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

NCT07133620 | Not Yet Recruiting

• 1 other identifier: FirstAHXiamenU-YB-4
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Gastrointestinal Dysfunction (POGD)

Outcome Measures

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.

  Three days after the operation

Secondary Outcomes (10)

• The time of the first postoperative defecation and flatus expulsion

  postoperative 3 days

• The concentrations of motilin (MTL)

  postoperative 5 days

• Platelet/lymphocyte ratio (PLR)

  postoperative 5 days

• Visual analogue scale (VAS) Score

  postoperative 5 days

• Quality-of-recovery 15 (Qor-15) Score

  postoperative 1 day

Study Arms (2)

Sham group

SHAM COMPARATOR

Device: Sham transcutaneous Electrical Acupoint Stimulation

TEAS group

EXPERIMENTAL

Device: Transcutaneous electrical acupoint stimulation

Interventions

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 ("Qi arrival") were maintained for 30 minutes. The stimulation method in the post-anesthesia care unit (PACU) was consistent with that before the operation.

TEAS group

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.

Sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• BMI \< 28 kg/m2
• ASA classification is I-III grade
• Preoperative pathological diagnosis is clear
• Laparoscopic surgury in urology under general anesthesia as a
• The patient has normal comprehension ability, and the patient or their family members can cooperate in filling out the questionnaire
• Voluntary to sign the informed consent form

You may not qualify if:

• Not meeting the above standards
• Having severe heart, lung or cerebrovascular diseases (such as severe coronary heart diseases, valve diseases, respiratory failure, cerebral hemorrhage, cerebral infarction, etc.)
• Having taken analgesic and gastrointestinal motility drugs before the operation
• Contraindications for TEAS (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 long-term gastrointestinal motility disorders

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Central Study Contacts

Linhong Wang

CONTACT

+86-13807548496; 2797424071@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share