Clinical trial NCT06472193: The Utility of Shanfield Implantation Technique During Creation of Mitrofanoff Procedure in Pediatric Age Group
Official title: The Utility of Shanfield Implantation Technique During Creation of Mitrofanoff Procedure in Pediatric Age Group
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Dysfunction
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 10
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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Primary outcomes:
measure: antireflux competence of stomal end of the Mitrofanoff conduit
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Paludo AO, Castro LFC, Gorgen ARH, Schwengber VHV, Dos Santos EB, Tavares P, Rosito TE, Corbetta JP. Garrahan U-Stitch laparoscopic appendicovesicostomy - Making surgery easier. J Pediatr Urol. 2020 Oct;16(5):719-720. doi: 10.1016/j.jpurol.2020.07.046. Epub 2020 Aug 10.
citation: Gander R, Asensio M, Royo GF, Lopez M. Pediatric laparoscopic mitrofanoff procedure- preliminary results of a simplified technique. J Pediatr Urol. 2022 Apr;18(2):112.e1-112.e7. doi: 10.1016/j.jpurol.2021.12.018. Epub 2022 Jan 7.
citation: Gundeti MS, Petravick ME, Pariser JJ, Pearce SM, Anderson BB, Grimsby GM, Akhavan A, Dangle PP, Shukla AR, Lendvay TS, Cannon GM Jr, Gargollo PC. A multi-institutional study of perioperative and functional outcomes for pediatric robotic-assisted laparoscopic Mitrofanoff appendicovesicostomy. J Pediatr Urol. 2016 Dec;12(6):386.e1-386.e5. doi: 10.1016/j.jpurol.2016.05.031. Epub 2016 Jun 15.
citation: Shanfield I. New experimental methods for implantation of the ureter in bladder and conduit. Transplant Proc. 1972 Dec;4(4):637-8. No abstract available.