An observational study in Dural Tear, Bedrest and Lumbar Spine Surgery, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-11.
Sponsored by Rigshospitalet, Denmark · Observational
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
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.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's planned enrollment of 175 is above the median of 100 across 203 observational studies indexed under Rupture.
Browse Rupture studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing lumbar surgery with and without peroperative accidential dural lesion
Lumbar surgery patients age >18 years
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Exclusion Criteria:
Trauma surgery Cancer surgery lumbar fusion surgery
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
Time frame: 9 month
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark