Anglais

Visit 4: POD 3

13 Formulaires  
  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
Date of visit
Description

Date of visit

Alias
UMLS CUI [1,1]
C1320303
Date of visit
Description

Date of visit

Type de données

date

Alias
UMLS CUI [1,1]
C1320303
Postoperative pancreativ fistua (POPF)
Description

Postoperative pancreativ fistua (POPF)

Alias
UMLS CUI [1,1]
C0241311
UMLS CUI [1,2]
C0030290
Postoperative pancreativ fistua (POPF)
Description

POPF

Type de données

boolean

Alias
UMLS CUI [1,1]
C0241311
UMLS CUI [1,2]
C0030290
If POPF ocurred, please fill out eForm 'Adverse Events'
Description

If POPF ocurred, please fill out eForm 'Adverse Events'

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3273494
Other postoperative morbidities
Description

Other postoperative morbidities

Alias
UMLS CUI [1,1]
C0241311
UMLS CUI [1,2]
C0589603
UMLS CUI [1,3]
C0009488
Postinterventional pancreatitis
Description

Postinterventional pancreatitis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030305
UMLS CUI [1,2]
C2347647
Perioperative sepsis
Description

Perioperative sepsis

Type de données

boolean

Alias
UMLS CUI [1,1]
C1518988
UMLS CUI [1,2]
C0243026
Delayed gastric emptying (DGE)
Description

DGE

Type de données

boolean

Alias
UMLS CUI [1,1]
C0740411
Delayed gastric emptying (DGE) according to the ISGPS definitions
Description

DGE ISGPS

Type de données

integer

Alias
UMLS CUI [1,1]
C0740411
UMLS CUI [1,2]
C1704788
Postpancreatectomy hemorrhage (PPH)
Description

PPH

Type de données

boolean

Alias
UMLS CUI [1,1]
C0687676
UMLS CUI [1,2]
C0030279
UMLS CUI [1,3]
C0019080
Postpancreatectomy hemorrhage (PPH) according to the ISGPS definitions
Description

PPH ISGPS

Type de données

integer

Alias
UMLS CUI [1,1]
C0687676
UMLS CUI [1,2]
C0030279
UMLS CUI [1,3]
C0019080
UMLS CUI [1,4]
C1704788
Intraabdominal fluid collection
Description

Intraabdominal fluid collection

Type de données

boolean

Alias
UMLS CUI [1,1]
C4285843
Intraabdominal fluid abscess
Description

Intraabdominal fluid abscess

Type de données

boolean

Alias
UMLS CUI [1,1]
C1512910
UMLS CUI [1,2]
C4726050
Lymphatic fistula / chylus ascites
Description

Lymphatic fistula / chylus ascites

Type de données

boolean

Alias
UMLS CUI [1,1]
C0340791
UMLS CUI [1,2]
C0008730
UMLS CUI [1,3]
C0003962
Wound infection
Description

Wound infection

Type de données

boolean

Alias
UMLS CUI [1,1]
C0043241
If yes, please specify wound infection
Description

specify

Type de données

integer

Alias
UMLS CUI [1,1]
C1521902
Burst abdomen
Description

Burst abdomen

Type de données

boolean

Alias
UMLS CUI [1,1]
C1739397
UMLS CUI [1,2]
C2711727
If any of above-mentioned complications occurred, please fill out eForm 'Adverse Events'.
Description

If any of above-mentioned complications occurred, please fill out eForm 'Adverse Events'.

