Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID06472193

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

Led by Sohag University · Updated on 2024-06-26

10

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on children with neurogenic bladder dysfunction who need an alternative way to empty their bladder because they cannot or do not want to use the natural urethral route. It explores the use of a surgical technique called the Shanfield implantation during the Mitrofanoff procedure, which aims to create a new route for catheterization. This procedure may also be used alongside bladder neck closure or reconstruction when necessary to help achieve continence. The Shanfield implantation technique involves making a small incision in the bladder wall to insert the appendix-Mitrofanoff conduit securely, creating a pathway for catheterization through the abdomen rather than the urethra. This is done either by open surgery or laparoscopically using 3 or 4 small incisions. The new connection is stabilized with special stitches to prevent reflux and maintain continence. The procedure supports patients who have undergone bladder reconstruction or have conditions such as urethral valves, prune belly syndrome, or bladder exstrophy. Participants will be monitored for 18 months after surgery to assess how well the new Mitrofanoff conduit prevents urine backflow. The study will evaluate the anti-reflux function of the stoma created by this technique. Throughout the study, doctors will check the surgical outcomes and bladder function to understand the benefits and challenges of this method. The trial does not involve medication but focuses on surgical outcomes and bladder management in pediatric patients.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with neurogenic bladder dysfunction who cannot or do not want to use the natural urethral route for catheterization
  • Cases requiring bladder neck closure or reconstruction to achieve continence
  • Patients with urethral valves, prune belly syndrome, or bladder exstrophy, either as an isolated procedure or with bladder augmentation
Not Eligible

You will not qualify if you...

  • Patients clinically unfit for surgery
  • Patients who have undergone a previous traditional Mitrofanoff procedure

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery

Duration - Single surgical procedure

Participants undergo the Shanfield implantation technique during the Mitrofanoff procedure to create a catheterizable channel using either open surgery or laparoscopy.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 18 months

Participants are monitored after surgery to assess recovery and the antireflux competence of the Mitrofanoff conduit.

Regular follow-up visits over 18 months

Trial Site Locations

Total: 1 location

1

Sohag university Hospital

Sohag, Egypt

Actively Recruiting

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Research Team

M

mahmoud s gad, assistant lecutrer

A

ahmed A Gafar, professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Garrahan U-Stitch laparoscopic appendicovesicostomy - Making surgery easier.

Artur de Oliveira Paludo, Luis Fernando de Cesaro Castro, Antônio Rebello Horta Gorgen...

https://pubmed.ncbi.nlm.nih.gov/32828684

A multi-institutional study of perioperative and functional outcomes for pediatric robotic-assisted laparoscopic Mitrofanoff appendicovesicostomy.

Mohan S Gundeti, Michael E Petravick, Joseph J Pariser...

https://pubmed.ncbi.nlm.nih.gov/27349147