Electroacupuncture for Gastrointestinal Dysmotility After Abdominal Surgery

Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04467528
• Other study ID #: CMUH109-REC3-040
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Surgery

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