Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT04891432
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2021-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2021-05-13', 'studyFirstSubmitQcDate': '2021-05-13', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of sympathetic plexus injury', 'timeFrame': 'Postoperative day one', 'description': 'The number of patiensts with sympathetic symptom such as edema of the lower extremity, change of skin temperature, pain, or paresthesia without other medical conditions'}], 'secondaryOutcomes': [{'measure': 'Other complications', 'timeFrame': 'Postoperative 6 month', 'description': 'the number of patients with any other complication such as Injury of vascular structure, ureter, peritoneum, or bowel.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fusion of Spine', 'Sympathetic Nervous System']}, 'descriptionModule': {'briefSummary': 'There would be no difference in the risk of sympathetic plexus damage between the pre sympathetic plexus approach and the post sympathetic plexus approach.', 'detailedDescription': 'Compare the incidence of sympathetic chain injury between front and back of sympathetic approach in oblique lumbar interbody fusion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with lumbar degenerative disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with lumbar degenerative disease needs a lateral lumbar interbody fusion of 1-2 segments between L2 to S1.\n\nExclusion Criteria:\n\n* Patients who had previously had lumbar surgery\n* Patients with muscle weakness of motor grade III or lower\n* Patients with neuropsychiatric diseases such as depression\n* Patients with musculoskeletal disease, inflammatory musculoskeletal disease, or infection\n* Patients with cancerous disease\n* Patients who do not want to participate in the study'}, 'identificationModule': {'nctId': 'NCT04891432', 'briefTitle': 'Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach', 'orgStudyIdInfo': {'id': '2101-142-1191'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lateral lumbar interbody fusion', 'type': 'PROCEDURE', 'otherNames': ['front versus back sympathetic chain approach'], 'description': 'oblique lumbar interbody fusion or direct lateral interbody fusion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Korea', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seoul National U Hospital', 'role': 'CONTACT', 'email': 'chiheon1@snu.ac.kr', 'phone': '22072358'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Chi Heon Kim, MD', 'role': 'CONTACT', 'email': 'chiheon1@snu.ac.kr', 'phone': '+82-2-2072-3398'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chi Heon Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}