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Modified Step by Step Mitrofanoff Continent Cystostomy : Functional Results of a Teachable Procedure

Modified Step by Step Mitrofanoff Continent Cystostomy : Functional Results of a Teachable Procedure

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04539743
Acronym
MCCR
Enrollment
70
Registered
2020-09-07
Start date
2020-10-15
Completion date
2021-02-28
Last updated
2020-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystostomy; Complications, Mitrofanoff Continent Cystostomy

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?

Detailed description

This research consists in highlighting that the Mitrofanoff surgery technique used by the CHUGA surgeons during a cystostomy is easier to perform while having the necessary same results as the other methods. To do this, we must validate the quality of this method and therefore we will evaluate the results expected from a continuous cystostomy via a questionnaire. After a first telephone contact by Dr BOILLOT for a presentation of the study, patient will therefore be contacted by telephone by the Clinical Research Associate of the service. During this interview patient will be asked to answer a questionnaire consisting of five questions.

Interventions

None listed

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adult who has undergone a Mitrofanoff cystostomy by Dr. BOILLOT

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
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 catheterize1 monthAverage of the Scores obtained on the questionnaires carried out

Countries

France

Contacts

Primary ContactBernard BOILLOT
BBoillot@chu-grenoble.fr+33 (0)4 76 76 59 19
Backup ContactAsilah BOUZIT
Abouzit@chu-grenoble.fr+33 (0)4 76 76 79 71

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026