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

Herniated Nucleus Pulposus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05521750
• Other study ID #: UGM_PELD
• Status: Completed
• Start date: February 28, 2020
• Est. completion date: August 3, 2021

Study information

• Verified date: September 2022
• Source: Gadjah Mada University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 3, 2021
• Est. primary completion date: June 6, 2021
• Gender: All
• Age group: 24 Years to 62 Years

Eligibility

Inclusion Criteria:

• patient with single level LDH

• treated with TPELD

Exclusion Criteria:

• reoperation

• inclomplete medical record

Related Conditions & MeSH terms

• Herniated Nucleus Pulposus

Intervention

Procedure:
• Transforaminal Percutaneous Endoscopic Lumbar Decompression
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Locations

Country	Name	City	State
Indonesia	RSUP dr. Sarjito	Sleman	DIY

Sponsors (1)

Lead Sponsor	Collaborator
Gadjah Mada University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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