The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study
The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study
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:
Researchers will compare to see if experimental group have better patient-reported outcomes (PROs) after surgery with no different in complications rate.
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.
Inclusion Criteria:
Exclusion Criteria:
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