Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ?

• Conditions: Neurogenic Bladder; Continent Cutaneous Urinary Diversion; Mitrofanoff
• Interventions: Procedure: Enterocystoplasty implantation; Procedure: Native bladder implantation

• Registration Number: NCT04922437
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-01-01
• Study First Submitted: 2021-05-24
• Status Verified: 2021-06
• Study Completion: 2021-06
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Study First Posted: 2021-06-10
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enterocystoplasty (EC)	Enterocystoplasty implantation	Patients who had an implantation of the catheterizable continent channel by seromuscular plicature on the anterior wall of the bladder augmentation.
Detrusor (D)	Native bladder implantation	Patients who had an implantation of the catheterizable continent channel in the detruosr of their native bladder (Lich-Gregoir or Cohen).

Primary Outcome Measures

Name	Time	Method
Comparison of the long term continence between the two groups	1 year	Continence of the channel at last followup : as being strictly dry day and night between clean intermittent catheterizations (CIC). Patients requirring at leat one pad for leaking and also those with leaks wetting their clothes were considered incontinent as well as those whose interval between CIC was strictly less than 3 hours.

Trial Locations

Locations (1)

Pierre Lecoanet; 🇫🇷 Vandœuvre-lès-Nancy, France