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NCT07714980
TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)
Conditions: Gastric Cancer (GC), Stomach Neoplasms
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: The Affiliated Hospital of Qingdao University
Location: Dongying People's Hospital Dongying Shandong
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 Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07714980). StuddyBuddy aggregates publicly available trial information.