ID

45592

Description

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

Keywords

Versions (1)
  1. 2/6/23 2/6/23 - Dr. Christian Niklas
Copyright Holder

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

Uploaded on

February 6, 2023

DOI

10.1186/1745-6215-11-47

License

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

English

Start Questionnaire

7 forms  
  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
Description

Date of Visit

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

Date of Visit

Data type

date

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

Quality of Life (Primary Endpoint)

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

QLQ-C30

Data type

boolean

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

QLQ-PAN26

Data type

boolean

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

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
Description

Hospital stay

Data type

boolean

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

specify

Data type

integer

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

Reoperation

Data type

boolean

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

I.82

Data type

text

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

first reoperation

Data type

date

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

second reoperation

Data type

date

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

Weight

Data type

integer

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

Diabetes mellitus

Data type

integer

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

exocrine insufficiency

Data type

integer

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

Serious Adverse Events

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

SAE

Data type

integer

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

please specify on SAE-form!

Investigator's Statement
Description

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.
Description

Investigator's Statement

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Start Questionnaire

7 forms
  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
Type
Description | Question | Decode (Coded Value)
Data type
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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