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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorSohag University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Shanfield implantation technique in Mitroffanof procedure

    Procedure/Surgery

    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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: casesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

antireflux competence of stomal end of the Mitrofanoff conduit

The percentage of patients with whom leakage of urine occured in between CICs

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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