TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Affiliated Hospital of Qingdao University
About this trial
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 three groups to see if TEAS works better when given before, during, and after surgery compared with only after surgery.
Group 1 receives TEAS before, during, and after surgery.
Group 2 receives a sham (inactive) treatment before and during surgery, and real TEAS after surgery.
Group 3 receives sham treatment at all 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 three groups
Receive TEAS or sham treatment for 30 minutes before surgery, during surgery, and for 30 minutes each day 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 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 300 adults aged 18 to 80 years who are scheduled to have laparoscopic surgery for stomach cancer at 13 hospitals in Shandong Province, China.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 80 years, both sexes
Endoscopically and radiographically confirmed resectable stage I-III gastric cancer (AJCC 8th edition)
Scheduled to undergo laparoscopic radical gastrectomy
Willing to sign the informed consent form and able to comply with all study procedures
Disqualifiers
American Society of Anesthesiologists (ASA) physical status ≥ IV
Clinical stage IV gastric cancer
Severe hepatic, renal, cardiovascular, or cerebrovascular diseases, or uncontrolled psychiatric disorders that may affect compliance or safety assessment
Participation in another clinical trial or receipt of any form of acupoint stimulation (acupuncture, electroacupuncture, TEAS, etc.) within 1 month prior to enrollment
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Electrical Acupoint Stimulation
DeviceTranscutaneous electrical acupoint stimulation (TEAS) using the Hwato SDZ-V electronic acupuncture device (Suzhou Medical Appliance Factory Co., Ltd., China). Four bilateral acupoints are stimulated: Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37), following WHO standard locations. Stimulation parameters: dense-disperse wave (2 Hz alternating with 100 Hz, 5s/10s duty cycle, pulse width 0.2 ms ± 30%). Intensity is individually titrated to the maximal tolerable threshold using a dual-threshold calibration method.
Sham Transcutaneous Electrical Acupoint Stimulation
DeviceSham TEAS using the same Hwato SDZ-V device with identical appearance, indicator lights, and audible signals. The output leads are internally disconnected to deliver no electrical current. The operator performs the same procedural steps, including simulated dial adjustments, to maintain participant blinding.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Peri-TEAS GroupExperimental treatment 1 intervention
Group B: Post-TEAS GroupExperimental treatment 1 intervention
Group C: Sham-TEAS GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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. NRS is a 11-point scale (0 = no pain, 10 = worst possible pain). 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 a替代, 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 postoperatively2
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)3
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)4
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)Other outcomes
1
Inflammatory Cytokines - CRP, IL-6, IL-1β, TNF-α
Serum levels of inflammatory cytokines, including C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β), and tumor necrosis factor-α (TNF-α), measured from fasting blood samples to investigate whether TEAS exerts its effects through inhibition of systemic inflammation.
Time frame
Postoperative days 1, 3, and 5 (or at discharge if earlier)2
Gastrointestinal Hormones - Motilin, Gastrin, Substance P, VIP, CCK
Serum levels of gastrointestinal hormones, including motilin (MTL), gastrin (GAS), substance P (SP), vasoactive intestinal peptide (VIP), and cholecystokinin (CCK), measured from fasting blood samples.
Time frame
Postoperative days 1, 3, and 5 (or at discharge if earlier)3
Immunoglobulins - IgA, IgG, IgM
Serum levels of immunoglobulins, including IgA, IgG, and IgM, measured from fasting blood samples to explore whether TEAS attenuates postoperative immunosuppression.
Time frame
Postoperative days 1, 3, and 5 (or at discharge if earlier)Sponsors and contacts
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Source ClinicalTrials.gov