Colorectal Cancer (CRC)
Conditions
Brief summary
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.
Interventions
DEVICETEA
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).
DEVICEsham-TEA
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
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 65 years old. * Elective minimally invasive (laparoscopic or robotic) resection of colorectal cancer. * American Society of Anesthesiologists classification (ASA) 1-4. * Able to understand the research process and the use of various assessment scales, and able to communicate effectively with the researchers. * The patient voluntarily participates in this study and signs the informed consent form.
Exclusion criteria
* Previous history of abdominal gastrointestinal surgery. * Planned for palliative or emergency surgery. * Planned for open abdominal surgery or creation of a new stoma. * Transfer to ICU. * Diagnosed with severe heart, liver, kidney or mental system diseases. * Patients with implanted cardiac pacemakers. * Patients currently using or having used in the past month glucagon-like peptide-1 (GLP-1) receptor agonists, dual glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, and sodium-glucose cotransporter-2 (SGLT-2) inhibitors. * Planned to use epidural anesthesia or epidural analgesia. * Presence of local skin lesions, infection at the stimulation site, or obvious skin allergy or severe skin sensitivity to electrodes/adhesive materials. * Participated in other clinical studies within the past 3 months or received acupuncture treatment within the past month. * Other conditions that the investigator considers make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Flatus | Assessed up to 10 days after surgery | Defined as the period from the end of the surgery to the time of first flatus (hours). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged post operative ileus (PPOI) | Assessed up to 72 hours after surgery | defined as no flatus for more than 72 hours |
| time to first defecation | Assessed up to 10 days after surgery | Defined as the period from the end of the surgery to the time of first defecation (hours). |
| time to first water intake | Assessed up to 10 days after surgery | The time from the end of the surgery to the first water intake (hours) |
| Time to tolerance of liquid diet | Assessed up to 10 days after surgery | "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 to tolerance of semi-liquid diet | Assessed up to 10 days after surgery | "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 to tolerance of solid food | Assessed up to 10 days after surgery | "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 to first ambulation | Assessed up to 10 days after surgery | The time from the end of the surgery to the first ambulation (hours). |
| Postoperative nausea | At 24, 48, and 72 hours after surgery | The number and frequency of postoperative nausea episodes |
| postoperative vomiting | At 24, 48, and 72 hours after surgery | The number and frequency of postoperative vomiting |
| postoperative abdominal distension | At 24, 48, and 72 hours after surgery | The number and frequency of postoperative abdominal distension |
| Use of anti-emetic drugs after surgery | At 24, 48, and 72 hours after surgery | Number of participants using antiemetic drugs |
| Severity of postoperative pain | At 24, 48, and 72 hours after surgery | 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). |
| Use of opioids drugs after surgery | At 24, 48, and 72 hours after surgery | The total dosage of all opioid analgesics used within 24 hours, 48 hours, and 72 hours after surgery, converted into morphine equivalents. |
| Postoperative quality of recovery | baseline and postoperative day 1 to day 7 (or until discharge, whichever comes first) | 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. |
| TEA Security | Assessed up to 3 days after surgery | assessing the adverse events related to the equipment (including numbness in the hands, pain, and skin allergies) |
| Postoperative complications | From the time the patient signs the informed consent form until the end of the study follow-up (30 days after surgery) | 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. |
| Total length of hospital stay | Assessed up to 30 days after surgery | primary admission plus any readmission up to 30 days |
| Unplanned readmission | Assessed up to 30 days after surgery | Record the number of unplanned re-admissions within 30 days of hospital discharge |
Countries
China
Contacts
CONTACTXin Yu
Outcome results
None listed