| CTRI Number |
CTRI/2026/01/102156 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Lumbar Disc Herniation: Endoscopic Surgery Compared with Microdiscectomy |
|
Scientific Title of Study
|
A Comparative Study of The Outcomes of Lumbar Disc Herniation Treated by Percutaneous Endoscopic Discectomy And Microdiscectomy: A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dakuri Satvik Reddy |
| Designation |
Junior resident |
| Affiliation |
AIIMS Bibinagar |
| Address |
Department of Orthopedics
AIIMS Bibinagar,Medchal,Telangana
Medchal
TELANGANA
508126
India |
| Phone |
8328314871 |
| Fax |
|
| Email |
satvik0805@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maheshwar Lakkireddy |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS bibinagar |
| Address |
Department of Orthopedics
AIIMS Bibinagar
Telangana
Hyderabad
TELANGANA
508126
India |
| Phone |
9440634372 |
| Fax |
|
| Email |
maheshwar.ortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dakuri Satvik Reddy |
| Designation |
Junior resident |
| Affiliation |
AIIMS Bibinagar |
| Address |
Department of Orthopedics
Aiims Bibinagar,Medchal,Telangana
Medchal
TELANGANA
508126
India |
| Phone |
8328314871 |
| Fax |
|
| Email |
satvik0805@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopaedics,AIIMS Bibinagar, Medchal, Telangana, 508126 |
|
|
Primary Sponsor
|
| Name |
Aiims bibinagar |
| Address |
Aiims Bibinagar,hyderabad,telangana,508126 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dakuri Satvik Reddy |
Aiims bibinagar |
Department of orthopaedics, Aiims bibinagar,hyderabad,telangana,508126
Medchal
TELANGANA |
8328314871
satvik0805@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G50-G59||Nerve, nerve root and plexus disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endoscopic Discectomy |
All of the endoscopic procedures in this study will be performed using a multichannel endoscope, which will include a set of forceps and specialised tools for spine surgery. For direct radicular decompression, two endoscopic techniques are available: the interlaminar (IL) technique and the traditional transforaminal (TF) technique. Anatomical obstacles to TF access in L5–S1 when a bur can’t be utilised will include elevated iliac crests, the angulation of sacral inclination, and foraminal anatomy. Additionally, an IL approach will be made possible by a very large window between the laminae of L5 and S1 and a dural sac with a lower concentration of roots. In this study, the surgeons preference for IL or TF will be decided depending on the particular patient |
| Comparator Agent |
Microscopic Discectomy |
MD will be carried out using a surgical microscope or magnifying loupes in the traditional manner. To penetrate the spinal canal, eliminate disc herniation, and decompress the nerve root, a conservative laminotomy and ligamentum flavum excision are carried out. Using the same standards, the patients are released one or two days following the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Surgical indication and MRI in concordance with clinical symptoms
Presence of single symptomatic disc herniation
Failure of atleast 6 weeks of non operative treatment
|
|
| ExclusionCriteria |
| Details |
In subjects where endoscopic resection and microdiscectomy is not possible which includes subjects who require foraminotomy or bone resection or with bone stenosis of the canal
or with foraminal stenosis or with previous surgery on the lumbar spine or with cauda equina syndrome or who are unfit for surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain Assessment & Functional Assessment |
POD1, POD1week, POD1, 3, 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
05/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
Response - Analytic Code
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 30-03-2027 and end date provided 31-03-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Lumbar disc herniation is a common spinal disorder causing
pain,disability and significant health care burden. The gold standard surgical procedure for
treating lumbar disc herniations is microdiscectomy (MD).
In addition to the potential for surgical site infection, there is
still worry about the risks of injury to muscles, including the multifidus, and
excessive articular facet resection during laminectomy, which can result in
instability, the development of widespread epidural fibrosis, and the
persistence of radiated pain. An approach that is less intrusive is endoscopic
discectomy (ED). There were no appreciable changes in
post-operative pain and function between the groups in a few prospective
randomised clinical trials comparing standard MD with ED. On the other hand, ED led to decreased rates
of pain and complications, shorter hospital stays, less bleeding, and fewer
inflammatory serum markers. We felt that this type of study was required
because there weren’t many published prospective randomised clinical trials.
Comparing standard MD and ED in terms of symptom alleviation over a 06-month
follow-up is the primary goal of this study. |