Patients undergoing lumbar spine decompression surgery (with or without stabilization)
Conditions
Interventions
Intervention arm (n = 10):
Standard lumbar decompression (with or without instrumentation). At the end of surgery, after decompression/instrumentation, haemostasis, warm saline irrigation and suction
the field is not re-irrigated afterwards
any drain is placed laterally, away from the gel
the wound is closed in layers.
Control arm (n = 10):
Identical standard lumbar spine surgery without any barrier agent.
Allocation by random number table (1:1).
Surgery is performed by consultant s
operating surgeon not blinded. Clinical follow-up at 1, 3 and 6 months
contrast-enhanced MRI at 6 months. Analysed by intention-to-treat.
Sponsors
University of Indonesia
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Undergoing lumbar decompression surgery (with or without stabilisation) at the participating hospitals during the study period 2. Aged 18 years or older 3. Willing to participate in the study (provided consent)
Exclusion criteria
Exclusion criteria: 1. History of previous spine surgery 2. Immune disorder or autoimmune disease 3. Spinal malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low back pain and leg pain measured using the Visual Analogue Scale at preoperative baseline and 1, 3 and 6 months postoperatively;Disability measured using the Oswestry Disability Index at preoperative baseline and 1, 3 and 6 months postoperatively;Severity of epidural fibrosis measured using contrast-enhanced (gadolinium) T2 axial MRI, graded 0–4 across four quadrants on five consecutive slices and averaged (Ross-type grading), at 6 months postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative complications measured using any deviation from the normal postoperative course at through 6 months | — |
Countries
Indonesia
Contacts
Public ContactLatsarizul Alfariq Senja;Dewa Gde Prema Belantara;Ananda
;
Outcome results
None listed