<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/NCT03754751</url>
  </required_header>
  <id_info>
    <org_study_id>ERLAC</org_study_id>
    <nct_id>NCT03754751</nct_id>
  </id_info>
  <brief_title>Enhanced Recovery in Laparoscopic Cholecystectomy</brief_title>
  <acronym>ERLAC</acronym>
  <official_title>Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pirogov Russian National Research Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pirogov Russian National Research Medical University</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 study assesses the impact of the modified enhanced recovery protocol on the results of&#xD;
      surgical treatment of patients with acute cholecystitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic cholecystectomy (LC) is the most common surgical procedures in the world.&#xD;
      Elective LC is commonly performed as one-day surgery, while in an emergency setting of acute&#xD;
      cholecystitis the in-hospital stay averages 4.5 days. Causes of prolonged rehabilitation&#xD;
      period are often associated with severe pain syndrome, dyspepsia and postoperative&#xD;
      complications. The complications rate after LC is about 6% and has no tendency to decrease.&#xD;
      The implementation of enhanced recovery after surgery (ERAS) programs may potentially reduce&#xD;
      stress-associated complications and improve the quality of rehabilitation. A few&#xD;
      retrospective studies examined their advantages and setbacks in the treatment of acute&#xD;
      cholecystitis with encouraging results. The aim of this randomized control study is to&#xD;
      evaluate the modified ERAS program for patients with acute cholecystitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative length of stay (pLOS)</measure>
    <time_frame>30 days</time_frame>
    <description>Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients who develop postoperative complications (surgical site infections, intraabdominal organ-specific infection, postoperative ileus) in relation to the total number of patients, measured in percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rate</measure>
    <time_frame>30 days</time_frame>
    <description>Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>24 hours</time_frame>
    <description>Level of postoperative pain syndrome measured with a visual analog scale in centimeters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder pain incidence</measure>
    <time_frame>24 hours</time_frame>
    <description>Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder pain level</measure>
    <time_frame>24 hours</time_frame>
    <description>Level of shoulder pain syndrome measured with a visual analog scale in centimeters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">189</enrollment>
  <condition>Acute Cholecystitis</condition>
  <condition>Gangrenous Cholecystitis</condition>
  <arm_group>
    <arm_group_label>Modified ERAS program group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopic cholecystectomy with the implementation of modified ERAS program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional care group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic cholecystectomy with standard perioperative treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic cholecystectomy with the implementation of modified ERAS program</intervention_name>
    <description>Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.&#xD;
1) Patient informing and brochure&#xD;
Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia&#xD;
Low-pressure pneumoperitoneum (8-9 mmHg)&#xD;
Trocar wound and intraabdominal anesthesia with 0.25% ropivacaine&#xD;
PONV prophylaxis in patients of risk&#xD;
Postoperative care&#xD;
Early mobilization (2 h after surgery)&#xD;
Early fluid intake (2 h after surgery)&#xD;
Early liquid food (6 h after surgery) Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality &quot;on demand&quot;: Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery</description>
    <arm_group_label>Modified ERAS program group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic cholecystectomy with standard perioperative treatment</intervention_name>
    <description>Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.&#xD;
1) Patient oral informing. No brochure&#xD;
Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia&#xD;
Standard CO2 pressure (12-14 mmHg)&#xD;
No additional anesthesia&#xD;
Postoperative care&#xD;
Mobilization in 4-6 h after surgery&#xD;
Fluid intake in 6 hours&#xD;
Liquid food intake in 12 hours Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality &quot;on demand&quot;: Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery</description>
    <arm_group_label>Conventional care group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Grade I and II acute cholecystitis according to Tokyo Guidelines 2013 classification&#xD;
             (TG13)&#xD;
&#xD;
          -  ASA I and II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe acute cholecystitis (Grade III on TG13);&#xD;
&#xD;
          -  Patient's refusal to participate;&#xD;
&#xD;
          -  The language barrier;&#xD;
&#xD;
          -  Transfer to the intensive care unit after surgery;&#xD;
&#xD;
          -  ASA class ≥ III;&#xD;
&#xD;
          -  Conversion to open procedure;&#xD;
&#xD;
          -  Biliary hypertension detected during preoperative examination or intraoperatively.&#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>Alexander Sazhin, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Pirogov Russian National Research Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Taras Nechay</name>
      <address>
        <city>Moscow</city>
        <zip>115569</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>January 14, 2021</last_update_submitted>
  <last_update_submitted_qc>January 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>enhanced recovery</keyword>
  <keyword>intraperitoneal anesthesia</keyword>
  <keyword>low pressure pneumoperitoneum</keyword>
  <keyword>cholecystitis</keyword>
  <keyword>in-hospital stay</keyword>
  <keyword>laparoscopic cholecystectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
    <mesh_term>Acalculous Cholecystitis</mesh_term>
    <mesh_term>Cholecystitis, Acute</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/NCT03754751
org study id: ERLAC
nct id: NCT03754751
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study assesses the impact of the modified enhanced recovery protocol on the results of
      surgical treatment of patients with acute cholecystitis.
