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

G

Gadjah Mada University

Status

Completed

Conditions

Herniated Nucleus Pulposus

Treatments

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Study type

Observational

Funder types

Other

Identifiers

NCT05521750
UGM_PELD

Details and patient eligibility

About

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.

Full 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).

Enrollment

33 patients

Sex

All

Ages

24 to 62 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patient with single level LDH
  • treated with TPELD

Exclusion criteria

  • reoperation
  • inclomplete medical record

Trial design

33 participants in 13 patient groups

Age
Description:
Patient age
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
Gender
Description:
Patient's gender
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
Surgical Time
Description:
Duration of surgery, begin from incision until skin closure
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
Intraoperative Blood loss
Description:
Total blood loss during operation
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
Length of Stay
Description:
Duration of hospitalization
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
VAS Pre-op
Description:
Pain scale measured with visual analog scale (VAS) prior to the operation
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
1 Month VAS
Description:
Pain scale measured with visual analog scale (VAS) 1 month after the operation
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
3 Month VAS
Description:
Pain scale measured with visual analog scale (VAS) 3 month after the operation
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
Decrease VAS 1 month
Description:
Difference of VAS score within 1 month of evaluation
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
Decrease VAS 3 month
Description:
Difference of VAS score within 3 month of evaluation
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
Disc weight
Description:
Estimation of total disc weight
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
Removed disc weight
Description:
weight of removed disc measured after operation
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression
Percentage of Removed Disc
Description:
Percentage of removed disc as seen on the axial MRI
Treatment:
Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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