Mobilisation Algorithm After Incidental Durotomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Cerebrospinal Fluid Leak
• Intervention / Treatment: Procedure: Bed Rest; Procedure: Early Mobilization

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mazda Farshad, MD MPH; Phone Number: +413861274; Email: mazda.farshad@balgrist.ch
• Study Contact Backup: Name: David Bauer, MD; Phone Number: +413865759; Email: david.bauer@balgrist.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Recruiting
    • University Hospital Balgrist
    • Contact: Mazda Farshad, MD MPH; Phone Number: +413861274; Email: mazda.farshad@balgrist.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bed Rest; 48 hours of strict bed rest after incidental durotomy during lumbar spinal surgery	Procedure: 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°.
Experimental: Early Mobilization; Immediate Mobilization after incidental durotomy during lumbar spinal surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Balgrist University Hospital
• Investigators: Principal Investigator: Mazda Farshad, MD MPH, University Hospital Balgrist Zurich

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (Estimate): October 7, 2016

Study Record Updates

• Last Update Posted (Estimate): October 7, 2016
• Last Update Submitted That Met QC Criteria: October 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Lumbar; Cerebrospinal Fluid Leak
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cerebrospinal Fluid Leak
• Other Study ID Numbers: W569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No