Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-01 @ 9:13 PM
Study NCT ID:
NCT05149404
Status:
UNKNOWN
Last Update Posted:
2021-12-08
First Post:
2021-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-11-24', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'range of motion on X - ray', 'timeFrame': 'preoperation', 'description': 'range of motion the neck in extension and flexion on X - ray'}, {'measure': 'range of motion on X - ray', 'timeFrame': 'intraoperation', 'description': 'range of motion the neck in extension and flexion on X - ray'}, {'measure': 'range of motion on X - ray', 'timeFrame': '72 hours after surgery', 'description': 'range of motion the neck in extension and flexion on X - ray'}, {'measure': 'range of motion on X - ray', 'timeFrame': '3 months after surgery', 'description': 'range of motion the neck in extension and flexion on X - ray'}, {'measure': 'range of motion on X - ray', 'timeFrame': '6 months after surgery', 'description': 'range of motion the neck in extension and flexion on X - ray'}, {'measure': 'Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）', 'timeFrame': 'preoperation', 'description': 'A questionare to evaluate the severity of cervical spondylosis myelopathy'}, {'measure': 'Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）', 'timeFrame': 'intraoperation', 'description': 'A questionare to evaluate the severity of cervical spondylosis myelopathy'}, {'measure': 'Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）', 'timeFrame': '72 hours after surgery', 'description': 'A questionare to evaluate the severity of cervical spondylosis myelopathy'}, {'measure': 'Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）', 'timeFrame': '3 months after surgery', 'description': 'A questionare to evaluate the severity of cervical spondylosis myelopathy'}, {'measure': 'Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire（JOACMEQ）', 'timeFrame': '6 months after surgery', 'description': 'A questionare to evaluate the severity of cervical spondylosis myelopathy'}, {'measure': 'multi-cervical-unit system（MCU）', 'timeFrame': 'preoperation', 'description': 'To locate the cervical responsible section'}, {'measure': 'multi-cervical-unit system（MCU）', 'timeFrame': 'intraoperation', 'description': 'To locate the cervical responsible section'}, {'measure': 'multi-cervical-unit system（MCU）', 'timeFrame': '72 hours after surgery', 'description': 'To locate the cervical responsible section'}, {'measure': 'multi-cervical-unit system（MCU）', 'timeFrame': '3 months after surgery', 'description': 'To locate the cervical responsible section'}, {'measure': 'multi-cervical-unit system（MCU）', 'timeFrame': '6 months after surgery', 'description': 'To locate the cervical responsible section'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['enhanced recovery after surgery', 'Posterior cervical surgery', 'posterior cervical laminoplasty', 'Clinical pathway'], 'conditions': ['Cervical Spondylotic Myelopathy', 'Ossification of Posterior Longitudinal Ligament in Cervical Region']}, 'descriptionModule': {'briefSummary': 'This study intends to establish a multidisciplinary collaborative ERAS clinical pathway of cervical posterior surgery,and to verify its effectiveness, safety and value in health economics.', 'detailedDescription': 'Enhanced recovery after surgery (ERAS) is a new model of deep cooperation between surgery，rehabilitation medicine, anesthesiology, nursing and other disciplines in recent years, which enables patients to start rehabilitation training as soon as possible after surgery and improves the comprehensive effect of surgery. Posterior cervical surgery is traumatic, and it is significant to enhance postoperative rehabilitation to improve the overall efficacy of patients. Currently, there are no clear guidelines supporting the clinical effectiveness of ERAS in reducing complications, reducing costs, and enhancing recovery after posterior cervical surgery. Therefore, this study aims to establish a multidisciplinary ERAS model for posterior cervical surgery in Peking University Third Hospital and verify its clinical effectiveness. This is a multi-center, multidisciplinary prospective cohort study,in which the orthopedics department was combined with the anesthesiology department, rehabilitation department, nutrition department, operating room and nursing team to establish the ERAS clinical pathways for posterior cervical spine surgery. Clinical pathways include surgical procedure optimization, rehabilitation procedure optimization, anesthesia and nursing procedure optimization. As it is optimized and promoted,the ERAS clinical pathways will improve the curative effect and prognosis of posterior cervical surgery, so that more patients with cervical spondylosis will benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. Preoperative ASA score ≥III;\n2. One-stage combined anterior and posterior surgery of cervical spine;\n3. Correction of cervical deformity;\n4. Patients with gastric emptied disorders (such as gastroesophageal reflux, chronic history of aspiration, delayed gastric emptied), complete obstruction of the digestive tract, and inability to use enteral preparations;\n5. Patients with high risk conditions, such as severe cardio-renal insufficiency, affecting the safety evaluation of the trial;\n6. People with mental disorders, alcohol dependence or drug abuse history;\n7. women in the period of lactation and pregnancy;\n8. People with allergic constitution or previous allergies to a variety of drugs;\n9. Other researchers consider it inappropriate to participate in this study', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-70, gender unlimited;\n2. Diagnostic diagnosis of cervical spondylosis and consistent with the indications of posterior spinal canal extended laminoplasty;\n3. Basis of serious diseases of centerlessness, brain, lung, kidney or other important organs, preoperative ASA score I-II;\n4. Agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05149404', 'briefTitle': 'The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'The Application of Enhanced Recovery After Surgery Clinical Pathway in Posterior Cervical Spine Surgery:a Multicenter, Non-interventional Cohort Study', 'orgStudyIdInfo': {'id': 'LM2020289'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ERAS group'}, {'label': 'Conventional group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Sun, Dr.', 'role': 'CONTACT', 'email': 'sunyuor@vip.sina.com', 'phone': '13501221484'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yu Sun, Dr.', 'role': 'CONTACT', 'email': 'sunyuor@vip.sina.com', 'phone': '13501221484'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, {'name': 'Peking University International Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}