MOdified Urinary Conduit to Lower Strictures After radIcal Cystectomy
NCT ID: NCT04391790
Last Updated: 2023-04-27
Study Results
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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UNKNOWN
NA
300 participants
INTERVENTIONAL
2020-05-27
2024-09-01
Brief Summary
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Ureteral strictures are diagnosed in 15% of the cystectomized patients, and these patients are at increased risk of infections, loss of renal function and repeated interventions. The left ureter is diagnosed with 70% of all strictures, presumably due to the construction of the urinary diversion.
A modified urinary diversion have been tested in two small studies. The modified diversion is prolonged with 5cm compared to the conventional urinary diversion. The prolongation permits the urinary diversion to reach both the left and the right side of the abdomen, resulting in greater resection of non-viably distal ureter and less mobilization of the left ureter, lowering the rates of strictures.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
Study subject will cohere to current national guidlines with a cystectomy and standard urinary conduit ad modum Bricker
Cystectomy and standard urinary conduit ad modum Bricker
The conduit is constructed using approximately 15 cm of terminal ileum and placed in the right side of the abdomen. In order for the left ureter to reach the conduit, it is mobilized behind the sigmoideum to the conduit.
Intervention
Subject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid conduit
Cystectomy and modified urinary conduit
The modified retrosigmoid conduit is extended aorund 5 cm, so the left ureter does not have to cross under the mesentery wheras the presumed more robust ileal segment does.
Interventions
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Cystectomy and modified urinary conduit
The modified retrosigmoid conduit is extended aorund 5 cm, so the left ureter does not have to cross under the mesentery wheras the presumed more robust ileal segment does.
Cystectomy and standard urinary conduit ad modum Bricker
The conduit is constructed using approximately 15 cm of terminal ileum and placed in the right side of the abdomen. In order for the left ureter to reach the conduit, it is mobilized behind the sigmoideum to the conduit.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ileal conduit ad modum Bricker as planned urinary diversion
* Ability to understand the participant information orally and in writing
* Signed consent form
Exclusion Criteria
* Previous major abdominal surgery involving resection of bowel or construction of an enteric stoma
* Urostomy planned on the left side of the abdomen
* Single kidney
* Complete ureteral duplication (either uni- or bilaterally), known at time of inclusion
* Pregnancy
18 Years
ALL
No
Sponsors
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Jørgen Bjerggaard Jensen
OTHER
Responsible Party
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Jørgen Bjerggaard Jensen
Professor, Consultant, MD, DMSc
Locations
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Department of Urology, Aalborg University Hospital
Aalborg, , Denmark
Department of Urology, Aarhus University Hospital
Aarhus, , Denmark
Department of Urology, Rigshospitalet
Copenhagen, , Denmark
Department of Urology, Herlev and Gentofte Hospital
Herlev, , Denmark
Department of Urology, Odense University Hospital
Odense, , Denmark
Countries
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Other Identifiers
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DaBlaCa-16
Identifier Type: OTHER
Identifier Source: secondary_id
MOSAIC
Identifier Type: -
Identifier Source: org_study_id
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