Electroacupuncture for Gastrointestinal Dysmotility After Abdominal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Abdominal Surgery

Intervention / Treatment
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* Device: Electroacupuncture
* Drug: Conventional drug therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: more than 20 years old. Underwent abdominal surgery within one month Meet one or both of the following indications Participants have abdominal distension after abdominal surgery which affects gastrointestinal motility. After medical treatment, the visual pain scale score remained above three points 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 Had signed the informed consent with fully understand the aim of the clinical trial Exclusion Criteria: Hemorrhagic disease or coagulation dysfunction Local skin infection Fear of needles or electrical stimulation Any severe chronic or uncontrollable complications

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture combined with conventional drug therapy<br>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<br>* 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<br>Drug: Conventional drug therapy<br>* Conventional drug therapy: All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial<br>|
| Active Comparator: Conventional drug therapy<br>Conventional drug therapy: All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial | Drug: Conventional drug therapy<br>* Conventional drug therapy: All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, abdominal surgery, electroacupuncture