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3273494
Reintervention/ -operation
Description

Reintervention/ -operation

Alias
UMLS CUI [1,1]
C5452916
UMLS CUI [1,2]
C0035110
Reintervention/ -operation
Description

Reintervention/ -operation

Type de données

boolean

Alias
UMLS CUI [1,1]
C5452916
UMLS CUI [1,2]
C0035110
Number of Reinterventions / Reoperations
Description

Number

Type de données

integer

Alias
UMLS CUI [1,1]
C0449788
1st reintervention / reoperation
Description

1st reintervention / reoperation

Alias
UMLS CUI [1,1]
C0205435
UMLS CUI [1,2]
C5452916
UMLS CUI [1,3]
C0035110
Date of 1st reintervention / reoperation
Description

Date

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
Procedures
Description

Procedures

Type de données

integer

Alias
UMLS CUI [1,1]
C0199171
If other, please specify
Description

specify

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
Reason (Diagnosis)
Description

Diagnosis

Type de données

text

Alias
UMLS CUI [1,1]
C0011900
2nd reintervention / reoperation
Description

2nd reintervention / reoperation

Alias
UMLS CUI [1,1]
C0205435
UMLS CUI [1,2]
C5452916
UMLS CUI [1,3]
C0035110
Date of 2nd reintervention / reoperation
Description

Date

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
Procedures
Description

Procedures

Type de données

integer

Alias
UMLS CUI [1,1]
C0199171
If other, please specify
Description

specify

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
Reason (Diagnosis)
Description

Diagnosis

Type de données

text

Alias
UMLS CUI [1,1]
C0011900
3rd reintervention / reoperation
Description

3rd reintervention / reoperation

Alias
UMLS CUI [1,1]
C0205435
UMLS CUI [1,2]
C5452916
UMLS CUI [1,3]
C0035110
Date of 3rd reintervention / reoperation
Description

Date

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
Procedures
Description

Procedures

Type de données

integer

Alias
UMLS CUI [1,1]
C0199171
If other, please specify
Description

specify

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
Reason (Diagnosis)
Description

Diagnosis

Type de données

text

Alias
UMLS CUI [1,1]
C0011900
4th reintervention / reoperation
Description

4th reintervention / reoperation

Alias
UMLS CUI [1,1]
C0205435
UMLS CUI [1,2]
C5452916
UMLS CUI [1,3]
C0035110
Date of 4th reintervention / reoperation
Description

Date

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
Procedures
Description

Procedures

Type de données

integer

Alias
UMLS CUI [1,1]
C0199171
If other, please specify
Description

specify

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
Reason (Diagnosis)
Description

Diagnosis

Type de données

text

Alias
UMLS CUI [1,1]
C0011900
5th reintervention / reoperation
Description

5th reintervention / reoperation

Alias
UMLS CUI [1,1]
C0205435
UMLS CUI [1,2]
C5452916
UMLS CUI [1,3]
C0035110
Date of 5th reintervention / reoperation
Description

Date

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
Procedures
Description

Procedures

Type de données

integer

Alias
UMLS CUI [1,1]
C0199171
If other, please specify
Description

specify

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
Reason (Diagnosis)
Description

Diagnosis

Type de données

text

Alias
UMLS CUI [1,1]
C0011900
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI [1,1]
C2347852
Any changes in Concomitant Medication since last visit
Description

changes in Concomitant Medication since last visit

Type de données

boolean

Alias
UMLS CUI [1,1]
C3872643
UMLS CUI [1,2]
C0580105
If yes, please fill out eForm 'Concomitant Medication'.
Description

If yes, please fill out eForm 'Concomitant Medication'.

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

Adverse Events

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

Any new Adverse Events occurred since last visit

Type de données

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C3872643
If yes, please fill out eForm 'Adverse Events'.
Description

If yes, please fill out eForm 'Adverse Events'.

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

Protocol violations

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

Any protocol violations occurred since last visit

Type de données

boolean

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C3872643
If yes, please fill out eForm 'Protocol Violation'.
Description

If yes, please fill out eForm 'Protocol Violation'.

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

Visit 4: POD 3

13 Formulaires
  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
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Date of visit
C1320303 (UMLS CUI [1,1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
Item Group
Postoperative pancreativ fistua (POPF)
C0241311 (UMLS CUI [1,1])
C0030290 (UMLS CUI [1,2])
POPF
Item
Postoperative pancreativ fistua (POPF)
boolean
C0241311 (UMLS CUI [1,1])
C0030290 (UMLS CUI [1,2])
Item Group
If POPF ocurred, please fill out eForm 'Adverse Events'
C0877248 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
Item Group
Other postoperative morbidities
C0241311 (UMLS CUI [1,1])
C0589603 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Postinterventional pancreatitis
Item
Postinterventional pancreatitis
boolean
C0030305 (UMLS CUI [1,1])
C2347647 (UMLS CUI [1,2])
Perioperative sepsis
Item
Perioperative sepsis
boolean
C1518988 (UMLS CUI [1,1])
C0243026 (UMLS CUI [1,2])
DGE
Item
Delayed gastric emptying (DGE)
boolean
C0740411 (UMLS CUI [1,1])
Item
Delayed gastric emptying (DGE) according to the ISGPS definitions
integer
C0740411 (UMLS CUI [1,1])
C1704788 (UMLS CUI [1,2])
CL.25
Code List
Delayed gastric emptying (DGE) according to the ISGPS definitions
CL Item
no DGE (1)
C1298908 (UMLS CUI [1,1])
CL Item
Grade A (2)
C0309195 (UMLS CUI [1,1])
CL Item
Grade B (3)
C0441806 (UMLS CUI [1,1])
CL Item
Grade C (4)
C0441807 (UMLS CUI [1,1])
PPH
Item
Postpancreatectomy hemorrhage (PPH)
boolean
C0687676 (UMLS CUI [1,1])
C0030279 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
Item
Postpancreatectomy hemorrhage (PPH) according to the ISGPS definitions
integer
C0687676 (UMLS CUI [1,1])
C0030279 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
C1704788 (UMLS CUI [1,4])
CL.26
Code List
Postpancreatectomy hemorrhage (PPH) according to the ISGPS definitions
CL Item
no PPH (1)
C1298908 (UMLS CUI [1,1])
CL Item
Grade A (2)
C0309195 (UMLS CUI [1,1])
CL Item
Grade B (3)
C0441806 (UMLS CUI [1,1])
CL Item
Grade C (4)
C0441807 (UMLS CUI [1,1])
Intraabdominal fluid collection
Item
Intraabdominal fluid collection
boolean
C4285843 (UMLS CUI [1,1])
Intraabdominal fluid abscess
Item
Intraabdominal fluid abscess
boolean
C1512910 (UMLS CUI [1,1])
C4726050 (UMLS CUI [1,2])
Lymphatic fistula / chylus ascites
Item
Lymphatic fistula / chylus ascites
boolean
C0340791 (UMLS CUI [1,1])
C0008730 (UMLS CUI [1,2])
C0003962 (UMLS CUI [1,3])
Wound infection
Item
Wound infection
boolean
C0043241 (UMLS CUI [1,1])
Item
If yes, please specify wound infection
integer
C1521902 (UMLS CUI [1,1])
CL.27
Code List
If yes, please specify wound infection
CL Item
superficial incisional surgical site infection (1)
C3662309 (UMLS CUI [1,1])
CL Item
deep incisional surgical site infection (2)
C3662302 (UMLS CUI [1,1])
Burst abdomen
Item
Burst abdomen
boolean
C1739397 (UMLS CUI [1,1])
C2711727 (UMLS CUI [1,2])
Item Group
If any of above-mentioned complications occurred, please fill out eForm 'Adverse Events'.
C0877248 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
Item Group
