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

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.

Study Overview

• Status: Recruiting
• Conditions: Bladder Dysfunction
• Intervention / Treatment: Procedure: Shanfield implantation technique in Mitroffanof procedure

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mahmoud s gad, assistant lecutrer; Phone Number: 01010674328; Email: mahmoud_abdelraheem@med.sohag.edu.eg
• Study Contact Backup: Name: ahmed A Gafar, professor; Phone Number: 01005768450

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospital
    • Contact: Magdy M Amin, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: cases

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
antireflux competence of stomal end of the Mitrofanoff conduit	The percentage of patients with whom leakage of urine occured in between CICs	18 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: June 9, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-24-05-07MD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No