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| Name | Class |
|---|---|
| Second Affiliated Hospital of Nanchang University | OTHER |
| The First Hospital of Qinhuangdao | OTHER_GOV |
| Affiliated Hospital of Hebei University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEAS + TCM + Prehabilitation + ERAS | Experimental | 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. |
|
| Prehabilitation + ERAS | Active Comparator | All participants receive identical perioperative management and postoperative care, including prehabilitation and Enhanced Recovery After Surgery (ERAS) protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Defecation | Defined as the interval from the end of surgery to the first observed bowel movement. | 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 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) | Measured preoperatively (day 1 before surgery) and on postoperative day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Hospital Stay | Postoperative hospital stay was defined as the duration from end of surgery to hospital discharge, measured in days | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Elimination Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quanda Liu Liu | Contact | +8688001037 | 15549437482@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| Handan Central Hospital |
| OTHER |
| Liaoning Cancer Hospital & Institute | OTHER |
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| Transcutaneous Electrical Acupoint Stimulation (TEAS) | Procedure | 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. |
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| ERAS | Other | "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. |
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| Multimodal Prehabilitation Program | Other | (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. |
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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 |
| 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 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. | 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 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. | postoperative day 30 |
| Serum gastrin levels | Assessed via ELISA or chemiluminescence at three time points: | Preoperative day 1 Postoperative day 3 Postoperative day 7 |
| ID | Term |
|---|---|
| C121414 | dai-kenchu-to |
| C000713927 | ginger extract |
| C000713447 | Asian ginseng |
| D008320 | Maltose |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D000073893 | Sugars |
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