Failed Back Surgery Syndrome Clinical Trial
Official title:
The Effect of Mediclore as an Anti-adhesion Agent and Safety in Full-endoscopic Spine Surgery: a Preliminary Study
NCT number | NCT06034041 |
Other study ID # | 66 |
Secondary ID | |
Status | Not yet recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | October 2023 |
Est. completion date | June 2024 |
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.
Status | Not yet recruiting |
Enrollment | 78 |
Est. completion date | June 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | King Chulalongkorn Memorial Hospital | Pathum Wan | Bangkok |
Lead Sponsor | Collaborator |
---|---|
King Chulalongkorn Memorial Hospital |
Thailand,
Ahn JH, Yoon SG, Yi JW, Kim SJ, Lee KE. Anti-adhesive effect and safety of a thermosensitive adhesion barrier (Mediclore) for thyroid surgery: a double-blinded randomized controlled trial. Ann Surg Treat Res. 2022 Jun;102(6):313-322. doi: 10.4174/astr.202 — View Citation
Asch HL, Lewis PJ, Moreland DB, Egnatchik JG, Yu YJ, Clabeaux DE, Hyland AH. Prospective multiple outcomes study of outpatient lumbar microdiscectomy: should 75 to 80% success rates be the norm? J Neurosurg. 2002 Jan;96(1 Suppl):34-44. doi: 10.3171/spi.2002.96.1.0034. — View Citation
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Choi HJ, Ryu JM, Chae BJ, Kim EK, Min JW, Shin HJ, Nam SJ, Yu J, Lee JE, Lee SK, Kim SW. Effect of Poloxamer-Based Thermo-Sensitive Sol-Gel Agent on Upper Limb Dysfunction after Axillary Lymph Node Dissection: A Double-Blind Randomized Clinical Trial. J B — View Citation
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analogue Score for Leg pain (VAS Leg) | 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. | 3 month after surgery | |
Secondary | Visual Analogue Score for Leg and Back pain (VAS Leg, Back) | The VAS Leg and Back 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. | 1, 3 and 6 month after surgery (for VAS Back) and 1 and 6 month after surgery (for VAS Leg) | |
Secondary | Oswestry Disability Index (ODI) | The ODI consists of 10 questions to assess the function in daily activities living, in which the responses are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability). | 1, 3 and 6 month after surgery | |
Secondary | EQ-5D-5L | The EQ-5D-5L has 2 parts. In the first part, consist of 5 questions to assess the function in daily activities living, in which the responses are presented as 5 level (1 means no problems to 5 means extreme problems). The digits for the five questions can be combined into a 5-digit number that describes the patient's health state. The results will interpreted with the country specific utility score (Thailand) and reported as three decimal digit range from 0 (the worst health you can imagine) to 1 (the best health you can imagine). | 1, 3 and 6 month after surgery | |
Secondary | Epidural Fibrosis | Evaluation of epidural fibrosis by method proposed by Ross et al (1999) by MRI. From MRI axial cut, A surgical intervertebral level will be marked as level 3, 2 adjacent cephalic image will be marked as level 1 and 2. 2 adjacent caudad level will be marked as level 4 and 5. Then each image will be separated into 4 quadrant. Fibrosis will be graded on a scale of 0-4 for each quadrant at each imaging slice encompassing the operative level: 0 = no/trace scar; 1 = > 0-25% of quadrant filled with scar; 2 = 25-50% of quadrant filled with scar; 3 = 50-75% of quadrant filled with scar; 4 = > 75% of quadrant filled with scar. The highest grade of epidural fibrosis from any image will represent the degree of epidural ficrosis. | 3 month after surgery | |
Secondary | Complication rate | peri-operation, 1, 3 and 6 month after surgery | ||
Secondary | Straight leg raising test | Straight leg raising test will be performed at each visit. Results will be recorded as negative or positive. If positive, the degree that make a test positive will be also recorded. | 1, 3 and 6 month after surgery |
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