The Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Gastrointestinal Dysfunction After Urological Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- I-FEED(Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms)Score
研究概览
简要总结
The purpose of this clinical trial is to understand the effect of percutaneous acupoint electrical stimulation on postoperative gastrointestinal dysfunction. It will also investigate the safety of percutaneous acupoint electrical stimulation. The main questions that this trial aims to answer are:
Can percutaneous acupoint electrical stimulation alleviate postoperative gastrointestinal dysfunction? Through which mechanisms do they function?
Participants will:
Preoperatively, patients were either given or not given percutaneous acupoint electrical stimulation.
Record their symptoms and biological indicators within 5 days after the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •BMI < 28 kg/m2
- •ASA classification is I-III grade
- •Laparoscopic urological procedures under general anesthesia, including but not limited to laparoscopic nephrectomy and laparoscopic radical prostatectomy for prostate cancer
- •Normal comprehension ability, and the patient or his/her family members can cooperate in filling out the questionnaire
- •Voluntary to sign the informed consent form
排除标准
- •Comprehensive assessment of severe cardiovascular, pulmonary and cerebrovascular diseases (such as severe coronary heart disease, valve diseases, respiratory failure, cerebral hemorrhage, cerebral infarction, etc.)
- •Preoperative use of analgesic and gastrointestinal motility drugs
- •TEAS contraindications (having electronic devices in the body, skin damage or infection at the stimulation site)
- •Previous history of TEAS or electro-acupuncture treatment
- •Previous history of gastrointestinal surgery, long-term gastrointestinal motility disorders and severe intestinal diseases
- •Pregnancy
研究组 & 干预措施
TEAS group
干预措施: Transcutaneous electrical acupoint stimulation (Device)
Sham TEAS group
干预措施: Sham transcutaneous Electrical Acupoint Stimulation (Device)
结局指标
主要结局
I-FEED(Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms)Score
时间窗: Three days after the operation
The I-FEED score consists of five aspects: eating, nausea, vomiting, physical examination, and duration of symptoms. The lowest score is 0 and the highest is 14. The higher the score, the worse the result. The normal I-FEED score is 0-2 points. Postoperative gastrointestinal intolerance (POGI) is 3-5 points, and Postoperative gastrointestinal dysfunction (POGD) is ≥ 6 points.
次要结局
- The concentrations of motilin (MTL)(postoperative 5 days)
- Interleukin-6 (IL-6)(postoperative 5 days)
- Acetylcholine (Ach)(postoperative 5 days)
- Norepinephrine (NE)(postoperative 5 days)
- The time of the first postoperative defecation and flatus expulsion(postoperative 3 days)
- Platelet/lymphocyte ratio (PLR)(postoperative 5 days)
- Visual analogue scale (VAS) Score(postoperative 5 days)
- miR-10b-5p(postoperative 5 days)
- Interleukin-10 (IL-10)(postoperative 5 days)
- Quality-of-recovery 15 (Qor-15) Score(postoperative 5 days)
研究者
Yang Bin
Principal Investigator
The First Affiliated Hospital of Xiamen University