Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 2:13 PM
Study NCT ID:
NCT04794166
Status:
UNKNOWN
Last Update Posted:
2022-05-11
First Post:
2021-03-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Symptom Prevalence and Severity in Lumbar Spine Surgery With and Without Dura Rupture
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: