Engelsk

Visit 2: Endoscopic intervention

13 Formulär  
  1. StudyEvent: PREBOT Pilot
    1. Visit 1: Enrollment and Randomization
    2. Visit 2: Endoscopic intervention
    3. Visit 3: Operation
    4. Visit 4: POD 3
    5. Visit 5: Day of discharge
    6. Visit 6: POD 30
    7. Visit 7: 3 months post OP/ premature discontinuation
    8. Signature
  2. StudyEvent: Complications
    1. Complications
  3. StudyEvent: Readmission To Hospital (repeatable instrument)
    1. Readmission To Hospital (repeatable instrument)
  4. StudyEvent: Adverse Events (repeatable instrument)
    1. Adverse Events (repeatable instrument)
  5. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  6. StudyEvent: Protocol Violation (repeatable instrument)
    1. Protocol Violation (repeatable instrument)
  7. StudyEvent: Patient report: EORTC QLQ-C30
  8. StudyEvent: Patient report: EORTC QLQ-PAN26
(must only be filled out for patients in intervention group)
Beskrivning

(must only be filled out for patients in intervention group)

Alias
UMLS CUI [1,1]
C1533716
Laboratory Parameters (prior to endoscopic intervention)
Beskrivning

Laboratory Parameters (prior to endoscopic intervention)

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0184661
Date of blood test
Beskrivning

Date of blood test

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0849535
Measurement of Pancreatic amylase
Beskrivning

Measurement of Pancreatic amylase

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274428
If yes: Pancreatic amylase
Beskrivning

Pancreatic amylase

Datatyp

float

Måttenheter
  • U/I
Alias
UMLS CUI [1,1]
C0301812
U/I
Measurement of lipase
Beskrivning

Measurement of lipase

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0373670
If yes: Lipase
Beskrivning

Lipase

Datatyp

integer

Måttenheter
  • U/l
Alias
UMLS CUI [1,1]
C0023764
U/l
Bilirubin
Beskrivning

Bilirubin

Datatyp

float

Måttenheter
  • mg/dl
Alias
UMLS CUI [1,1]
C0201913
mg/dl
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

float

Måttenheter
  • g/dl
Alias
UMLS CUI [1,1]
C0019046
g/dl
Erythrocytes
Beskrivning

Erythrocytes

Datatyp

float

Måttenheter
  • /pl
Alias
UMLS CUI [1,1]
C0014792
/pl
Leucocytes
Beskrivning

Leucocytes

Datatyp

float

Måttenheter
  • /nl
Alias
UMLS CUI [1,1]
C0023516
/nl
Thrombocytes
Beskrivning

Thrombocytes

Datatyp

float

Måttenheter
  • /nl
Alias
UMLS CUI [1,1]
C0005821
/nl
INR
Beskrivning

INR

Datatyp

float

Alias
UMLS CUI [1,1]
C0525032
Creatinine clearance / GFR (estimated by Cockroft-Gault)
Beskrivning

GFR

Datatyp

float

Måttenheter
  • ml/min
Alias
UMLS CUI [1,1]
C2711451
UMLS CUI [1,2]
C0373595
ml/min
CRP
Beskrivning

CRP

Datatyp

float

Måttenheter
  • mg/l
Alias
UMLS CUI [1,1]
C0201657
mg/l
Endoscopic intervention
Beskrivning

Endoscopic intervention

Alias
UMLS CUI [1,1]
C0808232
UMLS CUI [1,2]
C0014245
Esophagogastroduodenoscopy performed
Beskrivning

Esophagogastroduodenoscopy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079304
UMLS CUI [1,2]
C0884358
If no: Please specify reason why not performed
Beskrivning

Specify

Datatyp

text

Alias
UMLS CUI [1,1]
C2919806
If yes: Date of endoscopic procedure
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
If yes: Start of endoscopic procedure
Beskrivning

