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Comparison of clinical outcome of endoscopic lumbar surgery as day surgery or inpatient surgery for lumbar disc herniation and lumbar spinal stenosis : A single-center non-inferiority randomized controlled trial

Comparison of clinical outcome of endoscopic lumbar surgery as day surgery or inpatient surgery for lumbar disc herniation and lumbar spinal stenosis : A single-center non-inferiority randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260627005
Enrollment
100
Registered
2026-06-27
Start date
2025-11-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Single-level lumbar disc herniation and single-level lumbar spinal stenosis requiring endoscopic lumbar spine surgery Outpatient surgery One day surgery Endoscopic discectomy Endoscopic decompression Endoscopic lumbar spine surgery Lumbar disc herniation Herniated nucleus pulposus Lumbar spinal stenosis Spinal canal stenosis

Interventions

Day surgery refers to a surgical procedure in which the patient undergoes surgery and is discharged on the same day, or is managed as an outpatient case. This approach may help reduce the length of ho
Experimental Procedure/Surgery,No Intervention Procedure/Surgery
One day surgery ,Inpatient surgery

Sponsors

Department of Orthopaedics, King Chulalongkorn memorial hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Body mass index (BMI) less than 35 2. Classified as American Society of Anesthesiologists (ASA) physical status I or II. 3. Having a family member or caregiver who is able and willing to provide assistance and care at home for 24 hours after discharge. 4. Residing within one hour of travel from the hospital. 5. Having access to a mobile phone at all times, 24 hours a day. 6. Diagnosed with single-level lumbar disc herniation or symptomatic single-level lumbar spinal stenosis based on history taking, physical examination, and imaging studies, including magnetic resonance imaging (MRI) or computed tomography myelography (CT myelogram). 7. Having failed appropriate conservative treatment for more than 6 months. 8. Voluntarily willing to participate in the study without coercion or undue influence, after receiving adequate and accurate information regarding the study.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with other concomitant spinal disorders, such as spinal instability, scoliosis, spinal trauma, spinal infection, primary spinal tumor, secondary spinal tumor, or other rheumatologic conditions. 2. Patients with a history of coronary heart disease, cerebrovascular disease, chronic kidney disease stage 3 to 5, or coagulopathy. 3. Patients with underlying medical conditions that make them unsuitable for surgery. 4. Patients with unstable vital signs or underlying conditions that impair activities of daily living, such as bedridden status or dementia. 5. Patients who have previously undergone lumbar spine surgery at the same spinal level. 6. Patients who are unable to provide medical history, undergo physical examination for symptom assessment, or complete the study questionnaires.

Design outcomes

Primary

MeasureTime frame
Oswestry disability index 12 months Patient reported outcome using a questionnaire interview

Secondary

MeasureTime frame
visual analog scale for back pain post-operative 2 weeks, 3 month, 6 months and 12 months visual analog scale,Oswestry disability index post-operative 2 weeks, 3 month, 6 months and 12 months Patient reported outcome using a questionnaire interview,visual analog scale for leg pain post-operative 2 weeks, 3 month, 6 months and 12 months visual analog scale,Patient satisfaction post-operative 2 weeks, 3 month, 6 months and 12 months Patient reported outcome using a scale form 0 to 10,EQ-5D-5L post-operative 2 weeks, 3 month, 6 months and 12 months Patient reported outcome using a questionnaire interview,Patient satisfaction by two-binary questions post-operative 2 weeks, 3 month, 6 months and 12 months Patient reported outcome using a questionnaire interview,Recurrent rate post-operative 6 months clinical report and investigation report,Readmission rate post-operative 1 month Hospital record, clinical report,Complication rate post-operative 1 month Post-operative record, clinical report,Estimated blood loss from operation stared to operation finished Operative record ,Operative time from operation stared to operation finished Operative record,Modified MacNab Criteria post-operative 2 weeks, 3 month, 6 months and 12 months Patient reported outcome using a questionnaire interview

Countries

Thailand

Contacts

Public ContactTechatorn Phermphoon

Department of Orthopaedics, King Chulalongkorn memorial hospital

joezacab@gmail.com022564510

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026