Effect of Acupuncture and Herbal Medicine on Bowel Recovery After Abdominal Surgery

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Not yet enrolling

Conditions: Traditional Chinese Medication (TCM); ERAS

Treatments: Drug: Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose); Procedure: Transcutaneous Electrical Acupoint Stimulation (TEAS); Other: Multimodal Prehabilitation Program; Other: ERAS

Study type: Interventional

Funder types: Other

Identifiers

NCT07081802

2025-037-KY-01

Details and patient eligibility

About

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.

Enrollment: 148 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

TEAS + TCM + Prehabilitation + ERAS

Experimental group

Description:

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.

Treatment:

Other: Multimodal Prehabilitation Program

Other: ERAS

Procedure: Transcutaneous Electrical Acupoint Stimulation (TEAS)

Drug: Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose)

Prehabilitation + ERAS

Active Comparator group

Description:

All participants receive identical perioperative management and postoperative care, including prehabilitation and Enhanced Recovery After Surgery (ERAS) protocols.

Treatment:

Other: Multimodal Prehabilitation Program

Other: ERAS