Efficacy of Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients With Colorectal Cancer: A Multicenter Randomized Controlled Trial Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Time to First Flatus
研究概览
简要总结
The goal of this clinical trial is to clarify the efficacy and safety of transcutaneous electrical acustimulation (TEA) in elderly patients with colorectal cancer, and to evaluate its clinical value in promoting postoperative intestinal function recovery and reducing the incidence of intestinal complications. The main questions it aims to answer are:
Can TEA promote the recovery of intestinal function in elderly patients with colon cancer after surgery? What medical problems might occur to the participants when using TEA? The researchers will compare TEA with the control group (non-acupoint sham stimulation) to see if TEA is effective in promoting the recovery of intestinal function after surgery.
Participants will:
Starting from the first day after the surgery, they received TEA or sham stimulation twice a day for a total of 3 days.
Record the time of the first defecation, defecation, and eating. Record their symptoms and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years old.
- •Elective minimally invasive (laparoscopic or robotic) resection of colorectal cancer.
- •American Society of Anesthesiologists classification (ASA) 1-
- •Able to understand the research process and the use of various assessment scales, and able to communicate effectively with the researchers.
- •The patient voluntarily participates in this study and signs the informed consent form.
排除标准
- •Previous history of abdominal gastrointestinal surgery.
- •Planned for palliative or emergency surgery.
- •Planned for open abdominal surgery or creation of a new stoma.
- •Transfer to ICU.
- •Diagnosed with severe heart, liver, kidney or mental system diseases.
- •Patients with implanted cardiac pacemakers.
- •Patients currently using or having used in the past month glucagon-like peptide-1 (GLP-1) receptor agonists, dual glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, and sodium-glucose cotransporter-2 (SGLT-2) inhibitors.
- •Planned to use epidural anesthesia or epidural analgesia.
- •Presence of local skin lesions, infection at the stimulation site, or obvious skin allergy or severe skin sensitivity to electrodes/adhesive materials.
- •Participated in other clinical studies within the past 3 months or received acupuncture treatment within the past month.
- •Other conditions that the investigator considers make the patient unsuitable for participation in this study.
研究组 & 干预措施
sham-TEA
干预措施: sham-TEA (Device)
TEA
干预措施: TEA (Device)
结局指标
主要结局
Time to First Flatus
时间窗: Assessed up to 10 days after surgery
Defined as the period from the end of the surgery to the time of first flatus (hours).
次要结局
- Prolonged post operative ileus (PPOI)(Assessed up to 72 hours after surgery)
- time to first defecation(Assessed up to 10 days after surgery)
- time to first water intake(Assessed up to 10 days after surgery)
- Time to tolerance of liquid diet(Assessed up to 10 days after surgery)
- Time to tolerance of semi-liquid diet(Assessed up to 10 days after surgery)
- Time to tolerance of solid food(Assessed up to 10 days after surgery)
- Time to first ambulation(Assessed up to 10 days after surgery)
- Postoperative nausea(At 24, 48, and 72 hours after surgery)
- postoperative vomiting(At 24, 48, and 72 hours after surgery)
- postoperative abdominal distension(At 24, 48, and 72 hours after surgery)
- Use of anti-emetic drugs after surgery(At 24, 48, and 72 hours after surgery)
- Severity of postoperative pain(At 24, 48, and 72 hours after surgery)
- Use of opioids drugs after surgery(At 24, 48, and 72 hours after surgery)
- Postoperative quality of recovery(baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first))
- TEA Security(Assessed up to 3 days after surgery)
- Postoperative complications(From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery))
- Total length of hospital stay(Assessed up to 30 days after surgery)
- Unplanned readmission(Assessed up to 30 days after surgery)
研究者
Xin Yu
professor
Sir Run Run Shaw Hospital