An interventional study of Transcutaneous Electrical Acupoint Stimulation and Sham Transcutaneous Electrical Acupoint Stimulation in Gastric Cancer (GC) and Stomach Neoplasms, sponsored by The Affiliated Hospital of Qingdao University. Recruiting at 8 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by The Affiliated Hospital of Qingdao University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if transcutaneous electrical acupoint stimulation (TEAS) works to help people recover faster after laparoscopic surgery for stomach cancer. TEAS is a treatment that uses small electrical pulses through sticky pads on the skin. It does not use needles. The main questions it aims to answer are: Does TEAS help people pass gas (a sign that the digestive system is waking up) sooner after surgery? Does TEAS help lower pain after surgery? Does TEAS reduce the need for extra pain medication after surgery? Researchers will compare two groups to see if TEAS works better than a sham (inactive) treatment. Group 1 (TA group) receives real TEAS after surgery. Group 2 (SA group) receives a sham treatment at the same time points. All participants will receive the same standard pain relief and recovery care after surgery. Participants will: Be randomly assigned (like flipping a coin) to one of the two groups. Receive TEAS or sham treatment for 30 minutes starting 2 hours after waking from anesthesia, and then once daily each morning on the first 3 days after surgery. Rate their pain on a 0-10 scale at 6, 12, 24, 48, and 72 hours after surgery. Complete quality-of-life and fatigue questionnaires before surgery, on day 4 after surgery, and 30 days after surgery. Have a follow-up visit or phone call 30 days after leaving the hospital. This study includes 104 adults aged 18 to 80 years who are scheduled to have laparoscopic surgery for stomach cancer at 8 hospitals in Shandong Province, China.
This study is a prospective, multicenter, two-arm, parallel-group, randomized, sham-controlled trial conducted at 8 tertiary hospitals in Shandong Province, China. A total of 104 eligible participants scheduled for laparoscopic radical gastrectomy for stage I-III gastric cancer will be enrolled and randomly assigned in a 1:1 ratio to one of two groups: TA group (real TEAS after surgery) or SA group (sham treatment at the same time points). Randomization will be performed using a centralized system with stratification by study center and a randomized block design with randomly assigned block sizes. Allocation concealment is ensured by the system, with group assignments revealed only after participant enrollment.
TEAS is delivered using a standardized electroacupuncture device (SDZ-V, Suzhou Medical Products Factory) with a dense-disperse wave (20 Hz alternating with 100 Hz, 5s/10s duty cycle) at individually titrated intensities. Four bilateral acupoints are selected: Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37), following WHO standard acupoint locations. For the TA group, TEAS begins 2 hours after emergence from anesthesia and continues for 30 minutes daily at 09:00 on postoperative days 1 through 3, with intensity set at the individually determined maximal tolerable threshold. The SA group receives sham stimulation at the same time points using the same device with identical appearance, indicator lights, and sounds, but with the internal output leads disconnected to deliver no electrical current. To maintain blinding, the device screen is shielded, and operators use standardized scripts to avoid unblinding.
All participants receive a standardized enhanced recovery after surgery (ERAS) protocol, including no bowel preparation, preoperative carbohydrate loading, minimally invasive incisions, goal-directed fluid therapy, no routine nasogastric tubes, early removal of drains and urinary catheters (within 24 hours), early mobilization, and a stepwise enteral nutrition plan. Postoperative analgesia is provided via patient-controlled intravenous analgesia (PCIA) with sufentanil (2 μg/kg in 100 mL normal saline, background infusion 2 mL/h, bolus 2 mL, lockout 15 min), supplemented with flurbiprofen axetil 50 mg twice daily. Rescue analgesia (morphine 2-4 mg IV or equivalent) is administered for breakthrough pain (NRS ≥ 4), with all rescue doses converted to morphine equivalent dose for analysis.
The primary endpoint is time to first flatus after surgery. Key secondary endpoints include the area under the curve of movement-evoked pain NRS scores over 0-72 hours and total rescue analgesic consumption in morphine equivalent dose. Additional secondary endpoints encompass gastrointestinal recovery parameters (time to first bowel movement, tolerance of liquid/semi-liquid/solid diets), pain and analgesic use (resting pain AUC, time to first PCIA press, total PCIA presses), ambulation and recovery (time to first independent ambulation ≥5 meters, postoperative hospital stay meeting uniform discharge criteria), and safety outcomes (incidence and severity of nausea, vomiting, abdominal distension, postoperative complications graded by Clavien-Dindo classification, and 30-day readmission rate). Patient-reported outcomes are assessed using the EORTC QLQ-C30 and QLQ-STO22 questionnaires, and perioperative fatigue is evaluated using the ICFS-10, all administered preoperatively, on postoperative day 4, and at 30 days after surgery. Exploratory endpoints include inflammatory cytokines (CRP, IL-6, IL-1β, TNF-α), gastrointestinal hormones (motilin, gastrin, substance P, VIP, cholecystokinin), and immunoglobulins (IgA, IgG, IgM) measured from fasting blood samples on postoperative days 1, 3, and 5 (or at discharge if earlier).
