Electroacupuncture for Gastrointestinal Dysmotility After Abdominal Surgery

NCT04467528 | Unknown

• 1 other identifier: CMUH109-REC3-040
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Surgery

Keywords

abdominal surgery; acupuncture; electroacupuncture

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Acute Physiology and Chronic Health Evaluation II score

  baseline, Day 3 of the intervention

• Sequential Organ Failure Assessment score

  baseline, Day 3 of the intervention

• Physiological and operative severity scores for the enumeration of mortality and morbidity score

  baseline

• Blood examination

  baseline, Day 3 of the intervention

• Laboratory examination

  baseline, Day 3 of the intervention

Study Arms (2)

Electroacupuncture combined with conventional drug therapy

EXPERIMENTAL

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; Drug: Conventional drug therapy

Conventional drug therapy

ACTIVE COMPARATOR

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

Drug: Conventional drug therapy

Interventions

Electroacupuncture 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

Electroacupuncture combined with conventional drug therapy

Conventional drug therapy DRUG

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

Conventional drug therapy; Electroacupuncture combined with conventional drug therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hemorrhagic disease or coagulation dysfunction
• Local skin infection
• Fear of needles or electrical stimulation
• Any severe chronic or uncontrollable complications

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Ming-Cheng Huang, M.D.

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Cheng Huang, M.D.

CONTACT

+886-4-22052121; mchuang1128@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: July 13, 2020
• Study Start: April 27, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: July 13, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)