Application of Auricular Acupuncture Therapy Based on Real-World Studies After Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Clinical total effective rate
研究概览
简要总结
Delayed gastric emptying (DGE) after surgery mainly occurs after gastrointestinal surgery A functional gastric emptying disorder, clinically characterized by weak or absent gastric peristalsis, gastric motility disorders, or gastric emptying Gastric retention, fullness, nausea and other uncomfortable symptoms caused by delay.This study is based on clinical diagnosis and treatment practice, observing, collecting, and analyzing Whipple surgery, pancreatectomy, and gastric cancer Perioperative data of subtotal resection surgery, mainly observing the diagnosis and treatment of ear acupoints in Whipple surgery, pancreatectomy, and subtotal gastrectomy.The application effect of DGE after resection surgery, exploring the diagnosis and treatment of ear acupoints in Whipple surgery, pancreatic body and tail resection surgery, and Diagnostic value of perioperative related diseases in abdominal surgery such as subtotal gastrectomy, and collection of health records.By comparing and analyzing the ear acupoint information of patients with abdominal tumors, we aim to explore the ear acupoints of the volunteers. The possible relationship between image and resistance specificity and common tumors in the abdominal cavity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 1) Age range: 40-70 years old (40 ≤ y ≤ 70), gender is not limited. 2) Accept abdominal surgeries including Whipple's surgery, pancreatectomy, and subtotal gastrectomy.
- •3) The subjects/guardians are able to understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form (ICF)
排除标准
- •1) Severe postoperative complications such as heart disease, pulmonary embolism, cerebral infarction, abdominal infection, and abdominal bleeding; 2) Patients with organic changes such as adhesions and obstructions indicated by imaging examinations such as gastrointestinal imaging; 3) The patient has damage, redness, bleeding, infection, and other conditions in both ears that are not suitable for ear acupuncture treatment.
- •Inclusion and exclusion criteria for the health group
- •Inclusion Criteria:
- •Age range: 40-70 years old (40 ≤ y ≤ 70), gender is not limited.
- •No history of abdominal surgery or tumor, and no significant abnormalities were found through abdominal imaging examination.
- •The subjects/guardians are able to understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and sign an informed consent form (ICF).
- •Exclusion Criteria:
- •Symptoms of digestive discomfort such as diarrhea, constipation, and vomiting have been present for the past 30 days.
- •The patient has conditions such as damage, redness, bleeding, and infection in both ears that affect the assessment of ear acupoint information.
结局指标
主要结局
Clinical total effective rate
时间窗: On the third day after surgery
The clinical total effective rate of ear acupuncture treatment for postoperative DGE in the abdomen, including Whipple surgery, pancreatectomy, and subtotal gastrectomy. Efficacy evaluation criteria: Measure the subjective symptom score (Gastroparesis Cardinal Symptom Index, GCSI score) of patients with gastroparesis on the third day after surgery, and calculate the clinical efficacy index of ear acupuncture treatment using the following formula (efficacy index=\[(total score of symptoms before treatment - total score of symptoms after treatment) ÷ total score of symptoms before treatment × 100%\]). Among them, significant effect: efficacy index\>75%; Effective: Efficacy index of 25% to 75%; Invalid: Efficacy index\<25%. Total effective rate=(number of significantly effective cases+number of effective cases)/total number of cases x 100%.
Perioperative Anxiety Scale-7 (PAS-7)
时间窗: 24±2h after the start of AP or first visit, 12±2h before surgery, and 2 h before surgery
This scale was used to evaluate the anxiety of patients before surgery. This scale evaluates some of the patient's conditions regarding the operation, and then, based on the actual situation during the days of hospitalization, selects the appropriate option among 5 options, circling the corresponding numbers. The higher the score, the more severe the patient's preoperative anxiety level.
次要结局
- Modified Pittsburgh Sleep Quality Index (M-PSQI)(24±2h after the start of AP or first visit (T1), 12±2h before surgery (T2), and 72±2h post-operatively)
- Self-Rating Anxiety Scale (SAS) Score(Multiple time points before and after surgery)
- Patient Satisfaction with Pre-operative Preparation Assessed with the Visual Analogue Scale (VAS-Satisfaction)(Preoperative)
- Visual Analogue Scale for Pain (VAS-Pain)(Multiple time points after surgery)