    <arm_group_label>IPOM Mesh-repair parastomal hernia</arm_group_label>
    <other_name>Device: Parastomal hernia patch BARD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parastomal hernia requiring surgery, over the age of 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient not accepting participation&#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>Pia Näsvall, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dep of Surgical and Perioperative Sciences, Umeå University</affiliation>
  </overall_official>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>May 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>March 19, 2015</last_update_submitted>
  <last_update_submitted_qc>March 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Norrbottens Lans Landsting</investigator_affiliation>
    <investigator_full_name>Pia Nasvall</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>parastomal</keyword>
  <keyword>hernia</keyword>
  <keyword>mesh</keyword>
  <keyword>parastomal hernia-repair with mesh</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT02233465
org study id: 09-021M
nct id: NCT02233465
lead sponsor: 
has dmc: No
Parastomal herniation is difficult to treat. Several different treatment has been tested but
      still none has revealed to be superior. The use of a mesh has been shown to be a promising
      way of treating. In this study the investigators will evaluate safety and hernia recurrence
      rate with a mesh tailored to treat parastomal hernias "Parastomal hernia mesh BARD" in
      patients with parastomal hernia requiring surgery.
Parastomal hernia is a common complication in patients with a stoma and may cause the patient
      difficulties with stomal dressing and leakage of stomal content, as well as pain and risk for
      incarceration. The exact hernia incidence is not known, it depends on the definition of
      whether a bulge is considered a hernia or not, as well as the duration of follow-up. The
      reported incidence ranges between 0 and 52%. The majority of parastomal hernias develop
      within a few years after the index operation, but can appear as late as 20 years after
      surgery.

      There is no superior treatment for an existing parastomal hernia. Several methods have been
      tested and used such as stoma relocation, sutures to narrow the opening in the fascia and
      abdominal wall and fixation and closure of the lateral space but none has proven to prevent
      from recurrence of herniation. Mesh repair has been shown to give a lower recurrence rate
      0-33%. No technical factor, such as site of stoma formation (through or lateral to rectus
      abdominis muscle), related to the construction of the stoma was proven to prevent hernia
      formation.

      To find a way to prevent the occurrence of parastomal hernia is an important issue. Today
      there are reports proposing a mesh in sublay position at the index operation would prevent
      hernia formation. Although the results are promising these studies are small and they do not
      meet the issue late complications according to the mesh implant.

      The use of intraperitoneal on-lay mesh (IPOM) is widely used to treat incisional hernia. A
      new mesh (Parastomal hernia mesh BARD) has been tailored to treat parastomal hernia. To
      evaluate safety and hernia recurrence rate using the BARD-mesh for treating parastomal hernia
      a prospective multicentre non-randomised study is performed. The aim is to include 50
      patients in the study.

      Patients with parastomal hernia requiring surgery due to leakage, problems with stoma
      dressing, bulging, incarceration and other problems related to the hernia will be offered
      enrollment in the study after informed consent. The preoperative examination include clinical
      examination, three dimensional ultrasonography (3D) and or computed tomography (CT) of the
      abdomen.

      Surgery at the four hospitals will be performed by experienced colorectal surgeons with a
      special interest in parastomal hernias. Postoperatively the patients will be allowed to
      mobilize according to each hospital postoperative routines. Follow-up visits at one month,
      one year and three year are scheduled. Early complications like infections, ileus, myocardial
      infarction, pneumonia, urinary infection and thrombosis are evaluated at one-month follow-up
      by clinical examination. At one and three year follow-up late complications and possible
      recurrence of parastomal hernias will be searched for. CT will be performed one year
      postoperatively. At the three year follow-up CT and or 3D will be performed.

      Important outcome measures are complications and recurrence of parastomal hernia.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Parastomal recurrence rate
time frame: One year and three year
measure: Complications
time frame: three months, one year and three year
arm group label: IPOM Mesh-repair parastomal hernia
arm group type: Experimental
description: Mesh-repair of para-stomal hernia. Patients with para-stomal hernia requiring surgery are offererd enrollment in the study. Preoperatively a CT-scan of the abdomen and or a 3D ultrasonography of the stoma is performed. All patients in the stydy are operated with IPOM-mesh designed for treatment of parastomal hernia.
arm group label: No mesh-repair
arm group type: No Intervention
description: Patients not attending the study
intervention type: Procedure
intervention name: IPOM Mesh-repair parastomal hernia
description: Safety study for mesh-repair of parastomal hernia
arm group label: IPOM Mesh-repair parastomal hernia
other name: Device: Parastomal hernia patch BARD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pia Näsvall, MD
role: Principal Investigator
affiliation: Dep of Surgical and Perioperative Sciences, Umeå University
responsible party type: Principal Investigator
investigator affiliation: Norrbottens Lans Landsting
investigator full name: Pia Nasvall
investigator title: MD
mesh term: Hernia