<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/NCT04467528</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH109-REC3-040</org_study_id>
    <nct_id>NCT04467528</nct_id>
  </id_info>
  <brief_title>Electroacupuncture for Gastrointestinal Dysmotility After Abdominal Surgery</brief_title>
  <official_title>Efficacy of Electroacupuncture as an Adjunctive Treatment in Gastrointestinal Motility in Patients After Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Taiwan, the number of patients who underwent abdominal surgery that attributed to&#xD;
      gastrointestinal diseases, gynecological diseases, and cancer is increasing. Practically,&#xD;
      some of the patients have unsatisfactory response to conventional medical treatment, which&#xD;
      result in abnormal gastrointestinal function, prolonged bedtime, and increased hospital stay,&#xD;
      as well as an increased risk of infection. Therefore, search for an effective and safe&#xD;
      treatment that could be integrated to current medical treatment is of importance in the care&#xD;
      of such patients.&#xD;
&#xD;
      Being with a long period of clinical experience and evidence-based curative effect,&#xD;
      acupuncture could be applied as an adjunctive treatment for the complications of abdominal&#xD;
      surgery. Currently, this patient-centered, pragmatic clinical trial compares the efficacy of&#xD;
      using conventional medication alone and a combination of electroacupuncture and conventional&#xD;
      drugs. The aim of this study is trying to explore acceptable and beneficial strategy to&#xD;
      reduce the clinical symptoms, to improve quality of life, and decrease medical expenses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 80 volunteers of patients underwent abdominal surgery will be recruited from the&#xD;
      intensive care unit of China Medical University Hospital. After diagnosis by surgeon, these&#xD;
      patients will be assigned to receive the conventional drug alone or the conventional drug&#xD;
      combined electroacupuncture treatment. All participants receive intravenous injection the&#xD;
      conventional drug, Metoclopramide, every 12 hours in the trial. Electroacupuncture, twice&#xD;
      daily for three days, is administered 48-72 hours after abdominal surgery. Visual analogue&#xD;
      scale, feeding volume, gastric residual volume and assessment of adverse events will be done&#xD;
      for every visit. Laboratory biochemistry analysis and other assessments including Visual&#xD;
      Analogue Scale, Acute Physiology and Chronic Health Evaluation II score, and Sequential Organ&#xD;
      Failure Assessment score will be completed at baseline and the end of intervention(3 days&#xD;
      after initation of the intervention). Physiological and operative severity scores for the&#xD;
      enumeration of mortality and morbidity (POSSUM) score will be done at the baseline.&#xD;
      Instrumental examinations including heart rate variability and traditional Chinese medicine&#xD;
      four examinations will be given before and after intervention. We expect that the efficacy of&#xD;
      combined electroacupuncture with conventional drug is superior to conventional drug only in&#xD;
      alleviation of gastrointestinal distension or/and improvement of motility in patients who&#xD;
      underwent abdominal surgery. Moreover, we will further speculate the mechanism by analyzing&#xD;
      laboratory data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 27, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention</time_frame>
    <description>Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily feeding volume</measure>
    <time_frame>baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention</time_frame>
    <description>Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastric residual volume</measure>
    <time_frame>baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention</time_frame>
    <description>Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute Physiology and Chronic Health Evaluation II score</measure>
    <time_frame>baseline, Day 3 of the intervention</time_frame>
    <description>Changes from baseline to 3rd day of the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sequential Organ Failure Assessment score</measure>
    <time_frame>baseline, Day 3 of the intervention</time_frame>
    <description>Changes from baseline to 3rd day of the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological and operative severity scores for the enumeration of mortality and morbidity score</measure>
    <time_frame>baseline</time_frame>
    <description>To predict morbidity and mortality of the patients in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood examination</measure>
    <time_frame>baseline, Day 3 of the intervention</time_frame>
    <description>Changes of CBC, ALT, AST, BUN, Creatinine, CRP from baseline to 3rd day of the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory examination</measure>
    <time_frame>baseline, Day 3 of the intervention</time_frame>
