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

NCT ID: NCT04162093

Last Updated: 2019-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-09-30

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.

Conditions

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Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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single trough

Group Type EXPERIMENTAL

uretero ileal anastomosis in single trough

Intervention Type PROCEDURE

Interventions

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uretero ileal anastomosis in single trough

Intervention Type PROCEDURE

Other Intervention Names

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combining wallace and subserous tunnel in uretero ileal anastomosis

Eligibility Criteria

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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.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Hossam Elawady

lecturer of urology

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Elawady H, Mahmoud MA, Mostafa DM, Abdelmaksoud A, Safa MW, Elia RZ. Computed tomography virtual cystoscopy for follow-up of patients with superficial bladder tumours in comparison to conventional cystoscopy: An exploratory study. Arab J Urol. 2016 Jul 25;14(3):192-7. doi: 10.1016/j.aju.2016.06.003. eCollection 2016 Sep.

Reference Type BACKGROUND
PMID: 27547459 (View on PubMed)

Fakhr I, Mohamed AM, Moustafa A, Al-Sherbiny M, Salama M. Neobladder long term follow-up. J Egypt Natl Canc Inst. 2013 Mar;25(1):43-9. doi: 10.1016/j.jnci.2013.01.001. Epub 2013 Feb 9.

Reference Type BACKGROUND
PMID: 23499206 (View on PubMed)

Taub DA, Dunn RL, Miller DC, Wei JT, Hollenbeck BK. Discharge practice patterns following cystectomy for bladder cancer: evidence for the shifting of the burden of care. J Urol. 2006 Dec;176(6 Pt 1):2612-7; discussion 2617-8. doi: 10.1016/j.juro.2006.07.150.

Reference Type BACKGROUND
PMID: 17085172 (View on PubMed)

Shigemura K, Yamanaka N, Imanishi O, Yamashita M. Wallace direct versus anti-reflux Le Duc ureteroileal anastomosis: comparative analysis in modified Studer orthotopic neobladder reconstruction. Int J Urol. 2012 Jan;19(1):49-53. doi: 10.1111/j.1442-2042.2011.02870.x. Epub 2011 Oct 17.

Reference Type BACKGROUND
PMID: 22004164 (View on PubMed)

Chang DT, Lawrentschuk N. Orthotopic neobladder reconstruction. Urol Ann. 2015 Jan-Mar;7(1):1-7. doi: 10.4103/0974-7796.148553.

Reference Type BACKGROUND
PMID: 25657535 (View on PubMed)

Hassan AA, Elgamal SA, Sabaa MA, Salem KA, Elmateet MS. Evaluation of direct versus non-refluxing technique and functional results in orthotopic Y-ileal neobladder after 12 years of follow up. Int J Urol. 2007 Apr;14(4):300-4. doi: 10.1111/j.1442-2042.2006.01716.x.

Reference Type BACKGROUND
PMID: 17470158 (View on PubMed)

Elfayoumy H, Abou-Elela A, Orban T, Emran A, Elghoneimy M, Morsy A. A novel antireflux technique for orthotopic ileal bladder substitutes-flat-segment technique: preliminary results. ISRN Urol. 2011;2011:431951. doi: 10.5402/2011/431951. Epub 2011 Sep 14.

Reference Type BACKGROUND
PMID: 22235380 (View on PubMed)

Other Identifiers

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new uretero-ileal anastomosis

Identifier Type: -

Identifier Source: org_study_id

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