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Recruiting NCT06820736

A Prospective, Randomized Comparison Of Drainage Techniques After One- Or Two-Level Open Posterior Lumbar Decompression Or Decompression And Fusion

No phase Interventional Complications, Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Drain.
Who it may be relevant to
Registry conditions: Complications, Postoperative. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This project is being done to understand if a drain reduces recovery problems after surgery, such as infection or the need for more surgery.

Detailed description

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.

Interventions

  • Device Drain
    A drain is a small flexible tube that is placed next to where the spine was operated upon.

Primary outcome measures

  • Reoperation [Time frame: 90 days postoperatively]
Secondary outcome measures (5)
  • Time to drain removal [Time frame: 90 days postoperatively]
  • Drain volume [Time frame: 90 days postoperatively]
  • Transfusion [Time frame: 90 days postoperatively]
  • Length of Stay [Time frame: 90 days postoperatively]
  • Complications [Time frame: 90 days postoperatively]

Eligibility criteria

Inclusion criteria

  • One or two-level open spinal decompression or decompression and fusion for the treatment of lumbar stenosis and/or spondylolisthesis

Exclusion criteria

  • Infection, tumor, or trauma
  • Prior lumbar fusion surgery
  • Lumbar fusion surgery at more than 2 levels
  • Anterior lumbar surgery
  • Perioperative anticoagulation treatment
  • Intraoperative incidental durotomy
  • Intraoperative or postoperative cerebrospinal fluid leakage
  • Intraoperative EBL greater than one liter

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Abbott Northwestern Hospital — Minneapolis

Publications

  • 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. PMID 35464540
  • 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. PMID 29680443
  • 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. PMID 28190206
  • 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. PMID 27365478
  • 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. PMID 26801088
  • 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. PMID 26944885
  • 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. PMID 16770213
  • 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. PMID 22120372

Identifiers

NCT: NCT06820736 · 2199368-6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