Health TrialsbyHealthPanel

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

ConditionComplications, Postoperative
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTwin Cities Spine Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Infection, tumor, or trauma

Prior lumbar fusion surgery

Lumbar fusion surgery at more than 2 levels

Anterior lumbar surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drain

    Device

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

Treatment groups

975 Participants
are divided into 3 treatment groups
Group A: Active DrainExperimental treatment 1 intervention
Group B: Passive DrainExperimental treatment 1 intervention
Group C: No DrainNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Reoperation

Relative risk of return to the operating room

Time frame
90 days postoperatively

Secondary outcomes

1

Time to drain removal

Time (minutes) to drain removal

Time frame
90 days postoperatively
2

Drain volume

Daily volume (mL) of fluid collected by the drain

Time frame
90 days postoperatively
3

Transfusion

Need (yes or no) for a postoperative transfusion

Time frame
90 days postoperatively
4

Length of Stay

Length of hospital stay

Time frame
90 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Twin Cities Spine Center

Lead sponsor

Allina Health System

Collaborator

Source ClinicalTrials.gov
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