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

Not Applicable

Not yet recruiting

• Conditions: ERAS; Traditional Chinese Medication (TCM)
• Interventions: Drug: Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose); Procedure: Transcutaneous Electrical Acupoint Stimulation (TEAS); Other: ERAS; Other: Multimodal Prehabilitation Program

• Registration Number: NCT07081802
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Study Start: 2025-08-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 148

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TEAS + TCM + Prehabilitation + ERAS	Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose)	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.
TEAS + TCM + Prehabilitation + ERAS	Transcutaneous Electrical Acupoint Stimulation (TEAS)	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.
TEAS + TCM + Prehabilitation + ERAS	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.
TEAS + TCM + Prehabilitation + ERAS	Multimodal Prehabilitation Program	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.
Prehabilitation + ERAS	ERAS	All participants receive identical perioperative management and postoperative care, including prehabilitation and Enhanced Recovery After Surgery (ERAS) protocols.
Prehabilitation + ERAS	Multimodal Prehabilitation Program	All participants receive identical perioperative management and postoperative care, including prehabilitation and Enhanced Recovery After Surgery (ERAS) protocols.

Primary Outcome Measures

Name	Time	Method
Time to First Defecation	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.
Time to first flatus	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.
Serological Markers	Measured preoperatively (day 1 before surgery) and on postoperative day 3.	White blood cell (WBC) count and C-reactive protein (CRP)

Secondary Outcome Measures

Name	Time	Method
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	Postoperative hospital stay was defined as the duration from end of surgery to hospital discharge, measured in days
Time to Tolerate Semi-Liquid and Solid Foods	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.
Postoperative Nausea and Vomiting (PONV)	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).
Postoperative Pain	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.
Serum gastrin levels	Preoperative day 1 Postoperative day 3 Postoperative day 7	Assessed via ELISA or chemiluminescence at three time points:
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	Defined as the interval from the end of surgery to the first out-of-bed activity.
30-Day Readmission Rate	postoperative day 30	The proportion of patients readmitted within 30 days after discharge due to surgery-related complications.