Abdominal SurgeryNCT04467528
Electroacupuncture for Gastrointestinal Dysmotility After Abdominal Surgery
A study testing Electroacupuncture and Conventional drug therapy in people with Abdominal Surgery, run by China Medical University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- Electroacupuncture and Conventional drug therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Apr 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Hemorrhagic disease or coagulation dysfunction
- Local skin infection
- Fear of needles or electrical stimulation
- Any severe chronic or uncontrollable complications
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung
Ming-Cheng Huang, M.D., +886-4-22052121 ext. 4561, mchuang1128@gmail.com
About this study
Official title: Efficacy of Electroacupuncture as an Adjunctive Treatment in Gastrointestinal Motility in Patients After Abdominal Surgery
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.
Read the 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
- Being tested
- Electroacupuncture, Conventional drug therapy
- Keywords
- abdominal surgery, acupuncture, electroacupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
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 therapyDrug
Conventional drug therapy:
All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Conventional drug therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Measured: 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
Measured: 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
Measured: 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
Changes from baseline to 3rd day of the intervention
Measured: baseline, Day 3 of the intervention
Sequential Organ Failure Assessment score
Changes from baseline to 3rd day of the intervention
Measured: 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
Measured: baseline
Blood examination
Changes of CBC, ALT, AST, BUN, Creatinine, CRP from baseline to 3rd day of the intervention
Measured: baseline, Day 3 of the intervention
Laboratory examination
Changes of cytokines (IL-1,6,10,12) from baseline to 3rd day of the intervention
Measured: 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
Measured: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start27 Apr 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Cheng Huang, M.D., Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467528
- Sponsor's protocol ID
- CMUH109-REC3-040
- Status last verified
- Jul 2020
- First submitted
- 20 May 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Electroacupuncture as an Adjunctive Treatment in Gastrointestinal Motility in Patients After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04467528
- Acronym / sponsor ID
- CMUH109-REC3-040
- Conditions
- Abdominal Surgery
- Keywords
- abdominal surgery, acupuncture, electroacupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture combined with conventional drug therapy | Experimental | Device: Electroacupuncture, Drug: Conventional drug therapyConventional 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 | Active comparator | Drug: Conventional drug therapyConventional drug therapy: All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- more than 20 years old.
- Underwent abdominal surgery within one month
- Meet one or both of the following indications
- Had signed the informed consent with fully understand the aim of the clinical trial
Key exclusion criteria (4 listed)
- Hemorrhagic disease or coagulation dysfunction
- Local skin infection
- Fear of needles or electrical stimulation
- Any severe chronic or uncontrollable complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureExperimental: 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 | Device | Electroacupuncture combined with conventional drug therapy |
| Conventional drug therapyConventional drug therapy: All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial | Drug | Conventional drug therapy, Electroacupuncture combined with conventional drug therapy |
Primary outcome
Visual Analogue Scale
Time frame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Daily feeding volume
Time frame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Gastric residual volume
Time frame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Changes from baseline to 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
6 secondary outcomes
Acute Physiology and Chronic Health Evaluation II score
Time frame: baseline, Day 3 of the intervention
Sequential Organ Failure Assessment score
Time frame: baseline, Day 3 of the intervention
Physiological and operative severity scores for the enumeration of mortality and morbidity score
Time frame: baseline
Blood examination
Time frame: baseline, Day 3 of the intervention
Laboratory examination
Time frame: baseline, Day 3 of the intervention
Heart rate variability
Time frame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Cheng Huang, M.D. principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Conventional drug therapy in people with Abdominal Surgery, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming-Cheng Huang, M.D. (+886-4-22052121 ext. 4561, mchuang1128@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020.