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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
148
"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.
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.
"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.
(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 frame: 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 first flatus
Defined as the interval from the end of surgery to the first passage of gas.
Time frame: Time to first flatus was recorded from the moment sugery finished until the first flatus occurred, with a maximum observation period of 4 days
Serological Markers
White blood cell (WBC) count and C-reactive protein (CRP)
Time frame: Measured preoperatively (day 1 before surgery) and on postoperative day 3.
Postoperative Hospital Stay
Postoperative hospital stay was defined as the duration from end of surgery to hospital discharge, measured in days
Time frame: 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
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.
Time frame: postoperative
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).
Time frame: postoperative day 1 to day 7
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.
Time frame: from postoperative day 1 to day 7
Time to First Ambulation
Defined as the interval from the end of surgery to the first out-of-bed activity.
Time frame: 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
The proportion of patients readmitted within 30 days after discharge due to surgery-related complications.
Time frame: postoperative day 30
Serum gastrin levels
Assessed via ELISA or chemiluminescence at three time points:
Time frame: Preoperative day 1 Postoperative day 3 Postoperative day 7
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