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/NCT05981937</url>
    </required_header>
    <id_info>
      <org_study_id>GREEN COLONIC SAFE ANASTOMOSIS</org_study_id>
      <nct_id>NCT05981937</nct_id>
    </id_info>
    <brief_title>ICG Anastomosis Control in Colon Surgery</brief_title>
    <official_title>Indocyanine Green ICG in Segmentary Resection in Colo-rectal Surgery is Usefull to Decrease Leak Threshold: A Paralel Retrospetive Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Azienda Unità Sanitaria Locale di Piacenza</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Azienda Unità Sanitaria Locale di Piacenza</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</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>
        This is a parallel monocentric, retrospective cohort study in Guglielmo da Saliceto Hospital,&#xD;
        Piacenza, Italy. Aim of this study is to investigate the protective role of Indocyanine green&#xD;
        (ICG) for Anastomotic leak (AL) in patients underwent elective segmentary colic resection&#xD;
        (transverse colic resection, sigmoidectomy, left colic resection and Hartmann's reversal).&#xD;
        Secondary aims are to detect and to investigate the impact of various risk factors on AL and&#xD;
        morbidity and surgical performance within 30 days to surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a parallel monocentric, retrospective cohort study observing consecutive series of&#xD;
        patients underwent colo-rectal surgery at our institution between 1 January 2017 and 31 July&#xD;
        2023.&#xD;
  &#xD;
        The primary endpoint of the study is Anastomotic leak (AL) at 30 days while secondary&#xD;
        endpoints are post-operative morbidity Clavien-Dindo score ≥III within 30 days from surgery&#xD;
        including readmission and redo-surgery, harvested nodes for patients with neoplastic disease,&#xD;
        Surgical Site Infection, rate of laparoscopic surgical procedure and rate of protection&#xD;
        stoma.&#xD;
  &#xD;
        Sex, BMI, smoking, diabetes mellitus, cardiovascular disease, tumor stage according to AJJC&#xD;
        8th edition will be considered confounding factor for onset of AL.&#xD;
  &#xD;
        Patients electronic database will be collected from extraction of medical record in operating&#xD;
        log and every digital medical record will be scanned including peri-operative outcomes and 30&#xD;
        days post-operative follow-up from post-operative visit, eventually readmission in emergency&#xD;
        department or any other specialistic wards of our local health institution according to&#xD;
        following inclusion criteria: elective setting of surgery, segmentary left colon surgery&#xD;
        including transverse resection and Hartmann stoma reversal even for benign or malign&#xD;
        pathology, at least 30 days of post-operative follow-up available from medical documentation,&#xD;
        primary colo-colic or colo-rectal anastomosis with or without preventing ostomy and adult&#xD;
        age.&#xD;
  &#xD;
        Exclusion criteria are terminal colonic stoma without anastomosis creation after demolitive&#xD;
        step, extended transverse right hemicolectomy, left hemicolectomy with high vascular&#xD;
        ligation, associated bowel or another splanchnic resection (i.e. neoplastic infiltration),&#xD;
        previous colic surgery, synchronous neoplasm, not reporting in operating form details about&#xD;
        vascular ligation, lack in reporting in medical records of primary outcomes, stage IV cancer,&#xD;
        less than 18 years old and emergency setting.&#xD;
  &#xD;
        The reconstruction time is performed with different anastomosis (colo-colic or colo-rectal),&#xD;
        technique (stapler or hand sewn) and connection (side to side, side to end, end to side or&#xD;
        end to end).&#xD;
  &#xD;
        ICG-ATT is available at our institute since 2019 using a near-infrared (NIR) light source and&#xD;
        special scope and camera equipped with xenon light (CARL STORZ GmbH &amp; Co. KG, Tuttlingen,&#xD;
        Germany); ICG was supplied as a sterile water-soluble lyophilized powder (Diagnostic Green®&#xD;
        GmbH). ICG-ATT is routinely used whenever available in daily practice with the following&#xD;
        protocol: after the specimen resection the two colonic stumps or colonic and rectal stumps&#xD;
        are checked with 5 cc of ICG 25 mg diluted in 10 cc of water sterile solution before&#xD;
        fashioned anastomosis. Two laparoscopes with ICG-optic system are nowadays available&#xD;
        department and ICG anastomosis control is always performed if ICG device are available (no&#xD;
        performed in case of not available ICG instrument for sterilization in case of two&#xD;
        consecutive surgery in the same day, concomitant ICG surgery or ICG malfunction).&#xD;
  &#xD;
        Statistical analysis and sample size:&#xD;
  &#xD;
        Quantitative variables will be described by mean± standard deviation or median and IQR, and&#xD;
        qualitative variables will be described by absolute and percentage frequencies. Normality&#xD;
        will be checked for all continuous variables. Comparisons of covariates will be conducted&#xD;
        using Pearson's X2 test or Fisher's exact test for categorical variables and a t-test or Mann&#xD;
        Whitney test for continuous variables. Univariable analysis will be conducted using logistic&#xD;
        regression to examine the association of each predictor variable with the anastomotic leakage&#xD;
        event. Next, variables with p&lt;0.1 will be considered for inclusion in a multivariable&#xD;
        regression model. For each risk factor, odds ratio with associated confidence intervals will&#xD;
        have been presented. All analyses will be performed using RStudio version 3.6.0 statistical&#xD;
