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| Name | Class |
|---|---|
| Allina Health System | OTHER |
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This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.
The primary objective is to prospectively evaluate drains used in lumbar spine surgery in patients undergoing one- or two-level open posterior lumbar decompression or decompression and fusion for the relative risk of return to the operating room within 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Drain | Experimental | The drain will be used with compression suction. |
|
| Passive Drain | Experimental | The drain will be used with gravity alone. |
|
| No Drain | No Intervention | No drain will be used. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drain | Device | A drain is a small flexible tube that is placed next to where the spine was operated upon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation | Relative risk of return to the operating room | 90 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Time to drain removal | Time (minutes) to drain removal | 90 days postoperatively |
| Drain volume | Daily volume (mL) of fluid collected by the drain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John M Dawson, PhD | Contact | 612-775-6200 | RSRCH1@tcspine.com | |
| Berit A Swanberg | Contact | 612-775-6200 | RSRCH1@tcspine.com |
| Name | Affiliation | Role |
|---|---|---|
| Ben Mueller, MD, PhD | Twin Cities Spine Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Northwestern Hospital | Recruiting | Minneapolis | Minnesota | 55404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35464540 | Background | Reier L, Fowler JB, Arshad M, Siddiqi J. Drains in Spine Surgery for Degenerative Disc Diseases: A Literature Review to Determine Its Usage. Cureus. 2022 Mar 13;14(3):e23129. doi: 10.7759/cureus.23129. eCollection 2022 Mar. | |
| 29680443 | Background | Davidoff CL, Rogers JM, Simons M, Davidson AS. A systematic review and meta-analysis of wound drains in non-instrumented lumbar decompression surgery. J Clin Neurosci. 2018 Jul;53:55-61. doi: 10.1016/j.jocn.2018.04.038. Epub 2018 Apr 19. |
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We do not want to share IPD
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| 90 days postoperatively |
| Transfusion | Need (yes or no) for a postoperative transfusion | 90 days postoperatively |
| Length of Stay | Length of hospital stay | 90 days postoperatively |
| Complications | Occurrence (yes/no) of wound complications, wound dehiscence, superficial wound infection or deep wound inflection | 90 days postoperatively |
| 28190206 | Background | Patel SB, Griffiths-Jones W, Jones CS, Samartzis D, Clarke AJ, Khan S, Stokes OM. The current state of the evidence for the use of drains in spinal surgery: systematic review. Eur Spine J. 2017 Nov;26(11):2729-2738. doi: 10.1007/s00586-017-4983-0. Epub 2017 Feb 11. |
| 27365478 | Background | Zijlmans JL, Buis DR, Verbaan D, Vandertop WP. Wound drains in non-complex lumbar surgery: a systematic review. Bone Joint J. 2016 Jul;98-B(7):984-9. doi: 10.1302/0301-620X.98B7.37190. |
| 26801088 | Background | Liu Y, Li Y, Miao J. Wound drains in posterior spinal surgery: a meta-analysis. J Orthop Surg Res. 2016 Jan 22;11:16. doi: 10.1186/s13018-016-0351-8. |
| 26944885 | Background | Liu JM, Chen WZ, Fu BQ, Chen JW, Liu ZL, Huang SH. The Use of Closed Suction Drainage in Lumbar Spinal Surgery: Is It Really Necessary? World Neurosurg. 2016 Jun;90:109-115. doi: 10.1016/j.wneu.2016.02.091. Epub 2016 Mar 2. |
