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临床试验/NCT04794166
NCT04794166Unknown不适用

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

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
175
试验地点
1
主要终点
Dura rupture symptom severity

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lumbar surgery patients age >18 years

排除标准

  • Trauma surgery Cancer surgery lumbar fusion surgery

结局指标

主要结局

Dura rupture symptom severity

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anette Maria Borgund Hansen

RN, Cand Scient San stud

Rigshospitalet, Denmark

研究点 (1)

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