Modified Step by Step Mitrofanoff Continent Cystostomy : Functional Results of a Teachable Procedure
MCCR
2 other identifiers
observational
70
1 country
1
Brief Summary
The creation of an abdominal continental cystostomy orifice is an irreplaceable surgical technique that allows for the simple self-sounding of the bladder in patients with severe disabilities or malformations, and to obtain urinary continence. This operation, the principle of which was described by Paul Mitrofanoff in 1980, has benefited from countless descriptions, difficult realization and questionable design, so it is insufficiently proposed. Faced with this learning difficulty at the beginning of the year, we decided to define a "step-by-step" technique, in seven well-differentiated steps. This approach has simplified the teaching and dissemination of this technique. To validate its quality, it is necessary to evaluate the expected results of a continental cystostomy, by answering two simple questions:
- is the cystostomy opening really continent? Is the cystostomy tube easy to catheterize?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2020
CompletedFirst Posted
Study publicly available on registry
September 7, 2020
CompletedStudy Start
First participant enrolled
October 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedDecember 4, 2020
December 1, 2020
4 months
August 31, 2020
December 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate, in a series of identically operated patients, the expected results of a continuous cystostomy: -is the cystostomy hole really continental? -is the cystostomy tube easy to catheterize
Average of the Scores obtained on the questionnaires carried out
1 month
Eligibility Criteria
adult who has undergone a Mitrofanoff cystostomy by Dr. BOILLOT
You may qualify if:
- adult who has undergone a Mitrofanoff cystostomy by Dr. BOILLOT
You may not qualify if:
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant women, parturient women, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure)
- Patients operated on by other surgeons
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Grenoble Alpes
Grenoble, 38043, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2020
First Posted
September 7, 2020
Study Start
October 15, 2020
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
December 4, 2020
Record last verified: 2020-12