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

NCT ID: NCT05521750

Last Updated: 2022-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-28

Study Completion Date

2021-08-03

Brief Summary

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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

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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).

Conditions

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Herniated Nucleus Pulposus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Age

Patient age

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Gender

Patient's gender

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Surgical Time

Duration of surgery, begin from incision until skin closure

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Intraoperative Blood loss

Total blood loss during operation

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Length of Stay

Duration of hospitalization

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

VAS Pre-op

Pain scale measured with visual analog scale (VAS) prior to the operation

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

1 Month VAS

Pain scale measured with visual analog scale (VAS) 1 month after the operation

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

3 Month VAS

Pain scale measured with visual analog scale (VAS) 3 month after the operation

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Decrease VAS 1 month

Difference of VAS score within 1 month of evaluation

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Decrease VAS 3 month

Difference of VAS score within 3 month of evaluation

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Disc weight

Estimation of total disc weight

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Removed disc weight

weight of removed disc measured after operation

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Percentage of Removed Disc

Percentage of removed disc as seen on the axial MRI

Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intervention Type PROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Interventions

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Transforaminal Percutaneous Endoscopic Lumbar Decompression

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Intervention Type PROCEDURE

Other Intervention Names

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TPELD

Eligibility Criteria

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Inclusion Criteria

* patient with single level LDH
* treated with TPELD

Exclusion Criteria

* reoperation
* inclomplete medical record
Minimum Eligible Age

24 Years

Maximum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gadjah Mada University

OTHER

Sponsor Role lead

Responsible Party

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Yudha Mathan Sakti

Head of Orthopedic residency program, Gadjah Mada University, Yogyakarta, Indonesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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RSUP dr. Sarjito

Sleman, DIY, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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UGM_PELD

Identifier Type: -

Identifier Source: org_study_id

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