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

NCT07081802 | Not Yet Recruiting DMC

• 1 other identifier: 2025-037-KY-01
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

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. 1.Age 18-80, no severe gastrointestinal dysfunction;
2. 2.Elective abdominal Grade IV surgeries (pancreas or colorectall surgeries) via open or laparoscopic methods;
3. 3.Preoperative ASA classification I-III;
4. 4.Signed informed consent.

Conditions

ERAS; Traditional Chinese Medication (TCM)

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (7)

• Postoperative Hospital Stay

  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

  postoperative

• Postoperative Nausea and Vomiting (PONV)

  postoperative day 1 to day 7

• Postoperative Pain

  from postoperative day 1 to day 7

• Time to First Ambulation

  Time to first Ambulation was recorded from the moment sugery finished until the first Ambulation occurred, with a maximum observation period of 4 days

Study Arms (2)

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.

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

Prehabilitation + ERAS

ACTIVE COMPARATOR

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

Other: ERAS; Other: Multimodal Prehabilitation Program

Interventions

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.

TEAS + TCM + Prehabilitation + ERAS

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.

TEAS + TCM + Prehabilitation + ERAS

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.

Also known as: Fast-Track Surgery

Prehabilitation + ERAS; TEAS + TCM + Prehabilitation + ERAS

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.

Prehabilitation + ERAS; TEAS + TCM + Prehabilitation + ERAS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Second Affiliated Hospital of Nanchang University: collaborator
• The First Hospital of Qinhuangdao: collaborator
• Affiliated Hospital of Hebei University: collaborator
• Handan Central Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator

MeSH Terms

Interventions

dai-kenchu-to; ginger extract; Asian ginseng; Maltose

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Central Study Contacts

Quanda Liu Liu

CONTACT

+8688001037; 15549437482@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 23, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share