<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/NCT03754777</url>
  </required_header>
  <id_info>
    <org_study_id>MERES</org_study_id>
    <nct_id>NCT03754777</nct_id>
  </id_info>
  <brief_title>Modified Enhanced Recovery Program in Emergency Surgery (MERES)</brief_title>
  <acronym>MERES</acronym>
  <official_title>Evaluation of Modified Enhanced Recovery Program in Emergency Surgery</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>Yes</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>
      Laparoscopic appendectomy (LA) is a widespread surgical procedure. Patients may develop&#xD;
      considerable postoperative pain and dyspepsia resulting in prolong in-hospital stay. Almost&#xD;
      10% of patients develop postoperative complications. Enhanced recovery after surgery (ERAS)&#xD;
      program has proven its effectiveness in elective surgery and can theoretically improve&#xD;
      outcomes of LA. To date there is no ERAS program for LA. The aim of the study was to&#xD;
      investigate the safety and efficacy of a modified ERAS protocol in LA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A modified ERAS (mERAS) protocol was investigated. The study is a prospective, randomized&#xD;
      nonblinded. All patients underwent LA. Modified ERAS protocol included patient informing,&#xD;
      limitation of drainage use; intraperitoneal anesthesia with long-acting anesthetics;&#xD;
      low-pressure pneumoperitoneum; early mobilization and oral nutrition. Pain level was assessed&#xD;
      in rest using visual analogue scale (VAS). The primary endpoint was postoperative length of&#xD;
      stay (pLOS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</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 visual analog scale in centimeters</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Acute Appendicitis</condition>
  <condition>Acute Appendicitis With Rupture</condition>
  <condition>Acute Appendicitis With Peritonitis</condition>
  <condition>Acute Appendicitis Without Peritonitis</condition>
  <arm_group>
    <arm_group_label>Modified ERAS protocol group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopic appendectomy with modified ERAS protocol group Preadmission. Not available due to the emergency setting. Preoperative care.&#xD;
1) Patient brochure with a detailed description of the type of pathology, surgery procedure, rehabilitation process, possible complications, and other.&#xD;
Surgery.&#xD;
Low pressure (8-9 mmHg) pneumoperitoneum.&#xD;
Routinely remove of appendix mesentery in presence of any signs of its inflammation.&#xD;
Additional local anesthesia with 0.25% ropivacaine.&#xD;
Abdominal cavity draining only in patients with perforated appendicitis and diffuse peritonitis (Gomes 5).&#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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard care laparoscopic appendectomy. Preadmission. Not available due to emergency setting. Preoperative care. 1) Patient oral informing about the type of pathology, surgery procedure and possible complications. No brochure.&#xD;
Surgery.&#xD;
Standard pressure (12-14 mmHg) pneumoperitoneum&#xD;
Abdominal draining for patients with perforated and not perforated appendicitis complicated by abscess, local or diffuse peritonitis (Gomez ≥ 3A).&#xD;
Appendix mesentery removing in the appearance of its necrotic changes.&#xD;
No intraabdominal anesthesia. Postoperative care.&#xD;
1) Mobilization in 4-6 h after surgery 2) Fluid intake in 6 hours 3) Liquid food intake in 12 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic appendectomy</intervention_name>
    <description>Preoperative care in both arms. Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.&#xD;
Surgery. General anesthesia with strict control of fluid therapy and hemodynamic changes during surgery. Appendectomy with the use of monopolar coagulation by experienced surgeons following appendix stump ligation by two Roeder knots.&#xD;
Postoperative care. Antibiotics for 3-5 days for patients with complicated appendicitis (Gomez ≥ 3A). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 2, 6, 12 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 protocol group</arm_group_label>
    <arm_group_label>Standard care group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with any stage of acute appendicitis except 3B according to Gomes&#xD;
             classification;&#xD;
&#xD;
          -  Class I-II surgical patients according to the classification of The American Society&#xD;
             of Anesthesiologists (ASA).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal to participate in the study or to sign the informed consent form;&#xD;
&#xD;
          -  Language barrier;&#xD;
&#xD;
          -  Transfer to the intensive care unit (ICU) after surgery;&#xD;
&#xD;
          -  ASA class ≥ III;&#xD;
&#xD;
          -  Conversion to open procedure;&#xD;
