the Effect of Perioperative Transcutaneous Electrical Acupoint Stimulation Combined With Traditional Chinese Medicine on Gastrointestinal Function Recovery in Abdominal Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Time to First Defecation
研究概览
简要总结
Protocol Summary Project Name:Effect of Perioperative TEAS Combined with TCM on Gastrointestinal Function Recovery in Abdominal Surgery Patients Research Objective:To evaluate the impact of perioperative TEAS combined with TCM on postoperative gastrointestinal function, pain, adverse reactions, hospital stay, and complications, as well as its safety, aiming to enrich the ERAS and prehabilitation theory and promote the integration of TCM in surgical practice.
Research Design:Prospective, randomized, open-label trial involving 148 abdominal surgery patients (Grade IV surgeries) randomly assigned 1:1 to the experimental group (TCM + TEAS + prehabilitation + ERAS) or the control group (prehabilitation + ERAS).
Total Cases:148 Case Selection
Inclusion Criteria:
- Age 18-80, no severe gastrointestinal dysfunction;
- Elective abdominal Grade IV surgeries (pancreas or colorectall surgeries) via open or laparoscopic methods;
- Preoperative ASA classification I-III;
- Signed informed consent.
Exclusion Criteria:
Severe comorbidities, skin abnormalities at acupoints, long-term use of gastrointestinal motility drugs, or other factors affecting the trial.
Elimination Criteria:
Poor compliance, significant missing data, or severe adverse events unrelated to the intervention.
Treatment Plan TEAS combined with TCM from the day of surgery to postoperative day 4, alongside prehabilitation and ERAS.
Efficacy Evaluation
Primary Outcomes:
Time to first flatus and defecation.
Secondary Outcomes:
Postoperative hospital stay, time to tolerate semi-liquid/solid food, nausea/vomiting, pain, bloating, first ambulation, 30-day readmission rate, WBC/CRP levels, and gastrin levels.
Safety Evaluation: Any adverse events. Statistical Methods Continuous variables expressed as mean (SD) or median (IQR); independent t-test for normal distributions. Categorical variables summarized as frequencies/percentages, analyzed using χ² or Fisher's exact test. Group differences reported as 95% CI and two-sided P-values (P < 0.05 significant). Preset subgroup analyses by surgery type and frailty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >18 years with no severe preoperative gastrointestinal dysfunction (e.g., no chronic gastrointestinal diseases such as long-term constipation or diarrhea).
- •Scheduled abdominal Grade IV surgeries (limited to liver, gallbladder, pancreas, stomach, or intestinal procedures) performed via open or laparoscopic approach.
- •Preoperative American Society of Anesthesiologists (ASA) Physical Status Classification of I-III.
- •Patients and their families fully understand the study's purpose, methods, potential risks/benefits, and provide signed informed consent.
排除标准
- •Comorbid severe systemic diseases.
- •Local skin abnormalities at acupoints (e.g.,broken skin, infection, allergies, or scarring).
- •Preoperative long-term use (>1 month) of gastrointestinal motility-affecting drugs (e.g., mosapride, domperidone) that cannot be discontinued, or allergies to TCM components/electrode materials.
- •Psychiatric disorders or cognitive impairment rendering patients unable to comply with the study.
- •Elimination Criteria:
- •Non-compliance with treatment protocols (e.g., receiving <80% of planned sessions).
- •Significant missing data.
- •Occurrence of severe adverse events unrelated to the study intervention.
研究组 & 干预措施
TEAS + TCM + Prehabilitation + ERAS
Experimental Group:
TEAS:
Administered once daily from the day of surgery until postoperative day 4. Each session lasts 30 minutes, except on the day of surgery, when treatment begins 30 minutes preoperatively and continues for 1 hour.
Acupoints: ST36 (Zusanli), ST37 (Shangjuxu), PC6 (Neiguan), and LI4 (Hegu) Note: Intraoperatively, only bilateral ST36 and ST37 are stimulated due to anesthesia constraints.
Parameters: Continuous wave at 10 Hz; intensity adjusted to elicit deqi sensation (heaviness, numbness, or soreness) within patient tolerance.
Traditional Chinese Medicine (TCM):
Intraoperative & Postoperative (up to day 4): Fixed prescription of Da Jian Zhong Tang Zanthoxyli Pericarpium (Sichuan Pepper) 3g, Zingiberis Rhizoma (Dried Ginger) 12g, Ginseng Radix et Rhizoma (Ginseng) 6g, Maltosum (Malt Sugar) 30g.
All participants receive identical perioperative management and postoperative care, including prehabilitation and Enhanced Recovery After Surgery (ERAS) protocols.
干预措施: Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose) (Drug)
TEAS + TCM + Prehabilitation + ERAS
Experimental Group:
TEAS:
Administered once daily from the day of surgery until postoperative day 4. Each session lasts 30 minutes, except on the day of surgery, when treatment begins 30 minutes preoperatively and continues for 1 hour.
Acupoints: ST36 (Zusanli), ST37 (Shangjuxu), PC6 (Neiguan), and LI4 (Hegu) Note: Intraoperatively, only bilateral ST36 and ST37 are stimulated due to anesthesia constraints.
