Dural TearNCT04794166
Symptom Prevalence and Severity in Lumbar Spine Surgery With and Without Dura Rupture
An observational study of Dural Tear and Bedrest, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The primary purpose of this study is to assess whether lumbar spine surgery patients with dura rupture differ in symptom prevalence and severity from other lumbar spine surgery patients in the early postoperative phase. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dural Tear, Bedrest, Lumbar Spine Surgery
- How many people
- 175 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 1 Dec 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing lumbar surgery with and without peroperative accidential dural lesion
Who may be able to join
- Lumbar surgery patients age >18 years
- -
Who cannot join
- Trauma surgery Cancer surgery lumbar fusion surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet, Glostrup
Glostrup Municipality, 2600
Anette Bo Hansen, Rn, MSN stud, +45 22580306, anette.maria.hansen@regionh.dk
About this study
Official title: Do Lumbar Spine Surgery Patients With Dura Rupture Differ in Symptom Prevalence and Severity From Other Lumbar Spine Surgery Patients in the Early Postoperative Phase
The primary purpose of this study is to assess whether lumbar spine surgery patients with dura rupture differ in symptom prevalence and severity from other lumbar spine surgery patients in the early postoperative phase. This is in order to develop a symptom-specific mobilization algorithm (DURAMOB) that can be used to assess whether patients with dura rupture safe can be mobilized earlier after lumbar back surgery to prevent bed rest complications
Read the detailed description
Accidental dura rupture is a complication of lumbar spine surgery, with an incidence of 2-18% which can cause cerebrospinal fluid leakage leading to symptoms such as postural headache, photosensitivity, tinnitus, infection, and pseudomeningocele. Traditionally, the condition is treated with postoperatively flat bed rest ranging from 0-72 hours, entailing an increased risk of complications due to bed rest. There is inconsistency in the length of prescribed flat bed rest for these patients, and no consensus exists nationally or internationally. The prescription of flat bed rest is generally made by the surgeons based on their clinical experience.
This quality development project in the clinimetric field aims to develop an assessment tool (Duramob) of perioperative symptoms prevalence and severity in lumbar spine surgery patients with and without dura rupture in the early postoperative phase.
Data is based on clinical auditing comprising a consecutive samples of patients in collaboration with " Center for Rheumatology and Spine Diseases", Rigshospitalet-Glostrup, Denmark.
The Duramob instrument will be developed as an evidence-based algorithm for assessing the potential need for postoperatively restrictive bedrest after dura rupture, - and subsequently to be implemented in clinical perioperative practice. Further scientific testing will following be carried out in a feasibility study and / or as a Randomized Controlled Trial.
This initial study will generate observational evidence investigating the first steps towards establishing a safe mobilisation regime for patients with surgical dura rupture. Ultimately, we seek to avoid unnecessary bedrest and complications derived from perioperative immobilization. Data will be protected in a local clinical database RedCap hosted by the Capital Region Data Management system and follows GDPR regulations. The department leadership approved the project and the local ethical Committee' waived the need for approval.
- Conditions
- Dural Tear, Bedrest, Lumbar Spine Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Dura rupture symptom severity
To asses whether symptoms or compound of symptoms differ in patients with or without dura rupture in stand up up position 6 and 24 hours after lumbar surgery
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dural TearStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anette Maria Borgund Hansen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794166
- Sponsor's protocol ID
- dura010321
- Status last verified
- May 2022
- First submitted
- 9 Mar 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Lumbar Spine Surgery Patients With Dura Rupture Differ in Symptom Prevalence and Severity From Other Lumbar Spine Surgery Patients in the Early Postoperative Phase
- ClinicalTrials.gov ID
- NCT04794166
- Acronym / sponsor ID
- dura010321
- Conditions
- Dural Tear, Bedrest, Lumbar Spine Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 11 Mar 2021 (actual)
- 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.
The primary purpose of this study is to assess whether lumbar spine surgery patients with dura rupture differ in symptom prevalence and severity from other lumbar spine surgery patients in the early postoperative phase. This is in order to develop a symptom-specific mobilization algorithm (DURAMOB) that can be used to assess whether patients with dura rupture safe can be mobilized earlier after lumbar back surgery to prevent bed rest complications
Detailed description
Accidental dura rupture is a complication of lumbar spine surgery, with an incidence of 2-18% which can cause cerebrospinal fluid leakage leading to symptoms such as postural headache, photosensitivity, tinnitus, infection, and pseudomeningocele. Traditionally, the condition is treated with postoperatively flat bed rest ranging from 0-72 hours, entailing an increased risk of complications due to bed rest. There is inconsistency in the length of prescribed flat bed rest for these patients, and no consensus exists nationally or internationally. The prescription of flat bed rest is generally made by the surgeons based on their clinical experience.
This quality development project in the clinimetric field aims to develop an assessment tool (Duramob) of perioperative symptoms prevalence and severity in lumbar spine surgery patients with and without dura rupture in the early postoperative phase.
Data is based on clinical auditing comprising a consecutive samples of patients in collaboration with " Center for Rheumatology and Spine Diseases", Rigshospitalet-Glostrup, Denmark.
The Duramob instrument will be developed as an evidence-based algorithm for assessing the potential need for postoperatively restrictive bedrest after dura rupture, - and subsequently to be implemented in clinical perioperative practice. Further scientific testing will following be carried out in a feasibility study and / or as a Randomized Controlled Trial.
This initial study will generate observational evidence investigating the first steps towards establishing a safe mobilisation regime for patients with surgical dura rupture. Ultimately, we seek to avoid unnecessary bedrest and complications derived from perioperative immobilization. Data will be protected in a local clinical database RedCap hosted by the Capital Region Data Management system and follows GDPR regulations. The department leadership approved the project and the local ethical Committee' waived the need for approval.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing lumbar surgery with and without peroperative accidential dural lesion
Key inclusion criteria (2 listed)
- Lumbar surgery patients age >18 years
- -
Key exclusion criteria (1 listed)
- Trauma surgery Cancer surgery lumbar fusion surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dura rupture symptom severity
Time frame: 9 month
To asses whether symptoms or compound of symptoms differ in patients with or without dura rupture in stand up up position 6 and 24 hours after lumbar surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
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CerebroSpinal Fluid (CSF) Leak, Dural Tear
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dural Tear and Bedrest, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 2 inclusion and 1 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 11 May 2022. 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 Denmark. 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 Anette Bo Hansen, Rn, MSN stud (+45 22580306, anette.maria.hansen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dura rupture symptom severity (time frame: 9 month). 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 11 May 2022.