Learning Curve, Outcome Parameters, and MRI Assessment of Disc Evacuation After Transforaminal Percutaneous Endoscopic Lumbar Discectomy
NCT ID: NCT05521750
Last Updated: 2022-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
33 participants
OBSERVATIONAL
2020-02-28
2021-08-03
Brief Summary
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This study was a retrospective cohort study, involving patients who underwent TPELD in our institution hospital by a single surgeon.
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Detailed Description
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Pre 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.
All 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.
The 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).
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Age
Patient age
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
Gender
Patient's gender
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
Surgical Time
Duration of surgery, begin from incision until skin closure
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
Intraoperative Blood loss
Total blood loss during operation
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
Length of Stay
Duration of hospitalization
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
VAS Pre-op
Pain scale measured with visual analog scale (VAS) prior to the operation
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
1 Month VAS
Pain scale measured with visual analog scale (VAS) 1 month after the operation
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
3 Month VAS
Pain scale measured with visual analog scale (VAS) 3 month after the operation
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
Decrease VAS 1 month
Difference of VAS score within 1 month of evaluation
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
Decrease VAS 3 month
Difference of VAS score within 3 month of evaluation
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
Disc weight
Estimation of total disc weight
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
Removed disc weight
weight of removed disc measured after operation
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
Percentage of Removed Disc
Percentage of removed disc as seen on the axial MRI
Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
Interventions
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Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* treated with TPELD
Exclusion Criteria
* inclomplete medical record
24 Years
62 Years
ALL
No
Sponsors
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Gadjah Mada University
OTHER
Responsible Party
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Yudha Mathan Sakti
Head of Orthopedic residency program, Gadjah Mada University, Yogyakarta, Indonesia
Locations
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RSUP dr. Sarjito
Sleman, DIY, Indonesia
Countries
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Other Identifiers
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UGM_PELD
Identifier Type: -
Identifier Source: org_study_id
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