ID

45592

Descripción

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

Link

Publication

Palabras clave

Versiones (1)
  1. 6/2/23 6/2/23 - Dr. Christian Niklas
Titular de derechos de autor

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

Subido en

6 de febrero de 2023

DOI

10.1186/1745-6215-11-47

Licencia

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

Inglés

Start Questionnaire

7 formularios  
  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
Descripción

End of Study

Has the patient completed the trial regulary
Descripción

trial completed

Tipo de datos

boolean

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

fill out

Tipo de datos

text

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

early termination

Tipo de datos

date

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

Reason for premature end

Tipo de datos

integer

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

specify

Tipo de datos

text

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

Date death

Tipo de datos

date

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

Cause death

Tipo de datos

string

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

Protocol Violations

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

Protocol Violations

Tipo de datos

integer

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

specify

Tipo de datos

string

Alias
UMLS CUI [1,1]
C1521902
Serious Adverse Events
Descripción

Serious Adverse Events

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

SAE

Tipo de datos

integer

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

please specify on SAE-form!

Investigator's Statement
Descripción

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.
Descripción

Investigator's Statement

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Volver a la parte superior de la página

Similar models

Start Questionnaire

7 formularios
  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
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Volver a la parte superior de la página 

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