Reintervention/ -operation
C5452916 (UMLS CUI [1,1])
C0035110 (UMLS CUI [1,2])
Reintervention/ -operation
Item
Reintervention/ -operation
boolean
C5452916 (UMLS CUI [1,1])
C0035110 (UMLS CUI [1,2])
Item
Number of Reinterventions / Reoperations
integer
C0449788 (UMLS CUI [1,1])
CL.28
Code List
Number of Reinterventions / Reoperations
CL Item
1 (1)
C0205447 (UMLS CUI [1,1])
CL Item
2 (2)
C0205448 (UMLS CUI [1,1])
CL Item
3 (3)
C0205449 (UMLS CUI [1,1])
CL Item
4 (4)
C0205450 (UMLS CUI [1,1])
CL Item
5 (5)
C0205451 (UMLS CUI [1,1])
Item Group
1st reintervention / reoperation
C0205435 (UMLS CUI [1,1])
C5452916 (UMLS CUI [1,2])
C0035110 (UMLS CUI [1,3])
Date
Item
Date of 1st reintervention / reoperation
date
C0011008 (UMLS CUI [1,1])
Item
Procedures
integer
C0199171 (UMLS CUI [1,1])
CL.29
Code List
Procedures
CL Item
completion pancreatectomy (1)
C0040511 (UMLS CUI [1,1])
CL Item
relaprotomy without completion pancreatectomy (2)
C0205341 (UMLS CUI [1,1])
C0023038 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0040511 (UMLS CUI [1,4])
CL Item
interventional abdominal drainage (3)
C0184661 (UMLS CUI [1,1])
C1167781 (UMLS CUI [1,2])
CL Item
esophagogastroduodenoscopy (4)
C0079304 (UMLS CUI [1,1])
CL Item
radiologic management of postoperative bleeding (5)
C0344093 (UMLS CUI [1,1])
C0032788 (UMLS CUI [1,2])
CL Item
other (6)
C0205394 (UMLS CUI [1,1])
specify
Item
If other, please specify
text
C1521902 (UMLS CUI [1,1])
Diagnosis
Item
Reason (Diagnosis)
text
C0011900 (UMLS CUI [1,1])
Item Group
2nd reintervention / reoperation
C0205435 (UMLS CUI [1,1])
C5452916 (UMLS CUI [1,2])
C0035110 (UMLS CUI [1,3])
Date
Item
Date of 2nd reintervention / reoperation
date
C0011008 (UMLS CUI [1,1])
Item
Procedures
integer
C0199171 (UMLS CUI [1,1])
CL.29
Code List
Procedures
CL Item
completion pancreatectomy (1)
C0040511 (UMLS CUI [1,1])
CL Item
relaprotomy without completion pancreatectomy (2)
C0205341 (UMLS CUI [1,1])
C0023038 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0040511 (UMLS CUI [1,4])
CL Item
interventional abdominal drainage (3)
C0184661 (UMLS CUI [1,1])
C1167781 (UMLS CUI [1,2])
CL Item
esophagogastroduodenoscopy (4)
C0079304 (UMLS CUI [1,1])
CL Item
radiologic management of postoperative bleeding (5)
C0344093 (UMLS CUI [1,1])
C0032788 (UMLS CUI [1,2])
CL Item
other (6)
C0205394 (UMLS CUI [1,1])
specify
Item
If other, please specify
text
C1521902 (UMLS CUI [1,1])
Diagnosis
Item
Reason (Diagnosis)
text
C0011900 (UMLS CUI [1,1])
Item Group
3rd reintervention / reoperation
C0205435 (UMLS CUI [1,1])
C5452916 (UMLS CUI [1,2])
C0035110 (UMLS CUI [1,3])
Date
Item
Date of 3rd reintervention / reoperation
date
C0011008 (UMLS CUI [1,1])
Item
Procedures
integer
C0199171 (UMLS CUI [1,1])
CL.29
Code List
Procedures
CL Item
completion pancreatectomy (1)
C0040511 (UMLS CUI [1,1])
CL Item
relaprotomy without completion pancreatectomy (2)
C0205341 (UMLS CUI [1,1])
C0023038 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0040511 (UMLS CUI [1,4])
CL Item
interventional abdominal drainage (3)
C0184661 (UMLS CUI [1,1])
C1167781 (UMLS CUI [1,2])
CL Item
esophagogastroduodenoscopy (4)
