Effects of Fluid Gelatin for Lumbar Spinal Stenosis Undergoing Lumbar Endoscopic Bilateral Decompression: A Prospective, Randomized Controlled Trial

Abstract

Objectives: In patients with lumbar spinal stenosis (LSS), prolonged compression of the epidural venous plexus heightens the risk of bleeding and hematoma during minimally invasive surgery. While absorbable fluid gelatin, an animal protein–based hemostatic agent, is available, its effectiveness in lumbar endoscopic unilateral laminotomy with bilateral decompression (LE-ULBD) remains debated. Our research aims to conduct a prospective randomized controlled trial to investigate the effectiveness and safety of this hemostatic material in patients undergoing LE-ULBD for LSS.

Methods: From October 2023 to July 2024, a total of 90 patients with LSS who underwent LE-ULBD were enrolled in this study. The 90 patients were randomly divided into two groups: fluid gelatin group (45 cases, using fluid gelatin) and null-fluid gelatin group (45 cases, not using fluid gelatin). Primary outcomes included the success rate of achieving hemostasis within 3 min and symptomatic postoperative epidural hematoma (SPEH). Secondary outcomes encompassed surgical time, intraoperative blood loss, perioperative blood loss, length of stay, and complications. Independent sample t tests were used to compare continuous data. Chi-squared tests and Fisher's exact probability tests were used to analyze the categorical data.

Results: The success rate of achieving hemostasis within 3 min (p < 0.05) was significantly higher in fluid gelatin group compared to that in the null-fluid gelatin group, and perioperative blood loss (p < 0.05) and surgical time (p < 0.05) were notably lower in the fluid gelatin group. However, there were no statistically significant differences between the two groups regarding intraoperative blood loss, length of stay, and complications, such as SPEH, allergy, and thrombus.

Conclusion: In patients with LSS undergoing LE-ULBD surgery, using fluid gelatin can achieve rapid intraoperative hemostasis, shorten surgical time, and reduce perioperative blood loss without causing complications. Therefore, the conventional use of fluid gelatin in LE-ULBD surgery is an effective and safe strategy.

Keywords

fluid gelatin / hemostasis / lumbar decompression / lumbar endoscopic / lumbar spinal stenosis

References

[1] F. Zaina, C. Tomkins-Lane, E. Carragee, and S. Negrini, “Surgical Versus Non-Surgical Treatment for Lumbar Spinal Stenosis,” Cochrane Database of Systematic Reviews 2016, no. 1 (2016): CD010264.

[2] Y. Hijikata, T. Kamitani, K. Otani, S. Konno, S. Fukuhara, and Y. Yamamoto, “Association of Lumbar Spinal Stenosis With Severe Disability and Mortality Among Community-Dwelling Older Adults: The Locomotive Syndrome and Health Outcomes in the Aizu Cohort Study,” Spine (Phila Pa 1976) 46, no. 14 (2021): E784-E790.

[3] J. H. Park, S. Park, and S. A. Choi, “Incidence and Risk Factors of Spinal Epidural Hemorrhage After Spine Surgery: A Cross-Sectional Retrospective Analysis of a National Database,” BMC Musculoskeletal Disorders 21, no. 1 (2020): 324.

[4] D. K. Ahn, J. S. Lee, W. S. Shin, S. Kim, and J. Jung, “Postoperative Spinal Epidural Hematoma in a Biportal Endoscopic Spine Surgery,” Medicine (Baltimore) 100, no. 6 (2021): e24685.

[5] Y. Soejima, T. Arizono, H. Bekki, et al., “Factors Affecting Postoperative Spinal Epidural Hematoma and the Optimal Order of Vertebral Body Decompression in Multivertebral Microendoscopic Laminectomy,” Cureus 14, no. 5 (2022): e25404.

[6] C. I. Ju, P. Kim, S. W. Ha, S. W. Kim, and S. M. Lee, “Contraindications and Complications of Full Endoscopic Lumbar Decompression for Lumbar Spinal Stenosis: A Systematic Review,” World Neurosurgery 168 (2022): 398-410.

[7] C. W. Webb, K. Aguirre, and P. H. Seidenberg, “Lumbar Spinal Stenosis: Diagnosis and Management,” American Family Physician 109, no. 4 (2024): 350-359.

[8] X. B. Zhao, H. J. Ma, B. Geng, H. G. Zhou, and Y. Y. Xia, “Percutaneous Endoscopic Unilateral Laminotomy and Bilateral Decompression for Lumbar Spinal Stenosis,” Orthopaedic Surgery 13, no. 2 (2021): 641-650.

[9] C. I. Ju and S. M. Lee, “Complications and Management of Endoscopic Spinal Surgery,” Neurospine 20, no. 1 (2023): 56-77.

[10] K. Knusel, J. Y. Du, B. Ren, C. Y. Kim, U. M. Ahn, and N. U. Ahn, “Symptomatic Epidural Hematoma After Elective Posterior Lumbar Decompression: Incidence, Timing, Risk Factors, and Associated Complications,” HSS Journal 16, no. Suppl 2 (2020): 230-237.

[11] Q. Chen, X. Zhong, W. Liu, C. Wong, Q. He, and Y. Chen, “Incidence of Postoperative Symptomatic Spinal Epidural Hematoma Requiring Surgical Evacuation: A Systematic Review and Meta-Analysis,” European Spine Journal 31, no. 12 (2022): 3274-3285.

[12] Z. Pennington, D. Lubelski, C. Molina, E. M. Westbroek, A. K. Ahmed, and D. M. Sciubba, “Prolonged Post-Surgical Drain Retention Increases Risk for Deep Wound Infection After Spine Surgery,” World Neurosurgery 130 (2019): e846-e853.

[13] I. B. Ye, A. E. Thomson, R. A. Smith, et al., “FLOSEAL Versus SURGIFLO in Lumbar Surgery: Similar Outcomes, Different Costs in a Matched Cohort Analysis,” World Neurosurgery 177 (2023): e425-e432.

[14] A. El-Fattah, H. A. Ebada, and A. Tawfik, “Surgiflo(®) May Have a Potential Impact on the Healing Process in Cricotracheal Resection Anastomosis,” Clinical Otolaryngology 45, no. 6 (2020): 870-876.

[15] S. M. Park, D. R. Kang, J. H. Lee, et al., “Efficacy and Safety of a Thrombin-Containing Collagen-Based Hemostatic Agent in Spinal Surgery: A Randomized Clinical Trial,” World Neurosurgery 154 (2021): e215-e221.

[16] J. E. Kim, H. S. Yoo, D. J. Choi, et al., “Effectiveness of Gelatin-Thrombin Matrix Sealants (Floseal®) on Postoperative Spinal Epidural Hematoma During Single-Level Lumbar Decompression Using Biportal Endoscopic Spine Surgery: Clinical and Magnetic Resonance Image Study,” BioMed Research International 2020 (2020): 4801641.

[17] A. Landi, F. Gregori, N. Marotta, and R. Delfini, “Efficacy, Security, and Manageability of Gelified Hemostatic Matrix in Bleeding Control During Thoracic and Lumbar Spine Surgery: FloSeal Versus Surgiflo,” Journal of Neurological Surgery Part A: Central European Neurosurgery 77, no. 2 (2016): 139-143.

[18] R. Gazzeri, M. Galarza, C. Conti, and C. De Bonis, “Incidence of Thromboembolic Events After Use of Gelatin-Thrombin-Based Hemostatic Matrix During Intracranial Tumor Surgery,” Neurosurgical Review 41, no. 1 (2018): 303-310.

[19] L. Roberts, L. Braswell, G. Maves, K. Stumpf, M. Redmond, and J. D. Tobias, “Intraoperative Anaphylaxis Following Injection of a Bleomycin-Gelatin Solution for Sclerotherapy,” Journal of Medical Cases 13, no. 4 (2022): 159-162.

[20] K. F. Schulz, D. G. Altman, and D. Moher, “CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials,” BMJ 340 (2010): c332.

[21] E. P. Ng, K. L. Tung, S. L. Yip, M. S. Tse, T. K. Kwok, and K. K. Wong, “A Prospective Randomised Controlled Trial Evaluating Prophylactic Floseal, a Gelatin and Thrombin-Based Haemostatic Matrix, in Postoperative Drain Output and Blood Transfusion in Transforaminal Lumbar Interbody Fusion Surgery,” European Spine Journal 32, no. 7 (2023): 2282-2287.

