Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

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

Study information

Verified date September 2023
Source King Chulalongkorn Memorial Hospital
Contact Nattapat Tangchitcharoen, MD
Phone 6622565351
Email t-nattapat@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
Thailand King Chulalongkorn Memorial Hospital Pathum Wan Bangkok

Sponsors (1)

Lead Sponsor Collaborator
King Chulalongkorn Memorial Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (23)

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

Atlas SJ, Keller RB, Chang Y, Deyo RA, Singer DE. Surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: five-year outcomes from the Maine Lumbar Spine Study. Spine (Phila Pa 1976). 2001 May 15;26(10):1179-87. doi: 10.1097/00007632-200105150-00017. — View Citation

BenDebba M, Augustus van Alphen H, Long DM. Association between peridural scar and activity-related pain after lumbar discectomy. Neurol Res. 1999;21 Suppl 1:S37-42. doi: 10.1080/01616412.1999.11741025. — View Citation

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

Chung JH, Kim KS, Choi JD, Kim TH, Lee KS, Oh CY, Noh JH, Kim JS, Kim WT, Lee SH, Kim JH, Kim TN, Huh W, Lee SW. Effects of poloxamer-based thermo-sensitive sol-gel agent on urethral stricture after transurethral resection of the prostate for benign prost — View Citation

Du X, Wu L, Yan H, Jiang Z, Li S, Li W, Bai Y, Wang H, Cheng Z, Kong D, Wang L, Zhu M. Microchannelled alkylated chitosan sponge to treat noncompressible hemorrhages and facilitate wound healing. Nat Commun. 2021 Aug 5;12(1):4733. doi: 10.1038/s41467-021-24972-2. — View Citation

Fransen P. Reduction of postoperative pain after lumbar microdiscectomy with DuraSeal Xact Adhesion Barrier and Sealant System. Spine J. 2010 Sep;10(9):751-61. doi: 10.1016/j.spinee.2010.05.001. Epub 2010 Jun 12. — View Citation

Gerszten PC, Moossy JJ, Flickinger JC, Welch WC. Low-dose radiotherapy for the inhibition of peridural fibrosis after reexploratory nerve root decompression for postlaminectomy syndrome. J Neurosurg. 2003 Oct;99(3 Suppl):271-7. doi: 10.3171/spi.2003.99.3.0271. — View Citation

Guner D, Asik I, Ozgencil GE, Peker E, Erden MI. The Correlation of Epidural Fibrosis with Epiduroscopic and Radiologic Imaging for Chronic Pain after Back Surgery. Pain Physician. 2021 Dec;24(8):E1219-E1226. — View Citation

Hajosch R, Suckfuell M, Oesser S, Ahlers M, Flechsenhar K, Schlosshauer B. A novel gelatin sponge for accelerated hemostasis. J Biomed Mater Res B Appl Biomater. 2010 Aug;94(2):372-379. doi: 10.1002/jbm.b.31663. — View Citation

Hansson E, Hansson T. The cost-utility of lumbar disc herniation surgery. Eur Spine J. 2007 Mar;16(3):329-37. doi: 10.1007/s00586-006-0131-y. Epub 2006 May 9. — View Citation

Hosseini S, Niakan A, Dehghankhalili M, Dehdab R, Shahjouei S, Rekabdar Y, Shaghaghian E, Shaghaghian A, Ghaffarpasand F. Effects of adhesion barrier gel on functional outcomes of patients with lumbar disc herniation surgery; A systematic review and meta-analysis of clinical trials. Heliyon. 2021 Jun 11;7(6):e07286. doi: 10.1016/j.heliyon.2021.e07286. eCollection 2021 Jun. — View Citation

Ivanic GM, Pink PT, Schneider F, Stuecker M, Homann NC, Preidler KW. Prevention of epidural scarring after microdiscectomy: a randomized clinical trial comparing gel and expanded polytetrafluoroethylene membrane. Eur Spine J. 2006 Sep;15(9):1360-6. doi: 10.1007/s00586-006-0120-1. Epub 2006 Jun 9. — View Citation

Ivanic GM, Pink TP, Homann NC, Scheitza W, Goyal S. The post-discectomy syndrome. Aetiology, diagnosis, treatment, prevention. Arch Orthop Trauma Surg. 2001 Oct;121(9):494-500. doi: 10.1007/s004020100289. — View Citation

Kim YI, Lee M, Kim SI, Seol A, Lee EJ, Kim HS, Song YS. A Randomized Controlled Trial of Thermo-Sensitive Sol-Gel Anti-Adhesion Agent after Gynecologic Surgery. J Clin Med. 2020 Jul 16;9(7):2261. doi: 10.3390/jcm9072261. — View Citation

