<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/NCT03000465</url>
  </required_header>
  <id_info>
    <org_study_id>2015/0094</org_study_id>
    <nct_id>NCT03000465</nct_id>
  </id_info>
  <brief_title>Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery</brief_title>
  <acronym>IPPCollapseI</acronym>
  <official_title>Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse-I)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario La Fe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto de Investigacion Sanitaria La Fe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitario La Fe</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Optimizing all factors that increase the intra-abdominal volume and performing an&#xD;
      individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure&#xD;
      while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared&#xD;
      to the standard strategy of maintaining fixed intra-abdominal insufflation pressures (12-15&#xD;
      mmHg).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the context of multimodal rehabilitation in colorectal laparoscopic surgery (Fast Track or&#xD;
      ERAS (Enhance Recovery After Surgery)) multiple strategies have been introduced that have&#xD;
      managed to improve patient recovery, decrease postoperative complications, decrease hospital&#xD;
      days and decrease the overall costs per process.&#xD;
&#xD;
      The possibility of performing individualized colorectal laparoscopic surgery with the minimum&#xD;
      insufflation pressure guaranteeing optimal surgical conditions has not been evaluated and&#xD;
      this would allow us to reduce the impact of surgery on the patient, decrease perioperative&#xD;
      morbidity and improve patient recovery.&#xD;
&#xD;
      In our study, abdominal compliance, Pv0 and maximal Pv were determined during the initial&#xD;
      performance of the pneumoperitoneum, and then a stepwise protocol for the reduction of&#xD;
      intra-abdominal pressure (IAP) insufflation was stablished with evaluation by the surgeons,&#xD;
      until reaching the minimal insufflation IAP in which optimal surgical conditions are&#xD;
      maintained.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Minimal intra-abdominal pressure</measure>
    <time_frame>From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.</time_frame>
    <description>To obtain values of intra-abdominal pressure level of minimum insufflation that guarantees optimal surgical conditions following an individualized strategy [mmHg].</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ventilation pattern pressure</measure>
    <time_frame>From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.</time_frame>
    <description>Airway pressures at different levels of IAP (peak pressure, PEEP (positive end expiratory pressure), plateau pressure, driving pressure) [mmH2O].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-abdominal pressures (Pv0, maximal IAP)</measure>
    <time_frame>From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.</time_frame>
    <description>Pv0 (IAP with volume 0) and maximal IAP [mmHg].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-abdominal pressures (abdominal compliance).</measure>
    <time_frame>From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.</time_frame>
    <description>Dynamic abdominal compliance per liter (DV/DP, difference in volume/difference in pressure [L/mmHg]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon skills and experience</measure>
    <time_frame>Years of experience, up to 10 years.</time_frame>
    <description>Previous experience of the surgeon in laparoscopic surgery, annual cases, years of experience, previous experience with low IAP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of surgery</measure>
    <time_frame>The follow-up period will be extended during the intraoperative period, from initial incision until surgery completion, up to 300 minutes.</time_frame>
    <description>Duration of surgery in minutes from incision to abdominal wall closure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days.</time_frame>
    <description>Evolution and complications in the postoperative period: Postoperative pain in the first 24 hours. Postoperative complications were assessed using the Clavier-Dindo classification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days.</time_frame>
    <description>Hospital stay in days</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">92</enrollment>
  <condition>Individualized Pneumoperitoneum Pressure</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients undergoing laparoscopic colorectal surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic colorectal surgery</intervention_name>
    <description>Minimizing intra-abdominal insufflation pressure in laparoscopic colorectal surgery as an individualized strategy</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing colorectal laparoscopic surgery. Patients will be excluded of the&#xD;
        analysis if the surgery cannot be finished by laparoscopy,&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  ASA I-III (American Society of Anesthesiologists physical status classification)&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
          -  Absence of cognitive deficit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Urgent surgery&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Immune Disorder&#xD;
&#xD;
          -  Advanced renal, hepatic or cardiopulmonary disease&#xD;
&#xD;
          -  Negative to participate in the study&#xD;
&#xD;
          -  Under 18 years&#xD;
&#xD;
          -  Inability to give consent&#xD;
&#xD;
          -  Associated neuromuscular disorders&#xD;
&#xD;
          -  Allergy to rocuronium/sugammadex&#xD;
&#xD;
          -  Contraindication for use of rocuronium/sugammadex&#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>Oscar Diaz Cambronero</last_name>
    <role>Principal Investigator</role>
    <affiliation>Physician, Specialist in Anesthesiology</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario La Fe</investigator_affiliation>
    <investigator_full_name>Oscar Diaz-Cambronero</investigator_full_name>
    <investigator_title>Physician, specialist in Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>pneumoperitoneum pressure</keyword>
  <keyword>laparoscopic pressure</keyword>
  <keyword>intra-abdominal insufflation</keyword>
  <keyword>intra-abdominal pressures</keyword>
  <keyword>abdominal compliance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumoperitoneum</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03000465
org study id: 2015/0094
nct id: NCT03000465
lead sponsor: 
collaborator: 
has dmc: No
Optimizing all factors that increase the intra-abdominal volume and performing an
      individualized strategy should allow us to reduce the pneumoperitoneum insufflation pressure
      while maintaining optimal surgery conditions for a laparoscopic colorectal surgery, compared
      to the standard strategy of maintaining fixed intra-abdominal insufflation pressures (12-15
      mmHg).
In the context of multimodal rehabilitation in colorectal laparoscopic surgery (Fast Track or
      ERAS (Enhance Recovery After Surgery)) multiple strategies have been introduced that have
      managed to improve patient recovery, decrease postoperative complications, decrease hospital
      days and decrease the overall costs per process.

      The possibility of performing individualized colorectal laparoscopic surgery with the minimum
      insufflation pressure guaranteeing optimal surgical conditions has not been evaluated and
      this would allow us to reduce the impact of surgery on the patient, decrease perioperative
      morbidity and improve patient recovery.

      In our study, abdominal compliance, Pv0 and maximal Pv were determined during the initial
      performance of the pneumoperitoneum, and then a stepwise protocol for the reduction of
      intra-abdominal pressure (IAP) insufflation was stablished with evaluation by the surgeons,
      until reaching the minimal insufflation IAP in which optimal surgical conditions are
      maintained.
observational model: Case-Only
time perspective: Prospective
measure: Minimal intra-abdominal pressure
time frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
description: To obtain values of intra-abdominal pressure level of minimum insufflation that guarantees optimal surgical conditions following an individualized strategy [mmHg].
measure: Ventilation pattern pressure
time frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
description: Airway pressures at different levels of IAP (peak pressure, PEEP (positive end expiratory pressure), plateau pressure, driving pressure) [mmH2O].
measure: Intra-abdominal pressures (Pv0, maximal IAP)
time frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
description: Pv0 (IAP with volume 0) and maximal IAP [mmHg].
measure: Intra-abdominal pressures (abdominal compliance).
time frame: From pneumoperitoneum induction until surgery completion (during the intraoperative period), up to 300 minutes.
description: Dynamic abdominal compliance per liter (DV/DP, difference in volume/difference in pressure [L/mmHg]).
measure: Surgeon skills and experience
time frame: Years of experience, up to 10 years.
description: Previous experience of the surgeon in laparoscopic surgery, annual cases, years of experience, previous experience with low IAP.
measure: Duration of surgery
time frame: The follow-up period will be extended during the intraoperative period, from initial incision until surgery completion, up to 300 minutes.
description: Duration of surgery in minutes from incision to abdominal wall closure.
measure: Postoperative complications
time frame: The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days.
description: Evolution and complications in the postoperative period: Postoperative pain in the first 24 hours. Postoperative complications were assessed using the Clavier-Dindo classification.
measure: Hospital stay
time frame: The follow-up period will be extended until hospital discharge for the evaluation of complications, an average of 7 to 10 days.
description: Hospital stay in days
arm group label: Patients
description: Patients undergoing laparoscopic colorectal surgery
intervention type: Procedure
intervention name: Laparoscopic colorectal surgery
description: Minimizing intra-abdominal insufflation pressure in laparoscopic colorectal surgery as an individualized strategy
arm group label: Patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Oscar Diaz Cambronero
role: Principal Investigator
affiliation: Physician, Specialist in Anesthesiology
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario La Fe
investigator full name: Oscar Diaz-Cambronero
investigator title: Physician, specialist in Anesthesiology
mesh term: Pneumoperitoneum
sharing ipd: Undecided