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NCT Number: NCT07133620

the Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Gastrointestinal Dysfunction After Urological Laparoscopic Surgery

The purpose of this clinical trial is to understand the effect of percutaneous acupoint electrical stimulation on postoperative gastrointestinal dysfunction. It will also investigate the safety of percutaneous acupoint electrical stimulation. The main questions that this trial aims to answer are:

Can percutaneous acupoint electrical stimulation alleviate postoperative gastrointestinal dysfunction? Through which mechanisms do they function?

Participants will:

Preoperatively, patients were either given or not given percutaneous acupoint electrical stimulation.

Record their symptoms and biological indicators within 5 days after the operation.

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Key information

Conditions

Postoperative Gastrointestinal Dysfunction (POGD)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

Location status: Recruiting

Location contact

Linhong Wang

CONTACT

[email protected]

+86-13807548496

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years
  • BMI < 28 kg/m2
  • ASA classification is I-III grade
  • Laparoscopic urological procedures under general anesthesia, including but not limited to laparoscopic nephrectomy and laparoscopic radical prostatectomy for prostate cancer
  • Normal comprehension ability, and the patient or his/her family members can cooperate in filling out the questionnaire
  • Voluntary to sign the informed consent form

Exclusion criteria

  • Comprehensive assessment of severe cardiovascular, pulmonary and cerebrovascular diseases (such as severe coronary heart disease, valve diseases, respiratory failure, cerebral hemorrhage, cerebral infarction, etc.)
  • Preoperative use of analgesic and gastrointestinal motility drugs
  • TEAS contraindications (having electronic devices in the body, skin damage or infection at the stimulation site)
  • Previous history of TEAS or electro-acupuncture treatment
  • Previous history of gastrointestinal surgery, long-term gastrointestinal motility disorders and severe intestinal diseases
  • Pregnancy

Treatment and study plan

Transcutaneous electrical acupoint stimulation

Device

Before the operation, the patient received transcutaneous electrical acupoint stimulation (TEAS) at bilateral Zusanli (ST 36), Neiguan (PC 6), and Ciliao (BL 32) acupoints with sterilized electrode patches. The stimulation intensity and current intensity that gave the patient an effective pricking sensation ("deqi") were maintained for 30 minutes. The stimulation method in the post-anesthesia care unit (PACU) was consistent with that before the operation.

Sham Transcutaneous Electrical Acupoint Stimulation

Device

Before the operation, disinfection patches with electrodes were applied to Zusanli (ST 36), Neiguan (PC 6), and Ciliao (BL 32) acupointst, but no electrical stimulation was conducted. The stimulation method in the post-anesthesia care unit (PACU) was the same as that before the operation.

Primary outcomes

  1. I-FEED(Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms)Score

    Time frame: Three days after the operation

    The I-FEED score consists of five aspects: eating, nausea, vomiting, physical examination, and duration of symptoms. The lowest score is 0 and the highest is 14. The higher the score, the worse the result. The normal I-FEED score is 0-2 points. Postoperative gastrointestinal intolerance (POGI) is 3-5 points, and Postoperative gastrointestinal dysfunction (POGD) is ≥ 6 points.

Secondary outcomes

  1. The time of the first postoperative defecation and flatus expulsion

    Time frame: postoperative 3 days

  2. The concentrations of motilin (MTL)

    Time frame: postoperative 5 days

  3. Platelet/lymphocyte ratio (PLR)

    Time frame: postoperative 5 days

  4. Visual analogue scale (VAS) Score

    Time frame: postoperative 5 days

    The VAS score refers to drawing a 10-cm scale on a piece of paper. One end of the scale is marked as 0, indicating no pain; the other end is marked as 10, indicating severe pain; the values in between represent different degrees of pain.

  5. Quality-of-recovery 15 (Qor-15) Score

    Time frame: postoperative 5 days

    The QoR-15 includes 5 items related to physical comfort, 4 items regarding emotional state, 2 items concerning self-care ability, 2 items related to psychological support, and 2 items about pain. There are a total of 15 subjective parameters. Each item is scored on a scale of 0 to 10. The total score of QoR-15 ranges from 0 to 150. The higher the score, the better the condition.

  6. miR-10b-5p

    Time frame: postoperative 5 days

  7. Interleukin-6 (IL-6)

    Time frame: postoperative 5 days

  8. Interleukin-10 (IL-10)

    Time frame: postoperative 5 days

  9. Acetylcholine (Ach)

    Time frame: postoperative 5 days

  10. Norepinephrine (NE)

    Time frame: postoperative 5 days

Study contacts

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

Linhong Wang

CONTACT

[email protected]

+86-13807548496

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2025
Registry last updated
Jun 24, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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