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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04467528
Other study ID # CMUH109-REC3-040
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 27, 2020
Est. completion date March 31, 2021

Study information

Verified date July 2020
Source China Medical University Hospital
Contact Ming-Cheng Huang, M.D.
Phone +886-4-22052121
Email mchuang1128@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Taiwan China Medical University Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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