<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/NCT03813797</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2018/42</org_study_id>
    <nct_id>NCT03813797</nct_id>
  </id_info>
  <brief_title>LaPAroscopic Low pRessure cOlorectal Surgery</brief_title>
  <acronym>PAROS</acronym>
  <official_title>LaPAroscopic Low pRessure cOlorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</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>
      Laparoscopy by its mini-invasive character has revolutionized abdominal and colorectal&#xD;
      surgery but certain limitations remains (post-operative pain due to pneumoperitoneum,&#xD;
      pneumoperitoneum stability, visibility during bleeding, smoke evacuation). The medical device&#xD;
      for continuous pressure insufflation during laparoscopic procedures Airseal® would allow the&#xD;
      maintenance of pneumoperitoneum at a lower pressure. The stable low pressure (7mmHg) is&#xD;
      described in the literature for 15 years as the best way to reduce scapular pain, but until&#xD;
      the marketing of Airseal, working at 7mmHg was not possible because the space of work was not&#xD;
      stable. Moreover, this device makes it possible to obtain a better vision because of the&#xD;
      evacuation of the fumes potentially leading to a reduction in the operating time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research focuses on a medical device that allows the surgeon to perform the surgical&#xD;
      procedure at a lower pressure than usual.&#xD;
&#xD;
      The main objective of this study is to compare the duration of hospitalization of patients&#xD;
      with laparoscopic colectomy at low pressure (5-7 mmHg) versus standard pressure (12-15 mmHg)&#xD;
      It is a prospective randomized monocentric double blind study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">June 26, 2020</completion_date>
  <primary_completion_date type="Actual">May 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The study will be carried out:&#xD;
Blind patient: The patient will not know the group he belongs to, in order to minimize the bias related to the self-evaluation of postoperative pain&#xD;
Blind for the outpatient evaluator: the surgeon will blindly evaluate the primary endpoint: patient's discharge criteria. This &quot;evaluator&quot; surgeon will be different from the &quot;operator&quot; surgeon The blind will minimize the measurement bias.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Length of postoperative hospital stay</measure>
    <time_frame>From surgery to the end of the hospitalization (max 30 days)</time_frame>
    <description>To determine the length of hospitalization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgery time</measure>
    <time_frame>During surgery</time_frame>
    <description>To determine the surgery time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appreciation of visual quality by surgeon</measure>
    <time_frame>During surgery</time_frame>
    <description>To determine the rate of visual quality during surgery: poor, medium or good quality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the use of microlaparoscopic instruments</measure>
    <time_frame>During surgery</time_frame>
    <description>To determine the rate of use of the microsurgery microlaparoscopic instruments (3mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of conversion</measure>
    <time_frame>During surgery</time_frame>
    <description>Conversion to laparoscopy with standard pressure or conversion to laparotomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure (mmHg)</measure>
    <time_frame>During surgery</time_frame>
    <description>To examine the variation of blood pressure during surgery (at the beginning, middle and at the end)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac frequency (/ min)</measure>
    <time_frame>During surgery</time_frame>
    <description>To examine the variation of cardiac frequency during surgery (at the beginning, middle and at the end)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume replacement (mL)</measure>
    <time_frame>During surgery</time_frame>
    <description>To examine the volume replacement during surgery (at the beginning, middle and at the end)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Driving pressure (mmHg)</measure>
    <time_frame>During surgery</time_frame>
    <description>To examine the variation of drinving pressure during surgery (at the beginning, middle and at the end)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation (%)</measure>
    <time_frame>During surgery</time_frame>
    <description>To examine the variation of SA02 (%) during surgery (at the beginning, middle and at the end)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial pressure of mean expired of carbon dioxide (mmHg)</measure>
    <time_frame>During surgery</time_frame>
    <description>To examine the variation PECO2 (mmHg) during surgery (at the beginning, middle and at the end)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical and medical morbidity</measure>
    <time_frame>From surgery until 30 days (max 45 days)</time_frame>
    <description>To analyse the cumulative Clavien-Dindo at 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>2 hours, 4 hours, 8 hours and 24 hours after the surgery</time_frame>
    <description>Pain was evaluated with the Numeric Rating Scale (NRS, from 0 (no pain) to 10 (hurts worst)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of analgesics</measure>
    <time_frame>An average of 5 days after the surgery</time_frame>
    <description>To evaluate the rate of analgesics administrated (from step1 to step3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time before the passage of first stool (days)</measure>
    <time_frame>An average of 5 days after the surgery</time_frame>
    <description>To determine the delay of the laxation and gas response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time before the passage of first gas (days)</measure>
    <time_frame>An average of 5 days after the surgery</time_frame>
    <description>To determine the delay of the gas response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time before mobilization (Days before 1st time sitting and standing)</measure>
    <time_frame>An average of 5 days after the surgery</time_frame>
    <description>To determine the delay before mobilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of cancer surgery</measure>
    <time_frame>During surgery</time_frame>
    <description>Rate of curative surgery (R0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of lymph nodes examed</measure>
    <time_frame>During surgery</time_frame>
    <description>Number of lymph nodes examed during a cancer surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Malignant or Benign Pathology</condition>
  <arm_group>
    <arm_group_label>Arm A: Low Pressure (5-7 mmHg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopic colectomy surgery with low pressure (5-7mmHg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: Standard pressure (12-15 mmHg)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic colectomy surgery with standard pressure (12-15mmHg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Airseal®</intervention_name>
    <description>Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg</description>
    <arm_group_label>Arm A: Low Pressure (5-7 mmHg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Insufflation</intervention_name>
    <description>Medical device set to the mode &quot;Standard Insufflation&quot;, pressure adjustment between 12 and 15 mmHg</description>
    <arm_group_label>Arm B: Standard pressure (12-15 mmHg)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Colonic resection (right or left) performed for benign or malignant pathology&#xD;
&#xD;
          -  Laparoscopic procedure&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
          -  Social Insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Laparotomy procedure&#xD;
&#xD;
          -  Associated resection (except appendectomy or liver biopsy&#xD;
&#xD;
          -  Emergency procedure&#xD;
&#xD;
          -  Pelvic sepsis&#xD;
&#xD;
          -  Pregnant or breast-feeding woman.&#xD;
&#xD;
          -  Persons deprived of liberty or under guardianship&#xD;
&#xD;
          -  Impossibility for compliance to follow-up&#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>Quentin DENOST</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low Pressure</keyword>
  <keyword>Laparoscopy</keyword>
  <keyword>Colectomy</keyword>
  <keyword>Pneumoperitoneum</keyword>
  <keyword>AirSeal</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03813797
org study id: CHUBX 2018/42
nct id: NCT03813797
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Laparoscopy by its mini-invasive character has revolutionized abdominal and colorectal
      surgery but certain limitations remains (post-operative pain due to pneumoperitoneum,
      pneumoperitoneum stability, visibility during bleeding, smoke evacuation). The medical device
      for continuous pressure insufflation during laparoscopic procedures Airseal® would allow the
      maintenance of pneumoperitoneum at a lower pressure. The stable low pressure (7mmHg) is
      described in the literature for 15 years as the best way to reduce scapular pain, but until
      the marketing of Airseal, working at 7mmHg was not possible because the space of work was not
      stable. Moreover, this device makes it possible to obtain a better vision because of the
      evacuation of the fumes potentially leading to a reduction in the operating time.
