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

NCT ID: NCT07081802

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-09-28

Brief Summary

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.

Conditions

ERAS; Traditional Chinese Medication (TCM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TEAS + TCM + Prehabilitation + ERAS

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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)

Intervention Type: 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

Intervention Type: 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.

Multimodal Prehabilitation Program

Intervention Type: 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.

Prehabilitation + ERAS

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

Group Type: ACTIVE_COMPARATOR

ERAS

Intervention Type: 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.

Multimodal Prehabilitation Program

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Fast-Track Surgery

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

The First Hospital of Qinhuangdao

OTHER_GOV

Sponsor Role: collaborator

Affiliated Hospital of Hebei University

OTHER

Sponsor Role: collaborator

Handan Central Hospital

OTHER

Sponsor Role: collaborator

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Responsible Party

Quanda Liu

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Quanda Liu Liu

Role: CONTACT

15549437482@163.com

+8688001037

Other Identifiers

2025-037-KY-01

Identifier Type: -

Identifier Source: org_study_id