The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study

King Chulalongkorn Memorial Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Epidural Fibrosis; Failed Back Surgery Syndrome; Lumbar Disc Disease

Treatments: Drug: Normal Saline; Drug: Mediclore

Study type: Interventional

Funder types: Other

Identifiers

NCT06034041

66

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 2 patient groups, including a placebo group

Mediclore

Experimental group

Description:

After finish the operation, Mediclore group will be applied 1.5 CC of Mediclore at the surgical site. Mediclore is a Poloxamer-based thermosensitive anti-adhesive agent which is in a liquid solution and transform to a gel-state after being in a body temperature.

Treatment:

Drug: Mediclore

Control

Placebo Comparator group

Description:

After finish the operation, Control group will be applied 1.5 CC of normal saline at the surgical site.

Treatment:

Drug: Normal Saline