Efficacy and Safety of a Continent Cutaneous Urinary Diversion in Spinal Cord Injury Patients
NCT ID: NCT04936217
Last Updated: 2022-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
70 participants
OBSERVATIONAL
2020-08-01
2023-06-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* a follow-up \> 24 months,
* a continent cutaneous urinary diversion for a spinal cord injury.
* Patient affiliated to or beneficiary of a health insurance scheme.
* Adult patient (≥18 years of age) and under 85 years of age.
Exclusion Criteria
* 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
17 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Locations
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Nîmes University Hospital
Nîmes, Gard, France
Countries
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Facility Contacts
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Other Identifiers
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Local 2019/SD-01
Identifier Type: -
Identifier Source: org_study_id
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