    <description>Changes of cytokines (IL-1,6,10,12) from baseline to 3rd day of the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention</time_frame>
    <description>Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Abdominal Surgery</condition>
  <arm_group>
    <arm_group_label>Electroacupuncture combined with conventional drug therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventional drug therapy:&#xD;
All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial&#xD;
For participants with abdominal distension:&#xD;
Electroacupuncture will be applied to the acupoints (LI4, PC6, ST36, SP6) 30min&#xD;
For participants with post-operative ileus:&#xD;
Electroacupuncture will be applied to the acupoints (LI4, SJ6, ST36, ST37) 30min&#xD;
32# acupuncture needle used and twice daily for three days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional drug therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional drug therapy:&#xD;
All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <description>Experimental: Electroacupuncture combined with conventional drug therapy&#xD;
Conventional drug therapy:&#xD;
All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial&#xD;
For participants with abdominal distension:&#xD;
Electroacupuncture will be applied to the acupoints (LI4, PC6, ST36, SP6) 30min&#xD;
For participants with post-operative ileus:&#xD;
Electroacupuncture will be applied to the acupoints (LI4, SJ6, ST36, ST37) 30min&#xD;
32# acupuncture needle used and twice daily for three days</description>
    <arm_group_label>Electroacupuncture combined with conventional drug therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Conventional drug therapy</intervention_name>
    <description>Conventional drug therapy:&#xD;
All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial</description>
    <arm_group_label>Conventional drug therapy</arm_group_label>
    <arm_group_label>Electroacupuncture combined with conventional drug therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. more than 20 years old.&#xD;
&#xD;
          2. Underwent abdominal surgery within one month&#xD;
&#xD;
          3. Meet one or both of the following indications&#xD;
&#xD;
               1. Participants have abdominal distension after abdominal surgery which affects&#xD;
                  gastrointestinal motility. After medical treatment, the visual pain scale score&#xD;
                  remained above three points&#xD;
&#xD;
               2. Participants have post-operative ileus after abdominal surgery. After medical&#xD;
                  treatment, the gastric residual volume is still greater than 300 ml under the&#xD;
                  intestinal nutrition support&#xD;
&#xD;
          4. Had signed the informed consent with fully understand the aim of the clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hemorrhagic disease or coagulation dysfunction&#xD;
&#xD;
          2. Local skin infection&#xD;
&#xD;
          3. Fear of needles or electrical stimulation&#xD;
&#xD;
          4. Any severe chronic or uncontrollable complications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming-Cheng Huang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Medical University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming-Cheng Huang, M.D.</last_name>
    <phone>+886-4-22052121</phone>
    <phone_ext>4561</phone_ext>
    <email>mchuang1128@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming-Cheng Huang, M.D.</last_name>
      <phone>+886-4-22052121</phone>
      <phone_ext>4561</phone_ext>
      <email>mchuang1128@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>abdominal surgery</keyword>
  <keyword>acupuncture</keyword>
  <keyword>electroacupuncture</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/NCT04467528
org study id: CMUH109-REC3-040
nct id: NCT04467528
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In Taiwan, the number of patients who underwent abdominal surgery that attributed to
      gastrointestinal diseases, gynecological diseases, and cancer is increasing. Practically,
      some of the patients have unsatisfactory response to conventional medical treatment, which
      result in abnormal gastrointestinal function, prolonged bedtime, and increased hospital stay,
      as well as an increased risk of infection. Therefore, search for an effective and safe
      treatment that could be integrated to current medical treatment is of importance in the care
      of such patients.

      Being with a long period of clinical experience and evidence-based curative effect,
      acupuncture could be applied as an adjunctive treatment for the complications of abdominal
      surgery. Currently, this patient-centered, pragmatic clinical trial compares the efficacy of
      using conventional medication alone and a combination of electroacupuncture and conventional
      drugs. The aim of this study is trying to explore acceptable and beneficial strategy to
      reduce the clinical symptoms, to improve quality of life, and decrease medical expenses.
A total of 80 volunteers of patients underwent abdominal surgery will be recruited from the
      intensive care unit of China Medical University Hospital. After diagnosis by surgeon, these
      patients will be assigned to receive the conventional drug alone or the conventional drug
      combined electroacupuncture treatment. All participants receive intravenous injection the
      conventional drug, Metoclopramide, every 12 hours in the trial. Electroacupuncture, twice
      daily for three days, is administered 48-72 hours after abdominal surgery. Visual analogue
      scale, feeding volume, gastric residual volume and assessment of adverse events will be done
      for every visit. Laboratory biochemistry analysis and other assessments including Visual
      Analogue Scale, Acute Physiology and Chronic Health Evaluation II score, and Sequential Organ
      Failure Assessment score will be completed at baseline and the end of intervention(3 days
      after initation of the intervention). Physiological and operative severity scores for the
      enumeration of mortality and morbidity (POSSUM) score will be done at the baseline.
      Instrumental examinations including heart rate variability and traditional Chinese medicine
      four examinations will be given before and after intervention. We expect that the efficacy of
      combined electroacupuncture with conventional drug is superior to conventional drug only in
      alleviation of gastrointestinal distension or/and improvement of motility in patients who
      underwent abdominal surgery. Moreover, we will further speculate the mechanism by analyzing
      laboratory data.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Visual Analogue Scale
time frame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
description: Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
measure: Daily feeding volume
time frame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
description: Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
measure: Gastric residual volume
time frame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
description: Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
measure: Acute Physiology and Chronic Health Evaluation II score
time frame: baseline, Day 3 of the intervention
description: Changes from baseline to 3rd day of the intervention
measure: Sequential Organ Failure Assessment score
time frame: baseline, Day 3 of the intervention
description: Changes from baseline to 3rd day of the intervention
measure: Physiological and operative severity scores for the enumeration of mortality and morbidity score
time frame: baseline
description: To predict morbidity and mortality of the patients in ICU
measure: Blood examination
time frame: baseline, Day 3 of the intervention
description: Changes of CBC, ALT, AST, BUN, Creatinine, CRP from baseline to 3rd day of the intervention
measure: Laboratory examination
time frame: baseline, Day 3 of the intervention
description: Changes of cytokines (IL-1,6,10,12) from baseline to 3rd day of the intervention
measure: Heart rate variability
time frame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
description: Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
arm group label: Electroacupuncture combined with conventional drug therapy
arm group type: Experimental
description: Conventional drug therapy:
All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial
For participants with abdominal distension:
Electroacupuncture will be applied to the acupoints (LI4, PC6, ST36, SP6) 30min
For participants with post-operative ileus:
Electroacupuncture will be applied to the acupoints (LI4, SJ6, ST36, ST37) 30min
32# acupuncture needle used and twice daily for three days
arm group label: Conventional drug therapy
arm group type: Active Comparator
description: Conventional drug therapy:
All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial
intervention type: Device
intervention name: Electroacupuncture
description: Experimental: Electroacupuncture combined with conventional drug therapy
Conventional drug therapy:
All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial
For participants with abdominal distension:
Electroacupuncture will be applied to the acupoints (LI4, PC6, ST36, SP6) 30min
For participants with post-operative ileus:
Electroacupuncture will be applied to the acupoints (LI4, SJ6, ST36, ST37) 30min
32# acupuncture needle used and twice daily for three days
arm group label: Electroacupuncture combined with conventional drug therapy
intervention type: Drug
intervention name: Conventional drug therapy
description: Conventional drug therapy:
All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial
arm group label: Conventional drug therapy
arm group label: Electroacupuncture combined with conventional drug therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ming-Cheng Huang, M.D.
role: Principal Investigator
affiliation: China Medical University Hospital
last name: Ming-Cheng Huang, M.D.
phone: +886-4-22052121
phone ext: 4561
email: mchuang1128@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
sharing ipd: No