ID

36131

Beschreibung

The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy. ODM derived from: https://clinicaltrials.gov/show/NCT00937833

Link

https://clinicaltrials.gov/show/NCT00937833

Stichworte

Versionen (1)
  1. 17.04.19 17.04.19 -
Rechteinhaber

Cook Group Incorporated

Hochgeladen am

17. April 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling NCT00937833

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patient must be at least 18 years of age.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Patient must have organ confined prostate cancer.
Beschreibung

Diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0376358
UMLS CUI [1,2]
C1273595
Patient must have PSA < 15.
Beschreibung

Tumor markers

Datentyp

boolean

Alias
UMLS CUI [1]
C0201544
Patient must have clinical stage prostate cancer < cT3.
Beschreibung

Staging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3258246
UMLS CUI [1,2]
C0600139
Patient must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.
Beschreibung

Operative technique

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4039115
UMLS CUI [1,2]
C3844437
Patient must be able to provide written informed consent and HIPAA authorization for release of personal health information.
Beschreibung

HIPAA = Health Insurance Portability and Accountability Act

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C0600593
UMLS CUI [2,2]
C0680281
UMLS CUI [2,3]
C4045976
UMLS CUI [2,4]
C1283071
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patient has previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.
Beschreibung

Previous therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040771
UMLS CUI [1,2]
C1514463
UMLS CUI [2,1]
C1955835
UMLS CUI [2,2]
C0033572
UMLS CUI [2,3]
C1514463
UMLS CUI [3,1]
C0438674
UMLS CUI [3,2]
C1514463
UMLS CUI [4,1]
C1959818
UMLS CUI [4,2]
C1514463
UMLS CUI [5,1]
C0194790
UMLS CUI [5,2]
C1514463
Patient has previously undergone incision of urethral stricture or incision of bladder neck contracture.
Beschreibung

Prior operations

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4551691
UMLS CUI [1,2]
C0184898
UMLS CUI [1,3]
C1514463
UMLS CUI [2,1]
C3854305
UMLS CUI [2,2]
C0184898
UMLS CUI [2,3]
C1514463
Patient has previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.
Beschreibung

Prior diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4551691
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C3854305
UMLS CUI [2,2]
C0011900
UMLS CUI [3,1]
C0042024
UMLS CUI [3,2]
C0011900
Patient has previously been diagnosed with atonic bladder or neurogenic bladder.
Beschreibung

Bladder diseases

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0549252
UMLS CUI [1,2]
C0011900
UMLS CUI [2,1]
C0005697
UMLS CUI [2,2]
C0011900
Patient has significant pre-operative voiding symptoms as defined by an american urologic association symptom score of greater than 19.
Beschreibung

Voiding symptoms

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4053857
UMLS CUI [1,2]
C0445204
UMLS CUI [2]
C3831551
Patient has a prior history of radiation to the pelvis.
Beschreibung

History of radiation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0747411
UMLS CUI [1,2]
C0262926
Patient with persistent bacteriuria that cannot be cleared, as demonstrated by a positive urinalysis or urine culture, within 1 month of surgery.
Beschreibung

Bacteriuria

Datentyp

boolean

Alias
UMLS CUI [1]
C0004659
UMLS CUI [2,1]
C0042014
UMLS CUI [2,2]
C0587081
UMLS CUI [3,1]
C0848716
UMLS CUI [3,2]
C0243095
Patient has allergies to pig tissue or pig products or has religious or cultural objection to the use of pig tissue.
Beschreibung

Pig tissue

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3665571
UMLS CUI [2,1]
C3242198
UMLS CUI [2,2]
C3665571
UMLS CUI [3,1]
C3242196
UMLS CUI [3,2]
C0220814
UMLS CUI [3,3]
C3665571
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Patient must be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Diagnosis
Item
Patient must have organ confined prostate cancer.
boolean
C0376358 (UMLS CUI [1,1])
C1273595 (UMLS CUI [1,2])
Tumor markers
Item
Patient must have PSA < 15.
boolean
C0201544 (UMLS CUI [1])
Staging
Item
Patient must have clinical stage prostate cancer < cT3.
boolean
C3258246 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Operative technique
Item
Patient must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.
boolean
C4039115 (UMLS CUI [1,1])
C3844437 (UMLS CUI [1,2])
Informed consent
Item
Patient must be able to provide written informed consent and HIPAA authorization for release of personal health information.
boolean
C0021430 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0600593 (UMLS CUI [2,1])
C0680281 (UMLS CUI [2,2])
C4045976 (UMLS CUI [2,3])
C1283071 (UMLS CUI [2,4])
Item Group
C0680251 (UMLS CUI)
Previous therapy
Item
Patient has previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.
boolean
C0040771 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C1955835 (UMLS CUI [2,1])
C0033572 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C0438674 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C1959818 (UMLS CUI [4,1])
C1514463 (UMLS CUI [4,2])
C0194790 (UMLS CUI [5,1])
C1514463 (UMLS CUI [5,2])
Prior operations
Item
Patient has previously undergone incision of urethral stricture or incision of bladder neck contracture.
boolean
C4551691 (UMLS CUI [1,1])
C0184898 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C3854305 (UMLS CUI [2,1])
C0184898 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
Prior diagnosis
Item
Patient has previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.
boolean
C4551691 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C3854305 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C0042024 (UMLS CUI [3,1])
C0011900 (UMLS CUI [3,2])
Bladder diseases
Item
Patient has previously been diagnosed with atonic bladder or neurogenic bladder.
boolean
C0549252 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0005697 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
Voiding symptoms
Item
Patient has significant pre-operative voiding symptoms as defined by an american urologic association symptom score of greater than 19.
boolean
C4053857 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C3831551 (UMLS CUI [2])
History of radiation
Item
Patient has a prior history of radiation to the pelvis.
boolean
C0747411 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Bacteriuria
Item
Patient with persistent bacteriuria that cannot be cleared, as demonstrated by a positive urinalysis or urine culture, within 1 month of surgery.
boolean
C0004659 (UMLS CUI [1])
C0042014 (UMLS CUI [2,1])
C0587081 (UMLS CUI [2,2])
C0848716 (UMLS CUI [3,1])
C0243095 (UMLS CUI [3,2])
Pig tissue
Item
Patient has allergies to pig tissue or pig products or has religious or cultural objection to the use of pig tissue.
boolean
C0020517 (UMLS CUI [1,1])
C3665571 (UMLS CUI [1,2])
C3242198 (UMLS CUI [2,1])
C3665571 (UMLS CUI [2,2])
C3242196 (UMLS CUI [3,1])
C0220814 (UMLS CUI [3,2])
C3665571 (UMLS CUI [3,3])
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