Outcomes comparison between biportal endoscopic discectomy and open lumbar microdiscectomy for single-lumbar disc herniation; a randomized control trial

Phase 4

• Conditions: lumbar disc herniation; BESS Biportal endoscopic spine surgery; MD microscopic lumbar discectomy; LDH lumbar disc herniation

• Registration Number: TCTR20200901003
• Lead Sponsor: Khon Kaen hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study Completion: 2021-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1.Single level lumbar HNP patient who has
2.Neurologic claudication or radicular leg pain referring to lumbar disc herniation
3.Patient aged more than 18 years and less than 60 years old
4.MRI show single lumbar disc herniation
5.Failure of conservative treatment at least 6 weeks or severe pain not responded to conservative treatment

Exclusion Criteria

1.Pregnancy or lactation
2.Previous history of lumbar surgery
3.Patient refuse to do surgery.
4.Medical unfit for operation
5.Spondylolisthesis more than Grade I Mayerding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAS score for post-operative surgical site pain at PACU, 12, 24, 36, 48 and 72 hrs post-op VAS ,Morphine usage post-operative milligram

Secondary Outcome Measures

Name	Time	Method
VAS score for back and leg pain preop and post op at 2, 12 and 24 weeks VAS,ODI score pre-op, 2 wks, 12 wks and 24 wks post-op ODI score,Macnab criteria for patient satisfaction post-op 2 weeks, 12 weeks and 24 weeks Macnab criteria ,CRP pre-op and post-op at 24 and 72 hours blood for CRP Level ,CPK pre-op and post-op at 24 and 72 hours blood for CPK level