Clinical Trial: Mobilisation Algorithm After Incidental Durotomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Flat Bed Rest vs. Immediate Mobilisation After Incidental Durotomy During Lumbar Spinal Surgery: A Prospective Randomised Trial

Brief Summary:

Patients with persistent symptoms of cerebrospinal-fluid leakage (positional headache, photophobia, nausea and vomiting, clear drainage from the wound, fluctuant subcutaneous wound) after a primary repair should be considered for revision surgery to avoid potentially serious complications including CSF (cerebro spinal fluid) fistula formation. Prolonged bed rest immediatel after reapir of an ID () incidental durotomy) is widely accepted and frequently applied. current literature provides supporting retrospective evidence that prolonged bed rest may not be required after watertight closure of dural tears.

The purpose of this study is to further investigate the impact of prolonged bed rest on the need for early reoperation following primary repair of an ID after lumbar spinal surgery. The primary endpoint of this study is the difference in reoperation rate between the two study groups to further investigate if either one or the other postoperative mobilisation regimen provides a significant benefit in terms of persistent dural leakage.


Detailed Summary:

Patients with persistent symptoms of cerebrospinal-fluid leakage (positional headache, photophobia, nausea and vomiting, clear drainage from the wound, fluctuant subcutaneous wound) after a primary repair should be considered for revision surgery to avoid potentially serious complications including CSF (cerebro spinal fluid) fistula formation.

In a recent retrospective case series of 42 patients Radcliff et al. reported an increase in medical complications including pneumonia and wound infections associated with prolonged bed rest Current literature does not provide prospective nor retrospective evidence on the influence of early mobilization on complications or reoperation rate after ID (incidental durotomy).

Prolonged bed rest is widely accepted and frequently applied after ID. Contrarily, current literature provides supporting retrospective evidence that prolonged bed rest may not be required after watertight closure of dural tears.

The purpose of this study is to further investigate the impact of prolonged bed rest on the need for early reoperation following primary repair of an ID after lumbar spinal surgery. The primary endpoint of this study is the difference in reoperation rate between the two study groups to further investigate if either one or the other postoperative mobilisation regimen provides a significant benefit in terms of persistent dural leakage.

This study is designed as an unblinded, prospective randomised cohort trial. The treatment arms consist of either strict prolonged bed rest for 48 hours or immediate postoperative mobilisation. Patients are going to be randomised into either treatment arm after intraoperative verification of ID. Randomization into either treatment arm is going to be performed in a
Sponsor: Balgrist University Hospital

Current Primary Outcome: Reoperation rate [ Time Frame: 6 weeks ]

The primary endpoint of this study is the difference in reoperation rate between the two study groups to further investigate if either one or the other postoperative mobilisation regimen provides a significant benefit in terms of persistent dural leakage.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Balgrist University Hospital

Dates:
Date Received: October 6, 2016
Date Started: October 2015
Date Completion: May 2017
Last Updated: October 6, 2016
Last Verified: June 2016