Clinical trial NCT04467528: Electroacupuncture for Gastrointestinal Dysmotility After Abdominal Surgery
Official title: Efficacy of Electroacupuncture as an Adjunctive Treatment in Gastrointestinal Motility in Patients After Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Surgery
Keywords: abdominal surgery
acupuncture
electroacupuncture
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
measure: Daily feeding volume
timeFrame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
measure: Gastric residual volume
timeFrame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Secondary outcomes:
measure: Acute Physiology and Chronic Health Evaluation II score
timeFrame: baseline, Day 3 of the intervention
measure: Sequential Organ Failure Assessment score
timeFrame: baseline, Day 3 of the intervention
measure: Physiological and operative severity scores for the enumeration of mortality and morbidity score
timeFrame: baseline
measure: Blood examination
timeFrame: baseline, Day 3 of the intervention
measure: Laboratory examination
timeFrame: baseline, Day 3 of the intervention
measure: Heart rate variability
timeFrame: baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Ming-Cheng Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: