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NCT Number: NCT07081802

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

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.

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Key information

Conditions

ERAS Traditional Chinese Medication (TCM)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guang'anmen Hospital China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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

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.

Other names: Fast-Track Surgery

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.

Primary outcomes

  1. Time to First Defecation

    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

    Defined as the interval from the end of surgery to the first observed bowel movement.

  2. Time to first flatus

    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

    Defined as the interval from the end of surgery to the first passage of gas.

  3. Serological Markers

    Time frame: Measured preoperatively (day 1 before surgery) and on postoperative day 3.

    White blood cell (WBC) count and C-reactive protein (CRP)

Secondary outcomes

  1. Postoperative Hospital Stay

    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

    Postoperative hospital stay was defined as the duration from end of surgery to hospital discharge, measured in days

  2. Time to Tolerate Semi-Liquid and Solid Foods

    Time frame: postoperative

    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.

  3. Postoperative Nausea and Vomiting (PONV)

    Time frame: postoperative day 1 to day 7

    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).

  4. Postoperative Pain

    Time frame: from postoperative day 1 to day 7

    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.

  5. Time to First Ambulation

    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

    Defined as the interval from the end of surgery to the first out-of-bed activity.

  6. 30-Day Readmission Rate

    Time frame: postoperative day 30

    The proportion of patients readmitted within 30 days after discharge due to surgery-related complications.

  7. Serum gastrin levels

    Time frame: Preoperative day 1 Postoperative day 3 Postoperative day 7

    Assessed via ELISA or chemiluminescence at three time points:

Study contacts

Contact information is provided by the study sponsor or research team.

Quanda Liu Liu

CONTACT

[email protected]

+8688001037

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Collaborators

  • Affiliated Hospital of Hebei University
  • Handan Central Hospital
  • Liaoning Cancer Hospital & Institute
  • Second Affiliated Hospital of Nanchang University
  • The First Hospital of Qinhuangdao

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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