<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/NCT04456933</url>
  </required_header>
  <id_info>
    <org_study_id>HEMI-E-INTRACORPOREA-2020</org_study_id>
    <nct_id>NCT04456933</nct_id>
  </id_info>
  <brief_title>Intracorporeal Anastomosis in Laparoscopic Left Colectomy. Cohort Comparative Study</brief_title>
  <acronym>RIAL-COLECTOMY</acronym>
  <official_title>RESECTION AND INTRACORPOREAL ANASTOMOSIS IN LAPAROSCOPIC LEFT COLECTOMY AS AN ADAPTATION TO THE PANDEMIC CAUSED BY SARS-CoV-2 (COVID19). A COMPARATIVE COHORT STUDY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Irene Gómez Torres</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laura Mora López</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anna Pallisera-Lloveras</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sheila Serra-Pla</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Albert García Nalda</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anna Serracant-Barrera</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mercedes Muñoz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oriol Pino-Pérez</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Corporacion Parc Tauli</source>
  <oversight_info>
    <has_dmc>No</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>
      OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and&#xD;
      anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to&#xD;
      extracoprporeal resection and anastomosis, in terms of anastomotic leakage.&#xD;
&#xD;
      BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary to infection&#xD;
      by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced to adapt our&#xD;
      surgical procedures in order to minimize exposure to the virus as much as possible.&#xD;
&#xD;
      Based on the recommendations in case of surgery in patients with highly contagious viral&#xD;
      diseases, the latest studies suggest minimally invasive accesses to minimize the risk of&#xD;
      contagion. One of the proposed measures is the performance of intracorporeal anastomoses.&#xD;
      Therefore, given the extensive experience of our center in minimally invasive surgery and&#xD;
      studies on the validation of intracorporeal anastomosis techniques in both laparoscopic&#xD;
      surgery of the right colon and rectum (TaTME), and the study of advantages that they can&#xD;
      provide to the patient, our intention is to apply it to surgery on the left colon, sigma and&#xD;
      upper rectum. Our hypothesis is that exteriorization of the colon through an accessory&#xD;
      incision increases the risk of tension at the mesocolon level, thus increasing the risk of&#xD;
      vascular deficit at the level of the staple area and it may increase the rate of anastomotic&#xD;
      leakage. In this sense, studies that validate a standard technique of intracorporeal&#xD;
      anastomosis in left colon surgery and that demonstrate its benefit with respect to&#xD;
      extracorporeal anastomosis are lacking. We intend to describe a new intracorporeal&#xD;
      anastomosis technique (ICA) that is feasible and safe for the patient and that can be applied&#xD;
      universally. Once the ICA technique is established, it will allow us to determine its&#xD;
      non-inferiority compared to the standard technique performed up to now with extracorporeal&#xD;
      anastomosis.&#xD;
&#xD;
      METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinoma will&#xD;
      be included into a prospective cohort and treated by laparoscopy with totally intracorporeal&#xD;
      resection and anastomosis. They will be compared with a retrospective cohort of consecutive&#xD;
      patients of identical characteristics treated by laparoscopy with extracorporeal resection&#xD;
      and anastomosis, in the immediate chronological period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HYPOTHESIS Resection of the left colon / sigmoid with intracorporeal colorectal TT&#xD;
      anastomosis is safe and not inferior to that performed extracorporeally. With the benefits of&#xD;
      reduced intraoperative dissection, traction on the mesenteries, reduced vascular compromise&#xD;
      of the anastomosis, a smaller incision size and being able to choose its location.&#xD;
&#xD;
      Main Aim:&#xD;
&#xD;
      The objective of this study is to demonstrate that colorectal mechanical end-to-end&#xD;
      intracorporeal anastomosis is not inferior to extracorporeal approach in terms of anastomotic&#xD;
      dehiscence.&#xD;
&#xD;
      Secondary Aims:&#xD;
&#xD;
        -  To demonstrate the reproducibility of the colorectal mechanical end-to-end&#xD;
           intracorporeal anastomosis technique in terms of reconversion, anastomotic dehiscence,&#xD;
           organo-cavitary infection, and other postoperative complications.&#xD;
&#xD;
        -  To determine the benefits that the IC anastomosis technique can bring to patients with&#xD;
           obesity.&#xD;
&#xD;
        -  To determine the benefits that the IC anastomosis technique can provide in terms of&#xD;
           postoperative complications, hospital stay, and size of the accessory incision.&#xD;
&#xD;
        -  To determine the benefit of the application of indocyanine green to determine the point&#xD;
           of resection and anastomosis.&#xD;
&#xD;
      STUDY DESIGN&#xD;
&#xD;
      Comparative, single-center, controlled non-inferiority cohort study of resection and&#xD;
      mechanical end-to-end intracorporeal anastomosis in left colon, sigmoid, and upper rectum&#xD;
      surgery (prospective cohort) versus the standard technique of extracorporeal laparoscopic&#xD;
      surgery (retrospective cohort).&#xD;
&#xD;
      SUBJECTS OF THE STUDY&#xD;
&#xD;
      In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the&#xD;
      left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by&#xD;
      our unit, collected in our database, by laparoscopic oncological surgery applying the&#xD;
      conventional extracorporeal anastomosis technique.&#xD;
&#xD;
      In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left&#xD;
      colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological&#xD;
      surgical indication with a laparoscopic approach since July 2020, to which the resection and&#xD;
      intracoporeal anastomosis technique will be applied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">February 28, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Percentage of anastomotic leak (AL)</measure>
