The Effect of Perioperative Transcutaneous Electrical Acupoint Stimulation Combined With Traditional Chinese Medicine on Gastrointestinal Function Recovery in Patients Undergoing Abdominal Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose): "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): TEAS 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: "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: (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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Time to First Defecation — 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 — 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 — Measured preoperatively (day 1 before surgery) and on postoperative day 3.
  White blood cell (WBC) count and C-reactive protein (CRP)

Trial sites (1)

More Guang'anmen Hospital of China Academy of Chinese Medical Sciences trials in China

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