xml: <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/NCT05999162</url>
    </required_header>
    <id_info>
      <org_study_id>202306117RINA</org_study_id>
      <nct_id>NCT05999162</nct_id>
    </id_info>
    <brief_title>Mechanical Ileus in the Era of Minimally Invasive Colorectal Surgery</brief_title>
    <official_title>Changing Patterns and Surgical Outcomes for Mechanical Ileus in the Era of Minimally Invasive Colorectal Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The present study was to investigate if the incidence, patterns and surgical outcomes of&#xD;
        mechanical ileus have changed in the era of minimally invasive surgery (MIS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mechanical ileus, generally caused by post-operative bowel adhesion, represented 12-16% of&#xD;
        emergency surgical admissions and 20% of emergency surgical procedures. Opening the&#xD;
        peritoneal cavity, in whatever type of surgery, leads to the formation of potentially&#xD;
        obstructive structures (adhesions or bands) in almost 95% of patients. The adhesion resulted&#xD;
        from the irritation of the peritoneum caused by surgical trauma or intra-abdominal infection.&#xD;
        Bowel adhesions can lead to clinical manifestations within a few weeks or even several years&#xD;
        after the surgery. It has been reported that traditional open surgery (TOS) for colorectal&#xD;
        cancer were associated with a particularly higher risk of adhesion formation and related&#xD;
        complications. Within two years after colorectal surgery, 14.3% of the patients will suffer&#xD;
        from small bowel obstruction, and 2.6% will require a surgical intervention for the treatment&#xD;
        of this obstruction, and this incidence is even higher after rectal surgery. Adhesive ileus&#xD;
        has been a clinical conundrum. Overall, nearly one-fifth of patients needed re-admission for&#xD;
        a recurrent disease, even they had been successfully treated by surgical, or non-surgical&#xD;
        methods during the index admission.&#xD;
  &#xD;
        During the last decade, minimally invasive surgery (MIS), either via laparoscopic or robotic&#xD;
        approach, has become the standard procedures for the treatment of colorectal cancer.&#xD;
        Theoretically, MIS is associated with a much lower rate of postoperative formation of&#xD;
        adhesions than TOB, since adhesion formation represents a stepwise failure of peritoneal&#xD;
        tissue repair mechanisms, which can be prevented by the clean dissection, minimal blood loss&#xD;
        and/or less-environmental exposure of the bowel inherent in MIS. Some researchers supported&#xD;
        this concept by showing MIS colorectal surgery is associated with fewer adhesion-related&#xD;
        admissions than open surgery. However, most reported case series were retrospective&#xD;
        uncontrolled studies and were liable to some uncertainty; even in some rare randomized&#xD;
        controlled trials, the conclusions were contradictory. Moreover, adhesive ileus is just one&#xD;
        variant of mechanical ileus; some researchers have pointed out the MIS can paradoxically&#xD;
        create some specific types of mechanical ileus, such as internal or external herniation of&#xD;
        small intestine, or bowel twisting over the anastomotic site, and so on. Therefore, it&#xD;
        remains unclear whether MIS colorectal resection can reduce the incidence of the mechanical&#xD;
        ileus and improve the long-term bowel function, as compared with the TOS.&#xD;
  &#xD;
        Considering the aforementioned reasons, we conducted the present study to investigate if the&#xD;
        incidence, patterns and the treatment outcomes of post-operative mechanical ileus changed in&#xD;
        the era of MIS for colorectal cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Actual">August 13, 2023</completion_date>
    <primary_completion_date type="Actual">August 10, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Onset time</measure>
      <time_frame>Follow up period about five years with a median of 38.5 months.</time_frame>
      <description>Patients with mechanical ileus were stratified as acute, early, intermediate, and late onset, according to whether the mechanical ileus occurred within 3 months, 3-12 months, 1-2 years, or more than 2 years after the primary surgery for colorectal cancer, respectively.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The pattern of adhesion</measure>
      <time_frame>Follow up period about five years with a median of 38.5 months.</time_frame>
      <description>The pattern of adhesion may be recorded as follows: bands (&gt;1 cm long and &lt;1 cm diameter); simple adhesions (&lt;1 cm long and &gt;1 cm diameter) or matted adhesion (dense, multiple, and tangled)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The surgery of adhesive ileus</measure>
      <time_frame>Follow up period about five years with a median of 38.5 months.</time_frame>
