The Mechanism of Acupressure on Postoperative Ileus in Patients With Colorectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Heart rate variability
研究概览
简要总结
The goal of this clinical trial is to learn about acupressure in patients with colorectal cancer surgery. The main questions it aims to answer are:
- whether acupressure can improve the motility of vagus nerve in patients after colorectal cancer surgery
- whether acupressure can reduce the inflammatory response of the body
- whether acupressure can reduce the incidence of gastrointestinal paralysis in patients after colorectal cancer surgery
Participants will receive acupressure at ST36 twice daily starting from the first day after surgery and lasting for five days. Researchers will compare usual care group to see if acupressure has those above effects.
详细描述
- Purpose of the study 2.1 Main research objectives: To improve the gastrointestinal function of patients with colorectal cancer after surgery, with the design and implementation of acupressure as the intervention. Through clinical research, the effectiveness of acupressure in improving gastrointestinal function in patients with colorectal cancer surgery will be discussed, and the regulatory effect of acupressure on sympathetic and vagus nerves will be further revealed, and the mechanism affecting gastrointestinal function will be explored from the perspective of nerve and inflammatory response.
2.2 Secondary Research Objectives and Exploratory Research Objectives:
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To shorten the length of hospital stay, and save medical resources in patients with colorectal cancer surgery;
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To reveal the mechanism of acupressure, focusing on autonomic regulation and inflammatory response;
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To explore the association of autonomic regulation with self-reported anxiety, depression, and stress.
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Study plan 3.1 Design of experiments
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Investigate the general data and perioperative data of colorectal cancer surgery patients Investigators will independently design the questionnaire, including the following aspects: (1) general information: gender, age, height, weight, previous abdominal surgery history, preoperative radiotherapy and chemotherapy history, underlying diseases, etc.; (2) surgical conditions: surgical method, anesthesia method, duration of surgery, duration of anesthesia, intraoperative heat preservation measures and liquid input, etc.; (3) diet: drinking water, liquid diet, soft diet, ordinary diet time, etc.; (4) exercise: first time out of bed after surgery, etc.; (5) medication: antiemetics, Intramuscular analgesics, etc.
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Design and implementation of acupressure intervention program On the basis of the previous clinical trial, the technique of acupressure at ST36 will be used to promote gastrointestinal movement compared with control group. The evidence-based basis is mainly derived from domestic and international guideline recommendations, Cochrane systematic review results, meta-analysis results, and large multi-centre randomized controlled trials.
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Study on the mechanism of acupressure to promote gastrointestinal function By evaluating the 24-hour heart rate variability index of colorectal cancer surgery patients, the regulatory effect of acupressure on autonomic nerve will be evaluated, and the regulatory effect of acupressure on systemic inflammation will be revealed through the changes of postoperative inflammatory factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, 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
- •Patients with pathological diagnosis of colorectal cancer;
- •Adult patients (age ≥ 18 years);
- •Patients undergoing elective surgery, including open surgery, laparoscopic and combined surgery.
排除标准
- •Inability to communicate due to language impairment or severe cognitive impairment;
- •Skin infection or defect of the lower extremities, which may hinder the localization of ST36 or worsen the infection;
- •Plan to perform more than one surgery during hospitalization;
- •There are coagulation disorders or peripheral vascular diseases or signs of impaired blood circulation in the lower extremities.
结局指标
主要结局
Heart rate variability
时间窗: 24 hours after the end of acupressure on day 5
The differential change of successive heartbeat cycles. Wear a multi-lead Holter (Lepu 12-lead ECG monitor) for 24 consecutive hours.
次要结局
- Level of C-reactive protein(Early morning on the day after the end of acupressure on day 5)
- Bowel motility(Early morning on the day after surgery, up to 5 days)
- Abdominal distension(Early morning on the day after surgery, up to 5 days)
- Abdominal pain(Early morning on the day after surgery, up to 5 days)
- level of IL-6(Early morning on the day after the end of acupressure on day 5)
- First postoperative exhaust time, defecation time, getting out of bed activity time, drinking time, eating time(Early morning on the day after surgery, up to 5 days)
- Postoperative nausea(Early morning on the day after surgery, up to 5 days)
研究者
Yunhong Liu, PhD
Assistant professor
Qilu Hospital of Shandong University