Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ?

NCT ID: NCT04922437

Last Updated: 2021-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-06-30

Brief Summary

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PURPOSE. To compare the results between two sites of implantation of the continent catheterizable channel (CCC): native bladder or enterocystoplasty.

METHODS. Retrospective monocentric study of pediatrics and adult patients who underwent a continent cystostomy between 1991 and 2020 with a continent catheterizable channel implanted in the native bladder's detrusor (D group) or the enterocystoplasty (EC group).

Detailed Description

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This is a monocentric and retrospective study involving adult and pediatric population who underwent the creation of a CCC between June 1991 and January 2020. Two different surgical techniques were performed: on the first hand, the implantation of the channel in the native bladder's detrusor (D group), on the other hand the implantation of the channel by seromuscular plicature on the anterior wall of the enterocystoplasty (EC group).

The CCC were made from the appendix, an ileal or sigmoid segment, an ureter or a skin flap. Bladder augmentation and cervicoplasty (Kropp, Kurzrock, Young-Dees, artificial urinary sphincter, sling suspension of the bladder neck, closure of the bladder neck) were frequently associated.

The following informations were obtained in all included patients by charts reviews: age at surgery, gender, main underlying pathology, details of operative reports with the type of channel, bladder augmentation and/or associated cervicoplasty, early postoperative complications, complications appearing during the follow up period and the requirement of surgical or non-surgical revision, finally the channel continence at the last follow up.

Conditions

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Neurogenic Bladder Continent Cutaneous Urinary Diversion Mitrofanoff

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Enterocystoplasty (EC)

Patients who had an implantation of the catheterizable continent channel by seromuscular plicature on the anterior wall of the bladder augmentation.

Enterocystoplasty implantation

Intervention Type PROCEDURE

Continent catheterizable channel implanted by seromuscular plicature on the front wall of the bladder augmentation

Detrusor (D)

Patients who had an implantation of the catheterizable continent channel in the detruosr of their native bladder (Lich-Gregoir or Cohen).

Native bladder implantation

Intervention Type PROCEDURE

Continent catheterizable channel implanted in the detrusor of the native bladder

Interventions

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Native bladder implantation

Continent catheterizable channel implanted in the detrusor of the native bladder

Intervention Type PROCEDURE

Enterocystoplasty implantation

Continent catheterizable channel implanted by seromuscular plicature on the front wall of the bladder augmentation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult and pediatric patients who underwent a surgery for creation of a continent catheterizable channel
* Between 1991 and 2020
* In the pediatric surgery or urology department at Nancy University Hospital

Exclusion Criteria

* Ghoneim technique used for implantation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Pierre LECOANET

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre Lecoanet

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

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Pierre Lecoanet

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2020PI311

Identifier Type: -

Identifier Source: org_study_id

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