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NCT07714980
NA

TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

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.

Official title: Effect of Perioperative vs Postoperative-Only Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Recovery and Pain Control After Laparoscopic Radical Gastrectomy: A Multicenter, Three-Arm, Randomized, Sham-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-07

Completion Date

2028-08

Last Updated

2026-07-20

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

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.

Locations (13)

Dongying People's Hospital

Dongying, Shandong, China

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

The Third People's Hospital of Qingdao

Qingdao, Shandong, China

Qingdao Central Hospital, University of Health and Rehabilitation Sciences

Qingdao, Shandong, China

Peking University People's Hospital Qingdao

Qingdao, Shandong, China

Qingdao Chengyang District People's Hospital

Qingdao, Shandong, China

The People's Hospital of Jimo, Qingdao

Qingdao, Shandong, China

The People's Hospital of Rizhao

Rizhao, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Weihai Municipal Hospital

Weihai, Shandong, China

Weihai Central Hospital

Weihai, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China