Different Acupoint Stimulation for Postoperative Gastrointestinal Dysfunction in Primary Liver Cancer Patients
Application of Different Acupoint Stimulation Methods in the Prevention and Management of Postoperative Gastrointestinal Dysfunction in Patients With Primary Liver Cancer: A Randomized Controlled Trial
Brief Summary (Plain Language) The purpose of this clinical trial is to evaluate and compare the effects of four different intervention measures on preventing and managing postoperative gastrointestinal dysfunction in patients with primary liver cancer. The four measures include herbal acupoint application, transcutaneous acupoint electrical stimulation, the combination of the above two acupoint stimulation methods, and routine clinical nursing. This study aims to provide scientific evidence for the clinical application of acupoint stimulation therapies in postoperative rehabilitation of liver cancer patients.
The main research question of this study is whether acupoint stimulation interventions can effectively improve postoperative gastrointestinal recovery in primary liver cancer patients. The primary outcome measure is the time to first postoperative anal exhaust, which is a core indicator to reflect the recovery of gastrointestinal function after surgery.
By comparing the differences in gastrointestinal recovery among the four groups, this trial will clarify the optimal acupoint intervention scheme to prevent and relieve postoperative gastrointestinal dysfunction in primary liver cancer patients, so as to improve patients' postoperative rehabilitation quality.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Yan Zhu, Master of Nursing
- 电话号码：+86 18701869040
- 邮箱：zhu.yan4@zs-hospital.sh.cn
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients diagnosed with primary liver cancer scheduled for initial partial hepatectomy or laparoscopic partial hepatectomy.
- Aged between 18 and 75 years old.
- Clear consciousness and ability to communicate in writing.
- Voluntary participation with signed informed consent.
Exclusion Criteria:
- Patients receiving concurrent chemotherapy.
- Patients with adhesive plaster allergy or allergic constitution.
- Patients with local skin damage, infection or dermatitis at acupoint sites.
- Patients with cognitive dysfunction.
- Patients complicated with preoperative gastrointestinal dysfunction or with a history of gastrointestinal surgery.
- Patients undergoing associating liver partition and portal vein ligation for staged hepatectomy (ALPPS).
- Patients transferred to the intensive care unit (ICU) after surgery.
- Patients with implanted cardiac pacemakers.
学习计划
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：日常护理
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Patients receive standard postoperative routine nursing care only.
No additional acupoint-related interventions are provided throughout the study period.
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实验性的：联合干预
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Initiated after stable vital signs on the surgery day.
Receive transcutaneous acupoint electrical stimulation first, then herbal acupoint application.
The specific operation standards are the same as the above two groups, performed once daily until the first anal exhaust.
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实验性的：Acupoint Application
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Intervention starts after the patient returns to the ward with stable vital signs on the surgery day.
Herbal patches composed of Natrii Sulfas, Radix et Rhizoma Rhei, Fructus Aurantii Immaturus and Cortex Magnoliae Officinalis are applied to bilateral Zusanli (ST36), Shangjuxu (ST37) and Hegu (LI4).
Each application lasts 6 hours, once a day until the first anal exhaust.
Relevant observations are recorded during the process.
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实验性的：TAES
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Treatment begins on the surgery day when vital signs stabilize after returning to the ward.
Electrodes are placed on bilateral Zusanli (ST36), Shangjuxu (ST37) and Hegu (LI4) for transcutaneous acupoint electrical stimulation with 2/100 Hz dense-disperse waves.
Current ranges from 1 mA up to patient's maximum tolerance (no more than 10 mA), 30 minutes per session once daily.
Treatment data is recorded accordingly.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Time to first postoperative flatus
大体时间：Perioperative, from the end of surgery until the first postoperative flatus occurs
|
Perioperative, from the end of surgery until the first postoperative flatus occurs
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Time to first defecation
大体时间：Perioperative
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Perioperative
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Incidence of postoperative gastrointestinal dysfunction
大体时间：Within 7 days after surgery
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Within 7 days after surgery
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Incidence and severity of postoperative intestinal obstruction
大体时间：Within 14 days after surgery
|
Within 14 days after surgery
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合作者和调查者
调查人员
- 首席研究员：Yan Zhu、Fudan University
出版物和有用的链接
一般刊物
- Jiang T, Li J, Meng L, Wang J, Zhang H, Liu M. Effects of transcutaneous electrical acupoint stimulation on gastrointestinal dysfunction after gastrointestinal surgery: A meta-analysis. Complement Ther Med. 2023 May;73:102938. doi: 10.1016/j.ctim.2023.102938. Epub 2023 Feb 25.
- Wang MX. Effect of acupoint application during Chen period on gastrointestinal function recovery in patients with primary liver cancer after laparoscopic surgery[D]. Guangzhou University of Chinese Medicine, 2023.
- Shi XL, Li H, Bian LF, et al. Summary of best evidence for prevention and management of postoperative gastrointestinal dysfunction in patients with liver cancer. Journal of Enhanced Recovery After Surgery, 2024, 7 (4): 145-151.
- Li S, Liu KX, Deng XM, et al. Expert consensus on prevention and treatment of postoperative gastrointestinal dysfunction. International Journal of Anesthesiology and Resuscitation, 2021, 42 (11): 1133-1142.
- Expert Committee for the Guidelines for Diagnosis and Treatment of Primary Liver Cancer, Zhou J. Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition). Chinese Journal of Clinical Medicine, 2024, 31(2): 277-334.
- Cheng XN, Zhang X, Ji J, Zhou J. [Acupoints selection rules of acupuncture and moxibustion for promoting gastrointestinal function recovery after intestinal cancer surgery based on complex network analysis]. Zhen Ci Yan Jiu. 2024 Oct 25;49(10):1107-1120. doi: 10.13702/j.1000-0607.20230829. Chinese.
- Arfa S, Turco C, Lakkis Z, Bourgeois S, Fouet I, Evrard P, Sennegon E, Roucoux A, Paquette B, Devaux B, Rietsch-Koenig A, Heyd B, Doussot A. Delayed return of gastrointestinal function after hepatectomy in an ERAS program: incidence and risk factors. HPB (Oxford). 2022 Sep;24(9):1560-1568. doi: 10.1016/j.hpb.2022.03.014. Epub 2022 Apr 5.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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