<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/NCT04450758</url>
  </required_header>
  <id_info>
    <org_study_id>Skane University Hospital</org_study_id>
    <nct_id>NCT04450758</nct_id>
  </id_info>
  <brief_title>Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma</brief_title>
  <acronym>ACBC</acronym>
  <official_title>Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma: a Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Skane University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Skane University Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      P patients with acute obstructive colon cancer I resection or bridge to surgery with stent or&#xD;
      stoma C emergency procedure O morbidity and mortality within 30 days, 90 day mortality and 3&#xD;
      &amp; 5 years overall survival&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this prospective observational study is to evaluate primary resection for&#xD;
      malignant obstruction of the colon compared to only decompression as first intervention&#xD;
      regarding postoperative outcomes. We hypothesize that patients with malignant obstruction&#xD;
      benefit from avoidance of emergency cancer resection, by a two-stage procedure, with&#xD;
      decompression by a stoma or stent as first intervention, leading to decreased short-term&#xD;
      morbidity and mortality and improved long-term oncological outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2031</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</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>Number of patients with 30-day severe morbidity</measure>
    <time_frame>30 days</time_frame>
    <description>Clavien-Dindo &gt;3 within 30 days postop</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival after 3 years</measure>
    <time_frame>3 years</time_frame>
    <description>survival unspecified</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with 30 day mortality</measure>
    <time_frame>30 days</time_frame>
    <description>death within 30 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival after 5 years</measure>
    <time_frame>5 years</time_frame>
    <description>survival unspecified</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with 90 day mortality</measure>
    <time_frame>90 days</time_frame>
    <description>death within 90 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with locally radical resections</measure>
    <time_frame>90 days</time_frame>
    <description>resections regarded as R0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of examined mesenteric lymph nodes</measure>
    <time_frame>90 days</time_frame>
    <description>lymph nodes examined by pathologist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients receiving neoadjuvant or adjuvant treatment</measure>
    <time_frame>1 year</time_frame>
    <description>patients receiveing chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with stomas after 3 years</measure>
    <time_frame>3 years</time_frame>
    <description>patients with bowel continuity without stome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence rate after 3 after years</measure>
    <time_frame>3 years</time_frame>
    <description>relapse within 3 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival after 3 years</measure>
    <time_frame>3 years</time_frame>
    <description>survival without disease relapse after 3 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients not being subjected to resection of initially decompressed</measure>
    <time_frame>90 days</time_frame>
    <description>patients not proceeding to resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bridging interval</measure>
    <time_frame>90 days</time_frame>
    <description>interval between stenting or stoma and resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of stent complications (perforations, migration, bleeding, success rate etc)</measure>
    <time_frame>90 days</time_frame>
    <description>complications in stent group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of stoma complications</measure>
    <time_frame>90 days</time_frame>
    <description>complications in stoma group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity and survival and impact of tumour location</measure>
    <time_frame>5 years</time_frame>
    <description>30 day morbidity and mortality depending on tumour location i.e. right or left colon</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of laparoscopic resections</measure>
    <time_frame>90 days</time_frame>
    <description>numbers of laparoscopic vs open resections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of primary anastomosis</measure>
    <time_frame>90 days</time_frame>
    <description>number of primary anastomosis in the Bridge to Surgery vs up front resection group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of stomas after resection and type of stoma</measure>
    <time_frame>90 days</time_frame>
    <description>number of stomas in Bridge to Surgery vs up front resection group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total hospital stay in days</measure>
    <time_frame>90 days</time_frame>
    <description>days in hospital in Bridge to Surgery vs up front resection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>colorectal surgeon performing resectional surgery</measure>
    <time_frame>90 days</time_frame>
    <description>qualified colorectal surgeon, general surgeon or resident performing resectional surgery</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>resection</arm_group_label>
    <description>Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with acute resection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bridge to sugery</arm_group_label>
    <description>Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with bridge to surgery i.e. either stent or stoma and resection later on.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bridge to Surgery (stent or stoma)</intervention_name>
    <description>The study is an observational study and patients will not be randomized. Resection is defined as upfront surgical resection, Bridge to Surgery as a two stage procedure.</description>
    <arm_group_label>bridge to sugery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Prospective observational cohort study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Symptomatic large bowel obstruction requiring acute intervention&#xD;
&#xD;
          -  CT-verified colon obstruction due to colon cancer independent of presence of&#xD;
             metastases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Colonic perforation or bleeding&#xD;
&#xD;
          -  Colonic obstruction of other origin than colon cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pamela Buchwald, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Skane University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pamela Buchwald, PhD MD</last_name>
    <phone>0046331000</phone>
    <email>pamela.buchwald@med.lu.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ingrid Palmquist, RN</last_name>
    <phone>0046331000</phone>
    <email>ingrid.palmquist@med.lu.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Göteborg University</name>
      <address>
        <city>Göteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jennifer Park, PhD MD</last_name>
      <phone>031-3421000</phone>
    </contact>
    <contact_backup>
      <last_name>Forskningssk, RN</last_name>
      <phone>031-3421000</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Skane University Hospital</investigator_affiliation>
    <investigator_full_name>Pamela Buchwald</investigator_full_name>
    <investigator_title>consultant colorectal surgeon, associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT04450758/Prot_SAP_000.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/NCT04450758
org study id: Skane University Hospital
nct id: NCT04450758
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
P patients with acute obstructive colon cancer I resection or bridge to surgery with stent or
      stoma C emergency procedure O morbidity and mortality within 30 days, 90 day mortality and 3
      & 5 years overall survival
The aim of this prospective observational study is to evaluate primary resection for
      malignant obstruction of the colon compared to only decompression as first intervention
      regarding postoperative outcomes. We hypothesize that patients with malignant obstruction
      benefit from avoidance of emergency cancer resection, by a two-stage procedure, with
      decompression by a stoma or stent as first intervention, leading to decreased short-term
      morbidity and mortality and improved long-term oncological outcome.
