ID

45592

Beskrivning

Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head. Study Center of the German Surgical Society (SDGC) Trial protocol of a randomised controlled multicentre trial. Trials. 2010 Apr 29;11:47. doi: 10.1186/1745-6215-11-47. PMID: 20429912; PMCID: PMC2874785. Controlled-trials.com ISRCTN38973832

Länk

Publication

Nyckelord

Versioner (1)
  1. 2023-02-06 2023-02-06 - Dr. Christian Niklas
Rättsinnehavare

Diener MK, Bruckner T, Contin P, Halloran C, Glanemann M, Schlitt HJ, Mössner J, Kieser M, Werner J, Büchler MW, Seiler CM

Uppladdad den

6 februari 2023

DOI

10.1186/1745-6215-11-47

Licens

Creative Commons BY 4.0
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ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis

Engelsk

Start Questionnaire

7 Formulär  
  1. StudyEvent: Visit 1 : Screening
    1. Start Questionnaire
  2. StudyEvent: Visit 2 : Operation
    1. Start Questionnaire
  3. StudyEvent: Visit 3: Discharge
    1. Start Questionnaire
  4. StudyEvent: Visit 4: 6 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  5. StudyEvent: Visit 5: 12 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  6. StudyEvent: Visit 6: 24 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  7. StudyEvent: End of Study
    1. Start Questionnaire
Date of Visit
Beskrivning

Date of Visit

Alias
UMLS CUI[1,1]
C1320303
please enter the date of visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1,1]
C1320303
Quality of Life (Primary Endpoint)
Beskrivning

Quality of Life (Primary Endpoint)

Alias
UMLS CUI [1,1]
C0034380
UMLS CUI [2,1]
C2986535
EORTC QLQ-C30 form completed
Beskrivning

QLQ-C30

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3476431
EORTC QLQ-PAN26 form completed
Beskrivning

QLQ-PAN26

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3476431
Study-Related Examination (Secondary Endpoints)
Beskrivning

Study-Related Examination (Secondary Endpoints)

Alias
UMLS CUI[1,1]
C4528314
UMLS CUI [2,1]
C4321457
Wound infection (according to the CDC definition)
Beskrivning

Wound infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0043241
please specify:
Beskrivning

specify

Datatyp

string

Alias
UMLS CUI [1,1]
C1521902
Pulmonary infection
Beskrivning

Pulmonary infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0876973
Pancreatic fistula (according to Bassi definition)
Beskrivning

Pancreatic fistula

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030290
please specify
Beskrivning

specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C1521902
Hospital stay due to chronic pancreatitis since last visit
Beskrivning

Hospital stay

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3489408
UMLS CUI [1,2]
C2047944
UMLS CUI [1,3]
C0149521
please specify the total number of days
Beskrivning

specify days

Datatyp

integer

Måttenheter
  • days
Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0439228
days
Reoperation due to recurrence of chronic pancreatitis since last visit
Beskrivning

Reoperation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034897
UMLS CUI [1,2]
C0149521
UMLS CUI [1,3]
C2047944
UMLS CUI [1,4]
C0558347
please specify
Beskrivning

I.100

Datatyp

text

Alias
UMLS CUI[1,1]
C1521902
Date of first reoperation
Beskrivning

first reoperation

Datatyp

date

Alias
UMLS CUI [1,1]
C0205435
UMLS CUI [1,2]
C0035110
UMLS CUI [1,3]
C0011008
Date of second reoperation
Beskrivning

second reoperation

Datatyp

date

Alias
UMLS CUI [1,1]
C0205436
UMLS CUI [1,2]
C0035110
UMLS CUI [1,3]
C0011008
Weight
Beskrivning

Weight

Datatyp

integer

Måttenheter
  • kg
Alias
UMLS CUI [1,1]
C0005910
kg
Diabetes mellitus (under current oral or s.c. medication)
Beskrivning

Diabetes mellitus

Datatyp

integer

Alias
UMLS CUI[1,2]
C0013216
UMLS CUI[1,1]
C0011849
Development of exocrine insufficiency (continuous supplement of enzymes necessary)
Beskrivning

exocrine insufficiency

Datatyp

integer

Alias
UMLS CUI[1,1]
C0267963
UMLS CUI[1,2]
C0948571
Serious Adverse Events
Beskrivning

Serious Adverse Events

Alias
UMLS CUI [1,1]
C1519255
Were there any new serious adverse events since last visit
Beskrivning

SAE

Datatyp

integer

Alias
UMLS CUI [1,1]
C0205314
UMLS CUI [1,2]
C1519255
please specify on SAE-form!
Beskrivning

please specify on SAE-form!

