<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/NCT01694238</url>
  </required_header>
  <id_info>
    <org_study_id>Stoma-Const</org_study_id>
    <nct_id>NCT01694238</nct_id>
  </id_info>
  <brief_title>A Randomized Trial on the Technical Aspects of Stoma Construction.</brief_title>
  <official_title>Circular, Mesh Enforced or Cruciate Incision in the Abdominal Wall Fascia for coloStomy Construction - A Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Swedish Society of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Swedish agreement concerning research and education of doctors</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <brief_summary>
    <textblock>
      An investigation on the difference in stoma hernia frequency related to surgical technique&#xD;
      when incising the fascia. All patients planned for elective colostomy formation are to be&#xD;
      included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann's&#xD;
      procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting&#xD;
      colostomy for any reason are all included.&#xD;
&#xD;
      The three groups for randomization are:&#xD;
&#xD;
      A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall&#xD;
      fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is&#xD;
      the parastomal hernia rate within 12 months from index surgery. Secondary end-points include&#xD;
      clinical variables, re-admission and/or re-operation due to any stoma complication, quality&#xD;
      of life and health economy analyses, at 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colostomy formation has been a standard surgical procedure for more than 100 years. Initially&#xD;
      the quality of life for stoma patients was all but good, as the appliances to collect the&#xD;
      feces were cumbersome, smelly and did not ensure non-leakage. As late as in the 60-ies&#xD;
      bandages were still primitive(1). Gradually these problems have decreased as techniques for&#xD;
      bandages have improved. A well functioning colostomy may in itself not negatively affect the&#xD;
      patient's Quality of Life (QoL)(2), although thorough information and support from stoma care&#xD;
      nurses is of utmost importance (3). However, this can only be said if the stoma is well&#xD;
      functioning and if the complications are kept to a minimum. The complication rate after stoma&#xD;
      formation is still considerable, with figures of 21-70% (4, 5) and studies have shown that&#xD;
      adequate height; type of stoma, BMI, emergency surgery and gender may be of importance in&#xD;
      reducing the risk of complications both in the short and long-term (6-8).&#xD;
&#xD;
      The surgical technique of stoma formation is only partly evidence based. There are few&#xD;
      studies directed at technical details about stoma construction and their future impact on&#xD;
      stoma function, apart from the importance of the stoma height (6). One study has tested to&#xD;
      standardize the skin incision to 2/3rds of the width of the bowel (9), although the actual&#xD;
      impact of this on the functional outcome of the stoma was not presented.. In the surgical&#xD;
      literature a cruciate incision in the fascia and extraction of the bowel through a hole&#xD;
      sufficient in size is a short description of the surgical technique (10). In clinical&#xD;
      practice sufficient size of the hole has often been equal to &quot;two fingers-width&quot;, is commonly&#xD;
      used, which refers to the width of the surgeon's fingers, a fairly inexact measurement. A&#xD;
      pilot study from Sahlgrenska University Hospital has found that this clinical practice for&#xD;
      the most part results in a skin incision diameter of 50% of the bowel width.&#xD;
&#xD;
      There have been discussions regarding the placement of the stoma and effects on hernia&#xD;
      incidence, whether in the obliquous muscle or the rectus abdominis (11) or if the bowel&#xD;
      should take an extraperitoneal route (ad modum Goligher) or not (12). No studies have been&#xD;
      sufficient in design or size to thoroughly answer the question.&#xD;
&#xD;
      Parastomal hernia is a long-term complication that is common, in the literature figures up to&#xD;
      almost 50% have been reported (13, 14). Attempts to reduce the rates of parastomal hernias&#xD;
      have been made in the last few years with a placement of a mesh, at the construction of the&#xD;
      stoma, (15-19). This practice has not been universally accepted, in part due to a hesitance&#xD;
      in the surgical society because of the risk of infections with foreign body material, and&#xD;
      partly due to that most studies are underpowered for their main outcome variable. Another&#xD;
      suggestion for the basic construction of the stoma has been to make a circular incision in&#xD;
      the fascia instead of a cruciate, but this has not been documented in any studies. It has&#xD;
      been described in conjunction with use of circular stapling devices in the skin, no hernias&#xD;
      were found, however the patient numbers were small (20). It is apparent that further studies&#xD;
      are most welcome.&#xD;
&#xD;
      The evaluation of parastomal hernias has been discussed. Janes et al. used clinical&#xD;
