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
End of Study
Beskrivning

End of Study

Has the patient completed the trial regulary
Beskrivning

trial completed

Datatyp

boolean

Alias
UMLS CUI[1,1]
C0509584
please fill out the following:
Beskrivning

fill out

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
Date of early termination
Beskrivning

early termination

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2718058
Reason for premature end of study:
Beskrivning

Reason for premature end

Datatyp

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2361259
please specify
Beskrivning

specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
Date of death
Beskrivning

Date death

Datatyp

date

Alias
UMLS CUI [1,1]
C1148348
Cause of death
Beskrivning

Cause death

Datatyp

string

Alias
UMLS CUI [1,1]
C0007465
Protocol Violations
Beskrivning

Protocol Violations

Alias
UMLS CUI [1,1]
C1709750
Were there any protocol violations?
Beskrivning

Protocol Violations

Datatyp

integer

Alias
UMLS CUI [1,1]
C1709750
please specify
Beskrivning

specify

Datatyp

string

Alias
UMLS CUI [1,1]
C1521902
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
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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
End of Study
trial completed
Item
Has the patient completed the trial regulary
boolean
C0509584 (UMLS CUI[1,1])
fill out
Item
please fill out the following:
text
C1521902 (UMLS CUI [1,1])
early termination
Item
Date of early termination
date
C0011008 (UMLS CUI [1,1])
C2718058 (UMLS CUI [1,2])
Item
Reason for premature end of study:
integer
C0566251 (UMLS CUI [1,1])
C2361259 (UMLS CUI [1,2])
CL.27
Code List
Reason for premature end of study:
CL Item
Withdrawal of informed consent (1)
C0021430 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
CL Item
Lost to follow up (2)
C1302313 (UMLS CUI [1,1])
CL Item
Death (3)
C1306577 (UMLS CUI [1,1])
CL Item
Other, please specify: (4)
C1521902 (UMLS CUI [1,1])
specify
Item
please specify
text
C1521902 (UMLS CUI [1,1])
Date death
Item
Date of death
date
C1148348 (UMLS CUI [1,1])
Cause death
Item
Cause of death
string
C0007465 (UMLS CUI [1,1])
Item Group
Protocol Violations
C1709750 (UMLS CUI [1,1])
Protocol Violations
Item
Were there any protocol violations?
integer
C1709750 (UMLS CUI [1,1])
specify
Item
please specify
string
C1521902 (UMLS CUI [1,1])
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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