This research focuses on a medical device that allows the surgeon to perform the surgical
      procedure at a lower pressure than usual.

      The main objective of this study is to compare the duration of hospitalization of patients
      with laparoscopic colectomy at low pressure (5-7 mmHg) versus standard pressure (12-15 mmHg)
      It is a prospective randomized monocentric double blind study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The study will be carried out:
Blind patient: The patient will not know the group he belongs to, in order to minimize the bias related to the self-evaluation of postoperative pain
Blind for the outpatient evaluator: the surgeon will blindly evaluate the primary endpoint: patient's discharge criteria. This "evaluator" surgeon will be different from the "operator" surgeon The blind will minimize the measurement bias.
measure: Length of postoperative hospital stay
time frame: From surgery to the end of the hospitalization (max 30 days)
description: To determine the length of hospitalization
measure: Surgery time
time frame: During surgery
description: To determine the surgery time
measure: Appreciation of visual quality by surgeon
time frame: During surgery
description: To determine the rate of visual quality during surgery: poor, medium or good quality
measure: Impact of the use of microlaparoscopic instruments
time frame: During surgery
description: To determine the rate of use of the microsurgery microlaparoscopic instruments (3mm)
measure: Rates of conversion
time frame: During surgery
description: Conversion to laparoscopy with standard pressure or conversion to laparotomy
measure: Blood pressure (mmHg)
time frame: During surgery
description: To examine the variation of blood pressure during surgery (at the beginning, middle and at the end)
measure: Cardiac frequency (/ min)
time frame: During surgery
description: To examine the variation of cardiac frequency during surgery (at the beginning, middle and at the end)
measure: Volume replacement (mL)
time frame: During surgery
description: To examine the volume replacement during surgery (at the beginning, middle and at the end)
measure: Driving pressure (mmHg)
time frame: During surgery
description: To examine the variation of drinving pressure during surgery (at the beginning, middle and at the end)
measure: Oxygen saturation (%)
time frame: During surgery
description: To examine the variation of SA02 (%) during surgery (at the beginning, middle and at the end)
measure: Partial pressure of mean expired of carbon dioxide (mmHg)
time frame: During surgery
description: To examine the variation PECO2 (mmHg) during surgery (at the beginning, middle and at the end)
measure: Surgical and medical morbidity
time frame: From surgery until 30 days (max 45 days)
description: To analyse the cumulative Clavien-Dindo at 30 days
measure: Postoperative pain
time frame: 2 hours, 4 hours, 8 hours and 24 hours after the surgery
description: Pain was evaluated with the Numeric Rating Scale (NRS, from 0 (no pain) to 10 (hurts worst)
measure: Use of analgesics
time frame: An average of 5 days after the surgery
description: To evaluate the rate of analgesics administrated (from step1 to step3)
measure: Time before the passage of first stool (days)
time frame: An average of 5 days after the surgery
description: To determine the delay of the laxation and gas response
measure: Time before the passage of first gas (days)
time frame: An average of 5 days after the surgery
description: To determine the delay of the gas response
measure: Time before mobilization (Days before 1st time sitting and standing)
time frame: An average of 5 days after the surgery
description: To determine the delay before mobilization
measure: Quality of cancer surgery
time frame: During surgery
description: Rate of curative surgery (R0)
measure: Number of lymph nodes examed
time frame: During surgery
description: Number of lymph nodes examed during a cancer surgery
arm group label: Arm A: Low Pressure (5-7 mmHg)
arm group type: Experimental
description: Laparoscopic colectomy surgery with low pressure (5-7mmHg)
arm group label: Arm B: Standard pressure (12-15 mmHg)
arm group type: Active Comparator
description: Laparoscopic colectomy surgery with standard pressure (12-15mmHg)
intervention type: Device
intervention name: Airseal®
description: Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg
arm group label: Arm A: Low Pressure (5-7 mmHg)
intervention type: Device
intervention name: Standard Insufflation
description: Medical device set to the mode "Standard Insufflation", pressure adjustment between 12 and 15 mmHg
arm group label: Arm B: Standard pressure (12-15 mmHg)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Quentin DENOST
role: Principal Investigator
affiliation: University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No