Electroacupuncture for Gastrointestinal Dysmotility After Abdominal Surgery

NCT ID: NCT04467528

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-27
• Study Completion Date: 2021-03-31

Brief 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.

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.

Conditions

Abdominal Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: DEVICE

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

Conventional drug therapy

Intervention Type: DRUG

Conventional drug therapy:

All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial

Conventional drug therapy

Conventional drug therapy:

All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial

Group Type: ACTIVE_COMPARATOR

Conventional drug therapy

Intervention Type: DRUG

Conventional drug therapy:

All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial

Interventions

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

Intervention Type: DEVICE

Conventional drug therapy

Conventional drug therapy:

All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming-Cheng Huang, M.D.

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ming-Cheng Huang, M.D.

Role: CONTACT

mchuang1128@gmail.com

+886-4-22052121 ext. 4561

Facility Contacts

Ming-Cheng Huang, M.D.

Role: primary

mchuang1128@gmail.com

+886-4-22052121 ext. 4561

Other Identifiers

CMUH109-REC3-040

Identifier Type: -

Identifier Source: org_study_id