        software with two-side significance tests and a 5% significance level.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">July 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 20, 2024</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>Anastomotic leak at 30 days</measure>
      <time_frame>30 days</time_frame>
      <description>Anastomotic leak (a defect of intestinal wall at anastomotic site leading to a communication between the intra- and extraluminal compartments)at 30 days: abdominal CT scan IV and a Clavien Dindo Score ≥III</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Post-operative morbidity</measure>
      <time_frame>30 days</time_frame>
      <description>Clavien-Dindo score ≥III within 30 days from surgery including readmission and redo-surgery, harvested nodes for patients with neoplastic disease, Surgical Site Infection, rate of laparoscopic surgical procedure and rate of protection stoma.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Colon Surgery</condition>
    <condition>Anastomotic Leak</condition>
    <arm_group>
      <arm_group_label>Indocyanine Green</arm_group_label>
      <description>Indocyanine green infusion in left-side colorectal surgery (elective segmentary colic resection)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>non-Indocyanine Green</arm_group_label>
      <description>No infusion of Indocyanine green in left-side colorectal surgery (elective segmentary colic resection )</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ICG solution</intervention_name>
      <description>ICG-ATT is available at our institute since 2019 using a near-infrared (NIR) light source and special scope and camera equipped with xenon light (CARL STORZ GmbH &amp; Co. KG, Tuttlingen, Germany); ICG was supplied as a sterile water-soluble lyophilized powder (Diagnostic Green® GmbH). ICG-ATT is routinely used whenever available in daily practice with the following protocol: after the specimen resection the two colonic stumps or colonic and rectal stumps are checked with 5 cc of ICG 25 mg diluted in 10 cc of water sterile solution before fashioned anastomosis. Two laparoscopes with ICG-optic system are nowadays available department and ICG anastomosis control is always performed if ICG device are available (no performed in case of not available ICG instrument for sterilization in case of two consecutive surgery in the same day, concomitant ICG surgery or ICG malfunction).</description>
      <arm_group_label>Indocyanine Green</arm_group_label>
      <other_name>Indocyanine Green</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A consecutive series of patients underwent colo-rectal surgery at our institution between 1&#xD;
          January 2017 and 31 July 2023&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  elective setting of surgery&#xD;
  &#xD;
            -  segmentary left colon surgery including transverse resection and Hartmann stoma&#xD;
               reversal even for benign or malign pathology&#xD;
  &#xD;
            -  30 days of post-operative follow-up at least available from medical documentation&#xD;
  &#xD;
            -  primary colo-colic or colo-rectal anastomosis with or without preventing ostomy&#xD;
  &#xD;
            -  more than 18 years old, less than 90 years old&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  terminal colonic stoma without anastomosis creation after demolitive step&#xD;
  &#xD;
            -  extended transverse right hemicolectomy&#xD;
  &#xD;
            -  left hemicolectomy with high vascular ligation&#xD;
  &#xD;
            -  associated bowel or another splanchnic resection (i.e. neoplastic infiltration)&#xD;
  &#xD;
            -  previous colic surgery&#xD;
  &#xD;
            -  synchronous neoplasm&#xD;
  &#xD;
            -  not reporting in operating form details about vascular ligation&#xD;
  &#xD;
            -  lack in reporting in medical records of primary outcomes&#xD;
  &#xD;
            -  stage IV cancer&#xD;
  &#xD;
            -  less than 18 years old, more then 90 years old&#xD;
  &#xD;
            -  emergency setting&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Andrea Romboli, MD</last_name>
      <phone>+39 0523303161</phone>
      <email>a.romboli@ausl.pc.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Guglielmo da Saliceto Hospital</name>
        <address>
          <city>Piacenza</city>
          <zip>29121</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrea Romboli, MD</last_name>
        <email>a.romboli@ausl.pc.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Azienda Unità Sanitaria Locale di Piacenza</investigator_affiliation>
      <investigator_full_name>Elena Orlandi</investigator_full_name>
      <investigator_title>Principal Investigator, Medical Doctor</investigator_title>
    </responsible_party>
    <keyword>ICG</keyword>
    <keyword>Colon Surgery</keyword>
    <keyword>Anastomotic Leak</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anastomotic Leak</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05981937
  org study id: GREEN COLONIC SAFE ANASTOMOSIS
  nct id: NCT05981937
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This is a parallel monocentric, retrospective cohort study in Guglielmo da Saliceto Hospital,
        Piacenza, Italy. Aim of this study is to investigate the protective role of Indocyanine green
        (ICG) for Anastomotic leak (AL) in patients underwent elective segmentary colic resection
        (transverse colic resection, sigmoidectomy, left colic resection and Hartmann's reversal).
        Secondary aims are to detect and to investigate the impact of various risk factors on AL and
        morbidity and surgical performance within 30 days to surgery.
  This is a parallel monocentric, retrospective cohort study observing consecutive series of
        patients underwent colo-rectal surgery at our institution between 1 January 2017 and 31 July
        2023.
  