      <description>The surgery for treating ileus may be recorded as follows: 1) band section; 2) lysis of simple adhesion; 3) lysis of matted adhesion; 4) extensive adhesiolysis, sutured or not serosal defect or sutured accidental enterotomies; or 5) even the segmental bowel resection in addition to whatever the previously mentioned procedures.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood loss</measure>
      <time_frame>About 3-4 hours</time_frame>
      <description>The intraoperative blood loss was recorded in mL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Operation time</measure>
      <time_frame>About 3-4 hours</time_frame>
      <description>The operation time was recorded in minutes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surgical complication</measure>
      <time_frame>Within 30 days</time_frame>
      <description>The Clavien-Dindo classification system was used to score the severity of surgical complications. The Clavien-Dindo Classification consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The higher the grade, the severer the complication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospitalization</measure>
      <time_frame>About 7-10 days</time_frame>
      <description>The length of hospital stay was calculated from the date of surgery for mechanical ileus to the day of discharge from the hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Re-admission</measure>
      <time_frame>Within 30 days</time_frame>
      <description>The patient needs to be readmitted to hospital due to index surgery.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">1544</enrollment>
    <condition>Colorectal Cancer</condition>
    <condition>Adhesion</condition>
    <arm_group>
      <arm_group_label>Minimally invasive surgery (MIS)</arm_group_label>
      <description>The patients underwent minimally invasive surgery for the treatment of colorectal cancer.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Traditional open surgery (TOS)</arm_group_label>
      <description>The patients underwent traditional open surgery for the treatment of colorectal cancer.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Minimally invasive surgery</intervention_name>
      <description>Minimally invasive surgery includes laparoscopic surgery or robotic surgery for the treatment of colorectal surgery.</description>
      <arm_group_label>Minimally invasive surgery (MIS)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The patients who diagnosed as colorectal cancer and underwent curative intent surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients whose primary colorectal cancers were resected in the fashion of curative and&#xD;
               elective surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients who underwent palliative or emergency surgery to treat their primary&#xD;
               colorectal cancer;&#xD;
  &#xD;
            -  patients encountered anastomotic leakage, intra-abdominal abscess or the other&#xD;
               surgical complications requiring an additional abdominopelvic surgical or non-surgical&#xD;
               procedures to treat the complications;&#xD;
  &#xD;
            -  simultaneously underwent some other abdominal or pelvic surgical procedures before or&#xD;
               after the primary colorectal surgery, e.g., reverse Hartmann's procedure or closure of&#xD;
               the temporary colostoma.&#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>Jin-Tung LIANG</last_name>
      <role>Study Chair</role>
      <affiliation>National Taiwan University Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>adhesive ileus</keyword>
    <keyword>internal herniation</keyword>
    <keyword>colorectal cancer</keyword>
    <keyword>minimally invasive surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999162
  org study id: 202306117RINA
  nct id: NCT05999162
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The present study was to investigate if the incidence, patterns and surgical outcomes of
        mechanical ileus have changed in the era of minimally invasive surgery (MIS).
  Mechanical ileus, generally caused by post-operative bowel adhesion, represented 12-16% of
        emergency surgical admissions and 20% of emergency surgical procedures. Opening the
        peritoneal cavity, in whatever type of surgery, leads to the formation of potentially
        obstructive structures (adhesions or bands) in almost 95% of patients. The adhesion resulted
        from the irritation of the peritoneum caused by surgical trauma or intra-abdominal infection.
        Bowel adhesions can lead to clinical manifestations within a few weeks or even several years
        after the surgery. It has been reported that traditional open surgery (TOS) for colorectal
        cancer were associated with a particularly higher risk of adhesion formation and related
        complications. Within two years after colorectal surgery, 14.3% of the patients will suffer
        from small bowel obstruction, and 2.6% will require a surgical intervention for the treatment
        of this obstruction, and this incidence is even higher after rectal surgery. Adhesive ileus
        has been a clinical conundrum. Overall, nearly one-fifth of patients needed re-admission for
        a recurrent disease, even they had been successfully treated by surgical, or non-surgical
        methods during the index admission.
