NCT04539743

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitrofanoff Continent Cystostomy
• Cystostomy; Complications

Timeline

• Start date: 2020-10-15
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2020-09-07
• Last updated: 2020-12-04

Locations

1 site across 1 country: France