An interventional study of TEA and sham-TEA in Colorectal Cancer (CRC), sponsored by Sir Run Run Shaw Hospital. Recruiting at 2 sites in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Sir Run Run Shaw Hospital · Not applicable, Interventional, and Prevention
The goal of this clinical trial is to clarify the efficacy and safety of transcutaneous electrical acustimulation (TEA) in elderly patients with colorectal cancer, and to evaluate its clinical value in promoting postoperative intestinal function recovery and reducing the incidence of intestinal complications. The main questions it aims to answer are:
Can TEA promote the recovery of intestinal function in elderly patients with colon cancer after surgery? What medical problems might occur to the participants when using TEA? The researchers will compare TEA with the control group (non-acupoint sham stimulation) to see if TEA is effective in promoting the recovery of intestinal function after surgery.
Participants will:
Starting from the first day after the surgery, they received TEA or sham stimulation twice a day for a total of 3 days.
Record the time of the first defecation, defecation, and eating. Record their symptoms and adverse events.
Exclusion Criteria:
Device: TEA
Device: sham-TEA
The subjects in the TEA group were placed in the supine position and received transcutaneous electrical acupoint stimulation at the bilateral PC6 and bilateral ST36 . After confirming the location of the acupoints , special skin treatment was carried out. The stimulation parameters for PC6 were set as follows: 0.1 seconds of opening stimulation, 0.4 seconds of closing stimulation, pulse width of 0.5 ms, pulse frequency of 100 Hz, and amplitude ranging from 1 to 10 mA (based on the maximum level that the subject could tolerate). The stimulation parameters for ST36 were set as follows: 2 seconds of opening stimulation, 3 seconds of closing stimulation, pulse width of 0.5 ms, pulse frequency of 25 Hz, and amplitude ranging from 2 to 10 mA (based on the maximum level that the subject could tolerate).
Sham-TEA was the same except that non-acupoints were used to replace ST36 and PC6. The sham-acupoint for PC6 was located at about 15-20 cm away from PC6 (up to the elbow and outside of the coastal margin of the forearm not on any meridian) and the sham-point for ST36 was located at 10-15 cm down from and to the lateral side of ST36 not on any meridian
Time to First Flatus
Defined as the period from the end of the surgery to the time of first flatus (hours).
Time frame: Assessed up to 10 days after surgery
Prolonged post operative ileus (PPOI)
defined as no flatus for more than 72 hours
Time frame: Assessed up to 72 hours after surgery
time to first defecation
Defined as the period from the end of the surgery to the time of first defecation (hours).
Time frame: Assessed up to 10 days after surgery
time to first water intake
The time from the end of the surgery to the first water intake (hours)
Time frame: Assessed up to 10 days after surgery
Time to tolerance of liquid diet
"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after the liquid diet. Record the time (in hours) from the end of the surgery to the first tolerance to the liquid diet.
Time frame: Assessed up to 10 days after surgery
Time to tolerance of semi-liquid diet
"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after semi-liquid food. Record the time ( hours) from the end of the surgery to the first tolerance of semi-liquid food.
Time frame: Assessed up to 10 days after surgery
Time to tolerance of solid food
"Tolerance" is defined as no significant nausea or vomiting (PONV ≤ 4 points) within 4 hours after solid food. Record the time (hours) from the end of the surgery to the first tolerance of solid food.
Time frame: Assessed up to 10 days after surgery
Time to first ambulation
The time from the end of the surgery to the first ambulation (hours).
Time frame: Assessed up to 10 days after surgery
Postoperative nausea
The number and frequency of postoperative nausea episodes
Time frame: At 24, 48, and 72 hours after surgery
postoperative vomiting
The number and frequency of postoperative vomiting
Time frame: At 24, 48, and 72 hours after surgery
postoperative abdominal distension
The number and frequency of postoperative abdominal distension
Time frame: At 24, 48, and 72 hours after surgery
Use of anti-emetic drugs after surgery
Number of participants using antiemetic drugs
Time frame: At 24, 48, and 72 hours after surgery
Severity of postoperative pain
The assessment was conducted using a numerical rating scale (NRS). The scoring range was 0-10 (0 indicated no pain, while 10 indicated unbearable severe pain. Scores of 1-3 indicated mild pain that could be tolerated; 4-6 indicated pain that affected sleep but was still tolerable; 7-10 indicated severe pain that affected appetite and sleep).
Time frame: At 24, 48, and 72 hours after surgery
Use of opioids drugs after surgery
The total dosage of all opioid analgesics used within 24 hours, 48 hours, and 72 hours after surgery, converted into morphine equivalents.
Time frame: At 24, 48, and 72 hours after surgery
Postoperative quality of recovery
Assessed using the Quality of Recovery - 15 score (QoR-15) questionnaire preoperatively and daily. The total score ranges from 0 to 150 points. The higher the score, the better the post-anesthesia recovery quality.
Time frame: baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first)
TEA Security
assessing the adverse events related to the equipment (including numbness in the hands, pain, and skin allergies)
Time frame: Assessed up to 3 days after surgery
Postoperative complications
The severity of complications was evaluated using the Clavien-Dindo classification system (grades I to V), with Clavien-Dindo grade ≥ III complications serving as the major surgical complications.
Time frame: From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery)
Total length of hospital stay
primary admission plus any readmission up to 30 days
Time frame: Assessed up to 30 days after surgery
Unplanned readmission
Record the number of unplanned re-admissions within 30 days of hospital discharge
Time frame: Assessed up to 30 days after surgery
Plan to share: No
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