        The primary endpoint of the study is Anastomotic leak (AL) at 30 days while secondary
        endpoints are post-operative morbidity Clavien-Dindo score ≥III within 30 days from surgery
        including readmission and redo-surgery, harvested nodes for patients with neoplastic disease,
        Surgical Site Infection, rate of laparoscopic surgical procedure and rate of protection
        stoma.
  
        Sex, BMI, smoking, diabetes mellitus, cardiovascular disease, tumor stage according to AJJC
        8th edition will be considered confounding factor for onset of AL.
  
        Patients electronic database will be collected from extraction of medical record in operating
        log and every digital medical record will be scanned including peri-operative outcomes and 30
        days post-operative follow-up from post-operative visit, eventually readmission in emergency
        department or any other specialistic wards of our local health institution according to
        following inclusion criteria: elective setting of surgery, segmentary left colon surgery
        including transverse resection and Hartmann stoma reversal even for benign or malign
        pathology, at least 30 days of post-operative follow-up available from medical documentation,
        primary colo-colic or colo-rectal anastomosis with or without preventing ostomy and adult
        age.
  
        Exclusion criteria are terminal colonic stoma without anastomosis creation after demolitive
        step, extended transverse right hemicolectomy, left hemicolectomy with high vascular
        ligation, associated bowel or another splanchnic resection (i.e. neoplastic infiltration),
        previous colic surgery, synchronous neoplasm, not reporting in operating form details about
        vascular ligation, lack in reporting in medical records of primary outcomes, stage IV cancer,
        less than 18 years old and emergency setting.
  
