<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/NCT04429425</url>
  </required_header>
  <id_info>
    <org_study_id>CT-EPI-CRS-2020</org_study_id>
    <nct_id>NCT04429425</nct_id>
  </id_info>
  <brief_title>Does Epidural Anesthesia Reduce Postoperative Ileus Following Colorectal Surgery?</brief_title>
  <official_title>A Prospective Randomized Comparative Study of Effectiveness of Epidural Anesthesia to Reduce Postoperative Ileus in Patients Undergoing Colorectal Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sisli Hamidiye Etfal Training and Research Hospital</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>
      The use of epidural analgesia (EA) has been suggested as an integral part of an enhanced&#xD;
      recovery program for colorectal surgery. However, the effects of EA on postoperative ileus&#xD;
      remain controversial. Some authors suggest that EA has beneficial effects for postoperative&#xD;
      outcome and hospital stay, whereas others have reported that the role of EA in the modern&#xD;
      perioperative care of patients undergoing open colorectal surgery has been limited.&#xD;
      Therefore, the investigators aimed to investigate the effect of EA on postoperative outcome,&#xD;
      particularly postoperative ileus and hospital stay in patients with colorectal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 2016, results of Cochrane review of 22 trials on the efficacy of EA in patients undergoing&#xD;
      abdominal surgery showed that an epidural containing a local anesthetic, with or without the&#xD;
      addition of an opioid, accelerated the return of gastrointestinal transit (high quality of&#xD;
      evidence) and no difference in the incidence of vomiting or anastomotic leak (low quality of&#xD;
      evidence). For open surgery, an epidural containing a local anaesthetic would reduce the&#xD;
      length of hospital stay (very low quality of evidence).&#xD;
&#xD;
      However, in a recent analysis from American College of Surgeons revealed that the use of EA&#xD;
      did not improve postoperative recovery after elective colectomy in their analysis and was&#xD;
      associated with increased postoperative ileus and prolonged hospital stay after open&#xD;
      colectomy.&#xD;
&#xD;
      In this study, the investigators aimed to compare the efficacy of EA to reduce the&#xD;
      postoperative ileus and hospital stay, as well in the patients undergoing colorectal surgery.&#xD;
      This prospective randomized study planned to include 100 consecutive patients with colorectal&#xD;
      disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">March 10, 2022</start_date>
  <completion_date type="Anticipated">December 10, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 10, 2023</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>
    <intervention_model_description>each patient will be randomly asigned to each group (EA or non-EA)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>all patients undergoing colorectal surgery will be grouped consecutively as epidural anesthesia (EA) or non-EA</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative ileus</measure>
    <time_frame>up to 4 days</time_frame>
    <description>obstipation and intolerance of oral intake due to nonmechanical factors that disrupt propulsive activity of the gastrointestinal system following colorectal surgery..Obstipation was defined as abdominal distention or/and pain at physical examination and difficulty passing gas postoperatively. Intolerance of oral intake was defined as nause or vomiting associated with food intake</description>
  </primary_outcome>
  <primary_outcome>
    <measure>prolonged postoperative ileus</measure>
    <time_frame>up to 10 days</time_frame>
    <description>inability to tolerate oral intake, two or more of nause/ vomiting requiring cessation of oral diet or/and nasogastric decompression and intravenous support, and absence of flatus prolonging hospitalization beyond discharge goal..Prolonged PO was defined as by the postoperative day 5, in case of persistent symptoms mentioned above and radiological confirmation of ileus on plain abdominal film showing multiple distended loops with air and/or fluid and air in both small intestines and large intestines.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospital stay</measure>
    <time_frame>up to 1 year</time_frame>
    <description>time from the day of surgery to day of discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Colorectal Disorders</condition>
  <condition>Postoperative Ileus</condition>
  <arm_group>
    <arm_group_label>EA group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients with colorectal surgery that willl be performed epidural anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non -EA group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>patients with colorectal surgery that willl be performed only general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>epidural anesthesia</intervention_name>
    <description>epidural anesthesia through epidural injection of a local anaesthetic combined with an opioid</description>
    <arm_group_label>EA group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergoing colorectal surgery due to both benign and malign disorders&#xD;
