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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Процедура 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Time to First Defecation [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Measured preoperatively (day 1 before surgery) and on postoperative day 3.]

Вторичные конечные точки (7)

• Postoperative Hospital Stay [Срок оценки: 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 [Срок оценки: postoperative]
• Postoperative Nausea and Vomiting (PONV) [Срок оценки: postoperative day 1 to day 7]
• Postoperative Pain [Срок оценки: from postoperative day 1 to day 7]
• Time to First Ambulation [Срок оценки: 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 [Срок оценки: postoperative day 30]
• Serum gastrin levels [Срок оценки: Preoperative day 1 Postoperative day 3 Postoperative day 7]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guang'anmen Hospital China Academy of Chinese Medical Sciences — Пекин

Идентификаторы

NCT: NCT07081802 · 2025-037-KY-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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