observational model: Cohort
time perspective: Prospective
measure: Number of patients with 30-day severe morbidity
time frame: 30 days
description: Clavien-Dindo >3 within 30 days postop
measure: Overall survival after 3 years
time frame: 3 years
description: survival unspecified
measure: Number of patients with 30 day mortality
time frame: 30 days
description: death within 30 days
measure: Overall survival after 5 years
time frame: 5 years
description: survival unspecified
measure: Number of patients with 90 day mortality
time frame: 90 days
description: death within 90 days
measure: Number of patients with locally radical resections
time frame: 90 days
description: resections regarded as R0
measure: Number of examined mesenteric lymph nodes
time frame: 90 days
description: lymph nodes examined by pathologist
measure: Proportion of patients receiving neoadjuvant or adjuvant treatment
time frame: 1 year
description: patients receiveing chemotherapy
measure: Proportion of patients with stomas after 3 years
time frame: 3 years
description: patients with bowel continuity without stome
measure: Recurrence rate after 3 after years
time frame: 3 years
description: relapse within 3 years
measure: Disease-free survival after 3 years
time frame: 3 years
description: survival without disease relapse after 3 years
measure: Proportion of patients not being subjected to resection of initially decompressed
time frame: 90 days
description: patients not proceeding to resection
measure: bridging interval
time frame: 90 days
description: interval between stenting or stoma and resection
measure: Number of stent complications (perforations, migration, bleeding, success rate etc)
time frame: 90 days
description: complications in stent group
measure: Number of stoma complications
time frame: 90 days
description: complications in stoma group
measure: Morbidity and survival and impact of tumour location
time frame: 5 years
description: 30 day morbidity and mortality depending on tumour location i.e. right or left colon
measure: Number of laparoscopic resections
time frame: 90 days
description: numbers of laparoscopic vs open resections
measure: Number of primary anastomosis
time frame: 90 days
description: number of primary anastomosis in the Bridge to Surgery vs up front resection group
measure: Number of stomas after resection and type of stoma
time frame: 90 days
description: number of stomas in Bridge to Surgery vs up front resection group
measure: total hospital stay in days
time frame: 90 days
description: days in hospital in Bridge to Surgery vs up front resection
measure: colorectal surgeon performing resectional surgery
time frame: 90 days
description: qualified colorectal surgeon, general surgeon or resident performing resectional surgery
arm group label: resection
description: Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with acute resection.
arm group label: bridge to sugery
description: Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with bridge to surgery i.e. either stent or stoma and resection later on.
intervention type: Procedure
intervention name: Bridge to Surgery (stent or stoma)
description: The study is an observational study and patients will not be randomized. Resection is defined as upfront surgical resection, Bridge to Surgery as a two stage procedure.
arm group label: bridge to sugery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Pamela Buchwald, PhD MD
role: Principal Investigator
affiliation: Skane University Hospital
last name: Pamela Buchwald, PhD MD
phone: 0046331000
email: pamela.buchwald@med.lu.se
last name: Ingrid Palmquist, RN
phone: 0046331000
email: ingrid.palmquist@med.lu.se
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Skane University Hospital
investigator full name: Pamela Buchwald
investigator title: consultant colorectal surgeon, associate professor
mesh term: Colonic Neoplasms
sharing ipd: Yes
ipd info type: Study Protocol
provided document: 