Blinding is implemented for participants, outcome assessors, and statisticians. TEAS operators are not blinded but are strictly prohibited from participating in any post-treatment clinical assessments or data collection. The success of blinding will be evaluated using Bang's Blinding Index. An independent Data Monitoring Committee, composed of one statistician and two external experts, will regularly review safety and compliance data.
Sample size calculation: Based on pilot data showing a mean difference of 10.56 hours in time to first flatus between TA and SA groups (SD 18.02), with α = 0.05 (two-sided) and power = 80%, 47 participants per group are required. Accounting for a 10% dropout rate, the target enrollment is 104 participants (52 per group).
The statistical analysis will follow a fixed-sequence testing procedure to control the overall type I error at α = 0.05. Analyses will be performed on the full analysis set (intention-to-treat principle), with per-protocol analysis for sensitivity. All tests will be two-sided, with statistical significance set at P \< 0.05, using SAS 9.4.
The study protocol and informed consent form have been approved by the Ethics Committee of the Affiliated Hospital of Qingdao University and each participating center. The results will be disseminated through peer-reviewed academic journals.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 104 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →The Affiliated Hospital of Qingdao University is the lead sponsor of 149 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive real transcutaneous electrical acupoint stimulation (TEAS) starting 2 hours after emergence from anesthesia, and once daily at 09:00 on postoperative days 1 to 3. Each session lasts 30 minutes. TEAS is delivered via the SDZ-V device with a dense-disperse wave (20 Hz alternating with 100 Hz) at the individually determined maximal tolerable threshold. Bilateral acupoints LI4, PC6, ST36, and ST37 are stimulated.
Device: Transcutaneous Electrical Acupoint Stimulation
Participants receive sham stimulation at the same time points (2 hours after emergence from anesthesia and once daily on postoperative days 1 to 3). The same SDZ-V device is used, with identical appearance, indicator lights, and sounds, but internal output leads are disconnected to deliver no electrical current. Operators simulate dial adjustments and use standardized scripts to maintain blinding.
Device: Sham Transcutaneous Electrical Acupoint Stimulation
TEAS is delivered using a standardized electroacupuncture device (SDZ-V, Suzhou Medical Products Factory) with a dense-disperse wave (20 Hz alternating with 100 Hz, 5s/10s duty cycle, pulse width 0.2 ms ± 30%). Four bilateral acupoints are selected: Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37). The intensity is individually titrated to the maximal tolerable threshold using a dual-threshold method.
Sham TEAS uses the same SDZ-V device with identical appearance, indicator lights, and audible signals. The internal output leads are disconnected to deliver no electrical current. The operator performs the same procedural steps, including simulated dial adjustments, to maintain participant blinding.
Time to First Flatus After Surgery
Time from the end of surgery to the patient's first self-reported passage of flatus. Patients and their families are instructed to record the exact time (to the nearest minute) immediately upon first flatus using a postoperative recovery diary card. Bedside nurses verify and collect the diary cards three times daily during rounds. Bowel movements induced by glycerin suppository or enema are excluded.
Time frame: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Area Under the Curve of Movement-Evoked Pain NRS Scores Over 0-72 Hours
Area under the curve (AUC) of Numerical Rating Scale (NRS) scores for movement-evoked pain (MEP) from 0 to 72 hours postoperatively. The NRS ranges from 0 to 10, where 0 = no pain and 10 = worst possible pain. Higher scores mean a worse outcome. Pain is assessed immediately after coughing using standardized instructions ("Please hold your wound with one hand, take a deep breath, and cough forcefully") at 6, 12, 24, 48, and 72 hours after surgery by a blinded assessor. If the patient cannot perform a standard cough, pain during turning in bed is assessed as an alternative, with the reason recorded in the CRF. AUC is calculated using the trapezoidal rule. Pain during turning and ambulation are recorded simultaneously as exploratory analyses.
Time frame: 0 to 72 hours postoperatively
Total Rescue Analgesic Consumption in Morphine Equivalent Dose
Total dose of all rescue analgesic medications administered for breakthrough pain (NRS ≥ 4) from PACU admission (T0) until discontinuation of PCIA and transition to oral analgesia, converted to morphine equivalent dose (mg MEDD) according to standard conversion factors: IV morphine 1 mg = 1 mg MEDD; IV hydromorphone 0.2 mg = 1 mg MEDD; IV tramadol 10 mg = 1 mg MEDD; oral oxycodone 1 mg = 1.5 mg MEDD. The date, time, and dose of each administration are captured concurrently from nursing medication records and the CRF.
Time frame: From PACU admission (T0) until PCIA discontinuation (expected up to 72 hours postoperatively)
Time to First Bowel Movement
Time from the end of surgery to the first bowel movement, excluding those induced by glycerin suppository or enema.
Time frame: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time to First Tolerance of Liquid Diet
Time from the end of surgery to first tolerance of a liquid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion.
Time frame: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time to First Tolerance of Semi-Liquid Diet
Time from the end of surgery to first tolerance of a semi-liquid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion.
Time frame: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time to First Tolerance of Solid Diet
Time from the end of surgery to first tolerance of a solid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion.
Time frame: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Area Under the Curve of Resting Pain NRS Scores Over 0-72 Hours
Area under the curve (AUC) of Numerical Rating Scale (NRS) scores for resting pain from 0 to 72 hours postoperatively. The NRS ranges from 0 to 10, where 0 = no pain and 10 = worst possible pain. Higher scores mean a worse outcome. Assessed by a blinded assessor at 6, 12, 24, 48, and 72 hours after surgery. AUC is calculated using the trapezoidal rule.
Time frame: 0 to 72 hours postoperatively
Time to First PCIA Pump Press
Time from the end of surgery to the patient's first postoperative patient-controlled intravenous analgesia (PCIA) pump activation.
Time frame: Measured from the end of surgery up to 48 hours postoperatively
Total Number of PCIA Pump Presses Within 48 Hours Postoperatively
Total number of patient-controlled intravenous analgesia (PCIA) pump presses (both effective and ineffective attempts) within the first 48 hours after surgery.
Time frame: 0 to 48 hours postoperatively
Time to First Independent Ambulation of ≥5 Meters
Time from the end of surgery to the patient's first independent ambulation of at least 5 meters.
Time frame: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Postoperative Hospital Stay
Duration of postoperative hospital stay (hours), defined as meeting the uniform discharge criteria: tolerance of oral analgesia, tolerance of a semi-liquid diet, passage of flatus, and absence of uncontrolled complications.
Time frame: From the end of surgery to hospital discharge (expected up to 7 days postoperatively)
Incidence and Severity of Postoperative Nausea
Incidence of postoperative nausea. Severity is assessed using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10, where 0 = no nausea and 10 = most severe nausea. Higher scores mean a worse outcome.
Time frame: 0 to 72 hours postoperatively
Incidence and Number of Episodes of Postoperative Vomiting
Incidence and number of episodes of postoperative vomiting.
Time frame: 0 to 72 hours postoperatively
Rate of Rescue Antiemetic Use
Rate of postoperative rescue antiemetic administration.
Time frame: 0 to 72 hours postoperatively
Incidence and Severity of Abdominal Distension
Incidence of postoperative abdominal distension. Severity is assessed using the Numerical Rating Scale (NRS). The NRS ranges from 0 to 10, where 0 = no distension and 10 = most severe distension. Higher scores mean a worse outcome.
Time frame: 0 to 72 hours postoperatively
Incidence of Postoperative Complications
Incidence of postoperative complications, graded by the Clavien-Dindo classification.
Time frame: From the end of surgery up to 30 days post-discharge
30-Day Readmission Rate
Rate of hospital readmission within 30 days after discharge.
Time frame: 30 days after discharge
Quality of Life - EORTC QLQ-C30
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Scores are transformed to a 0 to 100 scale. For symptom scales, higher scores indicate worse symptoms. For functional scales, higher scores indicate better function.
Time frame: Preoperatively, on postoperative day 4, and at 30 days after surgery
Quality of Life - EORTC QLQ-STO22
Gastric cancer-specific quality of life assessed using the EORTC Quality of Life Questionnaire - Stomach Cancer Module (EORTC QLQ-STO22). Scores range from 0 to 100. Higher scores indicate worse symptoms.
Time frame: Preoperatively, on postoperative day 4, and at 30 days after surgery
Perioperative Fatigue - ICFS-10
Perioperative fatigue assessed using the Identity-Consequence Fatigue Scale-10 (ICFS-10). The scale contains 10 items. Higher scores mean a worse outcome (more severe fatigue). A total score \> 24 indicates postoperative fatigue syndrome (POF).
Time frame: Preoperatively, on postoperative day 4, and at 30 days after surgery
C-Reactive Protein (CRP) Levels
Serum levels of C-reactive protein (CRP) measured from fasting blood samples. (Unit: mg/L)
Time frame: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Interleukin-6 (IL-6) Levels
Serum levels of interleukin-6 (IL-6) measured from fasting blood samples. (Unit: pg/mL)
Time frame: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Interleukin-1β (IL-1β) Levels
Serum levels of interleukin-1β (IL-1β) measured from fasting blood samples. (Unit: pg/mL)
Time frame: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Tumor Necrosis Factor-α (TNF-α) Levels
Serum levels of tumor necrosis factor-α (TNF-α) measured from fasting blood samples. (Unit: pg/mL)
Time frame: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Motilin Levels
Serum levels of motilin measured from fasting blood samples. (Unit: pg/mL)
Time frame: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Gastrin Levels
Serum levels of gastrin measured from fasting blood samples. (Unit: pg/mL)
Time frame: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Substance P Levels
Serum levels of substance P measured from fasting blood samples. (Unit: pg/mL)
Time frame: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Vasoactive Intestinal Peptide (VIP) Levels
Serum levels of vasoactive intestinal peptide (VIP) measured from fasting blood samples. (Unit: pg/mL)
Time frame: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Cholecystokinin (CCK) Levels
Serum levels of cholecystokinin (CCK) measured from fasting blood samples. (Unit: pg/mL)
Time frame: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Plan to share: No — No plan for sharing individual participant data has been established for this investigator-initiated trial.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.
Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 25 months is below that.
Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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