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Completed

NCT Number: NCT05521750

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

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.

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Key information

Conditions

Herniated Nucleus Pulposus

Age range

24 year–62 year

Sex eligibility

All sexes

Study type

Observational

Primary location

RSUP dr. Sarjito

Sleman, DIY, 55000, Indonesia

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient with single level LDH
  • treated with TPELD

Exclusion criteria

  • reoperation
  • inclomplete medical record

Treatment and study plan

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Procedure

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Other names: TPELD

Primary outcomes

  1. Learning curve of surgeon based on the duration

    Time frame: measured within 24 hours after procedure is done

    Curve of milestone achieved by the surgeon in performing the procedyre

  2. Learning curve based on removed disc

    Time frame: measured within 24 hours after procedure is done

    Curve of milestone achieved by the surgeon based on extracting targeted disc weight

  3. Learning curve based on the C-arm shot

    Time frame: measured within 24 hours after procedure is done

    Curve of milestone achieved by the surgeon based on use of fluoroscopic imaging

Secondary outcomes

  1. Pain reduction after one month

    Time frame: 1 month after procedure

    We measured the pain with visual analog score (VAS) scale reduction on each patients (1-10)

  2. Pain reduction after three month

    Time frame: 3 month after procedure

    We measured the pain with visual analog score (VAS) scale reduction on each patients (1-10)

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 30, 2022
Registry last updated
Sep 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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