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

NCT04162093 | Completed DMC

• 1 other identifier: new uretero-ileal anastomosis
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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

Conditions

Bladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

  at the time of the operation

Study Arms (1)

single trough

EXPERIMENTAL

Procedure: uretero ileal anastomosis in single trough

Interventions

uretero ileal anastomosis in single trough PROCEDURE

Also known as: combining wallace and subserous tunnel in uretero ileal anastomosis

single trough

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (7)

• 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.

  PMID: 27547459 BACKGROUND

• 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.

  PMID: 23499206 BACKGROUND

• 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.

  PMID: 17085172 BACKGROUND

• 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.

  PMID: 22004164 BACKGROUND

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

  PMID: 25657535 BACKGROUND

• 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.

  PMID: 17470158 BACKGROUND

• 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.

  PMID: 22235380 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of urology

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

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 14, 2019
• Study Start: February 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: September 1, 2018
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: after publication
• Access Criteria: by the mail of central contact person