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

Cystostomy; Complications Clinical Trial

— MCCR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04539743
• Other study ID #: 38RC20.193
• Secondary ID: 2020-A0156534
• Status: Recruiting
• Start date: October 15, 2020
• Est. completion date: February 2021

Study information

• Verified date: December 2020
• Source: University Hospital, Grenoble
• Contact: Bernard BOILLOT
• Phone: +33 (0)4 76 76 59 19
• Email: BBoillot[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystostomy; Complications
• Mitrofanoff Continent Cystostomy

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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