&#xD;
          -  no contraindication for epidural anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  drug use (psychotropic drugs etc) that may cause paralytic ileus&#xD;
&#xD;
          -  immobile patients that ERAS protocol can not be applied on&#xD;
&#xD;
          -  Anticoagulated patients with the risk of epidural hematoma,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>pinar yazici</last_name>
    <role>Principal Investigator</role>
    <affiliation>sisli etfal training and research hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pinar Yazici</name>
      <address>
        <city>Istanbul</city>
        <state>Other</state>
        <zip>34317</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>March 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Pinar Yazici</investigator_full_name>
    <investigator_title>Assoc Prof</investigator_title>
  </responsible_party>
  <keyword>colorectal surgery</keyword>
  <keyword>postoperative ileus</keyword>
  <keyword>epidural anesthesia</keyword>
  <keyword>enhanced recovery after surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ileus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT04429425
org study id: CT-EPI-CRS-2020
nct id: NCT04429425
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of epidural analgesia (EA) has been suggested as an integral part of an enhanced
      recovery program for colorectal surgery. However, the effects of EA on postoperative ileus
      remain controversial. Some authors suggest that EA has beneficial effects for postoperative
      outcome and hospital stay, whereas others have reported that the role of EA in the modern
      perioperative care of patients undergoing open colorectal surgery has been limited.
      Therefore, the investigators aimed to investigate the effect of EA on postoperative outcome,
      particularly postoperative ileus and hospital stay in patients with colorectal surgery.
In 2016, results of Cochrane review of 22 trials on the efficacy of EA in patients undergoing
      abdominal surgery showed that an epidural containing a local anesthetic, with or without the
      addition of an opioid, accelerated the return of gastrointestinal transit (high quality of
      evidence) and no difference in the incidence of vomiting or anastomotic leak (low quality of
      evidence). For open surgery, an epidural containing a local anaesthetic would reduce the
      length of hospital stay (very low quality of evidence).

      However, in a recent analysis from American College of Surgeons revealed that the use of EA
      did not improve postoperative recovery after elective colectomy in their analysis and was
      associated with increased postoperative ileus and prolonged hospital stay after open
      colectomy.

      In this study, the investigators aimed to compare the efficacy of EA to reduce the
      postoperative ileus and hospital stay, as well in the patients undergoing colorectal surgery.
      This prospective randomized study planned to include 100 consecutive patients with colorectal
      disorders.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: each patient will be randomly asigned to each group (EA or non-EA)
primary purpose: Prevention
masking: None (Open Label)
masking description: all patients undergoing colorectal surgery will be grouped consecutively as epidural anesthesia (EA) or non-EA
measure: postoperative ileus
time frame: up to 4 days
description: obstipation and intolerance of oral intake due to nonmechanical factors that disrupt propulsive activity of the gastrointestinal system following colorectal surgery..Obstipation was defined as abdominal distention or/and pain at physical examination and difficulty passing gas postoperatively. Intolerance of oral intake was defined as nause or vomiting associated with food intake
measure: prolonged postoperative ileus
time frame: up to 10 days
description: inability to tolerate oral intake, two or more of nause/ vomiting requiring cessation of oral diet or/and nasogastric decompression and intravenous support, and absence of flatus prolonging hospitalization beyond discharge goal..Prolonged PO was defined as by the postoperative day 5, in case of persistent symptoms mentioned above and radiological confirmation of ileus on plain abdominal film showing multiple distended loops with air and/or fluid and air in both small intestines and large intestines.
measure: hospital stay
time frame: up to 1 year
description: time from the day of surgery to day of discharge
arm group label: EA group
arm group type: Other
description: patients with colorectal surgery that willl be performed epidural anesthesia
arm group label: non -EA group
arm group type: No Intervention
description: patients with colorectal surgery that willl be performed only general anesthesia
intervention type: Procedure
intervention name: epidural anesthesia
description: epidural anesthesia through epidural injection of a local anaesthetic combined with an opioid
arm group label: EA group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: pinar yazici
role: Principal Investigator
affiliation: sisli etfal training and research hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: Pinar Yazici
investigator title: Assoc Prof
mesh term: Ileus
mesh term: Anesthetics