NCT05521750

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
Last Updated

September 6, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

August 19, 2022

Last Update Submit

September 1, 2022

Conditions

Herniated Nucleus Pulposus

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Pain reduction after one month

    1 month after procedure

  • Pain reduction after three month

    3 month after procedure

Study Arms (13)

Age

Patient age

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Gender

Patient's gender

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Surgical Time

Duration of surgery, begin from incision until skin closure

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Intraoperative Blood loss

Total blood loss during operation

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Length of Stay

Duration of hospitalization

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

VAS Pre-op

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

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

1 Month VAS

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

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

3 Month VAS

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

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Decrease VAS 1 month

Difference of VAS score within 1 month of evaluation

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Decrease VAS 3 month

Difference of VAS score within 3 month of evaluation

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Disc weight

Estimation of total disc weight

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Removed disc weight

weight of removed disc measured after operation

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Percentage of Removed Disc

Percentage of removed disc as seen on the axial MRI

Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression

Interventions

Transforaminal Percutaneous Endoscopic Lumbar DecompressionPROCEDURE

TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting

Also known as: TPELD
1 Month VAS3 Month VASAgeDecrease VAS 1 monthDecrease VAS 3 monthDisc weightGenderIntraoperative Blood lossLength of StayPercentage of Removed DiscRemoved disc weightSurgical TimeVAS Pre-op

Eligibility Criteria

Age24 Years - 62 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • patient with single level LDH
  • treated with TPELD

You may not qualify if:

  • reoperation
  • inclomplete medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUP dr. Sarjito

Sleman, DIY, 55000, Indonesia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Weight of Intervertebral disc which taken during TPELD in our institution hospital.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Orthopedic residency program, Gadjah Mada University, Yogyakarta, Indonesia

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 30, 2022

Study Start

February 28, 2020

Primary Completion

June 6, 2021

Study Completion

August 3, 2021

Last Updated

September 6, 2022

Record last verified: 2022-09

Locations

ID(1)