Gastric Cancer (GC), Stomach Neoplasms
Conditions
Keywords
Gastric Cancer, Stomach Neoplasms, Transcutaneous Electrical Acupoint Stimulation, TEAS, Acupoint Stimulation, Randomized Controlled Trial, Postoperative Recovery, Pain Management, Gastrointestinal Function
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.
Detailed description
This study is a prospective, multicenter, three-arm, parallel-group, randomized, sham-controlled trial conducted at 13 tertiary hospitals in Shandong Province, China. A total of 300 eligible participants scheduled for laparoscopic radical gastrectomy for stage I-III gastric cancer will be enrolled and randomly assigned in a 1:1:1 ratio to one of three groups: Peri-TEAS (transcutaneous electrical acupoint stimulation administered before, during, and after surgery), Post-TEAS (sham treatment before and during surgery, with real TEAS after surgery), or Sham-TEAS (sham treatment at all time points). Randomization will be performed using a centralized system with stratification by study center and a randomized block design with randomly assigned block sizes. Allocation concealment is ensured by the system, with group assignments revealed only after participant enrollment. TEAS is delivered using a standardized electroacupuncture device (SDZ-V, Suzhou Medical Products Factory) with a dense-disperse wave (2 Hz alternating with 100 Hz, 5s/10s duty cycle) at individually titrated intensities. Four bilateral acupoints are selected: Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37), following WHO standard acupoint locations. For the Peri-TEAS group, stimulation begins 30 minutes before anesthesia induction at the individually determined maximal tolerable threshold, continues throughout surgery at the same intensity, and resumes postoperatively for 30 minutes daily on postoperative days 1 through 3. For the Post-TEAS group, sham stimulation is applied before and during surgery, with real TEAS administered postoperatively using the same protocol as the Peri-TEAS group. The Sham-TEAS group receives sham stimulation at all time points. To maintain blinding, the device screen is shielded, and operators use standardized scripts to avoid unblinding. All participants receive a standardized enhanced recovery after surgery (ERAS) protocol, including no bowel preparation, preoperative carbohydrate loading, minimally invasive incisions, goal-directed fluid therapy, no routine nasogastric tubes, early removal of drains and urinary catheters (within 24 hours), early mobilization, and a stepwise enteral nutrition plan. Postoperative analgesia is provided via patient-controlled intravenous analgesia (PCIA) with sufentanil (2 μg/kg in 100 mL normal saline, background infusion 2 mL/h, bolus 2 mL, lockout 15 min), supplemented with flurbiprofen axetil 50 mg twice daily. Rescue analgesia (morphine 2-4 mg IV or equivalent) is administered for breakthrough pain (NRS ≥ 4), with all rescue doses converted to morphine equivalent dose for analysis. The primary endpoint is time to first flatus after surgery. Key secondary endpoints include the area under the curve of movement-evoked pain NRS scores over 0-72 hours and total rescue analgesic consumption in morphine equivalent dose. Additional secondary endpoints encompass gastrointestinal recovery parameters (time to first bowel movement, tolerance of liquid/semi-liquid/solid diets), pain and analgesic use (resting pain AUC, time to first PCIA press, total PCIA presses, intraoperative propofol and remifentanil dosages), ambulation and recovery (time to first independent ambulation ≥5 meters, postoperative hospital stay meeting uniform discharge criteria), and safety outcomes (incidence and severity of nausea, vomiting, abdominal distension, postoperative complications graded by Clavien-Dindo classification, and 30-day readmission rate). Patient-reported outcomes are assessed using the EORTC QLQ-C30 and QLQ-STO22 questionnaires, and perioperative fatigue is evaluated using the ICFS-10, all administered preoperatively, on postoperative day 4, and at 30 days after surgery. Exploratory endpoints include inflammatory cytokines (CRP, IL-6, IL-1β, TNF-α), gastrointestinal hormones (motilin, gastrin, substance P, VIP, cholecystokinin), and immunoglobulins (IgA, IgG, IgM) measured from fasting blood samples on postoperative days 1, 3, and 5 (or at discharge if earlier). Blinding is implemented for participants, surgeons, anesthesiologists, outcome assessors, and statisticians. TEAS operators are not blinded but are strictly prohibited from participating in any post-treatment clinical assessments or data collection. The success of blinding will be evaluated using Bang's Blinding Index. An independent Data Monitoring Committee, composed of one statistician and two external experts, will regularly review safety and compliance data. Sample size calculation: Based on pilot data showing a mean difference of 8.22 hours in time to first flatus between Peri-TEAS and Post-TEAS (SD 18.36) and 15.35 hours between Peri-TEAS and Sham-TEAS (SD 25.74), with α = 0.05 (two-sided) and power = 80%, 80 participants per group are required. Accounting for a 20% dropout rate, the target enrollment is 300 participants (100 per group). The statistical analysis will follow a fixed-sequence testing procedure to control the overall type I error at α = 0.05. Analyses will be performed on the full analysis set (intention-to-treat principle), with per-protocol analysis for sensitivity. All tests will be two-sided, with statistical significance set at P \< 0.05, using SAS 9.4. The study protocol and informed consent form have been approved by the Ethics Committee of the Affiliated Hospital of Qingdao University and each participating center. The results will be disseminated through peer-reviewed academic journals.
Interventions
DEVICETranscutaneous 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 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.
