Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ? (ICODE)

June 9, 2021 updated by: Pierre LECOANET, Central Hospital, Nancy, France

Site of Implantation of Continent Catheterizable Channel : Native Bladder or Enterocystoplasty ? Comparison in 106 Patients

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54500
        • Pierre Lecoanet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Enterocystoplasty (EC)
Patients who had an implantation of the catheterizable continent channel by seromuscular plicature on the anterior wall of the bladder augmentation.
Procedure: Enterocystoplasty implantation
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).
Procedure: Native bladder implantation
Continent catheterizable channel implanted in the detrusor of the native bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the long term continence between the two groups
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Pierre Lecoanet, CHRU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI311

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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