<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/NCT03750942</url>
  </required_header>
  <id_info>
    <org_study_id>NL63259.068.17</org_study_id>
    <nct_id>NCT03750942</nct_id>
  </id_info>
  <brief_title>PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial</brief_title>
  <acronym>PROMISS</acronym>
  <official_title>PROphylactic Mesh to Prevent Incisional Hernias at the Former Stoma Site: the PROMISS-trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maastricht University Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale:&#xD;
&#xD;
      Approximately 7000 stomata are created in the Netherlands every year. The occurrence of a&#xD;
      parastomal herniation is high, with a reported incidence of 4-48%. Also, the former stoma&#xD;
      site is at increased risk for the development of an incisional hernia. A clinical incisional&#xD;
      hernia rate of 30% is reported after stoma reversal. Herniation can cause pain, deformity and&#xD;
      possibly incarceration, which results in a significant impact on the quality of life of the&#xD;
      patient.&#xD;
&#xD;
      The hypothesis of this study is that the use of a prophylactic mesh at the time of stoma&#xD;
      formation leads to a lower incidence of incisional hernias after stoma reversal, an improved&#xD;
      quality of life and therefore a possible cost reduction in healthcare.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To evaluate the incidence of incisional hernias after stoma reversal after preventive mesh&#xD;
      placement compared to no mesh placement. In addition, we aim to assess the effect of&#xD;
      preventive mesh placement on the quality of life and the effect on healthcare cost reduction&#xD;
      by avoiding re-intervention.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      A multicentre double blind randomized controlled trial with a total follow up of 24 months.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      Adults (18-99) undergoing bowel resection with the formation of a temporary stoma.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      A preventive mesh will be placed using a sublay keyhole technique (pre-peritoneal,&#xD;
      retromuscular) at stoma formation. The mesh will be left in situ after stoma reversal and the&#xD;
      hole in the mesh will be closed, to prevent incisional herniation.&#xD;
&#xD;
      Main study parameters/endpoints:&#xD;
&#xD;
        -  Primary: Incidence of incisional hernias after stoma reversal&#xD;
&#xD;
        -  Secondary: Quality of life, stoma related prolapse or parastomal herniation, cost&#xD;
           effectiveness and mesh related complications.&#xD;
&#xD;
      Nature and extent of the burden and the risks associated with participation, benefit and&#xD;
      group relatedness:&#xD;
&#xD;
      The standard surgical procedure for the treatment of parastomal hernias is used in a&#xD;
      prophylactic fashion. As this is standard care in parastomal hernias the risks are minimal.&#xD;
      The mesh that is used is CE approved. The burden of participation in this study is minimal&#xD;
      for the patient all follow-up visits coincide with the regular visits for colorectal cancer.&#xD;
      Hence, no extra outpatient department visits, and even no additional diagnostics nor other&#xD;
      medical procedures that could potentially burden the patient, are required.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of incisional hernia at the former stoma site.</measure>
    <time_frame>24 months</time_frame>
    <description>Incidence of incisional hernia Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of parastomal hernia</measure>
    <time_frame>24 months</time_frame>
    <description>Incidence of parastomal hernia Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of prolapse</measure>
    <time_frame>24 months</time_frame>
    <description>Incidence of prolapse Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of mesh infection</measure>
    <time_frame>24 months</time_frame>
    <description>Incidence of mesh infection Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of wound infections</measure>
    <time_frame>24 months</time_frame>
    <description>Incidence of wound infections Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of Seroma</measure>
    <time_frame>24 months</time_frame>
    <description>Incidence of seroma Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life score</measure>
    <time_frame>24 months</time_frame>
    <description>Quality of life postoperatively assessed through questionnaires.&#xD;
- EQ-5D-5L (0-25), lower is considered a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life score</measure>
    <time_frame>24 months</time_frame>
    <description>Quality of life postoperatively assessed through questionnaires.&#xD;
- Carolina Comfort scale (0-40), lower is considered a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life score</measure>
    <time_frame>24 months</time_frame>
    <description>Quality of life postoperatively assessed through questionnaires.&#xD;
- EORTC QLQ-CR29 (0-228), lower is considered a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operation length</measure>
    <time_frame>during operation</time_frame>
    <description>Time from start of the operation to finish (min), longer operation time can be an indication of a more complex procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to stoma reversal</measure>
    <time_frame>time from stoma creation to reversal</time_frame>
    <description>Time between creation of the stoma and its reversal, will be expressed in days. (minimum of 14 days to a maximum of 730 days). It will be measured from creation of stoma to reversal, which is 6 weeks on average, if the stoma is not reversed within 24 months the patient is excluded. For it will not be able to reach the primary endpoint. Delay of reversal of the stoma may indicate that patient condition or other patient related factors are not optimal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>24 months</time_frame>
    <description>Cost benefit analysis involving health cost and societal cost due to inability to participate in work. Lower health care cost are considered a better outcome, it is hypothesised that preventive treatment results in less cost by avoiding reoperations and readmission on the long term.&#xD;
Assessment will be performed using questionnaires; the iMCQ questionnaires for cost effectiveness analysis.&#xD;
The questions of the questionnaire will be analysed separately, for the questions range from yes/no questions to multiple choice or questions regarding number of days/ hours worked.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>24 months</time_frame>
    <description>Cost benefit analysis involving health cost and societal cost due to inability to participate in work. Lower health care cost are considered a better outcome, it is hypothesised that preventive treatment results in less cost by avoiding reoperations and readmission on the long term.&#xD;
Assessment will be performed using questionnaires; the iPCQ questionnaires for cost effectiveness analysis.&#xD;
The questions of the questionnaire will be analysed separately, for the questions range from yes/no questions to multiple choice or questions regarding number of days/ hours worked.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Incisional Hernia</condition>
  <arm_group>
    <arm_group_label>Adhesix® monofilament polypropylene mesh (Bard Davol) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention arm will receive a mesh surrounding the stoma at the time of creation of the stoma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will not receive a mesh and the stoma will be created according local protocol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adhesix® monofilament polypropylene mesh (Bard Davol)</intervention_name>
    <description>The intervention group will receive preventive mesh placement and in the control group no mesh is placed, the stoma is closed according to standard practise.</description>
    <arm_group_label>Adhesix® monofilament polypropylene mesh (Bard Davol) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Diagnosed with colorectal carcinoma&#xD;
&#xD;
          -  Bowel resection following stoma formation, intended to be temporary.&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
          -  ASA-score I-III&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency operation&#xD;
&#xD;
          -  Peritonitis (i.e. bowel perforation)&#xD;
&#xD;
          -  Bowel obstruction&#xD;
&#xD;
          -  A life expectancy of less than 2 years (distant metastasis i.e. located in the liver,&#xD;
             peritoneum, lung, cerebral or bone)&#xD;
&#xD;
          -  Earlier hernia repair with mesh placed in a 10cm proximity of the future stoma site.&#xD;
&#xD;
          -  Chronic use of antibiotics&#xD;
&#xD;
          -  Chronic use of immunosuppressive medication&#xD;
&#xD;
          -  ASA-score IV or above&#xD;
&#xD;
          -  Not able to sign informed consent&#xD;
&#xD;
          -  Patient being unable to speak Dutch&#xD;
&#xD;
          -  Patient allergic to one of the components of the mesh&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole D Bouvy, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Centre, department of Surgery</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicole D Bouvy, MD, PhD</last_name>
    <phone>+3143-3875492</phone>
    <email>n.bouvy@mumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sebastiaan Steensel, MD</last_name>
    <phone>+3143-3872354</phone>
    <email>s.vansteensel@maastrichtuniversity.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maastricht University Medical Centre</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <contact>
      <last_name>Nicole Bouvy, MD, PhD</last_name>
      <phone>043-3875492</phone>
      <email>n.bouvy@mumc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 20, 2018</last_update_submitted>
  <last_update_submitted_qc>November 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maastricht University Medical Center</investigator_affiliation>
    <investigator_full_name>Sebastiaan van Steensel</investigator_full_name>
    <investigator_title>PhD candidate</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03750942
org study id: NL63259.068.17
nct id: NCT03750942
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Rationale:

