Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients
2026年8月12日 更新者：Xin Yu、Sir Run Run Shaw Hospital
Efficacy of Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients With Colorectal Cancer: A Multicenter Randomized Controlled Trial Study Protocol
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.
研究概览
研究类型
介入性
注册 (估计的)
190
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Xin Yu
- 电话号码：86006663
- 邮箱：xinxin_yu@zju.edu.cn
学习地点
-
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Shandong
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Binzhou、Shandong、中国
- 尚未招聘
- Shandong Medical and Pharmaceutical University Hospital
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接触：
- Shuhui Zhang
- 电话号码：18354017338
- 邮箱：3259998310@qq.com
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Zhejiang
-
Hangzhou、Zhejiang、中国
- 招聘中
- Sir Run Run Shaw Hospital
-
接触：
- Xin Yu
- 电话号码：86006663
- 邮箱：xinxin_yu@zju.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age ≥ 65 years old.
- Elective minimally invasive (laparoscopic or robotic) resection of colorectal cancer.
- American Society of Anesthesiologists classification (ASA) 1-4.
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：TEA
|
The subjects in the TEA group were placed in the supine position and received transcutaneous electrical acupoint stimulation at the bilateral PC6 and bilateral ST36 .
After confirming the location of the acupoints , special skin treatment was carried out.
The stimulation parameters for PC6 were set as follows: 0.1 seconds of opening stimulation, 0.4 seconds of closing stimulation, pulse width of 0.5 ms, pulse frequency of 100 Hz, and amplitude ranging from 1 to 10 mA (based on the maximum level that the subject could tolerate).
The stimulation parameters for ST36 were set as follows: 2 seconds of opening stimulation, 3 seconds of closing stimulation, pulse width of 0.5 ms, pulse frequency of 25 Hz, and amplitude ranging from 2 to 10 mA (based on the maximum level that the subject could tolerate).
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假比较器：sham-TEA
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Sham-TEA was the same except that non-acupoints were used to replace ST36 and PC6.
The sham-acupoint for PC6 was located at about 15-20 cm away from PC6 (up to the elbow and outside of the coastal margin of the forearm not on any meridian) and the sham-point for ST36 was located at 10-15 cm down from and to the lateral side of ST36 not on any meridian
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to First Flatus
大体时间：Assessed up to 10 days after surgery
|
Defined as the period from the end of the surgery to the time of first flatus (hours).
|
Assessed up to 10 days after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prolonged post operative ileus (PPOI)
大体时间：Assessed up to 72 hours after surgery
|
defined as no flatus for more than 72 hours
|
Assessed up to 72 hours after surgery
|
|
time to first defecation
大体时间：Assessed up to 10 days after surgery
|
Defined as the period from the end of the surgery to the time of first defecation (hours).
|
Assessed up to 10 days after surgery
|
|
time to first water intake
大体时间：Assessed up to 10 days after surgery
|
The time from the end of the surgery to the first water intake (hours)
|
Assessed up to 10 days after surgery
|
|
Time to tolerance of liquid diet
大体时间：Assessed up to 10 days after surgery
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"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after the liquid diet.
Record the time (in hours) from the end of the surgery to the first tolerance to the liquid diet.
|
Assessed up to 10 days after surgery
|
|
Time to tolerance of semi-liquid diet
大体时间：Assessed up to 10 days after surgery
|
"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after semi-liquid food.
Record the time ( hours) from the end of the surgery to the first tolerance of semi-liquid food.
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Assessed up to 10 days after surgery
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Time to tolerance of solid food
大体时间：Assessed up to 10 days after surgery
|
"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after solid food.
Record the time (hours) from the end of the surgery to the first tolerance of solid food.
|
Assessed up to 10 days after surgery
|
|
Time to first ambulation
大体时间：Assessed up to 10 days after surgery
|
The time from the end of the surgery to the first ambulation (hours).
|
Assessed up to 10 days after surgery
|
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Postoperative nausea
大体时间：At 24, 48, and 72 hours after surgery
|
The number and frequency of postoperative nausea episodes
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At 24, 48, and 72 hours after surgery
|
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postoperative vomiting
大体时间：At 24, 48, and 72 hours after surgery
|
The number and frequency of postoperative vomiting
|
At 24, 48, and 72 hours after surgery
|
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postoperative abdominal distension
大体时间：At 24, 48, and 72 hours after surgery
|
The number and frequency of postoperative abdominal distension
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At 24, 48, and 72 hours after surgery
|
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Use of anti-emetic drugs after surgery
大体时间：At 24, 48, and 72 hours after surgery
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Number of participants using antiemetic drugs
|
At 24, 48, and 72 hours after surgery
|
|
Severity of postoperative pain
大体时间：At 24, 48, and 72 hours after surgery
|
The assessment was conducted using a numerical rating scale (NRS).
The scoring range was 0-10 (0 indicated no pain, while 10 indicated unbearable severe pain.
Scores of 1-3 indicated mild pain that could be tolerated; 4-6 indicated pain that affected sleep but was still tolerable; 7-10 indicated severe pain that affected appetite and sleep).
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At 24, 48, and 72 hours after surgery
|
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Use of opioids drugs after surgery
大体时间：At 24, 48, and 72 hours after surgery
|
The total dosage of all opioid analgesics used within 24 hours, 48 hours, and 72 hours after surgery, converted into morphine equivalents.
|
At 24, 48, and 72 hours after surgery
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TEA Security
大体时间：Assessed up to 3 days after surgery
|
assessing the adverse events related to the equipment (including numbness in the hands, pain, and skin allergies)
|
Assessed up to 3 days after surgery
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Postoperative complications
大体时间：From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery)
|
The severity of complications was evaluated using the Clavien-Dindo classification system (grades I to V), with Clavien-Dindo grade ≥ III complications serving as the major surgical complications.
|
From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery)
|
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Total length of hospital stay
大体时间：Assessed up to 30 days after surgery
|
primary admission plus any readmission up to 30 days
|
Assessed up to 30 days after surgery
|
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Unplanned readmission
大体时间：Assessed up to 30 days after surgery
|
Record the number of unplanned re-admissions within 30 days of hospital discharge
|
Assessed up to 30 days after surgery
|
|
Postoperative quality of recovery
大体时间：baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first)
|
Assessed using the Quality of Recovery - 15 score (QoR-15) questionnaire preoperatively and daily.
The total score ranges from 0 to 150 points.
The higher the score, the better the post-anesthesia recovery quality.
|
baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月14日
初级完成 (估计的)
2027年4月30日
研究完成 (估计的)
2028年5月31日
研究注册日期
首次提交
2026年4月30日
首先提交符合 QC 标准的
2026年4月30日
首次发布 (实际的)
2026年5月8日
研究记录更新
最后更新发布 (实际的)
2026年8月14日
上次提交的符合 QC 标准的更新
2026年8月12日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.