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

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Unknown

Conditions

Cystostomy; Complications
Mitrofanoff Continent Cystostomy

Study type

Observational

Funder types

Other

Identifiers

NCT04539743
38RC20.193
2020-A0156534 (Other Identifier)

Details and patient eligibility

About

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?

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Bernard BOILLOT; Asilah BOUZIT

Data sourced from clinicaltrials.gov

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