      Approximately 7000 stomata are created in the Netherlands every year. The occurrence of a
      parastomal herniation is high, with a reported incidence of 4-48%. Also, the former stoma
      site is at increased risk for the development of an incisional hernia. A clinical incisional
      hernia rate of 30% is reported after stoma reversal. Herniation can cause pain, deformity and
      possibly incarceration, which results in a significant impact on the quality of life of the
      patient.

      The hypothesis of this study is that the use of a prophylactic mesh at the time of stoma
      formation leads to a lower incidence of incisional hernias after stoma reversal, an improved
      quality of life and therefore a possible cost reduction in healthcare.

      Objective:

      To evaluate the incidence of incisional hernias after stoma reversal after preventive mesh
      placement compared to no mesh placement. In addition, we aim to assess the effect of
      preventive mesh placement on the quality of life and the effect on healthcare cost reduction
      by avoiding re-intervention.

      Study design:

      A multicentre double blind randomized controlled trial with a total follow up of 24 months.

      Study population:

      Adults (18-99) undergoing bowel resection with the formation of a temporary stoma.

      Intervention:

      A preventive mesh will be placed using a sublay keyhole technique (pre-peritoneal,
      retromuscular) at stoma formation. The mesh will be left in situ after stoma reversal and the
      hole in the mesh will be closed, to prevent incisional herniation.

      Main study parameters/endpoints:

        -  Primary: Incidence of incisional hernias after stoma reversal

        -  Secondary: Quality of life, stoma related prolapse or parastomal herniation, cost
           effectiveness and mesh related complications.

      Nature and extent of the burden and the risks associated with participation, benefit and
      group relatedness:

      The standard surgical procedure for the treatment of parastomal hernias is used in a
      prophylactic fashion. As this is standard care in parastomal hernias the risks are minimal.
      The mesh that is used is CE approved. The burden of participation in this study is minimal
      for the patient all follow-up visits coincide with the regular visits for colorectal cancer.
      Hence, no extra outpatient department visits, and even no additional diagnostics nor other
      medical procedures that could potentially burden the patient, are required.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Prevention
masking: Single (Participant)
measure: Occurrence of incisional hernia at the former stoma site.
time frame: 24 months
description: Incidence of incisional hernia Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
measure: Occurrence of parastomal hernia
time frame: 24 months
description: Incidence of parastomal hernia Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
measure: Occurence of prolapse
time frame: 24 months
description: Incidence of prolapse Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
measure: Occurence of mesh infection
time frame: 24 months
description: Incidence of mesh infection Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
measure: Occurence of wound infections
time frame: 24 months
description: Incidence of wound infections Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
measure: Occurence of Seroma
time frame: 24 months
description: Incidence of seroma Expressed in % ranging from 0-100%, a lower percentage is considered a better outcome.
measure: Quality of life score
time frame: 24 months
description: Quality of life postoperatively assessed through questionnaires.
- EQ-5D-5L (0-25), lower is considered a better outcome
measure: Quality of life score
time frame: 24 months
description: Quality of life postoperatively assessed through questionnaires.
- Carolina Comfort scale (0-40), lower is considered a better outcome.
measure: Quality of life score
time frame: 24 months
description: Quality of life postoperatively assessed through questionnaires.
- EORTC QLQ-CR29 (0-228), lower is considered a better outcome.
measure: Operation length
time frame: during operation
description: Time from start of the operation to finish (min), longer operation time can be an indication of a more complex procedure.
measure: Time to stoma reversal
time frame: time from stoma creation to reversal
description: Time between creation of the stoma and its reversal, will be expressed in days. (minimum of 14 days to a maximum of 730 days). It will be measured from creation of stoma to reversal, which is 6 weeks on average, if the stoma is not reversed within 24 months the patient is excluded. For it will not be able to reach the primary endpoint. Delay of reversal of the stoma may indicate that patient condition or other patient related factors are not optimal.
measure: Cost-effectiveness
time frame: 24 months
description: Cost benefit analysis involving health cost and societal cost due to inability to participate in work. Lower health care cost are considered a better outcome, it is hypothesised that preventive treatment results in less cost by avoiding reoperations and readmission on the long term.
Assessment will be performed using questionnaires; the iMCQ questionnaires for cost effectiveness analysis.
The questions of the questionnaire will be analysed separately, for the questions range from yes/no questions to multiple choice or questions regarding number of days/ hours worked.
measure: Cost-effectiveness
time frame: 24 months
description: Cost benefit analysis involving health cost and societal cost due to inability to participate in work. Lower health care cost are considered a better outcome, it is hypothesised that preventive treatment results in less cost by avoiding reoperations and readmission on the long term.
Assessment will be performed using questionnaires; the iPCQ questionnaires for cost effectiveness analysis.
The questions of the questionnaire will be analysed separately, for the questions range from yes/no questions to multiple choice or questions regarding number of days/ hours worked.
arm group label: Adhesix® monofilament polypropylene mesh (Bard Davol) group
arm group type: Experimental
description: The intervention arm will receive a mesh surrounding the stoma at the time of creation of the stoma.
arm group label: Control group
arm group type: No Intervention
description: The control group will not receive a mesh and the stoma will be created according local protocol.
intervention type: Device
intervention name: Adhesix® monofilament polypropylene mesh (Bard Davol)
description: The intervention group will receive preventive mesh placement and in the control group no mesh is placed, the stoma is closed according to standard practise.
arm group label: Adhesix® monofilament polypropylene mesh (Bard Davol) group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Nicole D Bouvy, MD, PhD
role: Principal Investigator
affiliation: Maastricht University Medical Centre, department of Surgery
last name: Nicole D Bouvy, MD, PhD
phone: +3143-3875492
email: n.bouvy@mumc.nl
last name: Sebastiaan Steensel, MD
phone: +3143-3872354
email: s.vansteensel@maastrichtuniversity.nl
facility: 
contact: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Maastricht University Medical Center
investigator full name: Sebastiaan van Steensel
investigator title: PhD candidate
mesh term: Hernia
mesh term: Incisional Hernia
sharing ipd: Undecided