Loupasis GA, Stamos K, Katonis PG, Sapkas G, Korres DS, Hartofilakidis G. Seven- to 20-year outcome of lumbar discectomy. Spine (Phila Pa 1976). 1999 Nov 15;24(22):2313-7. doi: 10.1097/00007632-199911150-00005. — View Citation

Ross JS, Obuchowski N, Modic MT. MR evaluation of epidural fibrosis: proposed grading system with intra- and inter-observer variability. Neurol Res. 1999;21 Suppl 1:S23-6. doi: 10.1080/01616412.1999.11758604. — View Citation

Ross JS, Robertson JT, Frederickson RC, Petrie JL, Obuchowski N, Modic MT, deTribolet N. Association between peridural scar and recurrent radicular pain after lumbar discectomy: magnetic resonance evaluation. ADCON-L European Study Group. Neurosurgery. 1996 Apr;38(4):855-61; discussion 861-3. — View Citation

Shin SJ, Lee JH, So J, Min K. Anti-adhesive effect of poloxamer-based thermo-sensitive sol-gel in rabbit laminectomy model. J Mater Sci Mater Med. 2016 Nov;27(11):162. doi: 10.1007/s10856-016-5773-7. Epub 2016 Sep 19. — View Citation

Tosteson AN, Skinner JS, Tosteson TD, Lurie JD, Andersson GB, Berven S, Grove MR, Hanscom B, Blood EA, Weinstein JN. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine (Phila Pa 1976). 2008 Sep 1;33(19):2108-15. doi: 10.1097/brs.0b013e318182e390. — View Citation

Wang H, Sun W, Fu D, Shen Y, Chen YY, Wang LL. Update on biomaterials for prevention of epidural adhesion after lumbar laminectomy. J Orthop Translat. 2018 Mar 7;13:41-49. doi: 10.1016/j.jot.2018.02.001. eCollection 2018 Apr. — View Citation

Zhao YF, Zhao JY, Hu WZ, Ma K, Chao Y, Sun PJ, Fu XB, Zhang H. Synthetic poly(vinyl alcohol)-chitosan as a new type of highly efficient hemostatic sponge with blood-triggered swelling and high biocompatibility. J Mater Chem B. 2019 Mar 21;7(11):1855-1866. doi: 10.1039/c8tb03181a. Epub 2019 Feb 21. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT01701804 - The Effectiveness of Non-surgical Integrative Package on Failed Back Surgery Syndrome
Not yet recruiting NCT01185665 - Predicting Outcome of Transcutaneous Electrical Nerve Stimulator (TENS) in Failed Back Surgery Syndrome N/A
Terminated NCT00974623 - Bone Graft Materials Observational Registry N/A
Recruiting NCT01181817 - Evaluation of the Brain Activity During Spinal Cord Stimulation in Failed Back Surgery Syndrome Using Functional MRI and MRS N/A
Recruiting NCT04732325 - Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain N/A
Completed NCT05018377 - Effectiveness and Safety of Percutaneous Adhesiolysis Using Rac'z Catheter Versus Navi Catheter in Management of Failed Back Surgery Syndrome N/A
Not yet recruiting NCT04268602 - The Effect of Intradermal Local Anesthetic Injection in FBSS (Failed Back Surgery Syndrome) N/A
Recruiting NCT03957395 - Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes N/A
Completed NCT04121104 - Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation N/A
Recruiting NCT05068011 - Differential Target Multiplexed Spinal Cord Stimulation
Completed NCT02837822 - Effects of Spinal Cord Stimulation on Sensory Perceptions of Chronic Pain Patients N/A
Completed NCT01966250 - Electroacupuncture as a Complement to Usual Care for Patients With Non-acute Pain After Back Surgery N/A
Completed NCT00018876 - Low-Dose Radiation to Prevent Complications of Back Surgery Phase 1
Completed NCT03523000 - Determining the Prognostic Value of Continuous Intrathecal Infusion Phase 4
Completed NCT01776749 - Subcutaneous Stimulation as Add on Therapy to SCS toTreat Low Back Pain in FBSS N/A
Recruiting NCT04244669 - Impact of the SCS With Different Waveforms Over the Quality of Life (SCS-Quality) N/A
Completed NCT02974101 - AdaptiveStim Objectifying Subjective Pain Questionnaires N/A
Terminated NCT01990287 - SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study N/A
Terminated NCT01711619 - SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients N/A
Completed NCT03702010 - Spinal Cord Stimulation in Patients With Post-Laminectomy Syndrome in Testing Phase N/A