The Utility of Shanfield Implantation Technique During Creation of Mitrofanoff Procedure in Pediatric Age Group

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Management of bladder dysfunction was revolutionized by the introduction of intermittent catheterization by Lapides. Later, Mitrofanoff described a trans-appendicular continent cystostomy, launching a new concept whereby the bladder could be emptied by a route other than the urethra.

Clean intermittent catheterization (CIC) is one of the main tools for neurogenic lower urinary tract dysfunction management, as it provides adequate bladder emptying and protects the upper urinary tract from high pressures, hence preventing progressive renal damage.

Despite its important role, CIC is difficult to perform in various situations: lack of manual dexterity, female wheelchair patients, body habitus, anatomical morbidity due to extensive surgery or psychological problems. For such patients, continent urinary diversion (CUD) is a viable option for bladder emptying optimization.

Various techniques have been described to create an anti-reflux appendicovesical anastomosis in pediatric lower urinary tract reconstruction, whether performed via an extravesical or an intravesical route, all share a common denominator of creating a submucosal tunnel in an attempt to replicate the physiological anti-reflux mechanism.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of a Diurnal Indwelling Urethral Catheter to Improve Quality of Life

NCT03573726

Spina Bifida Neurogenic Bladder

COMPLETED NA

The Outcome of Pre-transplant Bladder Cycling in Patients With Defunctionalized Bladder

NCT06787092

Bladder Cycling, Defunctionalized Bladder

COMPLETED NA

Bladder Neck Surgery in Children with Neurogenic Bladder

NCT06734390

Incontinence Bladder Dysfunction Spina Bifida +2 more

COMPLETED

Pelvic Osteotomy in Bladder Exstrophy

NCT06717386

Bladder Exstrophy

NOT_YET_RECRUITING NA

Urinary Artificial Sphincter in Children

NCT06734429

Neurogenic Bladder Disorder Bladder Dysfunction Spina Bifida +2 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cases

Group Type EXPERIMENTAL

Shanfield implantation technique in Mitroffanof procedure

Intervention Type PROCEDURE

a stab incision of the bladder wall 1-2 cm above the trigone is deepened down to the mucosa without penetrating it. The prolapsed mucosa is grasped through this window and incised. The spatulated appendix-Mitrofanoff is advanced through the window to the interior of the bladder and its lower lip is anchored to the trigone 1-2 cm distal to the stab wound with an appropriate size (4/0-6/0) vicryle suture using a U-stich. The stitch passes initially through the bladder wall to its interior, looping full thickness through posterior lip of the appendix, then back through the full thickness of the bladder wall to be knotted outside. Supplementary stitches are added externally between the adventitia of the conduit and the detrusor to stabilise the tube-bladder intersection. The detrusorotomy is closed over loosely forming a short subdetrusor tunnel. This technique will be done by open lower midline incision or by laparoscopy using 3 or 4-port access.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Shanfield implantation technique in Mitroffanof procedure

a stab incision of the bladder wall 1-2 cm above the trigone is deepened down to the mucosa without penetrating it. The prolapsed mucosa is grasped through this window and incised. The spatulated appendix-Mitrofanoff is advanced through the window to the interior of the bladder and its lower lip is anchored to the trigone 1-2 cm distal to the stab wound with an appropriate size (4/0-6/0) vicryle suture using a U-stich. The stitch passes initially through the bladder wall to its interior, looping full thickness through posterior lip of the appendix, then back through the full thickness of the bladder wall to be knotted outside. Supplementary stitches are added externally between the adventitia of the conduit and the detrusor to stabilise the tube-bladder intersection. The detrusorotomy is closed over loosely forming a short subdetrusor tunnel. This technique will be done by open lower midline incision or by laparoscopy using 3 or 4-port access.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* children with neurogenic bladder dysfunction, as an alternative route for catheterization for those who are unable or unwilling to utilize the native route being sensate urethra.
* in cases where bladder neck closure or reconstruction is necessary to achieve continence.
* Patients with urethral valves, prune belly syndrome and bladder exstrophy, performed either as an isolated procedure enabling patients to perform clean intermittent catheterization (CIC) or in relation with concomitant bladder augmentation