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RECRUITING
NCT07898293
NA

TEAS for Gastrectomy Recovery

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 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.

Official title: Effect of Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Recovery and Pain Control After Laparoscopic Radical Gastrectomy: A Multicenter, Randomized, Controlled Trial (GISSG+2402)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2024-10-07

Completion Date

2026-12-31

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

Sham Transcutaneous Electrical Acupoint Stimulation

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.

Locations (8)

Department of Gastrointestinal Surgery, Qingdao University Affiliated 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

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

Yantai Yuhuangding Hospital

Yantai, Shandong, China