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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xiamen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: Sham TEAS groupSham comparator 1 intervention
Group B: TEAS groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Three days after the operation

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

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.

Time frame
postoperative 5 days

Other outcomes

Sponsors and contacts

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