ClinicalTrials.gov
ClinicalTrials.gov Menu

Mobilisation Algorithm After Incidental Durotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02927782
Recruitment Status : Unknown
Verified June 2016 by Mazda Farshad, Balgrist University Hospital.
Recruitment status was:  Recruiting
First Posted : October 7, 2016
Last Update Posted : October 7, 2016
Sponsor:
Information provided by (Responsible Party):
Mazda Farshad, Balgrist University Hospital

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.


Condition or disease Intervention/treatment Phase
Cerebrospinal Fluid Leak Procedure: Early Mobilization Procedure: Bed Rest Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Flat Bed Rest vs. Immediate Mobilisation After Incidental Durotomy During Lumbar Spinal Surgery: A Prospective Randomised Trial
Study Start Date : October 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927782


Contacts
Contact: Mazda Farshad, MD MPH +413861274 mazda.farshad@balgrist.ch
Contact: David Bauer, MD +413865759 david.bauer@balgrist.ch

Locations
Switzerland
University Hospital Balgrist Recruiting
Zurich, Switzerland, 8008
Contact: Mazda Farshad, MD MPH    +413861274    mazda.farshad@balgrist.ch   
Sponsors and Collaborators
Balgrist University Hospital
Investigators
Principal Investigator: Mazda Farshad, MD MPH University Hospital Balgrist Zurich

Responsible Party: Mazda Farshad, MD MPH, Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT02927782     History of Changes
Other Study ID Numbers: W569
First Posted: October 7, 2016    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mazda Farshad, Balgrist University Hospital:
Cerebrospinal Fluid Leak
Lumbar

Additional relevant MeSH terms:
Cerebrospinal Fluid Leak
Cerebrospinal Fluid Rhinorrhea
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries