<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/NCT01720966</url>
  </required_header>
  <id_info>
    <org_study_id>RU-RTB-0004</org_study_id>
    <nct_id>NCT01720966</nct_id>
  </id_info>
  <brief_title>Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection</brief_title>
  <acronym>ALIVE</acronym>
  <official_title>Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion&#xD;
      formation might be reduced by laparoscopic surgery, however sound evidence is lacking.&#xD;
      Colorectal surgery would be a good clinical model to investigate adhesion formation between&#xD;
      open and laparoscopic surgery because of the adhesion formation propensity of colorectal&#xD;
      surgery. However, a randomized controlled study to provide direct evidence is unlikely&#xD;
      because of large numbers of patients needed for such a trial and the difficulty to check for&#xD;
      adhesion formation at second surgery. Therefore we investigate adhesion formation after&#xD;
      laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases.&#xD;
&#xD;
      Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic&#xD;
      versus open surgery for colorectal malignancies during liver resection for colorectal&#xD;
      metastases.&#xD;
&#xD;
      Study design: The study is designed as a prospective observational cohort study.&#xD;
&#xD;
      Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for&#xD;
      intended liver resection or radio frequency ablation for liver metastases of a colorectal&#xD;
      malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions.&#xD;
&#xD;
      Main study parameters/endpoints:&#xD;
&#xD;
        -  Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site&#xD;
           of the original incision.&#xD;
&#xD;
        -  Secondary endpoints are episodes of bowel obstruction between index surgery and liver&#xD;
           surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of&#xD;
           adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative&#xD;
           complications: enterotomy, seromuscular injury, inadvertent organ injury during&#xD;
           adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: This study is an observational study. The existence of adhesions will be&#xD;
      assessed during laparotomy or laparoscopy for the treatment of liver metastases. The&#xD;
      laparotomy is indicated for medical treatment and should not be enlarged solely for the&#xD;
      assessment of adhesions nor will the operating time be influenced for this purpose.&#xD;
&#xD;
      Adhesions and peroperative complications have to be scored by the operating surgeon during or&#xD;
      directly after surgery. The postoperative complications have to be scored during the&#xD;
      postoperative course by the doctors on the ward. These assessments do not interfere with the&#xD;
      treatment of the patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 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>Incidence of adhesion to ventral abdominal wall</measure>
    <time_frame>peroperative (1 day)</time_frame>
    <description>To compare the incidence of adhesions to the ventral abdominal wall in patients undergoing laparotomy or laparoscopy for intended liver resection for colorectal metastases after open versus laparoscopic resection of the primary tumour.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adhesions</measure>
    <time_frame>peroperative (1 day)</time_frame>
    <description>Total incidence of adhesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extent of adhesions</measure>
    <time_frame>peroperative (1 day)</time_frame>
    <description>Extent of adhesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adhesion Score</measure>
    <time_frame>peroperative (1 day)</time_frame>
    <description>Adhesion score according to Zühlke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adhesiolysis</measure>
    <time_frame>peroperative (1 day)</time_frame>
    <description>need to perform adhesiolysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of adhesiolysis</measure>
    <time_frame>peroperative (1 day)</time_frame>
    <description>Duration of adhesiolysis in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inadvertent bowel injury</measure>
    <time_frame>peroperative (1 day)</time_frame>
    <description>Inadvertent bowel injury made during operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative mobidity</measure>
    <time_frame>30 days</time_frame>
    <description>Incidence of predetermined postoperative complications:&#xD;
mortality&#xD;
incisional wound infection&#xD;
abdominal sepsis&#xD;
pneumonia&#xD;
urinary tract infection</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Small bowel obstruction in history</measure>
    <time_frame>in history (up to 5 years preceeding second operation)</time_frame>
    <description>Patient has episode of small bowel obstruction in medical history</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Adhesions</condition>
  <arm_group>
    <arm_group_label>Laparoscopy</arm_group_label>
    <description>Patients who will undergo liver resection who have a laparoscopically performed colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparotomy</arm_group_label>
    <description>Patients who will undergo liver resection who have an open colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver resection</intervention_name>
    <description>Liver resection performed for metastatic disease from colorectal carcinoma</description>
    <arm_group_label>Laparoscopy</arm_group_label>
    <arm_group_label>Laparotomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients undergoing laparotomy or laparoscopy for intended liver resection&#xD;
        or radio frequency ablation for colorectal metastases in the before mentioned centers will&#xD;
        be assessed for eligibility. The planned number of patients will be recruited in&#xD;
        approximately 1 year.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  laparotomy or laparoscopy for intended liver resection or radio frequency ablation for&#xD;
             colorectal metastases&#xD;
&#xD;
          -  laparoscopy or laparotomy for colorectal malignancy in history&#xD;
&#xD;
          -  age ≥18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a history of abdominal surgery with a high risk of adhesions either before resection&#xD;
             of the primary tumour or during the interval between resection of the primary tumour&#xD;
             and liver resection. These high risk surgeries are:&#xD;
&#xD;
               -  Colorectal surgery&#xD;
&#xD;
               -  Ovarian surgery&#xD;
&#xD;
               -  Abdominal wall surgery&#xD;
&#xD;
          -  mental incompetence&#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>Harry P van Goor, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboud University Nijmegen Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gelre Ziekenhuis</name>
      <address>
        <city>Apeldoorn</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Gelderse Vallei</name>
      <address>
        <city>Ede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daniel de hoed kliniek</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maxima Medisch Centrum</name>
      <address>
        <city>Veldhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>ten Broek RP, Strik C, Issa Y, Bleichrodt RP, van Goor H. Adhesiolysis-related morbidity in abdominal surgery. Ann Surg. 2013 Jul;258(1):98-106. doi: 10.1097/SLA.0b013e31826f4969.</citation>
    <PMID>23013804</PMID>
  </reference>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>November 9, 2015</last_update_submitted>
  <last_update_submitted_qc>November 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adhesions</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>laparotomy</keyword>
  <keyword>liver resection</keyword>
  <keyword>colorectal malignancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Tissue Adhesions</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/NCT01720966
org study id: RU-RTB-0004
nct id: NCT01720966
lead sponsor: 
has dmc: No
Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion
      formation might be reduced by laparoscopic surgery, however sound evidence is lacking.
      Colorectal surgery would be a good clinical model to investigate adhesion formation between
      open and laparoscopic surgery because of the adhesion formation propensity of colorectal
      surgery. However, a randomized controlled study to provide direct evidence is unlikely
      because of large numbers of patients needed for such a trial and the difficulty to check for
      adhesion formation at second surgery. Therefore we investigate adhesion formation after
      laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases.

      Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic
      versus open surgery for colorectal malignancies during liver resection for colorectal
      metastases.

      Study design: The study is designed as a prospective observational cohort study.

      Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for
      intended liver resection or radio frequency ablation for liver metastases of a colorectal
      malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions.

      Main study parameters/endpoints:

        -  Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site
           of the original incision.

        -  Secondary endpoints are episodes of bowel obstruction between index surgery and liver
           surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of
           adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative
           complications: enterotomy, seromuscular injury, inadvertent organ injury during
           adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: This study is an observational study. The existence of adhesions will be
      assessed during laparotomy or laparoscopy for the treatment of liver metastases. The
      laparotomy is indicated for medical treatment and should not be enlarged solely for the
      assessment of adhesions nor will the operating time be influenced for this purpose.

      Adhesions and peroperative complications have to be scored by the operating surgeon during or
      directly after surgery. The postoperative complications have to be scored during the
      postoperative course by the doctors on the ward. These assessments do not interfere with the
      treatment of the patients.
observational model: Cohort
time perspective: Prospective
measure: Incidence of adhesion to ventral abdominal wall
time frame: peroperative (1 day)
description: To compare the incidence of adhesions to the ventral abdominal wall in patients undergoing laparotomy or laparoscopy for intended liver resection for colorectal metastases after open versus laparoscopic resection of the primary tumour.
measure: Incidence of adhesions
time frame: peroperative (1 day)
description: Total incidence of adhesions
measure: Extent of adhesions
time frame: peroperative (1 day)
description: Extent of adhesions
measure: Adhesion Score
time frame: peroperative (1 day)
description: Adhesion score according to Zühlke
measure: Adhesiolysis
time frame: peroperative (1 day)
description: need to perform adhesiolysis
measure: Duration of adhesiolysis
time frame: peroperative (1 day)
description: Duration of adhesiolysis in minutes
measure: Inadvertent bowel injury
time frame: peroperative (1 day)
description: Inadvertent bowel injury made during operation
measure: Postoperative mobidity
time frame: 30 days
description: Incidence of predetermined postoperative complications:
mortality
incisional wound infection
abdominal sepsis
pneumonia
urinary tract infection
measure: Small bowel obstruction in history
time frame: in history (up to 5 years preceeding second operation)
description: Patient has episode of small bowel obstruction in medical history
arm group label: Laparoscopy
description: Patients who will undergo liver resection who have a laparoscopically performed colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.
arm group label: Laparotomy
description: Patients who will undergo liver resection who have an open colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.
intervention type: Procedure
intervention name: Liver resection
description: Liver resection performed for metastatic disease from colorectal carcinoma
arm group label: Laparoscopy
arm group label: Laparotomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Harry P van Goor, MD, PhD
role: Principal Investigator
affiliation: Radboud University Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
citation: ten Broek RP, Strik C, Issa Y, Bleichrodt RP, van Goor H. Adhesiolysis-related morbidity in abdominal surgery. Ann Surg. 2013 Jul;258(1):98-106. doi: 10.1097/SLA.0b013e31826f4969.
PMID: 23013804
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Tissue Adhesions