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

27 september 2022 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Verwacht)

70

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

17 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

NVT

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Retrospectief

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Efficacy of continent cutaneous urinary derivation: catheterisation.
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Surgical complications and impact on the patient's quality of life: Age at start of care
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 3 -16 years after their operation
All immediate or later complications will be recorded.
3 -16 years after their operation

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2020

Primaire voltooiing (Verwacht)

1 januari 2023

Studie voltooiing (Verwacht)

1 juni 2023

Studieregistratiedata

Eerst ingediend

18 juni 2021

Eerst ingediend dat voldeed aan de QC-criteria

18 juni 2021

Eerst geplaatst (Werkelijk)

23 juni 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2022

Laatste update ingediend die voldeed aan QC-criteria

27 september 2022

Laatst geverifieerd

1 september 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Local 2019/SD-01

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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