ERASNCT07081802
The Effect of Perioperative Transcutaneous Electrical Acupoint Stimulation Combined With Traditional Chinese Medicine on Gastrointestinal Function Recovery in Patients Undergoing Abdominal Surgery
A study testing Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose), Transcutaneous Electrical Acupoint Stimulation (TEAS) and ERAS in people with ERAS and Traditional Chinese Medication (TCM), run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ERAS, Traditional Chinese Medication (TCM)
- What is being tested?
- Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose), Transcutaneous Electrical Acupoint Stimulation (TEAS) and ERAS
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 28 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
About this study
Official title: the Effect of Perioperative Transcutaneous Electrical Acupoint Stimulation Combined With Traditional Chinese Medicine on Gastrointestinal Function Recovery in Abdominal Surgery Patients
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).
Read more
Total Cases:148 Case Selection
Inclusion Criteria:
- Age 18-80, no severe gastrointestinal dysfunction;
- Elective abdominal Grade IV surgeries (pancreas or colorectall surgeries) via open or laparoscopic methods;
- Preoperative ASA classification I-III;
- 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)
- Being tested
- Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose), Transcutaneous Electrical Acupoint Stimulation (TEAS), ERAS, Multimodal Prehabilitation Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
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.
ERASOther
Also called Fast-Track Surgery
"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 ProgramOther
(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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: ERAS; Other: Multimodal Prehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Defecation
Defined as the interval from the end of surgery to the first observed bowel movement.
Measured: 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.
Measured: 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: Measured preoperatively (day 1 before surgery) and on postoperative day 3.
Secondary outcomes (7)
Postoperative Hospital Stay
Postoperative hospital stay was defined as the duration from end of surgery to hospital discharge, measured in days
Measured: 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
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.
Measured: postoperative
Postoperative Nausea and Vomiting (PONV)
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).
Measured: postoperative day 1 to day 7
Postoperative Pain
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.
Measured: from postoperative day 1 to day 7
Time to First Ambulation
Defined as the interval from the end of surgery to the first out-of-bed activity.
Measured: Time to first Ambulation was recorded from the moment sugery finished until the first Ambulation occurred, with a maximum observation period of 4 days
30-Day Readmission Rate
The proportion of patients readmitted within 30 days after discharge due to surgery-related complications.
Measured: postoperative day 30
Serum gastrin levels
Assessed via ELISA or chemiluminescence at three time points:
Measured: Preoperative day 1 Postoperative day 3 Postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERASStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Nanchang University, The First Hospital of Qinhuangdao, Affiliated Hospital of Hebei University, Handan Central Hospital, Liaoning Cancer Hospital & Institute
- Responsible party
- Principal investigator, Quanda Liu, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081802
- Sponsor's protocol ID
- 2025-037-KY-01
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Perioperative Transcutaneous Electrical Acupoint Stimulation Combined With Traditional Chinese Medicine on Gastrointestinal Function Recovery in Abdominal Surgery Patients
- ClinicalTrials.gov ID
- NCT07081802
- Acronym / sponsor ID
- 2025-037-KY-01
- Conditions
- ERAS, Traditional Chinese Medication (TCM)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Nanchang University, The First Hospital of Qinhuangdao, Affiliated Hospital of Hebei University, Handan Central Hospital, Liaoning Cancer Hospital & Institute
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Age 18-80, no severe gastrointestinal dysfunction;
- Elective abdominal Grade IV surgeries (pancreas or colorectall surgeries) via open or laparoscopic methods;
- Preoperative ASA classification I-III;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS + TCM + Prehabilitation + ERAS | Experimental | Drug: Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose), Procedure: Transcutaneous Electrical Acupoint Stimulation (TEAS), Other: ERAS, Other: Multimodal Prehabilitation ProgramExperimental 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 | Active comparator | Other: ERAS, Other: Multimodal Prehabilitation ProgramAll participants receive identical perioperative management and postoperative care, including prehabilitation and Enhanced Recovery After Surgery (ERAS) protocols. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- Non-compliance with treatment protocols (e.g., receiving <80% of planned sessions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | TEAS + TCM + Prehabilitation + ERAS |
| 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. | Procedure or surgery | TEAS + TCM + Prehabilitation + ERAS |
| ERASAlso: Fast-Track Surgery"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 | Prehabilitation + ERAS, TEAS + TCM + Prehabilitation + ERAS |
| 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. | Other | Prehabilitation + ERAS, TEAS + TCM + Prehabilitation + ERAS |
Primary outcome
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.
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.
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)
7 secondary outcomes
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
Time to Tolerate Semi-Liquid and Solid Foods
Time frame: postoperative
Postoperative Nausea and Vomiting (PONV)
Time frame: postoperative day 1 to day 7
Postoperative Pain
Time frame: from postoperative day 1 to day 7
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
30-Day Readmission Rate
Time frame: postoperative day 30
Serum gastrin levels
Time frame: Preoperative day 1 Postoperative day 3 Postoperative day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Da Jian Zhong Tang (Zanthoxylum, Ginger, Ginseng, Maltose), Transcutaneous Electrical Acupoint Stimulation (TEAS) and ERAS in people with ERAS and Traditional Chinese Medication (TCM), run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quanda Liu Liu (+8688001037, 15549437482@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.