Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients (ELESDUCCBM)
Long-term Evaluation of the Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients
Continent Cutaneous Urinary Deviation (CUD), using the Mitrofanoff, Yang-Monti or Casale principle, is offered to patients with neurological diseases who are unable to perform intermittent catheterisation through the native urethra due to upper limb disability.
There is very little data in the literature examining the long-term efficacy and complications of this technique. The main objective of this study is to evaluate the effectiveness of long-term CUDs in spinal cord injury patients. The secondary objectives are to evaluate the surgical complications and the impact on the patient's quality of life.
For each patient, several data will be collected and analyzed: age at operation, sex, Body Mass Index (BMI), ASA score, ASIA score, type of bladder dysfunction assessed by urodynamic evaluation, urinary abnormalities assessed by morphological examination (ultrasound and / or computed tomography) and cystoscopy, creatinine clearance, operative indications, initial mictional mode, surgical assembly and any immediate or late complications. In a second stage, a questionnaire survey will be conducted by telephone.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Gard
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Nîmes、Gard、法国、30029
- 招聘中
- Nîmes University Hospital
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接触：
- HILAL AL RASHDI, Dr.
- 电话号码：+33 4.66.68.32.30
- 邮箱：hah24212@hotmail.com
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接触：
- STEPHANE DROUPY, Pr.
- 电话号码：+33 4.66.68.32.30
- 邮箱：stephane.DROUPY@chu-nimes.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Specific inclusion criteria for the study :
- no history of continuous cystostomy in another centre
- a follow-up > 24 months,
- a continent cutaneous urinary diversion for a spinal cord injury.
General inclusion criteria :
- Patient affiliated to or beneficiary of a health insurance scheme.
- Adult patient (≥18 years of age) and under 85 years of age.
Exclusion Criteria:
- Criteria for non-inclusion specific to the study :
- All urinary incontinence outside of medullary waiting period.
- A history of continuous cystostomy in another centre.
- A follow-up of less than 24 months,
- a continent cutaneous urinary diversion for a neurological pathology other than spinal cord injury.
General criteria for non-inclusion :
- Patient in a period of exclusion determined by another study.
- Patient for whom it is impossible to give enlightened information.
- Patient under legal protection, guardianship or curatorship.
- Patient unable to express consent
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：追溯
队列和干预
团体/队列 |
干预/治疗 |
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Patients operated for Continent Cutaneous Urinary Diversion, April 2004 - October 2017
The study focuses of a population of 70 patients operated between April 2004 and October 2017 au Nîmes University Hospital for Cutaneous Urinary Diversion.
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For each patient, the following data will be collected and analyzed: age at operation, sex, Body Mass Index (BMI), ASA score, ASIA score, type of bladder dysfunction assessed by urodynamic evaluation, urinary abnormalities assessed by morphological examination (ultrasound and / or computed tomography) and cystoscopy, creatinine clearance, operative indications, initial mictional mode, surgical assembly, immediate and later complications.
A telephone survey will be conducted by means of a questionnaire in order to evaluate the patient's quality of life.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Efficacy of continent cutaneous urinary derivation: catheterisation.
大体时间：3 -16 years after their operation
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The minimum frequency of urinary catheterisation in spinal injured patients equipped with a continent cutaneous urinary derivation will be recorded.
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3 -16 years after their operation
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Efficacy of continent cutaneous urinary derivation:leakage
大体时间：3 -16 years after their operation
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Absence of leakage through the cystostomy in spinal injured patients equipped with a continent cutaneous urinary derivation will be recorded.
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3 -16 years after their operation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Surgical complications and impact on the patient's quality of life: Age at start of care
大体时间：3 -16 years after their operation
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The patient's age will be noted at the start of care
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3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: Sex
大体时间：3 -16 years after their operation
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The patient's sex will be noted at the start of care
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3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: Body Mass Index
大体时间：3 -16 years after their operation
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The patient's Body Mass Index will be noted at the start of care
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3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: ASA score
大体时间：3 -16 years after their operation
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The ASA Physical Status Classification System is used to assess and communicate a patient's pre-anesthesia medical comorbidities. The classification system alone does not predict the perioperative risks, but used with other factors (eg, type of surgery, frailty, level of deconditioning) it can be helpful in predicting perioperative risks. ASA I = A normal healthy patient ASA II = A patient with mild systemic disease ASA III = A patient with severe systemic disease ASA IV = A patient with severe systemic disease that is a constant threat to life ASA V = A moribund patient who is not expected to survive without the operation ASA VI = A declared brain-dead patient whose organs are being removed for donor purposes |
3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: ASIA score
大体时间：3 -16 years after their operation
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The ASIA (American Spinal Injury Association) assessment is the gold standard for assessing and documenting sensory and motor impairments after Spinal Cord Injury. The score ranges from A to E as follows: A = Complete injury. No motor or sensory function is preserved in the sacral segments S4 or S5. B = Sensory incomplete. Sensory but not motor function is preserved below the level of injury, including the sacral segments. C = Motor incomplete. Motor function is preserved below the level of injury, and more than half of muscles tested below the level of injury have a muscle grade less than 3 (see muscle strength scores table). D = Motor incomplete. Motor function is preserved below the level of injury and at least half of the key muscles below the neurological level have a muscle grade of 3 or more. E = Normal. No motor or sensory deficits, but deficits existed in the past. This score will be used to evaluate the patient at the start of care. |
3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: Bladder dysfunction
大体时间：3 -16 years after their operation
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The type of bladder dysfunction will be evaluated by urodynamic evaluation
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3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: urinary tract anomalies evaluated via a morphological examination.
大体时间：3 -16 years after their operation
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Urinary tract anomalies will be evaluated via a morphological examination (using ultrasound and / or tomodensitometry).
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3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: cytometry
大体时间：3 -16 years after their operation
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Urinary tract anomalies will be evaluated via cytometry
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3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: creatinine clearance
大体时间：3 -16 years after their operation
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Urinary tract anomalies will be evaluated according to the patient's creatinine clearance
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3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: operative indications
大体时间：3 -16 years after their operation
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The indications for the initial surgery will be recorded.
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3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: mictional mode
大体时间：3 -16 years after their operation
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The patient's initial mictional mode will be recorded.
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3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: surgical set-up
大体时间：3 -16 years after their operation
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The patient's surgical set-up will be recorded.
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3 -16 years after their operation
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Surgical complications and impact on the patient's quality of life: immediate or later complications
大体时间：3 -16 years after their operation
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All immediate or later complications will be recorded.
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3 -16 years after their operation
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Data collection的临床试验
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Cliniques universitaires Saint-Luc- Université...Université de Liège招聘中
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Steno Diabetes Center CopenhagenUniversity of Southern Denmark; Steno Diabetes Center Sjaelland主动，不招人