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
Date of Visit
Descripción

Date of Visit

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

Date of Visit

Tipo de datos

date

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

Quality of Life (Primary Endpoint)

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

QLQ-C30

Tipo de datos

boolean

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

QLQ-PAN26

Tipo de datos

boolean

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

Study-Related Examination (Secondary Endpoints)

Alias
UMLS CUI[1,1]
C4528314
UMLS CUI [2,1]
C4321457
Hospital stay due to chronic pancreatitis since last visit
Descripción

Hospital stay

Tipo de datos

boolean

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

specify

Tipo de datos

integer

Unidades de medida
  • days
Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0439228
days
Reoperation due to recurrence of chronic pancreatitis since last visit
Descripción

Reoperation

Tipo de datos

boolean

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

I.82

Tipo de datos

text

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

first reoperation

Tipo de datos

date

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

second reoperation

Tipo de datos

date

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

Weight

Tipo de datos

integer

Unidades de medida
  • kg
Alias
UMLS CUI [1,1]
C0005910
kg
Diabetes mellitus (under current oral or s.c. medication)
Descripción

Diabetes mellitus

Tipo de datos

integer

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

exocrine insufficiency

Tipo de datos

integer

Alias
UMLS CUI[1,1]
C0267963
UMLS CUI[1,2]
C0948571
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 [2,1]
C2346576
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
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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
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])
Hospital stay
Item
Hospital stay due to chronic pancreatitis since last visit
boolean
C3489408 (UMLS CUI [1,1])
C0149521 (UMLS CUI [1,2])
C2047944 (UMLS CUI [1,3])
specify
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.82
Item
please specify
text
C1521902 (UMLS CUI[1,1])
first reoperation
Item
Date of first reoperation
date
C0011008 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0035110 (UMLS CUI [1,3])
second reoperation
Item
Date of second reoperation
date
C0011008 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C0035110 (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 [2,1])
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])
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