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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Procedure: uretero ileal anastomosis in single trough


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: the new technique was observed in a group of patients for effectiveness and complications.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single trough<br> | Procedure: uretero ileal anastomosis in single trough<br> <br> * Other names: combining wallace and subserous tunnel in uretero ileal anastomosis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of vesicoureteral reflux (VUR) | the incidence of occurrence of reflux in the patients was assessed | after 6 months and after one year | 
| the incidence of anastomotic stricture | the incidence of occurrence of uretero ileal stricture in the patients was recorded | after 6 months and after one year | 
| the post operative changes in the mean serum creatinine level | the change in mean serum creatinine level of the patients was assessed | after 6 months and after one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of pyelonephritis |  | after 6 months and after one year | 
| the incidence of urinary incontinence |  | after 6 months and after one year | 
| the mean operative time of urinary diversion | the time elapsing from bowel selection till the beginning of wound closure | at the time of the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder Cancer, Orthotopic diversion, Wallace, sub-serous extramural tunnel.