&#xD;
          -  Appendicular mass found during laparoscopy;&#xD;
&#xD;
          -  Gomes 3B appendicitis requiring immersion of the appendicular stump;&#xD;
&#xD;
          -  Pregnancy.&#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 V 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>September 2018</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>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>enhanced recovery</keyword>
  <keyword>fast-track</keyword>
  <keyword>appendectomy</keyword>
  <keyword>intraperitoneal anesthesia</keyword>
  <keyword>low pressure pneumoperitoneum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
    <mesh_term>Peritonitis</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Acute Disease</mesh_term>
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 14, 2021</submitted>
    <returned>February 3, 2021</returned>
    <submitted>May 1, 2021</submitted>
    <returned>May 24, 2021</returned>
  </pending_results>
  <!-- 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/NCT03754777
org study id: MERES
nct id: NCT03754777
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Laparoscopic appendectomy (LA) is a widespread surgical procedure. Patients may develop
      considerable postoperative pain and dyspepsia resulting in prolong in-hospital stay. Almost
      10% of patients develop postoperative complications. Enhanced recovery after surgery (ERAS)
      program has proven its effectiveness in elective surgery and can theoretically improve
      outcomes of LA. To date there is no ERAS program for LA. The aim of the study was to
      investigate the safety and efficacy of a modified ERAS protocol in LA.
A modified ERAS (mERAS) protocol was investigated. The study is a prospective, randomized
      nonblinded. All patients underwent LA. Modified ERAS protocol included patient informing,
      limitation of drainage use; intraperitoneal anesthesia with long-acting anesthetics;
      low-pressure pneumoperitoneum; early mobilization and oral nutrition. Pain level was assessed
      in rest using visual analogue scale (VAS). The primary endpoint was postoperative length of
      stay (pLOS).
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 visual analog scale in centimeters
arm group label: Modified ERAS protocol group
arm group type: Experimental
description: Laparoscopic appendectomy with modified ERAS protocol group Preadmission. Not available due to the emergency setting. Preoperative care.
1) Patient brochure with a detailed description of the type of pathology, surgery procedure, rehabilitation process, possible complications, and other.
Surgery.
Low pressure (8-9 mmHg) pneumoperitoneum.
Routinely remove of appendix mesentery in presence of any signs of its inflammation.
Additional local anesthesia with 0.25% ropivacaine.
Abdominal cavity draining only in patients with perforated appendicitis and diffuse peritonitis (Gomes 5).
Postoperative care.
Early mobilization (2 h after surgery)
Early fluid intake (2 h after surgery)
Early liquid food (6 h after surgery)
arm group label: Standard care group
arm group type: Placebo Comparator
description: Standard care laparoscopic appendectomy. Preadmission. Not available due to emergency setting. Preoperative care. 1) Patient oral informing about the type of pathology, surgery procedure and possible complications. No brochure.
Surgery.
Standard pressure (12-14 mmHg) pneumoperitoneum
Abdominal draining for patients with perforated and not perforated appendicitis complicated by abscess, local or diffuse peritonitis (Gomez ≥ 3A).
Appendix mesentery removing in the appearance of its necrotic changes.
No intraabdominal anesthesia. Postoperative care.
1) Mobilization in 4-6 h after surgery 2) Fluid intake in 6 hours 3) Liquid food intake in 12 hours
intervention type: Procedure
intervention name: Laparoscopic appendectomy
description: Preoperative care in both arms. Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.
Surgery. General anesthesia with strict control of fluid therapy and hemodynamic changes during surgery. Appendectomy with the use of monopolar coagulation by experienced surgeons following appendix stump ligation by two Roeder knots.
Postoperative care. Antibiotics for 3-5 days for patients with complicated appendicitis (Gomez ≥ 3A). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 2, 6, 12 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 protocol group
arm group label: Standard care group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander V Sazhin, Prof.
role: Study Chair
affiliation: Pirogov Russian National Research Medical University
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Appendicitis
mesh term: Peritonitis
mesh term: Emergencies
mesh term: Acute Disease
mesh term: Rupture
sharing ipd: Undecided
submitted: January 14, 2021
returned: February 3, 2021
submitted: May 1, 2021
returned: May 24, 2021