    <time_frame>30 days</time_frame>
    <description>Percentage of anastomic leak (defined in accordance with Peel et al.).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of global morbidity</measure>
    <time_frame>30 days</time_frame>
    <description>Dindo-Clavien Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Surgical site infection</measure>
    <time_frame>30 days</time_frame>
    <description>SSI in accordance with the Center for Disease Control (CDC) National</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Re-interventions</measure>
    <time_frame>30 days</time_frame>
    <description>Percentage of re-interventions due to surgical complications</description>
  </secondary_outcome>
  <enrollment type="Anticipated">148</enrollment>
  <condition>Colon Cancer</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Extracorporeal left hemicolectomy anastomosis</intervention_name>
    <description>Standard surgical technique protocolized in the unit for laparoscopic surgery of the left colon, sigma and high rectum for the last 10 years.&#xD;
After sectioning the distal colon using a mechanical stapler (60mm blue load), a pfannestiel-type suprapubic accessory incision is made, with externalization of the tumor under wound protection with a ringed retraction device. Both the resection of the left mesocolon or mesosigma, and the placement of the head of the circular stapler are performed extracorporeally by proximal section of the colon with a pursetring® self-suturing device, removal of the piece, placement of the head, and reconnection of the pneumoperitoneum for colorectal anastomosis with Circular Stapler Curved B. Braun®</description>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intracorporeal left hemicolectomy anastomosis</intervention_name>
    <description>o Intracorporeal resection of the left mesocolon&#xD;
The mesocolon resection will be performed totally intracorporeally to its proximal end. The distal colon section will be performed using a mechanical stapler (blue charge 60mm)&#xD;
o Preparation of Intracorporeal Anastomosis&#xD;
The anastomosis will be performed in a mechanical end-to-end manner using a Circular Stapler Curved B. Braun®.&#xD;
The Insertion of the stapler head into the proximal colon will be placed intracorporeally with an incision distal to the staple section. Once the head has been exteriorized at the terminal end of the proximal colon, a circular purse-type suture with prolene 2.0 will be made.&#xD;
Once the mechanical colorectal anastomosis is performed, 4-6 stitches of anastomotic reinforcement with silk 2.0 will be placed.&#xD;
The extraction of the piece will be carried out with endobag protection and with an accessory incision (pfannestiel or other location depending on the patient)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the&#xD;
        left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically&#xD;
        by our unit, collected in our database, by laparoscopic oncological surgery applying the&#xD;
        conventional extracorporeal anastomosis technique.&#xD;
&#xD;
        In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left&#xD;
        colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological&#xD;
        surgical indication with a laparoscopic approach since July 2020, to which the resection&#xD;
        and intracoporeal anastomosis technique will be applied.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Left Colonic Adenocarcinoma. Location of the tumor in the left colon, sigma or high&#xD;
             rectum (with the anastomosis performed above the peritoneal reflection).&#xD;
             Non-metastatic stage. Scheduled oncological surgery with curative intention operated&#xD;
             on with laparoscopic surgery with resection technique and intracorporeal anastomosis.&#xD;
             Over 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other tumor locations. Non-adenocarcinoma tumors. Synchronous tumors. T4 tumor stage&#xD;
             and stage IV of TNM classification. ASA IV (American Society of Anesthesiologists).&#xD;
             Non-optimal nutritional study (preoperative albumin ≤3.4 g / dl). Do not sign informed&#xD;
             consent. Pregnant patients. Diagnosis of another type of neoplasm with active disease.&#xD;
             Liver cirrhosis, Chronic kidney failure on dialysis treatment, patients with stent&#xD;
             bridge to elective surgery.&#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>Xavier Serra-Aracil, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corporacio Parc Tauli. Parc Tauli University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xavier Serra-Aracil, MD,PhD</last_name>
    <phone>34-93-723-1010</phone>
    <phone_ext>21490</phone_ext>
    <email>jserraa@tauli.cat</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital Universitario Parc Tauli de Sabadel</name>
      <address>
        <city>Sabadell</city>
        <state>Barceelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier Serra-Aracil, MD,PhD</last_name>
      <phone>937 231 010‬</phone>
      <phone_ext>21490</phone_ext>
      <email>jserraa@tauli.cat</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Serra-Aracil X, Mora-Lopez L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27.</citation>
    <PMID>25814073</PMID>
  </reference>
  <reference>
    <citation>Akamatsu H, Omori T, Oyama T, Tori M, Ueshima S, Nakahara M, Abe T, Nishida T. Totally laparoscopic sigmoid colectomy: a simple and safe technique for intracorporeal anastomosis. Surg Endosc. 2009 Nov;23(11):2605-9. doi: 10.1007/s00464-009-0406-6. Epub 2009 Mar 6.</citation>
    <PMID>19266229</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 15, 2021</last_update_submitted>
  <last_update_submitted_qc>November 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Xavier Serra-Aracil</investigator_full_name>
    <investigator_title>Head of Colorectal Unit</investigator_title>
  </responsible_party>
  <keyword>Left Colon Cancer,</keyword>
  <keyword>Left hemicolectomy</keyword>
  <keyword>Laparoscopic left hemicolectomy</keyword>
  <keyword>Intracorporeal resection and anastomosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</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/NCT04456933
org study id: HEMI-E-INTRACORPOREA-2020
nct id: NCT04456933
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and
      anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to
      extracoprporeal resection and anastomosis, in terms of anastomotic leakage.

      BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary to infection
      by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced to adapt our
      surgical procedures in order to minimize exposure to the virus as much as possible.

      Based on the recommendations in case of surgery in patients with highly contagious viral
      diseases, the latest studies suggest minimally invasive accesses to minimize the risk of
      contagion. One of the proposed measures is the performance of intracorporeal anastomoses.
      Therefore, given the extensive experience of our center in minimally invasive surgery and
      studies on the validation of intracorporeal anastomosis techniques in both laparoscopic
      surgery of the right colon and rectum (TaTME), and the study of advantages that they can
      provide to the patient, our intention is to apply it to surgery on the left colon, sigma and
      upper rectum. Our hypothesis is that exteriorization of the colon through an accessory
      incision increases the risk of tension at the mesocolon level, thus increasing the risk of
      vascular deficit at the level of the staple area and it may increase the rate of anastomotic
      leakage. In this sense, studies that validate a standard technique of intracorporeal
      anastomosis in left colon surgery and that demonstrate its benefit with respect to
      extracorporeal anastomosis are lacking. We intend to describe a new intracorporeal
      anastomosis technique (ICA) that is feasible and safe for the patient and that can be applied
      universally. Once the ICA technique is established, it will allow us to determine its
      non-inferiority compared to the standard technique performed up to now with extracorporeal
      anastomosis.

      METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinoma will
      be included into a prospective cohort and treated by laparoscopy with totally intracorporeal
      resection and anastomosis. They will be compared with a retrospective cohort of consecutive
      patients of identical characteristics treated by laparoscopy with extracorporeal resection
      and anastomosis, in the immediate chronological period.
HYPOTHESIS Resection of the left colon / sigmoid with intracorporeal colorectal TT
      anastomosis is safe and not inferior to that performed extracorporeally. With the benefits of
      reduced intraoperative dissection, traction on the mesenteries, reduced vascular compromise
      of the anastomosis, a smaller incision size and being able to choose its location.

      Main Aim:

      The objective of this study is to demonstrate that colorectal mechanical end-to-end
      intracorporeal anastomosis is not inferior to extracorporeal approach in terms of anastomotic
      dehiscence.

      Secondary Aims:

        -  To demonstrate the reproducibility of the colorectal mechanical end-to-end
           intracorporeal anastomosis technique in terms of reconversion, anastomotic dehiscence,
           organo-cavitary infection, and other postoperative complications.

        -  To determine the benefits that the IC anastomosis technique can bring to patients with
           obesity.

        -  To determine the benefits that the IC anastomosis technique can provide in terms of
           postoperative complications, hospital stay, and size of the accessory incision.

        -  To determine the benefit of the application of indocyanine green to determine the point
           of resection and anastomosis.

      STUDY DESIGN

      Comparative, single-center, controlled non-inferiority cohort study of resection and
      mechanical end-to-end intracorporeal anastomosis in left colon, sigmoid, and upper rectum
      surgery (prospective cohort) versus the standard technique of extracorporeal laparoscopic
      surgery (retrospective cohort).

      SUBJECTS OF THE STUDY

      In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the
      left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by
      our unit, collected in our database, by laparoscopic oncological surgery applying the
      conventional extracorporeal anastomosis technique.

      In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left
      colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological
      surgical indication with a laparoscopic approach since July 2020, to which the resection and
      intracoporeal anastomosis technique will be applied.
observational model: Cohort
time perspective: Prospective
measure: Percentage of anastomotic leak (AL)
time frame: 30 days
description: Percentage of anastomic leak (defined in accordance with Peel et al.).
measure: Rate of global morbidity
time frame: 30 days
description: Dindo-Clavien Classification
measure: Rate of Surgical site infection
time frame: 30 days
description: SSI in accordance with the Center for Disease Control (CDC) National
measure: Rate of Re-interventions
time frame: 30 days
description: Percentage of re-interventions due to surgical complications
intervention type: Procedure
intervention name: Extracorporeal left hemicolectomy anastomosis
description: Standard surgical technique protocolized in the unit for laparoscopic surgery of the left colon, sigma and high rectum for the last 10 years.
After sectioning the distal colon using a mechanical stapler (60mm blue load), a pfannestiel-type suprapubic accessory incision is made, with externalization of the tumor under wound protection with a ringed retraction device. Both the resection of the left mesocolon or mesosigma, and the placement of the head of the circular stapler are performed extracorporeally by proximal section of the colon with a pursetring® self-suturing device, removal of the piece, placement of the head, and reconnection of the pneumoperitoneum for colorectal anastomosis with Circular Stapler Curved B. Braun®
intervention type: Procedure
intervention name: Intracorporeal left hemicolectomy anastomosis
description: o Intracorporeal resection of the left mesocolon
The mesocolon resection will be performed totally intracorporeally to its proximal end. The distal colon section will be performed using a mechanical stapler (blue charge 60mm)
o Preparation of Intracorporeal Anastomosis
The anastomosis will be performed in a mechanical end-to-end manner using a Circular Stapler Curved B. Braun®.
The Insertion of the stapler head into the proximal colon will be placed intracorporeally with an incision distal to the staple section. Once the head has been exteriorized at the terminal end of the proximal colon, a circular purse-type suture with prolene 2.0 will be made.
Once the mechanical colorectal anastomosis is performed, 4-6 stitches of anastomotic reinforcement with silk 2.0 will be placed.
The extraction of the piece will be carried out with endobag protection and with an accessory incision (pfannestiel or other location depending on the patient)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xavier Serra-Aracil, MD,PhD
role: Principal Investigator
affiliation: Corporacio Parc Tauli. Parc Tauli University Hospital
last name: Xavier Serra-Aracil, MD,PhD
phone: 34-93-723-1010
phone ext: 21490
email: jserraa@tauli.cat
facility: 
status: Recruiting
contact: 
country: Spain
citation: Serra-Aracil X, Mora-Lopez L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27.
PMID: 25814073
citation: Akamatsu H, Omori T, Oyama T, Tori M, Ueshima S, Nakahara M, Abe T, Nishida T. Totally laparoscopic sigmoid colectomy: a simple and safe technique for intracorporeal anastomosis. Surg Endosc. 2009 Nov;23(11):2605-9. doi: 10.1007/s00464-009-0406-6. Epub 2009 Mar 6.
PMID: 19266229
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Xavier Serra-Aracil
investigator title: Head of Colorectal Unit
mesh term: Colonic Neoplasms