Start

Datatyp

time

Alias
UMLS CUI [1,1]
C2712338
If yes: End of endoscopic procedure
Beskrivning

End

Datatyp

time

Alias
UMLS CUI [1,1]
C1522314
BOTOX injection
Beskrivning

BOTOX injection

Alias
UMLS CUI [1,1]
C0700702
UMLS CUI [1,2]
C1533685
BOTOX injection performed?
Beskrivning

BOTOX injection performed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0884358
UMLS CUI [1,2]
C0700702
UMLS CUI [1,3]
C1272883
If no: Please specify reason why not perfomed
Beskrivning

Specify

Datatyp

text

Alias
UMLS CUI [1,1]
C2919806
If BOTOX injection performed: Papilla vateri identifiable
Beskrivning

Papilla vateri identifiable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013293
UMLS CUI [1,2]
C0205396
If BOTOX injection performed: Injection at 1 o-clock successful
Beskrivning

Injection at 1 o-clock successful

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0940892
If no, please specify
Beskrivning

Specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
If BOTOX injection performed: Time of injection
Beskrivning

Time of injection

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
If BOTOX injection performed: Volume of Botox
Beskrivning

Volume

Datatyp

float

Måttenheter
  • ml
Alias
UMLS CUI [1,1]
C0449468
ml
If BOTOX injection performed: Dosage of Botox
Beskrivning

Dosage of Botox

Datatyp

float

Måttenheter
  • units
Alias
UMLS CUI [1,1]
C0178602
units
Concomitant Medication
Beskrivning

Concomitant Medication

Alias
UMLS CUI [1,1]
C2826666
Any changes in Concomitant Medication since last visit
Beskrivning

Changes since last visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1711239
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0580105
If yes, please fill out eForm 'Concomitant Medication'
Beskrivning

If yes, please fill out eForm 'Concomitant Medication'

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3273494
Adverse Events
Beskrivning

Adverse Events

Alias
UMLS CUI [1,1]
C0877248
Any Adverse Events occurred since last visit
Beskrivning

Adverse Events occurred since last visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1711239
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0545082
UMLS CUI [1,4]
C0877248
If yes, please fill out eForm 'Adverse Events'
Beskrivning

If yes, please fill out eForm 'Adverse Events'

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3273494
Protocol violations
Beskrivning

Protocol violations

Alias
UMLS CUI [1,1]
C1709750
Any protocol violations occurred since last visit
Beskrivning

protocol violations since last visit

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1711239
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0545082
If yes, please fill out eForm 'Protocol violation'
Beskrivning

If yes, please fill out eForm 'Protocol violation'

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C3273494
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Similar models

Visit 2: Endoscopic intervention

13 Formulär
  1. StudyEvent: PREBOT Pilot
    1. Visit 1: Enrollment and Randomization
    2. Visit 2: Endoscopic intervention
    3. Visit 3: Operation
    4. Visit 4: POD 3
    5. Visit 5: Day of discharge
    6. Visit 6: POD 30
    7. Visit 7: 3 months post OP/ premature discontinuation
    8. Signature
  2. StudyEvent: Complications
    1. Complications
  3. StudyEvent: Readmission To Hospital (repeatable instrument)
    1. Readmission To Hospital (repeatable instrument)
  4. StudyEvent: Adverse Events (repeatable instrument)
    1. Adverse Events (repeatable instrument)
  5. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  6. StudyEvent: Protocol Violation (repeatable instrument)
    1. Protocol Violation (repeatable instrument)
  7. StudyEvent: Patient report: EORTC QLQ-C30
  8. StudyEvent: Patient report: EORTC QLQ-PAN26
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
(must only be filled out for patients in intervention group)
C1533716 (UMLS CUI [1,1])
Item Group
Laboratory Parameters (prior to endoscopic intervention)
C1254595 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Date of blood test
Item
Date of blood test
date
C0011008 (UMLS CUI [1,1])
C0849535 (UMLS CUI [1,2])
Measurement of Pancreatic amylase
Item
Measurement of Pancreatic amylase
boolean
C3274428 (UMLS CUI [1,1])
Pancreatic amylase
Item
If yes: Pancreatic amylase
float
C0301812 (UMLS CUI [1,1])
Measurement of lipase
Item
Measurement of lipase
boolean
C0373670 (UMLS CUI [1,1])
Lipase
Item
If yes: Lipase
integer
C0023764 (UMLS CUI [1,1])
Bilirubin
Item
Bilirubin
float
C0201913 (UMLS CUI [1,1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1,1])
Erythrocytes
Item
Erythrocytes
float
C0014792 (UMLS CUI [1,1])
Leucocytes
Item
Leucocytes
float
C0023516 (UMLS CUI [1,1])
Thrombocytes
Item
Thrombocytes
float
C0005821 (UMLS CUI [1,1])
INR
Item
INR
float
C0525032 (UMLS CUI [1,1])
GFR
Item
Creatinine clearance / GFR (estimated by Cockroft-Gault)
float
C2711451 (UMLS CUI [1,1])
C0373595 (UMLS CUI [1,2])
CRP
Item
CRP
float
C0201657 (UMLS CUI [1,1])
Item Group
Endoscopic intervention
C0808232 (UMLS CUI [1,1])
C0014245 (UMLS CUI [1,2])
Esophagogastroduodenoscopy
Item
Esophagogastroduodenoscopy performed
boolean
C0079304 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Specify
Item
If no: Please specify reason why not performed
text
C2919806 (UMLS CUI [1,1])
Date
Item
If yes: Date of endoscopic procedure
date
C0011008 (UMLS CUI [1,1])
Start
Item
If yes: Start of endoscopic procedure
time
C2712338 (UMLS CUI [1,1])
End
Item
If yes: End of endoscopic procedure
time
C1522314 (UMLS CUI [1,1])
Item Group
BOTOX injection
C0700702 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
BOTOX injection performed
Item
BOTOX injection performed?
boolean
C0884358 (UMLS CUI [1,1])
C0700702 (UMLS CUI [1,2])
C1272883 (UMLS CUI [1,3])
Specify
Item
If no: Please specify reason why not perfomed
text
C2919806 (UMLS CUI [1,1])
Papilla vateri identifiable
Item
If BOTOX injection performed: Papilla vateri identifiable
boolean
C0013293 (UMLS CUI [1,1])
C0205396 (UMLS CUI [1,2])
Injection at 1 o-clock successful
Item
If BOTOX injection performed: Injection at 1 o-clock successful
boolean
C0940892 (UMLS CUI [1,1])
Specify
Item
If no, please specify
text
C1521902 (UMLS CUI [1,1])
Time of injection
Item
If BOTOX injection performed: Time of injection
time
C0040223 (UMLS CUI [1,1])
Volume
Item
If BOTOX injection performed: Volume of Botox
float
C0449468 (UMLS CUI [1,1])
Dosage of Botox
Item
If BOTOX injection performed: Dosage of Botox
float
C0178602 (UMLS CUI [1,1])
Item Group
Concomitant Medication
C2826666 (UMLS CUI [1,1])
Changes since last visit
Item
Any changes in Concomitant Medication since last visit
boolean
C1711239 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0580105 (UMLS CUI [1,4])
Item Group
If yes, please fill out eForm 'Concomitant Medication'
C2347852 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
Item Group
Adverse Events
C0877248 (UMLS CUI [1,1])
Adverse Events occurred since last visit
Item
Any Adverse Events occurred since last visit
boolean
C1711239 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])
Item Group
If yes, please fill out eForm 'Adverse Events'
C0877248 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
Item Group
Protocol violations
C1709750 (UMLS CUI [1,1])
protocol violations since last visit
Item
Any protocol violations occurred since last visit
boolean
C1711239 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,3])
Item Group
If yes, please fill out eForm 'Protocol violation'
C1709750 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
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