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

Primary Purpose

Bladder Cancer

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

uretero ileal anastomosis in single trough

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Bladder Cancer, Orthotopic diversion, Wallace, sub-serous extramural tunnel.

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single trough

Arm Description

Outcomes

Primary Outcome Measures

the rate of vesicoureteral reflux (VUR)

the incidence of occurrence of reflux in the patients was assessed

the incidence of anastomotic stricture

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

the post operative changes in the mean serum creatinine level

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

Secondary Outcome Measures

the incidence of pyelonephritis

the incidence of urinary incontinence

the mean operative time of urinary diversion

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

Full Information

NCT ID

NCT04162093

First Posted

November 11, 2019

Last Updated

November 13, 2019

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT04162093

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

February 2014 (Actual)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

Bladder Cancer, Orthotopic diversion, Wallace, sub-serous extramural tunnel.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

the new technique was observed in a group of patients for effectiveness and complications.

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single trough

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

uretero ileal anastomosis in single trough

Other Intervention Name(s)

combining wallace and subserous tunnel in uretero ileal anastomosis

Primary Outcome Measure Information:

Title

the rate of vesicoureteral reflux (VUR)

Description

the incidence of occurrence of reflux in the patients was assessed

Time Frame