Bladder CancerNCT04162093
New Technique for Uretero-ileal Anastomosis for Patient With Bladder Cancer Who Are Suitable for Orthotopic Neobladder
A study testing uretero ileal anastomosis in single trough in people with Bladder Cancer, run by Ain Shams University.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- uretero ileal anastomosis in single trough
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
About this study
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
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
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- uretero ileal anastomosis in single trough
- Keywords
- Bladder Cancer, Orthotopic diversion, Wallace, sub-serous extramural tunnel.
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uretero ileal anastomosis in single troughProcedure or surgery
Also called combining wallace and subserous tunnel in uretero ileal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| single trough | Experimental | Not described Receives: Procedure: uretero ileal anastomosis in single trough |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of vesicoureteral reflux (VUR)
the incidence of occurrence of reflux in the patients was assessed
Measured: 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
Measured: 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
Measured: after 6 months and after one year
Secondary outcomes (3)
the incidence of pyelonephritis
Measured: after 6 months and after one year
the incidence of urinary incontinence
Measured: 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
Measured: at the time of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study startFeb 2014
- Primary completionNov 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- the new technique was observed in a group of patients for effectiveness and complications.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Elawady, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162093
- Sponsor's protocol ID
- new uretero-ileal anastomosis
- Status last verified
- Nov 2019
- First submitted
- 11 Nov 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 27547459Fakhr 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.
PubMed 23499206Taub 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.
PubMed 17085172Shigemura 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.
PubMed 22004164Chang DT, Lawrentschuk N. Orthotopic neobladder reconstruction. Urol Ann. 2015 Jan-Mar;7(1):1-7. doi: 10.4103/0974-7796.148553.
PubMed 25657535Hassan 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.
PubMed 17470158Elfayoumy 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.
PubMed 22235380
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04162093
- Acronym / sponsor ID
- new uretero-ileal anastomosis
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Orthotopic diversion, Wallace, sub-serous extramural tunnel.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- the new technique was observed in a group of patients for effectiveness and complications.
| Arm | Type | Receives |
|---|---|---|
| single trough | Experimental | Procedure: uretero ileal anastomosis in single trough |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uretero ileal anastomosis in single troughAlso: combining wallace and subserous tunnel in uretero ileal anastomosis | Procedure or surgery | single trough |
Primary outcome
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
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
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
3 secondary outcomes
the incidence of pyelonephritis
Time frame: after 6 months and after one year
the incidence of urinary incontinence
Time frame: after 6 months and after one year
the mean operative time of urinary diversion
Time frame: at the time of the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Background: PubMed 27547459Elawady 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.
- Background: PubMed 23499206Fakhr 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.
- Background: PubMed 17085172Taub 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.
- Background: PubMed 22004164Shigemura 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.
- Background: PubMed 25657535Chang DT, Lawrentschuk N. Orthotopic neobladder reconstruction. Urol Ann. 2015 Jan-Mar;7(1):1-7. doi: 10.4103/0974-7796.148553.
- Background: PubMed 17470158Hassan 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.
- Background: PubMed 22235380Elfayoumy 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing uretero ileal anastomosis in single trough in people with Bladder Cancer, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of vesicoureteral reflux (VUR) (time frame: after 6 months and after one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04162093, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.