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:
1. Age 18-80, no severe gastrointestinal dysfunction; 2. Elective abdominal Grade IV surgeries (pancreas or colorectall surgeries) via open or laparoscopic methods; 3. Preoperative ASA classification I-III; 4. 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.
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.
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.
Parallel
Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose)
Drug"Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose)was administered orally twice daily from preoperative day 3 to postoperative day 3. The decoction aims to warm the middle jiao and promote gastrointestinal recovery, with dose adjustments based on syndrome differentiation.
Transcutaneous Electrical Acupoint Stimulation (TEAS)
Procedure/SurgeryTEAS was delivered at acupoints ST36/ST37 (10Hz continuous wave, 30min/session) once daily from intraoperative day to postoperative day 4. On surgery day, stimulation started 30min preoperatively for 1 hour. Intensity was adjusted to elicit deqi sensation.
ERAS
Other intervention"Standardized ERAS protocol included: (1) Preoperative carbohydrate loading; (2) Intraoperative goal-directed fluid therapy; (3) Minimally invasive surgery; (4) Multimodal opioid-sparing analgesia; (5) Early oral feeding (semi-liquid diet at 6h post-op); (6) Early ambulation (first mobilization at 8h post-op). Implemented by a multidisciplinary team.
Multimodal Prehabilitation Program
Other intervention(1) Exercise: Daily aerobic/resistance training (30min, 5×/week); (2) Nutrition: High-protein diet (1.5g/kg/day) + oral supplements if needed; (3) Psychological Support: Cognitive-behavioral therapy sessions (2×/week). Tailored to individual patient risk profiles.
Time to First Defecation
Defined as the interval from the end of surgery to the first observed bowel movement.
Time to first flatus
Defined as the interval from the end of surgery to the first passage of gas.
Serological Markers
White blood cell (WBC) count and C-reactive protein (CRP)
Postoperative Hospital Stay
Postoperative hospital stay was defined as the duration from end of surgery to hospital discharge, measured in days
Time to Tolerate Semi-Liquid and Solid Foods
Defined as the interval from the end of surgery to the first successful intake of semi-liquid (e.g., congee, egg custard) or solid food without nausea, vomiting, or other gastrointestinal adverse reactions. Tolerance criteria: No nausea or vomiting within 4 hours after eating.
Postoperative Nausea and Vomiting (PONV)
Assessed daily from postoperative day 1 to day 7 using a VAS (0-100 mm), where 0 = "no nausea" and 100 = "worst possible nausea." The frequency of nausea/vomiting episodes was recorded (intervals \>5 minutes counted as separate events).
Postoperative Pain
Evaluated daily (days 1-7) using VAS (0-100), where 0 = "no pain" and 100 = "worst imaginable pain." Recorded at 8:00 AM for the preceding 24-hour period.
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Lead sponsor
Second Affiliated Hospital of Nanchang University
Collaborator
The First Hospital of Qinhuangdao
Collaborator
Affiliated Hospital of Hebei University
Collaborator
Handan Central Hospital
Collaborator
Liaoning Cancer Hospital & Institute
Collaborator
