Cerebrospinal Fluid LeakNCT02927782
Mobilisation Algorithm After Incidental Durotomy
A study testing Early Mobilization and Bed Rest in people with Cerebrospinal Fluid Leak, run by Balgrist University Hospital at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cerebrospinal Fluid Leak
- What is being tested?
- Early Mobilization and Bed Rest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Balgrist
Zurich, 8008
Mazda Farshad, MD MPH, +413861274, mazda.farshad@balgrist.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebrospinal Fluid Leak
- Being tested
- Early Mobilization, Bed Rest
- Keywords
- Cerebrospinal Fluid Leak, Lumbar
- Medical subject headings
- Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early MobilizationProcedure or surgery
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 RestProcedure or surgery
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°.
| Study group | Role | What they receive |
|---|---|---|
| Bed Rest | Active comparator | 48 hours of strict bed rest after incidental durotomy during lumbar spinal surgery Receives: Procedure: Bed Rest |
| Early Mobilization | Experimental | Immediate Mobilization after incidental durotomy during lumbar spinal surgery Receives: Procedure: Early Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startOct 2015
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal Fluid LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mazda Farshad, Balgrist University Hospital
- Investigators
- Mazda Farshad, MD MPH, Principal investigator, University Hospital Balgrist Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927782
- Sponsor's protocol ID
- W569
- Status last verified
- Jun 2016
- First submitted
- 6 Oct 2016
- Last updated
- 7 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flat Bed Rest vs. Immediate Mobilisation After Incidental Durotomy During Lumbar Spinal Surgery: A Prospective Randomised Trial
- ClinicalTrials.gov ID
- NCT02927782
- Acronym / sponsor ID
- W569
- Conditions
- Cerebrospinal Fluid Leak
- Keywords
- Cerebrospinal Fluid Leak, Lumbar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 7 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bed Rest | Active comparator | Procedure: Bed Rest48 hours of strict bed rest after incidental durotomy during lumbar spinal surgery |
| Early Mobilization | Experimental | Procedure: Early MobilizationImmediate Mobilization after incidental durotomy during lumbar spinal surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Mobilizationearly 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. | Procedure or surgery | Early Mobilization |
| Bed Rest48 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°. | Procedure or surgery | Bed Rest |
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Cerebrospinal Fluid Leak
Not yet recruiting
A Prospective, Randomized, Two-Arm, Controlled, Single-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of ArtiFix® Dural Repair Sealant Graft in Cranial and Spine Surgery (NEOFIX Study)
CerebroSpinal Fluid (CSF) Leak, Dural Tear
Recruiting
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
Skull Base Neoplasms, Cerebrospinal Fluid Leakage
RecruitingObservational study
Immiseal™ Dural Sealant Post-Market Registry Study
Dural Defect, Cerebrospinal Fluid Leak
Recruiting
Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele
CSF Leak, CSF Pressure Increased
Recruiting
Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
CSF Leak
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mazda Farshad, MD MPH principal investigator
University Hospital Balgrist Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Mobilization and Bed Rest in people with Cerebrospinal Fluid Leak, run by Balgrist University Hospital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mazda Farshad, MD MPH (+413861274, mazda.farshad@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.