Long-term Evaluation of the Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Efficacy of continent cutaneous urinary derivation:leakage
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Data collection (Other)
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.
干预措施: Interview using a validated questionnaire (Other)
结局指标
主要结局
Efficacy of continent cutaneous urinary derivation:leakage
时间窗: 3 -16 years after their operation
Absence of leakage through the cystostomy in spinal injured patients equipped with a continent cutaneous urinary derivation will be recorded.
Efficacy of continent cutaneous urinary derivation: catheterisation.
时间窗: 3 -16 years after their operation
The minimum frequency of urinary catheterisation in spinal injured patients equipped with a continent cutaneous urinary derivation will be recorded.
次要结局
- Surgical complications and impact on the patient's quality of life: Body Mass Index(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: cytometry(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: Sex(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: urinary tract anomalies evaluated via a morphological examination.(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: ASA score(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: ASIA score(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: creatinine clearance(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: Age at start of care(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: surgical set-up(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: immediate or later complications(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: Bladder dysfunction(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: operative indications(3 -16 years after their operation)
- Surgical complications and impact on the patient's quality of life: mictional mode(3 -16 years after their operation)