Mobilisation Algorithm After Incidental Durotomy

Cerebrospinal Fluid Leak Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02927782
• Other study ID #: W569
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2016
• Last updated: October 6, 2016
• Start date: October 2015
• Est. completion date: May 2017

Study information

• Verified date: June 2016
• Source: Balgrist University Hospital
• Contact: Mazda Farshad, MD MPH
• Phone: +413861274
• Email: mazda.farshad[@]balgrist.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Description:

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 consecutive alternating manner. The according mobilisation regimen is going to be prescribed by the surgeon performing the index procedure immediately after wound closure as a standard option in the institutions proprietary hospital information system. Symptoms of persisting liquor leakage are going to be assessed by Investigator. Additional confirmation via MRI scan is routinely performed if persistent leakage is suspected and revision surgery is planned. For Patients with symptoms of persisting dural leakage after a 48 hours course of early mobilization a course of 24 hours of bed rest will be administered before revision surgery is scheduled.

Various case series, as well as large pro- and retrospective studies have been published describing incidence, intraoperative management as well as long- and short term outcome of ID. In addition, current literature provides retrospective evidence and small case series considering benefit and adverse events of prolonged bed rest after primarily recognised and repaired ID. To our knowledge this is the first prospective randomised trial to further investigate the impact of immediate mobilisation on the incidence of persistent cerebrospinal leakage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

All patients over the age of 18 years with an ID sustained during a primary or revision lumbar spinal procedure at our institution are the subject of this prospective, randomised analysis.

Exclusion Criteria:

Patients referred for repair of an externally sustained ID, cases in which durotomy was not primarily recognised and repaired as well as patient who refuse to sign informed consent are going to be excluded from this analysis. Informed consent is going to be obtained one day prior to index procedure.

Further Intervention because of Spondylitis/Spondylodiscitis, Tumor, Trauma. Pregnant patients

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak

Intervention

Procedure:
• Early Mobilization
early postoperative mobilisation (walking and sitting). Initial postoperative mobilisation is going to be under supervision of a qualified physiotherapist. The presence of a qualified physiotherapist at first mobilisation is solely for reasons of safety. No specific exercise or regimen is planned.
• Bed Rest
48 hours of strict bed rest followed by postoperative mobilisation under supervision of a qualified physiotherapist. During the bed rest period elevation of the head is tolerated to a maximum of 30°.

Locations

Country	Name	City	State
Switzerland	University Hospital Balgrist	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation rate	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.	6 weeks	No