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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06472193
Enrollment
10
Registered
2024-06-25
Start date
2024-02-01
Completion date
2025-08-01
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Dysfunction

Brief summary

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.

Interventions

PROCEDUREShanfield 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.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Exclusion criteria

patients clinically unfit for surgery patients underwent previous traditional Mitroffanof procedure \-

Design outcomes

Primary

MeasureTime frameDescription
antireflux competence of stomal end of the Mitrofanoff conduit18 monthsThe percentage of patients with whom leakage of urine occured in between CICs

Countries

Egypt

Contacts

Primary Contactmahmoud s gad, assistant lecutrer
mahmoud_abdelraheem@med.sohag.edu.eg01010674328
Backup Contactahmed A Gafar, professor
01005768450

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026