Postoperative Gastrointestinal Dysfunction (POGD)NCT07133620
the Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Gastrointestinal Dysfunction After Urological Laparoscopic Surgery
A study testing Transcutaneous electrical acupoint stimulation in people with Postoperative Gastrointestinal Dysfunction (POGD), run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Gastrointestinal Dysfunction (POGD)
- What is being tested?
- Transcutaneous electrical acupoint stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Linhong Wang, +86-13807548496, 2797424071@qq.com
About this study
Official title: 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.
- Being tested
- Transcutaneous electrical acupoint stimulation, Sham transcutaneous Electrical Acupoint Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical acupoint stimulationDevice
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 StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham TEAS group | Sham comparator | Not described Receives: Device: Sham transcutaneous Electrical Acupoint Stimulation |
| TEAS group | Experimental | Not described Receives: Device: Transcutaneous electrical acupoint stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three days after the operation
Secondary outcomes (10)
The time of the first postoperative defecation and flatus expulsion
Measured: postoperative 3 days
The concentrations of motilin (MTL)
Measured: postoperative 5 days
Platelet/lymphocyte ratio (PLR)
Measured: postoperative 5 days
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.
Measured: postoperative 5 days
Quality-of-recovery 15 (Qor-15) Score
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.
Measured: postoperative 5 days
miR-10b-5p
Measured: postoperative 5 days
Interleukin-6 (IL-6)
Measured: postoperative 5 days
Interleukin-10 (IL-10)
Measured: postoperative 5 days
Acetylcholine (Ach)
Measured: postoperative 5 days
Norepinephrine (NE)
Measured: postoperative 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Nov 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Gastrointestinal Dysfunction (POGD)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Bin, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133620
- Sponsor's protocol ID
- FirstAHXiamenU-YB-4
- Status last verified
- Jun 2026
- First submitted
- 9 Aug 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang L, Qiu G, Li Y, Chen L, Yang B. Effect of transcutaneous electrical acupoint stimulation on postoperative gastrointestinal dysfunction following laparoscopic urological surgery: a protocol for a randomised, controlled trial. BMJ Open. 2026 Jul 29;16(7):e113118. doi: 10.1136/bmjopen-2025-113118.
PubMed 42526917
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Gastrointestinal Dysfunction After Urological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT07133620
- Acronym / sponsor ID
- FirstAHXiamenU-YB-4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham TEAS group | Sham comparator | Device: Sham transcutaneous Electrical Acupoint Stimulation |
| TEAS group | Experimental | Device: Transcutaneous electrical acupoint stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical acupoint stimulationBefore 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. | Device | TEAS group |
| Sham transcutaneous Electrical Acupoint StimulationBefore 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. | Device | Sham TEAS group |
Primary outcome
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.
10 secondary outcomes
The time of the first postoperative defecation and flatus expulsion
Time frame: postoperative 3 days
The concentrations of motilin (MTL)
Time frame: postoperative 5 days
Platelet/lymphocyte ratio (PLR)
Time frame: postoperative 5 days
Visual analogue scale (VAS) Score
Time frame: postoperative 5 days
Quality-of-recovery 15 (Qor-15) Score
Time frame: postoperative 5 days
miR-10b-5p
Time frame: postoperative 5 days
Interleukin-6 (IL-6)
Time frame: postoperative 5 days
Interleukin-10 (IL-10)
Time frame: postoperative 5 days
Acetylcholine (Ach)
Time frame: postoperative 5 days
Norepinephrine (NE)
Time frame: postoperative 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Derived from this study: PubMed 42526917Wang L, Qiu G, Li Y, Chen L, Yang B. Effect of transcutaneous electrical acupoint stimulation on postoperative gastrointestinal dysfunction following laparoscopic urological surgery: a protocol for a randomised, controlled trial. BMJ Open. 2026 Jul 29;16(7):e113118. doi: 10.1136/bmjopen-2025-113118.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical acupoint stimulation in people with Postoperative Gastrointestinal Dysfunction (POGD), run by The First Affiliated Hospital of Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linhong Wang (+86-13807548496, 2797424071@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-FEED(Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms)Score (time frame: Three days after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07133620, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.