Parameters: Continuous wave at 10 Hz; intensity adjusted to elicit deqi sensation (heaviness, numbness, or soreness) within patient tolerance.
Traditional Chinese Medicine (TCM):
Intraoperative & Postoperative (up to day 4): Fixed prescription of Da Jian Zhong Tang Zanthoxyli Pericarpium (Sichuan Pepper) 3g, Zingiberis Rhizoma (Dried Ginger) 12g, Ginseng Radix et Rhizoma (Ginseng) 6g, Maltosum (Malt Sugar) 30g.
All participants receive identical perioperative management and postoperative care, including prehabilitation and Enhanced Recovery After Surgery (ERAS) protocols.
干预措施: Transcutaneous Electrical Acupoint Stimulation (TEAS) (Procedure)
TEAS + TCM + Prehabilitation + ERAS
Experimental Group:
TEAS:
Administered once daily from the day of surgery until postoperative day 4. Each session lasts 30 minutes, except on the day of surgery, when treatment begins 30 minutes preoperatively and continues for 1 hour.
Acupoints: ST36 (Zusanli), ST37 (Shangjuxu), PC6 (Neiguan), and LI4 (Hegu) Note: Intraoperatively, only bilateral ST36 and ST37 are stimulated due to anesthesia constraints.
Parameters: Continuous wave at 10 Hz; intensity adjusted to elicit deqi sensation (heaviness, numbness, or soreness) within patient tolerance.
Traditional Chinese Medicine (TCM):
Intraoperative & Postoperative (up to day 4): Fixed prescription of Da Jian Zhong Tang Zanthoxyli Pericarpium (Sichuan Pepper) 3g, Zingiberis Rhizoma (Dried Ginger) 12g, Ginseng Radix et Rhizoma (Ginseng) 6g, Maltosum (Malt Sugar) 30g.
All participants receive identical perioperative management and postoperative care, including prehabilitation and Enhanced Recovery After Surgery (ERAS) protocols.
干预措施: ERAS (Other)
TEAS + TCM + Prehabilitation + ERAS
Experimental Group:
TEAS:
Administered once daily from the day of surgery until postoperative day 4. Each session lasts 30 minutes, except on the day of surgery, when treatment begins 30 minutes preoperatively and continues for 1 hour.
Acupoints: ST36 (Zusanli), ST37 (Shangjuxu), PC6 (Neiguan), and LI4 (Hegu) Note: Intraoperatively, only bilateral ST36 and ST37 are stimulated due to anesthesia constraints.
Parameters: Continuous wave at 10 Hz; intensity adjusted to elicit deqi sensation (heaviness, numbness, or soreness) within patient tolerance.
Traditional Chinese Medicine (TCM):
Intraoperative & Postoperative (up to day 4): Fixed prescription of Da Jian Zhong Tang Zanthoxyli Pericarpium (Sichuan Pepper) 3g, Zingiberis Rhizoma (Dried Ginger) 12g, Ginseng Radix et Rhizoma (Ginseng) 6g, Maltosum (Malt Sugar) 30g.
All participants receive identical perioperative management and postoperative care, including prehabilitation and Enhanced Recovery After Surgery (ERAS) protocols.
干预措施: Multimodal Prehabilitation Program (Other)
Prehabilitation + ERAS
All participants receive identical perioperative management and postoperative care, including prehabilitation and Enhanced Recovery After Surgery (ERAS) protocols.
干预措施: ERAS (Other)
Prehabilitation + ERAS
All participants receive identical perioperative management and postoperative care, including prehabilitation and Enhanced Recovery After Surgery (ERAS) protocols.
干预措施: Multimodal Prehabilitation Program (Other)
结局指标
主要结局
Time to First Defecation
时间窗: Time to first defecation was recorded from the moment sugery finished until the first defecation occurred, with a maximum observation period of 4 days
Defined as the interval from the end of surgery to the first observed bowel movement.
Time to first flatus
时间窗: Time to first flatus was recorded from the moment sugery finished until the first flatus occurred, with a maximum observation period of 4 days
Defined as the interval from the end of surgery to the first passage of gas.
Serological Markers
时间窗: Measured preoperatively (day 1 before surgery) and on postoperative day 3.
White blood cell (WBC) count and C-reactive protein (CRP)
次要结局
- Postoperative Hospital Stay(Time to first defecation was recorded from the moment sugery finished until the first defecation occurred, with a maximum observation period of 4 days)
- Time to Tolerate Semi-Liquid and Solid Foods(postoperative)
- Postoperative Nausea and Vomiting (PONV)(postoperative day 1 to day 7)
- Postoperative Pain(from postoperative day 1 to day 7)
- Serum gastrin levels(Preoperative day 1 Postoperative day 3 Postoperative day 7)
- Time to First Ambulation(Time to first Ambulation was recorded from the moment sugery finished until the first Ambulation occurred, with a maximum observation period of 4 days)
- 30-Day Readmission Rate(postoperative day 30)
研究者
Quanda Liu
Chief Physician
Guang'anmen Hospital of China Academy of Chinese Medical Sciences