Herniated Nucleus PulposusNCT05521750
Learning Curve, Outcome Parameters, and MRI Assessment of Disc Evacuation After Transforaminal Percutaneous Endoscopic Lumbar Discectomy
An observational study of Herniated Nucleus Pulposus, run by Gadjah Mada University at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 24 to 62 years
- Conditions the study is for
- Herniated Nucleus Pulposus
- What is being tested?
- Transforaminal Percutaneous Endoscopic Lumbar Decompression
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Feb 2020to 3 Aug 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 62 years
- All sexes
- Adult
Study population: Patient with LDH under orthopedic spine division of RSUP dr. Sarjito Jogjakarta
Who may be able to join
- patient with single level LDH
- treated with TPELD
Who cannot join
- reoperation
- inclomplete medical record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Herniated Nucleus Pulposus
- Being tested
- Transforaminal Percutaneous Endoscopic Lumbar Decompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal Percutaneous Endoscopic Lumbar DecompressionProcedure or surgery
Also called TPELD
TPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting
| Study group | Role | What they receive |
|---|---|---|
| Age | Patient age Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| Gender | Patient's gender Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| Surgical Time | Duration of surgery, begin from incision until skin closure Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| Intraoperative Blood loss | Total blood loss during operation Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| Length of Stay | Duration of hospitalization Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| VAS Pre-op | Pain scale measured with visual analog scale (VAS) prior to the operation Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| 1 Month VAS | Pain scale measured with visual analog scale (VAS) 1 month after the operation Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| 3 Month VAS | Pain scale measured with visual analog scale (VAS) 3 month after the operation Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| Decrease VAS 1 month | Difference of VAS score within 1 month of evaluation Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| Decrease VAS 3 month | Difference of VAS score within 3 month of evaluation Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| Disc weight | Estimation of total disc weight Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| Removed disc weight | weight of removed disc measured after operation Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression | |
| Percentage of Removed Disc | Percentage of removed disc as seen on the axial MRI Receives: Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning curve of surgeon based on the duration
Curve of milestone achieved by the surgeon in performing the procedyre
Measured: 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: 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: measured within 24 hours after procedure is done
Secondary outcomes (2)
Pain reduction after one month
We measured the pain with visual analog score (VAS) scale reduction on each patients (1-10)
Measured: 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)
Measured: 3 month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start28 Feb 2020
- Primary completion6 Jun 2021
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herniated Nucleus PulposusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 33 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yudha Mathan Sakti, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521750
- Sponsor's protocol ID
- UGM_PELD
- Status last verified
- Sep 2022
- First submitted
- 19 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve, Outcome Parameters, and MRI Assessment Of Disc Evacuation After Transforaminal Percutaneous Endoscopic Lumbar Discectomy: a Single Center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05521750
- Acronym / sponsor ID
- UGM_PELD
- Conditions
- Herniated Nucleus Pulposus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Months
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Age | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionPatient age |
| Gender | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionPatient's gender |
| Surgical Time | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionDuration of surgery, begin from incision until skin closure |
| Intraoperative Blood loss | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionTotal blood loss during operation |
| Length of Stay | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionDuration of hospitalization |
| VAS Pre-op | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionPain scale measured with visual analog scale (VAS) prior to the operation |
| 1 Month VAS | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionPain scale measured with visual analog scale (VAS) 1 month after the operation |
| 3 Month VAS | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionPain scale measured with visual analog scale (VAS) 3 month after the operation |
| Decrease VAS 1 month | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionDifference of VAS score within 1 month of evaluation |
| Decrease VAS 3 month | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionDifference of VAS score within 3 month of evaluation |
| Disc weight | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionEstimation of total disc weight |
| Removed disc weight | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar Decompressionweight of removed disc measured after operation |
| Percentage of Removed Disc | – | Procedure: Transforaminal Percutaneous Endoscopic Lumbar DecompressionPercentage of removed disc as seen on the axial MRI |
Who may qualify
- Ages
- 24 to 62 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patient with LDH under orthopedic spine division of RSUP dr. Sarjito Jogjakarta
Key inclusion criteria (2 listed)
- patient with single level LDH
- treated with TPELD
Key exclusion criteria (2 listed)
- reoperation
- inclomplete medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transforaminal Percutaneous Endoscopic Lumbar DecompressionAlso: TPELDTPELD is procedure of percutaneous lumbar discectomy done under endoscopic setting | Procedure or surgery | 1 Month VAS, 3 Month VAS, Age, Decrease VAS 1 month, Decrease VAS 3 month, Disc weight, Gender, Intraoperative Blood loss, Length of Stay, Percentage of Removed Disc, Removed disc weight, Surgical Time, VAS Pre-op |
Primary outcome
Learning curve of surgeon based on the duration
Time frame: measured within 24 hours after procedure is done
Curve of milestone achieved by the surgeon in performing the procedyre
Learning curve based on removed disc
Time frame: measured within 24 hours after procedure is done
Curve of milestone achieved by the surgeon based on extracting targeted disc weight
Learning curve based on the C-arm shot
Time frame: measured within 24 hours after procedure is done
Curve of milestone achieved by the surgeon based on use of fluoroscopic imaging
2 secondary outcomes
Pain reduction after one month
Time frame: 1 month after procedure
Pain reduction after three month
Time frame: 3 month after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Herniated Nucleus Pulposus, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning curve of surgeon based on the duration (time frame: measured within 24 hours after procedure is done). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.