Electroacupuncture for Gastrointestinal Dysmotility After Abdominal Surgery

Efficacy of Electroacupuncture as an Adjunctive Treatment in Gastrointestinal Motility in Patients After Abdominal Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Surgery
• Intervention / Treatment: Device: Electroacupuncture; Drug: Conventional drug therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • China Medical University Hospital
    • Contact: Ming-Cheng Huang, M.D.; Phone Number: 4561 +886-4-22052121; Email: mchuang1128@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. more than 20 years old.
2. Underwent abdominal surgery within one month

3. Meet one or both of the following indications

   1. Participants have abdominal distension after abdominal surgery which affects gastrointestinal motility. After medical treatment, the visual pain scale score remained above three points
   2. Participants have post-operative ileus after abdominal surgery. After medical treatment, the gastric residual volume is still greater than 300 ml under the intestinal nutrition support
4. Had signed the informed consent with fully understand the aim of the clinical trial

Exclusion Criteria:

1. Hemorrhagic disease or coagulation dysfunction
2. Local skin infection
3. Fear of needles or electrical stimulation
4. Any severe chronic or uncontrollable complications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Device: Electroacupuncture; 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; Drug: Conventional drug therapy; Conventional drug therapy: All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial
Active Comparator: Conventional drug therapy; Conventional drug therapy: All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial	Drug: Conventional drug therapy; Conventional drug therapy: All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention	baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Daily feeding volume	Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention	baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Gastric residual volume	Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention	baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Physiology and Chronic Health Evaluation II score	Changes from baseline to 3rd day of the intervention	baseline, Day 3 of the intervention
Sequential Organ Failure Assessment score	Changes from baseline to 3rd day of the intervention	baseline, Day 3 of the intervention
Physiological and operative severity scores for the enumeration of mortality and morbidity score	To predict morbidity and mortality of the patients in ICU	baseline
Blood examination	Changes of CBC, ALT, AST, BUN, Creatinine, CRP from baseline to 3rd day of the intervention	baseline, Day 3 of the intervention
Laboratory examination	Changes of cytokines (IL-1,6,10,12) from baseline to 3rd day of the intervention	baseline, Day 3 of the intervention
Heart rate variability	Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention	baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Principal Investigator: Ming-Cheng Huang, M.D., China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: acupuncture; electroacupuncture; abdominal surgery
• Other Study ID Numbers: CMUH109-REC3-040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No