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临床试验/NCT04467528
NCT04467528Unknown不适用

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

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年4月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Gastric residual volume

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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

干预措施: Electroacupuncture (Device)

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

干预措施: Conventional drug therapy (Drug)

Conventional drug therapy

Active Comparator

Conventional drug therapy:

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

干预措施: Conventional drug therapy (Drug)

结局指标

主要结局

Gastric residual volume

时间窗: 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

Visual Analogue Scale

时间窗: 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

时间窗: 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

次要结局

  • Blood examination(baseline, Day 3 of the intervention)
  • Laboratory examination(baseline, Day 3 of the intervention)
  • 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)
  • Heart rate variability(baseline, 1st day of the intervention, 2nd day of the intervention, 3rd day of the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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