TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcutaneous Electrical Acupoint Stimulation: Transcutaneous 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: Sham 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.

Study summary

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

Primary outcome measure(s)

• Time to First Flatus After Surgery — Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
  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.

Trial sites (13)

More The Affiliated Hospital of Qingdao University trials in China

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