| 16770213 | Background | Mirzai H, Eminoglu M, Orguc S. Are drains useful for lumbar disc surgery? A prospective, randomized clinical study. J Spinal Disord Tech. 2006 May;19(3):171-7. doi: 10.1097/01.bsd.0000190560.20872.a7. |
| 22120372 | Background | Walid MS, Abbara M, Tolaymat A, Davis JR, Waits KD, Robinson JS 3rd, Robinson JS Jr. The role of drains in lumbar spine fusion. World Neurosurg. 2012 Mar-Apr;77(3-4):564-8. doi: 10.1016/j.wneu.2011.05.058. Epub 2011 Nov 7. |
| 15668633 | Background | Scuderi GJ, Brusovanik GV, Fitzhenry LN, Vaccaro AR. Is wound drainage necessary after lumbar spinal fusion surgery? Med Sci Monit. 2005 Feb;11(2):CR64-6. |
| 15131430 | Background | Brown MD, Brookfield KF. A randomized study of closed wound suction drainage for extensive lumbar spine surgery. Spine (Phila Pa 1976). 2004 May 15;29(10):1066-8. doi: 10.1097/00007632-200405150-00003. |
| 8938608 | Background | Payne DH, Fischgrund JS, Herkowitz HN, Barry RL, Kurz LT, Montgomery DM. Efficacy of closed wound suction drainage after single-level lumbar laminectomy. J Spinal Disord. 1996 Oct;9(5):401-3. |
| 34342631 | Background | Smith VA, Coffman CJ, Hudgens MG. Interpreting the Results of Intention-to-Treat, Per-Protocol, and As-Treated Analyses of Clinical Trials. JAMA. 2021 Aug 3;326(5):433-434. doi: 10.1001/jama.2021.2825. No abstract available. |
| 24834239 | Background | Pourhoseingholi MA, Vahedi M, Rahimzadeh M. Sample size calculation in medical studies. Gastroenterol Hepatol Bed Bench. 2013 Winter;6(1):14-7. |
| 31934522 | Background | Porto GBF, Jeffrey Wessell DO, Alvarado A, Arnold PM, Buchholz AL. Anticoagulation and Spine Surgery. Global Spine J. 2020 Jan;10(1 Suppl):53S-64S. doi: 10.1177/2192568219852051. Epub 2020 Jan 6. |
| 11429335 | Background | Horlocker TT, Nuttall GA, Dekutoski MB, Bryant SC. The accuracy of coagulation tests during spinal fusion and instrumentation. Anesth Analg. 2001 Jul;93(1):33-8. doi: 10.1097/00000539-200107000-00008. |
| 22120318 | Background | Tomasino A, Lumenta CB. To drain or not to drain: about using wound drainage after instrumented spine procedures. World Neurosurg. 2012 Mar-Apr;77(3-4):466-7. doi: 10.1016/j.wneu.2011.07.035. Epub 2011 Nov 7. No abstract available. |
| 34923504 | Background | Butler AJ, Donnally CJ 3rd, Goz V, Basques BA, Vaccaro AR, Schroeder GD. Symptomatic Postoperative Epidural Hematoma in the Lumbar Spine. Clin Spine Surg. 2022 Nov 1;35(9):354-362. doi: 10.1097/BSD.0000000000001278. Epub 2021 Dec 20. |
| 36260132 | Background | Chen Q, Zhong X, Liu W, Wong C, He Q, Chen Y. Incidence of postoperative symptomatic spinal epidural hematoma requiring surgical evacuation: a systematic review and meta-analysis. Eur Spine J. 2022 Dec;31(12):3274-3285. doi: 10.1007/s00586-022-07421-6. Epub 2022 Oct 19. |
| 18165756 | Background | Sokolowski MJ, Garvey TA, Perl J 2nd, Sokolowski MS, Cho W, Mehbod AA, Dykes DC, Transfeldt EE. Prospective study of postoperative lumbar epidural hematoma: incidence and risk factors. Spine (Phila Pa 1976). 2008 Jan 1;33(1):108-13. doi: 10.1097/BRS.0b013e31815e39af. |
| 20091386 | Result | Kanayama M, Oha F, Togawa D, Shigenobu K, Hashimoto T. Is closed-suction drainage necessary for single-level lumbar decompression?: review of 560 cases. Clin Orthop Relat Res. 2010 Oct;468(10):2690-4. doi: 10.1007/s11999-010-1235-6. Epub 2010 Jan 21. |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004322 | Drainage |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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