Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-01-04 @ 3:41 AM
Study NCT ID:
NCT05521750
Status:
COMPLETED
Last Update Posted:
2022-09-06
First Post:
2022-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Learning Curve, Outcome Parameters, and MRI Assessment of Disc Evacuation After Transforaminal Percutaneous Endoscopic Lumbar Discectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Weight of Intervertebral disc which taken during TPELD in our institution hospital.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-01', 'studyFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Learning curve of surgeon based on the duration', 'timeFrame': 'measured within 24 hours after procedure is done', 'description': 'Curve of milestone achieved by the surgeon in performing the procedyre'}, {'measure': 'Learning curve based on removed disc', 'timeFrame': 'measured within 24 hours after procedure is done', 'description': 'Curve of milestone achieved by the surgeon based on extracting targeted disc weight'}, {'measure': 'Learning curve based on the C-arm shot', 'timeFrame': 'measured within 24 hours after procedure is done', 'description': 'Curve of milestone achieved by the surgeon based on use of fluoroscopic imaging'}], 'secondaryOutcomes': [{'measure': 'Pain reduction after one month', 'timeFrame': '1 month after procedure', 'description': 'We measured the pain with visual analog score (VAS) scale reduction on each patients (1-10)'}, {'measure': 'Pain reduction after three month', 'timeFrame': '3 month after procedure', 'description': 'We measured the pain with visual analog score (VAS) scale reduction on each patients (1-10)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Herniated Nucleus Pulposus']}, 'descriptionModule': {'briefSummary': 'Transforaminal Percutaneous Endoscopic Lumbar Discectomy (TPELD) is a surgical technique for managing lumbar disc herniation. The procedure demands a steep learning curve with regards to clinical improvement and technical challenges for disc evacuation. This study was to evaluate learning curve, outcome parameters, and MRI assessment for successful procedure in single - center early experience of Transforaminal Percutaneous Endoscopic Lumbar Discectomy (TPELD).\n\nThis study was a retrospective cohort study, involving patients who underwent TPELD in our institution hospital by a single surgeon.', 'detailedDescription': "Investigators reviewed clinical evaluation, C-arm shot, and post-operative MRI findings as parameters for evaluation. All data was taken from the patients' medical records with single-level LDH (Lumbar Disc Herniation) following TPELD. Patients with incomplete data and those who underwent revision surgery were excluded. The collected data were regarding the sociodemographic characteristics of the patients (age and gender), surgical time, pre-operative pain scale (1-10), postoperative pain scale, complications, and weight of the removed disc and ODI (Oswestry Disability Index) score. The preoperative pain scale was assessed within 48 hours before the surgery while the post-operative pain scale was assessed at one month and three months after the surgery. The reduction of pain was assessed, comparing the pre-operative pain scale and the post-operative pain scale at 1 month and 3 months follow up.\n\nPre TPELD MRI data and 3 months post TPELD were collected to evaluate the percentage of disc removed referring to the quantification of the axial MRI by two independent radiology department personnel. The area of the bulging disc was measured using as many points as the user felt were necessary in order to trace a reasonable outline of disc herniation.\n\nAll of the TPELD procedures are performed by a single spine surgeon with only using one type of endoscopic instrumentation in one level LDH. The surgeon was not involved during data collection and data were collected by independent assessors.\n\nThe statistical analysis was performed using SPSS 23.0. investigator tested all the numeric variables with the Shapiro-Wilk test for the normality of distribution. The surgeon's learning curve was evaluated using negative curve-fit regression analysis (y = ae-bx+ c) described by Silva, et al (2013). Then all case are divided into two groups based on the surgical time: cases before and at reaching 50% proficiency (early group) and cases after reaching 50% proficiency (later group)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '24 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient with LDH under orthopedic spine division of RSUP dr. Sarjito Jogjakarta', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with single level LDH\n* treated with TPELD\n\nExclusion Criteria:\n\n* reoperation\n* inclomplete medical record'}, 'identificationModule': {'nctId': 'NCT05521750', 'briefTitle': 'Learning Curve, Outcome Parameters, and MRI Assessment of Disc Evacuation After Transforaminal Percutaneous Endoscopic Lumbar Discectomy', 'organization': {'class': 'OTHER', 'fullName': 'Gadjah Mada University'}, 'officialTitle': 'Learning Curve, Outcome Parameters, and MRI Assessment Of Disc Evacuation After Transforaminal Percutaneous Endoscopic Lumbar Discectomy: a Single Center Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'UGM_PELD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Age', 'description': 'Patient age', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': 'Gender', 'description': "Patient's gender", 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': 'Surgical Time', 'description': 'Duration of surgery, begin from incision until skin closure', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': 'Intraoperative Blood loss', 'description': 'Total blood loss during operation', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': 'Length of Stay', 'description': 'Duration of hospitalization', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': 'VAS Pre-op', 'description': 'Pain scale measured with visual analog scale (VAS) prior to the operation', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': '1 Month VAS', 'description': 'Pain scale measured with visual analog scale (VAS) 1 month after the operation', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': '3 Month VAS', 'description': 'Pain scale measured with visual analog scale (VAS) 3 month after the operation', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': 'Decrease VAS 1 month', 'description': 'Difference of VAS score within 1 month of evaluation', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': 'Decrease VAS 3 month', 'description': 'Difference of VAS score within 3 month of evaluation', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': 'Disc weight', 'description': 'Estimation of total disc weight', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': 'Removed disc weight', 'description': 'weight of removed disc measured after operation', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}, {'label': 'Percentage of Removed Disc', 'description': 'Percentage of removed disc as seen on the axial MRI', 'interventionNames': ['Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression']}], 'interventions': [{'name': 'Transforaminal Percutaneous Endoscopic Lumbar Decompression', 'type': 'PROCEDURE', 'otherNames': ['TPELD'], 'description': 'TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting', 'armGroupLabels': ['1 Month VAS', '3 Month VAS', 'Age', 'Decrease VAS 1 month', 'Decrease VAS 3 month', 'Disc weight', 'Gender', 'Intraoperative Blood loss', 'Length of Stay', 'Percentage of Removed Disc', 'Removed disc weight', 'Surgical Time', 'VAS Pre-op']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55000', 'city': 'Sleman', 'state': 'DIY', 'country': 'Indonesia', 'facility': 'RSUP dr. Sarjito', 'geoPoint': {'lat': -7.71556, 'lon': 110.35556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gadjah Mada University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Orthopedic residency program, Gadjah Mada University, Yogyakarta, Indonesia', 'investigatorFullName': 'Yudha Mathan Sakti', 'investigatorAffiliation': 'Gadjah Mada University'}}}}