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Completed

NCT Number: NCT04162093

New Technique for Uretero-ileal Anastomosis for Patient With Bladder Cancer Who Are Suitable for Orthotopic Neobladder

there are many techniques for uretero-ileal anastomosis some of them are antirefluxing for protection of the upper urinary tract with many complications including strictures and pyelonephritis with difficult technical issues and long operation time so a modified technique combining the 2 ureter by wallace technique and implanted them in a single trough in the neobladder making the surgery easier and shorter.

this technique was done after informed consent in 45 patients with muscle invasive bladder cancer candidate for radical cystectomy and ileal neobladder diversion

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Key information

About this study

This was a prospective study conducted from 2014 to 2017 in Ain shams university, 73 patients were enrolled from outpatient clinic diagnosed with muscle invasive bladder cancer and candidate for radical cystectomy and orthotopic urinary diversion, 45 patients were included according to patient's acceptance and the inclusion and exclusion criteria.

After having a written informed consent, all selected patients were assessed by detailed history and physical examination, contrast enhanced pelvi-abdominal Computed tomography (CT) scan (for patients with serum creatinine <1.5 mg/dl). Laboratory investigations in the form of complete blood count, coagulation profile, electrolytes, renal and liver function tests. Bowel preparation was done to all patients one or two days before operation.

Cases were diverted using a U-shaped pouch with uretero-ileal anastomosis done in a single trough combining the extramural serous-lined tunnel and Wallace techniques.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria:

  • Patients with invasive bladder cancer (T2, T3).
  • good performance status
  • patients with serum creatinine ≤ 2 mg/dL
  • prostatic urethra free of tumor.
  • willing to adhere to the follow up regimen.

The exclusion criteria:

  • patients not fit for surgical intervention.
  • patients with renal or hepatic dysfunction.
  • male patients with positive urethral biopsy or diffuse CIS.
  • female patients with bladder neck or vaginal involvement.
  • concomitant pathological condition in the distal ureters necessitating the excision of a significant segment that hinders proper fashioning of uretero-ileal anastomosis.
  • Cases with markedly dilated ureters.

Treatment and study plan

uretero ileal anastomosis in single trough

Procedure

Other names: combining wallace and subserous tunnel in uretero ileal anastomosis

Primary outcomes

  1. the rate of vesicoureteral reflux (VUR)

    Time frame: after 6 months and after one year

    the incidence of occurrence of reflux in the patients was assessed

  2. the incidence of anastomotic stricture

    Time frame: after 6 months and after one year

    the incidence of occurrence of uretero ileal stricture in the patients was recorded

  3. the post operative changes in the mean serum creatinine level

    Time frame: after 6 months and after one year

    the change in mean serum creatinine level of the patients was assessed

Secondary outcomes

  1. the incidence of pyelonephritis

    Time frame: after 6 months and after one year

  2. the incidence of urinary incontinence

    Time frame: after 6 months and after one year

  3. the mean operative time of urinary diversion

    Time frame: at the time of the operation

    the time elapsing from bowel selection till the beginning of wound closure

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Preliminary Report Following A Modified Uretero-Ileal Anastomosis in An Ileal Neobladder Combining Wallace Technique With an Extramural Subserous Tunnel in a Single Trough: Our Initial Short-term Results

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Nov 14, 2019
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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