Overview
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
