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

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.

Study Overview

• Status: Completed
• Conditions: Herniated Nucleus Pulposus
• Intervention / Treatment: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

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).

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Indonesia
  • DIY
    • Sleman, DIY, Indonesia, 55000
      • RSUP dr. Sarjito

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 62 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with LDH under orthopedic spine division of RSUP dr. Sarjito Jogjakarta

Description

Inclusion Criteria:

• patient with single level LDH
• treated with TPELD

Exclusion Criteria:

• reoperation
• inclomplete medical record

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

13

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Learning curve of surgeon based on the duration	Curve of milestone achieved by the surgeon in performing the procedyre	measured within 24 hours after procedure is done
Learning curve based on removed disc	Curve of milestone achieved by the surgeon based on extracting targeted disc weight	measured within 24 hours after procedure is done
Learning curve based on the C-arm shot	Curve of milestone achieved by the surgeon based on use of fluoroscopic imaging	measured within 24 hours after procedure is done

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain reduction after one month	We measured the pain with visual analog score (VAS) scale reduction on each patients (1-10)	1 month after procedure
Pain reduction after three month	We measured the pain with visual analog score (VAS) scale reduction on each patients (1-10)	3 month after procedure

Collaborators and Investigators

• Sponsor: Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Actual): June 6, 2021
• Study Completion (Actual): August 3, 2021

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: UGM_PELD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No