Investigator's Statement
Beskrivning

Investigator's Statement

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
With this electronic signature, I acknowledge that THIS REPORTED eFORM for this patient has been reviewed by me and agree that the data are true and accurate.
Beskrivning

Investigator's Statement

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Tillbaka till toppen

Similar models

Start Questionnaire

7 Formulär
  1. StudyEvent: Visit 1 : Screening
    1. Start Questionnaire
  2. StudyEvent: Visit 2 : Operation
    1. Start Questionnaire
  3. StudyEvent: Visit 3: Discharge
    1. Start Questionnaire
  4. StudyEvent: Visit 4: 6 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  5. StudyEvent: Visit 5: 12 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  6. StudyEvent: Visit 6: 24 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  7. StudyEvent: End of Study
    1. Start Questionnaire
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI[1,1])
Date of Visit
Item
please enter the date of visit
date
C1320303 (UMLS CUI [1,1])
Item Group
Quality of Life (Primary Endpoint)
C0034380 (UMLS CUI [1,1])
C2986535 (UMLS CUI [2,1])
QLQ-C30
Item
EORTC QLQ-C30 form completed
boolean
C3476431 (UMLS CUI [1,1])
QLQ-PAN26
Item
EORTC QLQ-PAN26 form completed
boolean
C3476431 (UMLS CUI [1,1])
Item Group
Study-Related Examination (Secondary Endpoints)
C4528314 (UMLS CUI[1,1])
C4321457 (UMLS CUI [2,1])
Wound infection
Item
Wound infection (according to the CDC definition)
boolean
C0043241 (UMLS CUI [1,1])
specify
Item
please specify:
string
C1521902 (UMLS CUI [1,1])
Pulmonary infection
Item
Pulmonary infection
boolean
C0876973 (UMLS CUI [1,1])
Pancreatic fistula
Item
Pancreatic fistula (according to Bassi definition)
boolean
C0030290 (UMLS CUI [1,1])
Item
please specify
integer
C1521902 (UMLS CUI [1,1])
CL.13
Code List
please specify
CL Item
Type A (1)
C0030290 (UMLS CUI [1,1])
CL Item
Type B (2)
C0030290 (UMLS CUI [1,1])
CL Item
Type C (3)
C0030290 (UMLS CUI [1,1])
Hospital stay
Item
Hospital stay due to chronic pancreatitis since last visit
boolean
C3489408 (UMLS CUI [1,1])
C2047944 (UMLS CUI [1,2])
C0149521 (UMLS CUI [1,3])
specify days
Item
please specify the total number of days
integer
C0439228 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Reoperation
Item
Reoperation due to recurrence of chronic pancreatitis since last visit
boolean
C0034897 (UMLS CUI [1,1])
C0149521 (UMLS CUI [1,2])
C2047944 (UMLS CUI [1,3])
C0558347 (UMLS CUI [1,4])
I.100
Item
please specify
text
C1521902 (UMLS CUI[1,1])
first reoperation
Item
Date of first reoperation
date
C0205435 (UMLS CUI [1,1])
C0035110 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
second reoperation
Item
Date of second reoperation
date
C0205436 (UMLS CUI [1,1])
C0035110 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1,1])
Item
Diabetes mellitus (under current oral or s.c. medication)
integer
C0013216 (UMLS CUI[1,2])
C0011849 (UMLS CUI[1,1])
CL.15
Code List
Diabetes mellitus (under current oral or s.c. medication)
CL Item
no (1)
C1298908 (UMLS CUI [1,1])
CL Item
New onset since last visit (2)
C0746890 (UMLS CUI [1,1])
C2047944 (UMLS CUI [1,2])
CL Item
Still present (3)
C0150312 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,1])
Item
Development of exocrine insufficiency (continuous supplement of enzymes necessary)
integer
C0267963 (UMLS CUI[1,1])
C0948571 (UMLS CUI[1,2])
CL.16
Code List
Development of exocrine insufficiency (continuous supplement of enzymes necessary)
CL Item
no (1)
C1298908 (UMLS CUI[1,1])
CL Item
New onset since last visit (2)
C0011849 (UMLS CUI[1,1])
C0013216 (UMLS CUI[1,2])
CL Item
Still present (3)
C0012634 (UMLS CUI[1,1])
C0150312 (UMLS CUI[1,2])
Item Group
Serious Adverse Events
C1519255 (UMLS CUI [1,1])
SAE
Item
Were there any new serious adverse events since last visit
integer
C0205314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
please specify on SAE-form!
Item Group
Investigator's Statement
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's Statement
Item
With this electronic signature, I acknowledge that THIS REPORTED eFORM for this patient has been reviewed by me and agree that the data are true and accurate.
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Tillbaka till toppen 

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