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Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients (ELESDUCCBM)

27 de septiembre de 2022 actualizado por: Centre Hospitalier Universitaire de Nīmes

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Anticipado)

70

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Francia
    • Gard
      • Nîmes, Gard, Francia, 30029
        • Reclutamiento
        • Nîmes University Hospital
        • Contacto:
          • HILAL AL RASHDI, Dr.
          • Número de teléfono: +33 4.66.68.32.30
          • Correo electrónico: hah24212@hotmail.com
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

17 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

N/A

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

All patients who have suffered a spinal cord injury, operated on between April 2004 and October 2017 at Nîmes University Hospital.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Retrospectivo

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Otro: Data collection
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.
Otro: Interview using a validated questionnaire
A telephone survey will be conducted by means of a questionnaire in order to evaluate the patient's quality of life.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Efficacy of continent cutaneous urinary derivation: catheterisation.
Periodo de tiempo: 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.
3 -16 years after their operation
Efficacy of continent cutaneous urinary derivation:leakage
Periodo de tiempo: 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.
3 -16 years after their operation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Surgical complications and impact on the patient's quality of life: Age at start of care
Periodo de tiempo: 3 -16 years after their operation
The patient's age will be noted at the start of care
3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Sex
Periodo de tiempo: 3 -16 years after their operation
The patient's sex will be noted at the start of care
3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: Body Mass Index
Periodo de tiempo: 3 -16 years after their operation
The patient's Body Mass Index will be noted at the start of care
3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: ASA score
Periodo de tiempo: 3 -16 years after their operation

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
Surgical complications and impact on the patient's quality of life: ASIA score
Periodo de tiempo: 3 -16 years after their operation

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
Surgical complications and impact on the patient's quality of life: Bladder dysfunction
Periodo de tiempo: 3 -16 years after their operation
The type of bladder dysfunction will be evaluated by urodynamic evaluation
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.
Periodo de tiempo: 3 -16 years after their operation
Urinary tract anomalies will be evaluated via a morphological examination (using ultrasound and / or tomodensitometry).
3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: cytometry
Periodo de tiempo: 3 -16 years after their operation
Urinary tract anomalies will be evaluated via cytometry
3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: creatinine clearance
Periodo de tiempo: 3 -16 years after their operation
Urinary tract anomalies will be evaluated according to the patient's creatinine clearance
3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: operative indications
Periodo de tiempo: 3 -16 years after their operation
The indications for the initial surgery will be recorded.
3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: mictional mode
Periodo de tiempo: 3 -16 years after their operation
The patient's initial mictional mode will be recorded.
3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: surgical set-up
Periodo de tiempo: 3 -16 years after their operation
The patient's surgical set-up will be recorded.
3 -16 years after their operation
Surgical complications and impact on the patient's quality of life: immediate or later complications
Periodo de tiempo: 3 -16 years after their operation
All immediate or later complications will be recorded.
3 -16 years after their operation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Centre Hospitalier Universitaire de Nīmes

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de agosto de 2020

Finalización primaria (Anticipado)

1 de enero de 2023

Finalización del estudio (Anticipado)

1 de junio de 2023

Fechas de registro del estudio

Enviado por primera vez

18 de junio de 2021

Primero enviado que cumplió con los criterios de control de calidad

18 de junio de 2021

Publicado por primera vez (Actual)

23 de junio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de septiembre de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

27 de septiembre de 2022

Última verificación

1 de septiembre de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Local 2019/SD-01

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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