      examination in their studies (16, 17), and confirmed in a later study that the concurrence&#xD;
      with a CT-verified parastomal hernia was (21) sufficient if performed in a prone position.&#xD;
      Another recent study found that results from a CT-scan was not correlated with patient&#xD;
      symptoms (22). Other studies have evaluated the use of ultrasound and found it feasible (23).&#xD;
      The conclusion must be that evaluation of parastomal hernias may be difficult and must be&#xD;
      standardized in a study.&#xD;
&#xD;
      The hypothesis to be tested in this study is that a circular incision or mesh enforced&#xD;
      cruciate incision in the abdominal wall fascia with a diameter of 50% of the width of the&#xD;
      patients left colon results carries less risk of parastomal herniation than a cruciate&#xD;
      incision where the each of the arms measure 1/2 of the diameter of the patients left colon.&#xD;
&#xD;
      The aim of this trial is to compare the parastomal hernia formation within 12 months after&#xD;
      stoma surgery between circular, mesh enforced cruciate and cruciate incision.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">September 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stoma hernia frequency at 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>The frequency of stoma hernia at 12 months measured either by clinical examination or CT scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>12 months</time_frame>
    <description>Number of readmissions in the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative infections</measure>
    <time_frame>12 months</time_frame>
    <description>Postoperative infections at 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total hospital stay</measure>
    <time_frame>12 months</time_frame>
    <description>The total number of days in hospital during 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other complications</measure>
    <time_frame>12 months</time_frame>
    <description>The number and type of complications during 12 months postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 day mortality</measure>
    <time_frame>30 days</time_frame>
    <description>30 day mortality</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">209</enrollment>
  <condition>Colostomy</condition>
  <condition>Colorectal Neoplasm</condition>
  <condition>Diverticulitis</condition>
  <arm_group>
    <arm_group_label>Cruciate incision</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cruciate incision in the abdominal wall fascia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Circular incision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Circular incision in the fascia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mesh enforced cruciate incision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mesh enforcement and then cruciate incision in the abdominal wall fascia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cruciate incision</intervention_name>
    <arm_group_label>Cruciate incision</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Circular incision</intervention_name>
    <arm_group_label>Circular incision</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mesh enforced cruciate incision</intervention_name>
    <arm_group_label>Mesh enforced cruciate incision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presenting with a cancer or other conditions for which an elective surgical procedure&#xD;
             is planned and includes a permanent colostomy formation&#xD;
&#xD;
          -  possible to operate in regard to concomitant disease&#xD;
&#xD;
          -  giving informed consent to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not possible to operate due to concomitant disease&#xD;
&#xD;
          -  Participation in other randomized trials in conflict with the protocol and end-points&#xD;
             of the Stoma-Const trial.&#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>Eva Angenete, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg University and SSORG - Scandinavian Surgical Outcomes Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital/östra</name>
      <address>
        <city>Gothenburg</city>
        <zip>41685</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://www.ssorg.net</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Eva Angenete</investigator_full_name>
    <investigator_title>M.D., Ph.D., senior consultant surgeon</investigator_title>
  </responsible_party>
  <keyword>Colostomy</keyword>
  <keyword>Surgical technique</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Diverticulitis</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/NCT01694238
org study id: Stoma-Const
nct id: NCT01694238
lead sponsor: 
collaborator: 
collaborator: 
An investigation on the difference in stoma hernia frequency related to surgical technique
      when incising the fascia. All patients planned for elective colostomy formation are to be
      included. Patients undergoing rectal resection with a TME and a colostomy (Hartmann's
      procedure) for rectal cancer, abdominoperineal resection for rectal cancer or diverting
      colostomy for any reason are all included.

      The three groups for randomization are:

      A. circular incision in the abdominal wall fascia B. cruciate incision in the abdominal wall
      fascia C. mesh enforced cruciate incision in the abdominal wall fascia Primary endpoint is
      the parastomal hernia rate within 12 months from index surgery. Secondary end-points include
      clinical variables, re-admission and/or re-operation due to any stoma complication, quality
      of life and health economy analyses, at 12 months.
Colostomy formation has been a standard surgical procedure for more than 100 years. Initially
      the quality of life for stoma patients was all but good, as the appliances to collect the
      feces were cumbersome, smelly and did not ensure non-leakage. As late as in the 60-ies
      bandages were still primitive(1). Gradually these problems have decreased as techniques for
      bandages have improved. A well functioning colostomy may in itself not negatively affect the
      patient's Quality of Life (QoL)(2), although thorough information and support from stoma care
      nurses is of utmost importance (3). However, this can only be said if the stoma is well
      functioning and if the complications are kept to a minimum. The complication rate after stoma
      formation is still considerable, with figures of 21-70% (4, 5) and studies have shown that
      adequate height; type of stoma, BMI, emergency surgery and gender may be of importance in
      reducing the risk of complications both in the short and long-term (6-8).

      The surgical technique of stoma formation is only partly evidence based. There are few
      studies directed at technical details about stoma construction and their future impact on
      stoma function, apart from the importance of the stoma height (6). One study has tested to
      standardize the skin incision to 2/3rds of the width of the bowel (9), although the actual
      impact of this on the functional outcome of the stoma was not presented.. In the surgical
      literature a cruciate incision in the fascia and extraction of the bowel through a hole
      sufficient in size is a short description of the surgical technique (10). In clinical
      practice sufficient size of the hole has often been equal to "two fingers-width", is commonly
      used, which refers to the width of the surgeon's fingers, a fairly inexact measurement. A
      pilot study from Sahlgrenska University Hospital has found that this clinical practice for
      the most part results in a skin incision diameter of 50% of the bowel width.

      There have been discussions regarding the placement of the stoma and effects on hernia
      incidence, whether in the obliquous muscle or the rectus abdominis (11) or if the bowel
      should take an extraperitoneal route (ad modum Goligher) or not (12). No studies have been
      sufficient in design or size to thoroughly answer the question.

      Parastomal hernia is a long-term complication that is common, in the literature figures up to
      almost 50% have been reported (13, 14). Attempts to reduce the rates of parastomal hernias
      have been made in the last few years with a placement of a mesh, at the construction of the
      stoma, (15-19). This practice has not been universally accepted, in part due to a hesitance
      in the surgical society because of the risk of infections with foreign body material, and
      partly due to that most studies are underpowered for their main outcome variable. Another
      suggestion for the basic construction of the stoma has been to make a circular incision in
      the fascia instead of a cruciate, but this has not been documented in any studies. It has
      been described in conjunction with use of circular stapling devices in the skin, no hernias
      were found, however the patient numbers were small (20). It is apparent that further studies
      are most welcome.

      The evaluation of parastomal hernias has been discussed. Janes et al. used clinical
      examination in their studies (16, 17), and confirmed in a later study that the concurrence
      with a CT-verified parastomal hernia was (21) sufficient if performed in a prone position.
      Another recent study found that results from a CT-scan was not correlated with patient
      symptoms (22). Other studies have evaluated the use of ultrasound and found it feasible (23).
      The conclusion must be that evaluation of parastomal hernias may be difficult and must be
      standardized in a study.

      The hypothesis to be tested in this study is that a circular incision or mesh enforced
      cruciate incision in the abdominal wall fascia with a diameter of 50% of the width of the
      patients left colon results carries less risk of parastomal herniation than a cruciate
      incision where the each of the arms measure 1/2 of the diameter of the patients left colon.

      The aim of this trial is to compare the parastomal hernia formation within 12 months after
      stoma surgery between circular, mesh enforced cruciate and cruciate incision.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Stoma hernia frequency at 12 months
time frame: 12 months
description: The frequency of stoma hernia at 12 months measured either by clinical examination or CT scan
measure: Readmission
time frame: 12 months
description: Number of readmissions in the two groups
measure: Postoperative infections
time frame: 12 months
description: Postoperative infections at 12 months
measure: Total hospital stay
time frame: 12 months
description: The total number of days in hospital during 12 months
measure: Other complications
time frame: 12 months
description: The number and type of complications during 12 months postoperatively
measure: 30 day mortality
time frame: 30 days
description: 30 day mortality
arm group label: Cruciate incision
arm group type: Active Comparator
description: Cruciate incision in the abdominal wall fascia
arm group label: Circular incision
arm group type: Experimental
description: Circular incision in the fascia
arm group label: Mesh enforced cruciate incision
arm group type: Experimental
description: Mesh enforcement and then cruciate incision in the abdominal wall fascia
intervention type: Procedure
intervention name: Cruciate incision
arm group label: Cruciate incision
intervention type: Procedure
intervention name: Circular incision
arm group label: Circular incision
intervention type: Other
intervention name: Mesh enforced cruciate incision
arm group label: Mesh enforced cruciate incision
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Eva Angenete, M.D., Ph.D.
role: Principal Investigator
affiliation: Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg University and SSORG - Scandinavian Surgical Outcomes Research Group
facility: 
country: Sweden
url: http://www.ssorg.net
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Eva Angenete
investigator title: M.D., Ph.D., senior consultant surgeon
mesh term: Colorectal Neoplasms
mesh term: Diverticulitis