| CTRI Number |
CTRI/2025/03/082533 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Endoscopic and Open Surgery for Single-Level Lumbar Spinal Canal Stenosis: A Randomized Controlled Study on Clinical and Surgical Outcomes |
|
Scientific Title of Study
|
Comparative study of Endoscopic vs Open Spinal Decompression For Single Level Lumbar Spinal Canal Stenosis based on clinical and surgical outcomes - A randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Papasani Anil Kumar Reddy |
| Designation |
Senior resident |
| Affiliation |
SVIMS Tirupati |
| Address |
Department of Neurosurgery, Sri Venkateswara Institute of Medical Sciences, Alipiri road, Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9010662949 |
| Fax |
|
| Email |
anilpapasani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Papasani Anil Kumar Reddy |
| Designation |
Senior resident |
| Affiliation |
SVIMS Tirupati |
| Address |
Department of Neurosurgery, Sri Venkateswara Institute of Medical Sciences, Alipiri road, Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9010662949 |
| Fax |
|
| Email |
anilpapasani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Papasani Anil Kumar Reddy |
| Designation |
Senior resident |
| Affiliation |
SVIMS Tirupati |
| Address |
Department of Neurosurgery, Sri Venkateswara Institute of Medical Sciences, Alipiri road, Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9010662949 |
| Fax |
|
| Email |
anilpapasani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, India, Pin code- 517507 |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
SVIMS, Alipiri road, Tirupati, 517507 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Papasani Anil Kumar Reddy |
Sri Venkateswara Institute of Medical Sciences |
Department of Neurosurgery, Sri Venkateswara Institute of Medical Sciences, Alipiri road, Tirupati
Chittoor
ANDHRA PRADESH |
09010662949
anilpapasani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES Alipiri Road SVIMS Campus |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endoscopic Lumbar Decompression |
The procedure for Endoscopic decompression exclusively use endoscopic equipment for visualization and decompression with a minimal incision and dilation without significant disruption of musculature. The procedure may not initially use a large midline incision, surgical microscope, loupe magnification, or retractors including tubular retractors.
Total duration ranges from 30 minutes to 150 minutes
|
| Intervention |
Open Lumbar Laminectomy |
The procedure for open laminectomy with or without use of a microscope, will not use tubular retraction or endoscopic guidance.
Total duration- ranges from 30 minutes to 120 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age 20-80 years with symptomatic single-level lumbar canal stenosis not relieved by conservative treatment.
Lumbar stenosis confirmed by MRI or CT requiring decompression
Symptoms of claudication and/or radiculopathy.
Competent and understands study protocol
Written informed consent to participate
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To investigate the safety of fully endoscopic decompression methods compared to open laminectomy for the treatment of degenerative lumbar spinal stenosis.
|
Baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| proportion of complications, operation length, length of stay, days of return to normal activities, all-cause mortality, readmission, reoperation rates, Visual Analogue Scale (VAS) for pain, and Oswestry Disability Index (ODI) |
3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anilpapasani@gmail.com].
- For how long will this data be available start date provided 01-02-2025 and end date provided 15-02-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Endoscopic and open spinal decompression are two surgical approaches for managing single-level lumbar spinal canal stenosis, each with distinct advantages and limitations. Open laminectomy, a traditional approach, provides direct visualization and effective decompression but is associated with increased muscle disruption, longer hospital stays, and delayed recovery. In contrast, fully endoscopic decompression offers a minimally invasive alternative with reduced tissue trauma, shorter recovery times, and quicker return to daily activities, though it requires specialized expertise and equipment. This study aims to compare both techniques in terms of clinical and surgical outcomes, focusing on safety, efficacy, complications, functional recovery, and long-term sustainability of results in a randomized control setting. |