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Learning Curve, Outcome Parameters, and MRI Assessment of Disc Evacuation After Transforaminal Percutaneous Endoscopic Lumbar Discectomy

Learning Curve, Outcome Parameters, and MRI Assessment Of Disc Evacuation After Transforaminal Percutaneous Endoscopic Lumbar Discectomy: a Single Center Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05521750
Enrollment
33
Registered
2022-08-30
Start date
2020-02-28
Completion date
2021-08-03
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herniated Nucleus Pulposus

Brief summary

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). This study was a retrospective cohort study, involving patients who underwent TPELD in our institution hospital by a single surgeon.

Detailed description

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. 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).

Interventions

PROCEDURETransforaminal Percutaneous Endoscopic Lumbar Decompression

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Sponsors

Gadjah Mada University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
24 Years to 62 Years

Inclusion criteria

* patient with single level LDH * treated with TPELD

Exclusion criteria

* reoperation * inclomplete medical record

Design outcomes

Primary

MeasureTime frameDescription
Learning curve of surgeon based on the durationmeasured within 24 hours after procedure is doneCurve of milestone achieved by the surgeon in performing the procedyre
Learning curve based on removed discmeasured within 24 hours after procedure is doneCurve of milestone achieved by the surgeon based on extracting targeted disc weight
Learning curve based on the C-arm shotmeasured within 24 hours after procedure is doneCurve of milestone achieved by the surgeon based on use of fluoroscopic imaging

Secondary

MeasureTime frameDescription
Pain reduction after one month1 month after procedureWe measured the pain with visual analog score (VAS) scale reduction on each patients (1-10)
Pain reduction after three month3 month after procedureWe measured the pain with visual analog score (VAS) scale reduction on each patients (1-10)

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026