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

November 13, 2019 updated by: Hossam Elawady, Ain Shams University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single trough
Procedure: uretero ileal anastomosis in single trough
Other Names:
  • combining wallace and subserous tunnel in uretero ileal anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 6 months and after one year
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
after 6 months and after one year
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
after 6 months and after one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of pyelonephritis
Time Frame: after 6 months and after one year
after 6 months and after one year
the incidence of urinary incontinence
Time Frame: after 6 months and after one year
after 6 months and after one year
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
at the time of the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • new uretero-ileal anastomosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

after publication

IPD Sharing Access Criteria

by the mail of central contact person

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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