[22] P. Slezak, C. Keibl, H. Redl, D. Labahn, and H. Gulle, “An Efficacy Comparison of Two Hemostatic Agents in a Porcine Liver Bleeding Model: Gelatin/Thrombin Flowable Matrix Versus Collagen/Thrombin Powder,” Journal of Investigative Surgery 33, no. 9 (2020): 828-838.

[23] S. B. Nadler, J. H. Hidalgo, and T. Bloch, “Prediction of Blood Volume in Normal Human Adults,” Surgery 51, no. 2 (1962): 224-232.

[24] A. Meunier, A. Petersson, L. Good, and G. Berlin, “Validation of a Haemoglobin Dilution Method for Estimation of Blood Loss,” Vox Sanguinis 95, no. 2 (2008): 120-124.

[25] D. D. Sun, D. Lv, W. Z. Wu, et al., “Estimation and Influence of Blood Loss Under Endoscope for Percutaneous Endoscopic Lumbar Discectomy (PELD): A Clinical Observational Study Combined With In Vitro Experiment,” Journal of Orthopaedic Surgery and Research 15, no. 1 (2020): 281.

[26] G. Y. Lee, J. W. Lee, H. S. Choi, K. J. Oh, and H. S. Kang, “A New Grading System of Lumbar Central Canal Stenosis on MRI: An Easy and Reliable Method,” Skeletal Radiology 40, no. 8 (2011): 1033-1039.

[27] A. J. Butler, C. J. Donnally, V. Goz, B. A. Basques, A. R. Vaccaro, and G. D. Schroeder, “Symptomatic Postoperative Epidural Hematoma in the Lumbar Spine,” Clinical Spine Surgery 35, no. 9 (2022): 354-362.

[28] I. Yüce, O. Kahyaoğlu, H. Çavuşoğlu, S. Kara, and Y. Aydın, “Epidural Hemostasis by Autologous Fat Graft in Minimally Invasive Surgery for Lumbar Spinal Stenosis: In Vivo Experimental Study,” Neuro-Chirurgie 67, no. 4 (2021): 362-368.

[29] L. Ma, L. Dai, Y. Yang, and H. Liu, “Comparison the Efficacy of Hemorrhage Control of Surgiflo Haemostatic Matrix and Absorbable Gelatin Sponge in Posterior Lumbar Surgery: A Randomized Controlled Study,” Medicine (Baltimore) 97, no. 49 (2018): e13511.

[30] T. Abe, M. Miyazaki, N. Sako, et al., “Efficacy of Gelatin-Thrombin Matrix Sealants for Blood Loss in Single-Level Transforaminal Lumbar Interbody Fusion,” Medicine (Baltimore) 102, no. 36 (2023): e34667.

[31] Y. H. Huang and C. Y. Ou, “Significant Blood Loss in Lumbar Fusion Surgery for Degenerative Spine,” World Neurosurgery 84, no. 3 (2015): 780-785.

[32] M. H. MacDonald, G. Zhang, L. Tasse, D. Wang, H. De Leon, and R. Kocharian, “Hemostatic Efficacy of Two Topical Adjunctive Hemostats in a Porcine Spleen Biopsy Punch Model of Moderate Bleeding,” Journal of Materials Science. Materials in Medicine 32, no. 10 (2021): 127.

[33] S. Kato, J. Miyahara, Y. Matsubayashi, et al., “Predictors for Hemostatic Thrombin-Gelatin Matrix Usage in Spine Surgery: A Multicenter Observational Study,” BMC Musculoskeletal Disorders 24, no. 1 (2023): 289.

[34] R. Z. White, L. Kerr, T. J. White, and M. J. Sampson, “Review of Topical Gelatin-Based Haemostatic Agents; an Insidious Culprit of Intraoperative Anaphylaxis,” ANZ Journal of Surgery 91, no. 10 (2021): 2002-2007.

RIGHTS & PERMISSIONS

2025 The Author(s). Orthopaedic Surgery published by Tianjin Hospital and John Wiley & Sons Australia, Ltd.