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Trials / Recruiting

RecruitingNCT06472193

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
10 (estimated)
Sponsor
Sohag University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREShanfield implantation technique in Mitroffanof procedurea 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.

Timeline

Start date
2024-02-01
Primary completion
2025-08-01
Completion
2025-08-01
First posted
2024-06-25
Last updated
2024-06-26

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06472193. Inclusion in this directory is not an endorsement.