        The reconstruction time is performed with different anastomosis (colo-colic or colo-rectal),
        technique (stapler or hand sewn) and connection (side to side, side to end, end to side or
        end to end).
  
        ICG-ATT is available at our institute since 2019 using a near-infrared (NIR) light source and
        special scope and camera equipped with xenon light (CARL STORZ GmbH & Co. KG, Tuttlingen,
        Germany); ICG was supplied as a sterile water-soluble lyophilized powder (Diagnostic Green®
        GmbH). ICG-ATT is routinely used whenever available in daily practice with the following
        protocol: after the specimen resection the two colonic stumps or colonic and rectal stumps
        are checked with 5 cc of ICG 25 mg diluted in 10 cc of water sterile solution before
        fashioned anastomosis. Two laparoscopes with ICG-optic system are nowadays available
        department and ICG anastomosis control is always performed if ICG device are available (no
        performed in case of not available ICG instrument for sterilization in case of two
        consecutive surgery in the same day, concomitant ICG surgery or ICG malfunction).
  
        Statistical analysis and sample size:
  
        Quantitative variables will be described by mean± standard deviation or median and IQR, and
        qualitative variables will be described by absolute and percentage frequencies. Normality
        will be checked for all continuous variables. Comparisons of covariates will be conducted
        using Pearson's X2 test or Fisher's exact test for categorical variables and a t-test or Mann
        Whitney test for continuous variables. Univariable analysis will be conducted using logistic
        regression to examine the association of each predictor variable with the anastomotic leakage
        event. Next, variables with p<0.1 will be considered for inclusion in a multivariable
        regression model. For each risk factor, odds ratio with associated confidence intervals will
        have been presented. All analyses will be performed using RStudio version 3.6.0 statistical
        software with two-side significance tests and a 5% significance level.
  observational model: Cohort
  time perspective: Retrospective
  measure: Anastomotic leak at 30 days
  time frame: 30 days
  description: Anastomotic leak (a defect of intestinal wall at anastomotic site leading to a communication between the intra- and extraluminal compartments)at 30 days: abdominal CT scan IV and a Clavien Dindo Score ≥III
  measure: Post-operative morbidity
  time frame: 30 days
  description: Clavien-Dindo score ≥III within 30 days from surgery including readmission and redo-surgery, harvested nodes for patients with neoplastic disease, Surgical Site Infection, rate of laparoscopic surgical procedure and rate of protection stoma.
  arm group label: Indocyanine Green
  description: Indocyanine green infusion in left-side colorectal surgery (elective segmentary colic resection)
  arm group label: non-Indocyanine Green
  description: No infusion of Indocyanine green in left-side colorectal surgery (elective segmentary colic resection )
  intervention type: Drug
  intervention name: ICG solution
  description: ICG-ATT is available at our institute since 2019 using a near-infrared (NIR) light source and special scope and camera equipped with xenon light (CARL STORZ GmbH & Co. KG, Tuttlingen, Germany); ICG was supplied as a sterile water-soluble lyophilized powder (Diagnostic Green® GmbH). ICG-ATT is routinely used whenever available in daily practice with the following protocol: after the specimen resection the two colonic stumps or colonic and rectal stumps are checked with 5 cc of ICG 25 mg diluted in 10 cc of water sterile solution before fashioned anastomosis. Two laparoscopes with ICG-optic system are nowadays available department and ICG anastomosis control is always performed if ICG device are available (no performed in case of not available ICG instrument for sterilization in case of two consecutive surgery in the same day, concomitant ICG surgery or ICG malfunction).
  arm group label: Indocyanine Green
  other name: Indocyanine Green
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Andrea Romboli, MD
  phone: +39 0523303161
  email: a.romboli@ausl.pc.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Azienda Unità Sanitaria Locale di Piacenza
  investigator full name: Elena Orlandi
  investigator title: Principal Investigator, Medical Doctor
  mesh term: Anastomotic Leak
  sharing ipd: No