Clinical trial NCT04922437: Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ?
Official title: Site of Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ? Comparison in 106 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurogenic Bladder
Continent Cutaneous Urinary Diversion
Mitrofanoff
Keywords: native bladder
enterocystoplasty
continent catheterizable channel
neurogenic bladder
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult and pediatric population recruited in the pediatric surgery and urology departments of Nancy University Hospital. Patients with congenital or acquired neurological bladder or malformative uropathies.

Surgery performed between 1991 and 2020, followed in the long term in iterative consultation or in hospitalization for evaluation of continence and postoperative complications with or without surgical revision

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the long term continence between the two groups
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Pierre Lecoanet
Study officials:
affiliation: CHRU Nancy
name: Pierre Lecoanet
role: PRINCIPAL_INVESTIGATOR
References: