The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Visual Analogue Score for Leg pain (VAS Leg)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar disc herniated patients
- •Failed proper conservative treatment more than 6 months
排除标准
- •Previous history of lumbar spine surgery OR lumbar epidural steroid injection
- •Infection OR malignancy
- •Allergic to any given components
- •Lactation and pregnency
研究组 & 干预措施
Mediclore
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.
干预措施: Mediclore (Drug)
Control
After finish the operation, Control group will be applied 1.5 CC of normal saline at the surgical site.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Visual Analogue Score for Leg pain (VAS Leg)
时间窗: 3 month after surgery
The VAS Leg consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('the worst pain in a lifetime'). The patient was asked to rate their current pain level by pointing the mark on the line.
次要结局
- EQ-5D-5L(1, 3 and 6 month after surgery)
- Straight leg raising test(1, 3 and 6 month after surgery)
- Epidural Fibrosis(3 month after surgery)
- Visual Analogue Score for Leg and Back pain (VAS Leg, Back)(1, 3 and 6 month after surgery (for VAS Back) and 1 and 6 month after surgery (for VAS Leg))
- Oswestry Disability Index (ODI)(1, 3 and 6 month after surgery)
- Complication rate(peri-operation, 1, 3 and 6 month after surgery)
研究者
Nattapat Tangchitcharoen
Clinical Fellow in Spine Surgery, Chulalongkorn University
King Chulalongkorn Memorial Hospital