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NCT Number: NCT07574502

Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients

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.

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Key information

Conditions

Colorectal Cancer (CRC) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shandong Medical and Pharmaceutical University Hospital, Binzhou, Shandong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEA

Device

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

Device

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

Primary outcomes

  1. Time to First Flatus

    Time frame: 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 outcomes

  1. Prolonged post operative ileus (PPOI)

    Time frame: Assessed up to 72 hours after surgery

    defined as no flatus for more than 72 hours

  2. time to first defecation

    Time frame: Assessed up to 10 days after surgery

    Defined as the period from the end of the surgery to the time of first defecation (hours).

  3. time to first water intake

    Time frame: Assessed up to 10 days after surgery

    The time from the end of the surgery to the first water intake (hours)

  4. Time to tolerance of liquid diet

    Time frame: 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.

  5. Time to tolerance of semi-liquid diet

    Time frame: 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.

  6. Time to tolerance of solid food

    Time frame: 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.

  7. Time to first ambulation

    Time frame: Assessed up to 10 days after surgery

    The time from the end of the surgery to the first ambulation (hours).

  8. Postoperative nausea

    Time frame: At 24, 48, and 72 hours after surgery

    The number and frequency of postoperative nausea episodes

  9. postoperative vomiting

    Time frame: At 24, 48, and 72 hours after surgery

    The number and frequency of postoperative vomiting

  10. postoperative abdominal distension

    Time frame: At 24, 48, and 72 hours after surgery

    The number and frequency of postoperative abdominal distension

  11. Use of anti-emetic drugs after surgery

    Time frame: At 24, 48, and 72 hours after surgery

    Number of participants using antiemetic drugs

  12. Severity of postoperative pain

    Time frame: 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).

  13. Use of opioids drugs after surgery

    Time frame: 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.

  14. Postoperative quality of recovery

    Time frame: 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.

  15. TEA Security

    Time frame: Assessed up to 3 days after surgery

    assessing the adverse events related to the equipment (including numbness in the hands, pain, and skin allergies)

  16. Postoperative 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)

    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.

  17. Total length of hospital stay

    Time frame: Assessed up to 30 days after surgery

    primary admission plus any readmission up to 30 days

  18. Unplanned readmission

    Time frame: Assessed up to 30 days after surgery

    Record the number of unplanned re-admissions within 30 days of hospital discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Xin Yu

CONTACT

[email protected]

86006663

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

Efficacy of Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients With Colorectal Cancer: A Multicenter Randomized Controlled Trial Study Protocol

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 8, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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