Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-01-02 @ 11:57 AM
Study NCT ID:
NCT07133620
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-21
First Post:
2025-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Gastrointestinal Dysfunction After Urological Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2025-08-09', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'I-FEED(Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms)Score', 'timeFrame': 'Three days after the operation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'The time of the first postoperative defecation and flatus expulsion', 'timeFrame': 'postoperative 3 days'}, {'measure': 'The concentrations of motilin (MTL)', 'timeFrame': 'postoperative 5 days'}, {'measure': 'Platelet/lymphocyte ratio (PLR)', 'timeFrame': 'postoperative 5 days'}, {'measure': 'Visual analogue scale (VAS) Score', 'timeFrame': 'postoperative 5 days', 'description': '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.'}, {'measure': 'Quality-of-recovery 15 (Qor-15) Score', 'timeFrame': 'postoperative 1 day', 'description': '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.'}, {'measure': 'miR-10b-5p', 'timeFrame': 'postoperative 5 days'}, {'measure': 'Interleukin-6 (IL-6)', 'timeFrame': 'postoperative 5 days'}, {'measure': 'Interleukin-10 (IL-10)', 'timeFrame': 'postoperative 5 days'}, {'measure': 'Acetylcholine (Ach)', 'timeFrame': 'postoperative 5 days'}, {'measure': 'Norepinephrine (NE)', 'timeFrame': 'postoperative 5 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Gastrointestinal Dysfunction (POGD)']}, 'descriptionModule': {'briefSummary': '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:\n\nCan percutaneous acupoint electrical stimulation alleviate postoperative gastrointestinal dysfunction? Through which mechanisms do they function?\n\nParticipants will:\n\nPreoperatively, patients were either given or not given percutaneous acupoint electrical stimulation.\n\nRecord their symptoms and biological indicators within 5 days after the operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* BMI \\< 28 kg/m2\n* ASA classification is I-III grade\n* Preoperative pathological diagnosis is clear\n* Laparoscopic surgury in urology under general anesthesia as a\n* The patient has normal comprehension ability, and the patient or their family members can cooperate in filling out the questionnaire\n* Voluntary to sign the informed consent form\n\nExclusion Criteria:\n\n* Not meeting the above standards\n* Having severe heart, lung or cerebrovascular diseases (such as severe coronary heart diseases, valve diseases, respiratory failure, cerebral hemorrhage, cerebral infarction, etc.)\n* Having taken analgesic and gastrointestinal motility drugs before the operation\n* Contraindications for TEAS (having electronic devices in the body， skin damage or infection at the stimulation site)\n* Previous history of TEAS or electro-acupuncture treatment\n* Previous history of long-term gastrointestinal motility disorders'}, 'identificationModule': {'nctId': 'NCT07133620', 'briefTitle': 'the Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Gastrointestinal Dysfunction After Urological Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Xiamen University'}, 'officialTitle': 'The Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Gastrointestinal Dysfunction After Urological Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'FirstAHXiamenU-YB-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'interventionNames': ['Device: Sham transcutaneous Electrical Acupoint Stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'TEAS group', 'interventionNames': ['Device: Transcutaneous electrical acupoint stimulation']}], 'interventions': [{'name': 'Transcutaneous electrical acupoint stimulation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['TEAS group']}, {'name': 'Sham transcutaneous Electrical Acupoint Stimulation', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Sham group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Linhong Wang', 'role': 'CONTACT', 'email': '2797424071@qq.com', 'phone': '+86-13807548496'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Xiamen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yang Bin', 'investigatorAffiliation': 'The First Affiliated Hospital of Xiamen University'}}}}