  
        During the last decade, minimally invasive surgery (MIS), either via laparoscopic or robotic
        approach, has become the standard procedures for the treatment of colorectal cancer.
        Theoretically, MIS is associated with a much lower rate of postoperative formation of
        adhesions than TOB, since adhesion formation represents a stepwise failure of peritoneal
        tissue repair mechanisms, which can be prevented by the clean dissection, minimal blood loss
        and/or less-environmental exposure of the bowel inherent in MIS. Some researchers supported
        this concept by showing MIS colorectal surgery is associated with fewer adhesion-related
        admissions than open surgery. However, most reported case series were retrospective
        uncontrolled studies and were liable to some uncertainty; even in some rare randomized
        controlled trials, the conclusions were contradictory. Moreover, adhesive ileus is just one
        variant of mechanical ileus; some researchers have pointed out the MIS can paradoxically
        create some specific types of mechanical ileus, such as internal or external herniation of
        small intestine, or bowel twisting over the anastomotic site, and so on. Therefore, it
        remains unclear whether MIS colorectal resection can reduce the incidence of the mechanical
        ileus and improve the long-term bowel function, as compared with the TOS.
  
        Considering the aforementioned reasons, we conducted the present study to investigate if the
        incidence, patterns and the treatment outcomes of post-operative mechanical ileus changed in
        the era of MIS for colorectal cancer.
  observational model: Cohort
  time perspective: Retrospective
  measure: Onset time
  time frame: Follow up period about five years with a median of 38.5 months.
  description: Patients with mechanical ileus were stratified as acute, early, intermediate, and late onset, according to whether the mechanical ileus occurred within 3 months, 3-12 months, 1-2 years, or more than 2 years after the primary surgery for colorectal cancer, respectively.
  measure: The pattern of adhesion
  time frame: Follow up period about five years with a median of 38.5 months.
  description: The pattern of adhesion may be recorded as follows: bands (>1 cm long and <1 cm diameter); simple adhesions (<1 cm long and >1 cm diameter) or matted adhesion (dense, multiple, and tangled)
  measure: The surgery of adhesive ileus
  time frame: Follow up period about five years with a median of 38.5 months.
  description: The surgery for treating ileus may be recorded as follows: 1) band section; 2) lysis of simple adhesion; 3) lysis of matted adhesion; 4) extensive adhesiolysis, sutured or not serosal defect or sutured accidental enterotomies; or 5) even the segmental bowel resection in addition to whatever the previously mentioned procedures.
  measure: Blood loss
  time frame: About 3-4 hours
  description: The intraoperative blood loss was recorded in mL.
  measure: Operation time
  time frame: About 3-4 hours
  description: The operation time was recorded in minutes.
  measure: Surgical complication
  time frame: Within 30 days
  description: The Clavien-Dindo classification system was used to score the severity of surgical complications. The Clavien-Dindo Classification consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The higher the grade, the severer the complication.
  measure: Hospitalization
  time frame: About 7-10 days
  description: The length of hospital stay was calculated from the date of surgery for mechanical ileus to the day of discharge from the hospital.
  measure: Re-admission
  time frame: Within 30 days
  description: The patient needs to be readmitted to hospital due to index surgery.
  arm group label: Minimally invasive surgery (MIS)
  description: The patients underwent minimally invasive surgery for the treatment of colorectal cancer.
  arm group label: Traditional open surgery (TOS)
  description: The patients underwent traditional open surgery for the treatment of colorectal cancer.
  intervention type: Procedure
  intervention name: Minimally invasive surgery
  description: Minimally invasive surgery includes laparoscopic surgery or robotic surgery for the treatment of colorectal surgery.
  arm group label: Minimally invasive surgery (MIS)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jin-Tung LIANG
  role: Study Chair
  affiliation: National Taiwan University Hospital
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Colorectal Neoplasms
  sharing ipd: Undecided