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned to one of three parallel groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve of Movement-Evoked Pain NRS Scores Over 0-72 Hours | 0 to 72 hours postoperatively | Area under the curve (AUC) of Numerical Rating Scale (NRS) scores for movement-evoked pain (MEP) from 0 to 72 hours postoperatively. NRS is a 11-point scale (0 = no pain, 10 = worst possible pain). Pain is assessed immediately after coughing using standardized instructions ("Please hold your wound with one hand, take a deep breath, and cough forcefully") at 6, 12, 24, 48, and 72 hours after surgery by a blinded assessor. If the patient cannot perform a standard cough, pain during turning in bed is assessed as a替代, with the reason recorded in the CRF. AUC is calculated using the trapezoidal rule. Pain during turning and ambulation are recorded simultaneously as exploratory analyses. |
| Total Rescue Analgesic Consumption in Morphine Equivalent Dose | From PACU admission (T0) until PCIA discontinuation (expected up to 72 hours postoperatively) | Total dose of all rescue analgesic medications administered for breakthrough pain (NRS ≥ 4) from PACU admission (T0) until discontinuation of PCIA and transition to oral analgesia, converted to morphine equivalent dose (mg MEDD) according to standard conversion factors: IV morphine 1 mg = 1 mg MEDD; IV hydromorphone 0.2 mg = 1 mg MEDD; IV tramadol 10 mg = 1 mg MEDD; oral oxycodone 1 mg = 1.5 mg MEDD. The date, time, and dose of each administration are captured concurrently from nursing medication records and the CRF. |
| Time to First Bowel Movement | Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively) | Time from the end of surgery to the first bowel movement, excluding those induced by glycerin suppository or enema. |
| Time to First Tolerance of Liquid Diet | Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively) | Time from the end of surgery to first tolerance of a liquid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion. |
| Time to First Tolerance of Semi-Liquid Diet | Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively) | Time from the end of surgery to first tolerance of a semi-liquid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion. |
| Time to First Tolerance of Solid Diet | Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively) | Time from the end of surgery to first tolerance of a solid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion. |
| Area Under the Curve of Resting Pain NRS Scores Over 0-72 Hours | 0 to 72 hours postoperatively | Area under the curve (AUC) of Numerical Rating Scale (NRS) scores for resting pain (PAR, Pain at Rest) from 0 to 72 hours postoperatively. NRS is a 11-point scale (0 = no pain, 10 = worst possible pain). Assessed by a blinded assessor at 6, 12, 24, 48, and 72 hours after surgery. AUC is calculated using the trapezoidal rule. |
| Time to First PCIA Pump Press | Measured from the end of surgery up to 48 hours postoperatively | Time from the end of surgery to the patient's first postoperative patient-controlled intravenous analgesia (PCIA) pump activation. |
| Total Number of PCIA Pump Presses Within 48 Hours Postoperatively | 0 to 48 hours postoperatively | Total number of patient-controlled intravenous analgesia (PCIA) pump presses (both effective and ineffective attempts) within the first 48 hours after surgery. |
| Intraoperative Propofol Dosage | During surgery (intraoperative) | Total intraoperative propofol dosage (mg) administered during surgery, recorded by the anesthesiologist. |
| Intraoperative Remifentanil Dosage | During surgery (intraoperative) | Total intraoperative remifentanil dosage (μg) administered during surgery, recorded by the anesthesiologist. |
| Time to First Independent Ambulation of ≥5 Meters | 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 independent ambulation of at least 5 meters. |
| Postoperative Hospital Stay | From the end of surgery to hospital discharge (expected up to 7 days postoperatively) | Duration of postoperative hospital stay (hours), defined as meeting the uniform discharge criteria: tolerance of oral analgesia, tolerance of a semi-liquid diet, passage of flatus, and absence of uncontrolled complications. |
| Incidence and Severity of Postoperative Nausea | 0 to 72 hours postoperatively | Incidence of postoperative nausea. Severity is assessed using the Numerical Rating Scale (NRS, 0 = no nausea, 10 = most severe nausea). |
| Incidence and Number of Episodes of Postoperative Vomiting | 0 to 72 hours postoperatively | Incidence and number of episodes of postoperative vomiting. |
| Rate of Rescue Antiemetic Use | 0 to 72 hours postoperatively | Rate of postoperative rescue antiemetic administration. |
| Incidence and Severity of Abdominal Distension | 0 to 72 hours postoperatively | Incidence of postoperative abdominal distension. Severity is assessed using the Numerical Rating Scale (NRS, 0 = no distension, 10 = most severe distension). |
| Incidence of Postoperative Complications | From the end of surgery up to 30 days post-discharge | Incidence of postoperative complications, graded by the Clavien-Dindo classification. |
| 30-Day Readmission Rate | 30 days after discharge | Rate of hospital readmission within 30 days after discharge. |
| Quality of Life - EORTC QLQ-C30 | Preoperatively, on postoperative day 4, and at 30 days after surgery | Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The questionnaire assesses 15 dimensions of HRQoL, including physical, psychological, and social functions. |
| Quality of Life - EORTC QLQ-STO22 | Preoperatively, on postoperative day 4, and at 30 days after surgery | Gastric cancer-specific quality of life assessed using the EORTC Quality of Life Questionnaire - Stomach Cancer Module (EORTC QLQ-STO22). The questionnaire includes five multi-item scales (dysphagia, pain, reflux, eating restrictions, anxiety) and four single items (dry mouth, body image, taste problems, hair loss). Higher scores indicate more severe symptoms. |
| Perioperative Fatigue - ICFS-10 | Preoperatively, on postoperative day 4, and at 30 days after surgery | Perioperative fatigue assessed using the Identity-Consequence Fatigue Scale-10 (ICFS-10). The scale contains 10 items; a total score \> 24 indicates postoperative fatigue syndrome (POF). |
Countries
China
Contacts
CONTACTYi Li, MD
CONTACTYanbing Zhou, MD
STUDY_CHAIRYanbing Zhou
The Affiliated Hospital of Qingdao University
Outcome results
None listed