Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04794166 |
| Other study ID # |
dura010321 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
December 1, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Rigshospitalet, Denmark |
| Contact |
Anette Bo Hansen, Rn, MSN stud |
| Phone |
+45 22580306 |
| Email |
anette.maria.hansen[@]regionh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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
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.
