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| ID | Type | Description | Link |
|---|---|---|---|
| DaBlaCa-16 | Other Identifier | Danish Bladder Cancer Group |
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Cystectomy is the chosen treatment of bladder cancer in 400 cases every year in DK. In replacement of the removed bladder, a urinary diversion is constructed using 15cm of terminal ilium (Ad Modum Bricker).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Study subject will cohere to current national guidlines with a cystectomy and standard urinary conduit ad modum Bricker |
|
| Intervention | Experimental | Subject in the interventional arm, will be treated with a cystectomy and modified retrosigmoid conduit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cystectomy and modified urinary conduit | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Strictures | Number of participants with benign strictures in the left ureter | Within 2 years after cystectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Aalborg University Hospital | Aalborg | 9100 | Denmark | |||
| Department of Urology, Aarhus University Hospital |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015653 | Cystectomy |
| ID | Term |
|---|---|
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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A prospective, multicenter, randomized clinical trial
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|
| Cystectomy and standard urinary conduit ad modum Bricker | Procedure | 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. |
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|
| Aarhus |
| 8200 |
| Denmark |
| Department of Urology, Rigshospitalet | Copenhagen | 2100 | Denmark |
| Department of Urology, Herlev and Gentofte Hospital | Herlev | 2730 | Denmark |
| Department of Urology, Odense University Hospital | Odense | 5000 | Denmark |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |