TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)

NCT07714980 | Not Yet Recruiting DMC

• 1 other identifier: TEAS-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Gastric Cancer (GC); Stomach Neoplasms

Keywords

Gastric Cancer; Stomach Neoplasms; Transcutaneous Electrical Acupoint Stimulation; TEAS; Acupoint Stimulation; Randomized Controlled Trial; Postoperative Recovery; Pain Management; Gastrointestinal Function

Outcome Measures

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.

  Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)

Secondary Outcomes (22)

• Area Under the Curve of Movement-Evoked Pain NRS Scores Over 0-72 Hours

  0 to 72 hours postoperatively

• Total Rescue Analgesic Consumption in Morphine Equivalent Dose

  From PACU admission (T0) until PCIA discontinuation (expected up to 72 hours postoperatively)

• Time to First Bowel Movement

  Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)

• Time to First Tolerance of Liquid Diet

  Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)

• Time to First Tolerance of Semi-Liquid Diet

  Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)

Other Outcomes (3)

• Inflammatory Cytokines - CRP, IL-6, IL-1β, TNF-α

  Postoperative days 1, 3, and 5 (or at discharge if earlier)

• Gastrointestinal Hormones - Motilin, Gastrin, Substance P, VIP, CCK

  Postoperative days 1, 3, and 5 (or at discharge if earlier)

• Immunoglobulins - IgA, IgG, IgM

  Postoperative days 1, 3, and 5 (or at discharge if earlier)

Study Arms (3)

Peri-TEAS Group

EXPERIMENTAL

Participants receive active transcutaneous electrical acupoint stimulation (TEAS) before, during, and after surgery. Stimulation begins 30 minutes before anesthesia induction, continues throughout the surgery, and is repeated for 30 minutes daily on postoperative days 1 through 3.

Device: Transcutaneous Electrical Acupoint Stimulation

Post-TEAS Group

EXPERIMENTAL

Participants receive sham (inactive) TEAS before and during surgery, and active TEAS after surgery. Postoperative stimulation is given for 30 minutes daily on postoperative days 1 through 3.

Device: Transcutaneous Electrical Acupoint Stimulation

Sham-TEAS Group

SHAM COMPARATOR

Participants receive sham (inactive) TEAS at all time points: before surgery, during surgery, and after surgery (postoperative days 1 through 3, 30 minutes daily).

Device: Sham Transcutaneous Electrical Acupoint Stimulation

Interventions

Transcutaneous Electrical Acupoint Stimulation DEVICE

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.

Peri-TEAS Group; Post-TEAS Group

Sham Transcutaneous Electrical Acupoint Stimulation DEVICE

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.

Sham-TEAS Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Continuous use of opioids for more than 3 months prior to enrollment, with a daily dose ≥ 30 mg oral morphine equivalent
• Implanted cardiac pacemaker or other electronic stimulation device, or skin infection/lesion at the stimulation site
• Pregnancy or lactation
• Emergency surgery due to bleeding, perforation, obstruction, etc.
• Planned epidural anesthesia for the surgery

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (13)

Dongying People's Hospital

Dongying, Shandong, 257091, China

Location

Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital

Qingdao, Shandong, 266000, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, 266000, China

Location

The Third People's Hospital of Qingdao

Qingdao, Shandong, 266041, China

Location

Qingdao Central Hospital, University of Health and Rehabilitation Sciences

Qingdao, Shandong, 266042, China

Location

Peking University People's Hospital Qingdao

Qingdao, Shandong, 266109, China

Location

Qingdao Chengyang District People's Hospital

Qingdao, Shandong, 266109, China

Location

The People's Hospital of Jimo, Qingdao

Qingdao, Shandong, 266200, China

Location

The People's Hospital of Rizhao

Rizhao, Shandong, 276826, China

Location

Weifang People's Hospital

Weifang, Shandong, 261041, China

Location

Weihai Municipal Hospital

Weihai, Shandong, 264200, China

Location

Weihai Central Hospital

Weihai, Shandong, 264400, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

Related Publications (5)

• Pei L, Wang G, Yang S, Zhou S, Xu T, Zhou J, Zhang W, Lu K, Hu L, Wang Y, Wang K, You D, Wu Y, Li L, Guo J, Sun J. Electroacupuncture Reduces Duration of Postoperative Ileus After Laparoscopic Gastrectomy for Gastric Cancer: A Multicenter Randomized Trial. Gastroenterology. 2025 Jul;169(1):73-84. doi: 10.1053/j.gastro.2025.02.006. Epub 2025 Feb 18.

  PMID: 39978558 BACKGROUND

• Zhou X, Cao SG, Tan XJ, Liu XD, Li ZQ, Kong LX, Tian YL, Liu D, Shen S, Sun YQ, Jiang HT, Zhou YB. Effects of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Postoperative Recovery in Patients with Gastric Cancer: A Randomized Controlled Trial. Cancer Manag Res. 2021 Feb 12;13:1449-1458. doi: 10.2147/CMAR.S292325. eCollection 2021.

  PMID: 33603487 BACKGROUND

• Tan SY, Jiang H, Ma Q, Ye X, Fu X, Ren YF, You FM. Effects of transcutaneous electrical acupoint stimulation on early postoperative pain and recovery: a comprehensive systematic review and meta-analysis of randomized controlled trials. Front Med (Lausanne). 2024 Apr 29;11:1302057. doi: 10.3389/fmed.2024.1302057. eCollection 2024.

  PMID: 38745738 BACKGROUND

• Jiang T, Li J, Meng L, Wang J, Zhang H, Liu M. Effects of transcutaneous electrical acupoint stimulation on gastrointestinal dysfunction after gastrointestinal surgery: A meta-analysis. Complement Ther Med. 2023 May;73:102938. doi: 10.1016/j.ctim.2023.102938. Epub 2023 Feb 25.

  PMID: 36842636 BACKGROUND

• Szmit M, Krajewski R, Rudnicki J, Agrawal S. Application and efficacy of transcutaneous electrical acupoint stimulation (TEAS) in clinical practice: A systematic review. Adv Clin Exp Med. 2023 Sep;32(9):1063-1074. doi: 10.17219/acem/159703.

  PMID: 37026972 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yanbing Zhou

  The Affiliated Hospital of Qingdao University

  STUDY CHAIR

Central Study Contacts

Yi Li, MD

CONTACT

+86 186 6180 0210; zhanmusi8755@163.com

Yanbing Zhou, MD

CONTACT

+86 137 0897 1773; zhouyanbing999@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Anesthesiologists are also masked to group allocation. The TEAS device screen is shielded during surgery to prevent anesthesiologists and surgeons from viewing the stimulation parameters. Study statisticians remain masked until database lock. TEAS operators are not masked but are prohibited from participating in any post-treatment clinical assessments or data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon-in-Chief, Chief Physician, Professor of Surgery

Model Details: Participants will be randomly assigned to one of three parallel groups.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)