Clinical trial NCT06034041: The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study
Official title: The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Lumbar Disc Disease
Epidural Fibrosis
Failed Back Surgery Syndrome
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare efficacy and safety of Mediclore as anti-adhesion agent in patient who undergo endoscopic lumbar discectomy. The main question\[s\] it aims to answer are:

* efficacy (patient-reported outcomes, epidural fibrosis)
* safety (complications) Participants will received Mediclore at surgical site after finish the operation in experimental group and normal saline in control group.

Researchers will compare to see if experimental group have better patient-reported outcomes (PROs) after surgery with no different in complications rate.

Detailed description: This study is a randomized clinical trial arrange in King Chulalongkorn Memorial Hospital. Participant will be randomly assigned into 2 groups by computer-generated sequence. Patients based-line characteristic data, patient-reported outcomes (VAS back/leg, ODI and EQ-5D) and a results of straight leg raising test will be collected. Participant will undergo a endoscopic lumbar discectomy by a singer spine surgeon. In experimental group, 1.5 CC. of Mediclore (poloxamer-based thermosensitive anti-adhesive agent) will be applied in after finish the operation. In control group normal saline 1.5 CC. will be applied instead.

Participants will proceed to regular follow-up protocol which include 1, 3 and 6 months visit at out-patient department. All of the PROs and a result of a straight leg raising test will be collected at each visit. MRI will be performed at 3 month after the surgery. The amount of epidural fibrosis will be evaluated according to Ross's method.

Eligibility criteria: Inclusion Criteria:

* Lumbar disc herniated patients
* Failed proper conservative treatment more than 6 months

Exclusion Criteria:

* Previous history of lumbar spine surgery OR lumbar epidural steroid injection
* Infection OR malignancy
* Allergic to any given components
* Lactation and pregnency

Primary outcomes:
measure: Visual Analogue Score for Leg pain (VAS Leg)
timeFrame: 3 month after surgery
Secondary outcomes:
measure: Visual Analogue Score for Leg and Back pain (VAS Leg, Back)
timeFrame: 1, 3 and 6 month after surgery (for VAS Back) and 1 and 6 month after surgery (for VAS Leg)
measure: Oswestry Disability Index (ODI)
timeFrame: 1, 3 and 6 month after surgery
measure: EQ-5D-5L
timeFrame: 1, 3 and 6 month after surgery
measure: Epidural Fibrosis
timeFrame: 3 month after surgery
measure: Complication rate
timeFrame: peri-operation, 1, 3 and 6 month after surgery
measure: Straight leg raising test
timeFrame: 1, 3 and 6 month after surgery
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
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