C0079304 (UMLS CUI [1,1])
CL Item
radiologic management of postoperative bleeding (5)
C0344093 (UMLS CUI [1,1])
C0032788 (UMLS CUI [1,2])
CL Item
other (6)
C0205394 (UMLS CUI [1,1])
specify
Item
If other, please specify
text
C1521902 (UMLS CUI [1,1])
Diagnosis
Item
Reason (Diagnosis)
text
C0011900 (UMLS CUI [1,1])
Item Group
4th reintervention / reoperation
C0205435 (UMLS CUI [1,1])
C5452916 (UMLS CUI [1,2])
C0035110 (UMLS CUI [1,3])
Date
Item
Date of 4th reintervention / reoperation
date
C0011008 (UMLS CUI [1,1])
Item
Procedures
integer
C0199171 (UMLS CUI [1,1])
CL.29
Code List
Procedures
CL Item
completion pancreatectomy (1)
C0040511 (UMLS CUI [1,1])
CL Item
relaprotomy without completion pancreatectomy (2)
C0205341 (UMLS CUI [1,1])
C0023038 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0040511 (UMLS CUI [1,4])
CL Item
interventional abdominal drainage (3)
C0184661 (UMLS CUI [1,1])
C1167781 (UMLS CUI [1,2])
CL Item
esophagogastroduodenoscopy (4)
C0079304 (UMLS CUI [1,1])
CL Item
radiologic management of postoperative bleeding (5)
C0344093 (UMLS CUI [1,1])
C0032788 (UMLS CUI [1,2])
CL Item
other (6)
C0205394 (UMLS CUI [1,1])
specify
Item
If other, please specify
text
C1521902 (UMLS CUI [1,1])
Diagnosis
Item
Reason (Diagnosis)
text
C0011900 (UMLS CUI [1,1])
Item Group
5th reintervention / reoperation
C0205435 (UMLS CUI [1,1])
C5452916 (UMLS CUI [1,2])
C0035110 (UMLS CUI [1,3])
Date
Item
Date of 5th reintervention / reoperation
date
C0011008 (UMLS CUI [1,1])
Item
Procedures
integer
C0199171 (UMLS CUI [1,1])
CL.29
Code List
Procedures
CL Item
completion pancreatectomy (1)
C0040511 (UMLS CUI [1,1])
CL Item
relaprotomy without completion pancreatectomy (2)
C0205341 (UMLS CUI [1,1])
C0023038 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C0040511 (UMLS CUI [1,4])
CL Item
interventional abdominal drainage (3)
C0184661 (UMLS CUI [1,1])
C1167781 (UMLS CUI [1,2])
CL Item
esophagogastroduodenoscopy (4)
C0079304 (UMLS CUI [1,1])
CL Item
radiologic management of postoperative bleeding (5)
C0344093 (UMLS CUI [1,1])
C0032788 (UMLS CUI [1,2])
CL Item
other (6)
C0205394 (UMLS CUI [1,1])
specify
Item
If other, please specify
text
C1521902 (UMLS CUI [1,1])
Diagnosis
Item
Reason (Diagnosis)
text
C0011900 (UMLS CUI [1,1])
Item Group
Concomitant Medication
C2347852 (UMLS CUI [1,1])
changes in Concomitant Medication since last visit
Item
Any changes in Concomitant Medication since last visit
boolean
C3872643 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
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])
Any new Adverse Events occurred since last visit
Item
Any new Adverse Events occurred since last visit
boolean
C0877248 (UMLS CUI [1,1])
C3872643 (UMLS CUI [1,2])
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])
Any protocol violations occurred since last visit
Item
Any protocol violations occurred since last visit
boolean
C1709750 (UMLS CUI [1,1])
C3872643 (UMLS CUI [1,2])
Item Group
If yes, please fill out eForm 'Protocol Violation'.
C3273494 (UMLS CUI [1,1])
C1709750 (UMLS CUI [1,2])
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