Viewing Study NCT04922437



Ignite Creation Date: 2024-05-06 @ 4:15 PM
Last Modification Date: 2024-10-26 @ 2:06 PM
Study NCT ID: NCT04922437
Status: UNKNOWN
Last Update Posted: 2021-06-10
First Post: 2021-05-24

Brief Title: Implantation of Continent Catheterizable Channel Native Bladder or Enterocystoplasty
Sponsor: Central Hospital Nancy France
Organization: Central Hospital Nancy France

Study Overview

Official Title: Site of Implantation of Continent Catheterizable Channel Native Bladder or Enterocystoplasty Comparison in 106 Patients
Status: UNKNOWN
Status Verified Date: 2021-06
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ICODE
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 bladders 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 bladders 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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None