Laparoscopic cholecystectomy (LC) is the most common surgical procedures in the world.
      Elective LC is commonly performed as one-day surgery, while in an emergency setting of acute
      cholecystitis the in-hospital stay averages 4.5 days. Causes of prolonged rehabilitation
      period are often associated with severe pain syndrome, dyspepsia and postoperative
      complications. The complications rate after LC is about 6% and has no tendency to decrease.
      The implementation of enhanced recovery after surgery (ERAS) programs may potentially reduce
      stress-associated complications and improve the quality of rehabilitation. A few
      retrospective studies examined their advantages and setbacks in the treatment of acute
      cholecystitis with encouraging results. The aim of this randomized control study is to
      evaluate the modified ERAS program for patients with acute cholecystitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative length of stay (pLOS)
time frame: 30 days
description: Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days
measure: Complication rate
time frame: 30 days
description: Number of patients who develop postoperative complications (surgical site infections, intraabdominal organ-specific infection, postoperative ileus) in relation to the total number of patients, measured in percentage
measure: Readmission rate
time frame: 30 days
description: Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage
measure: Postoperative pain
time frame: 24 hours
description: Level of postoperative pain syndrome measured with a visual analog scale in centimeters
measure: Shoulder pain incidence
time frame: 24 hours
description: Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage
measure: Shoulder pain level
time frame: 24 hours
description: Level of shoulder pain syndrome measured with a visual analog scale in centimeters
arm group label: Modified ERAS program group
arm group type: Experimental
description: Laparoscopic cholecystectomy with the implementation of modified ERAS program
arm group label: Conventional care group
arm group type: Active Comparator
description: Laparoscopic cholecystectomy with standard perioperative treatment
intervention type: Procedure
intervention name: Laparoscopic cholecystectomy with the implementation of modified ERAS program
description: Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.
1) Patient informing and brochure
Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia
Low-pressure pneumoperitoneum (8-9 mmHg)
Trocar wound and intraabdominal anesthesia with 0.25% ropivacaine
PONV prophylaxis in patients of risk
Postoperative care
Early mobilization (2 h after surgery)
Early fluid intake (2 h after surgery)
Early liquid food (6 h after surgery) Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery
arm group label: Modified ERAS program group
intervention type: Procedure
intervention name: Laparoscopic cholecystectomy with standard perioperative treatment
description: Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.
1) Patient oral informing. No brochure
Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia
Standard CO2 pressure (12-14 mmHg)
No additional anesthesia
Postoperative care
Mobilization in 4-6 h after surgery
Fluid intake in 6 hours
Liquid food intake in 12 hours Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery
arm group label: Conventional care group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Sazhin, Prof.
role: Study Chair
affiliation: Pirogov Russian National Research Medical University
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Cholecystitis
mesh term: Acalculous Cholecystitis
mesh term: Cholecystitis, Acute