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. 2023-02-06 2023-02-06 - 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

6 februari 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 Discharge
Description

Date of Discharge

please enter the date of Discharge
Description

date of Discharge

Data type

date

Alias
UMLS CUI[1,1]
C1635072
Final Histological Examination
Description

Final Histological Examination

Alias
UMLS CUI [1,1]
C0019638
Chronic pancreatitis proven by histological examination
Description

Histology

Data type

integer

Alias
UMLS CUI [1,1]
C0149521
UMLS CUI [1,2]
C0456369
UMLS CUI [1,3]
C0344441
Other findings
Description

Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
please specify
Description

specify

Data type

string

Alias
UMLS CUI [1,1]
C1521902
Study-Related Examination (Secondary Endpoints)
Description

Study-Related Examination (Secondary Endpoints)

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

Wound infection

Data type

boolean

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

specify

Data type

integer

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

Pulmonary infection

Data type

boolean

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

Pancreatic fistula

Data type

boolean

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

specify

Data type

integer

Alias
UMLS CUI [1,1]
C1521902
Delayed gastric emptying (according to Wente definition)
Description

gastric emptying

Data type

boolean

Alias
UMLS CUI [1,1]
C0740411
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[1,1]
C0011849
UMLS CUI[1,2]
C0013216
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

boolean

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 [1,1]
C0011008
UMLS CUI [1,2]
C2346576
With this electronic signature, I acknowledge that ALL REPORTED eFORMS (Cover, Eligibility Criteria, Screening1, Screening2, Operation, and Discharge) for this patient have 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 Discharge
date of Discharge
Item
please enter the date of Discharge
date
C1635072 (UMLS CUI[1,1])
Item Group
Final Histological Examination
C0019638 (UMLS CUI [1,1])
Histology
Item
Chronic pancreatitis proven by histological examination
integer
C0149521 (UMLS CUI [1,1])
C0456369 (UMLS CUI [1,2])
C0344441 (UMLS CUI [1,3])
Other
Item
Other findings
boolean
C0205394 (UMLS CUI [1,1])
specify
Item
please specify
string
C1521902 (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])
Item
please specify:
integer
C1521902 (UMLS CUI [1,1])
CL.8
Code List
please specify:
CL Item
Superficial (1)
C0205124 (UMLS CUI[1,1])
CL Item
Deep (2)
C0205125 (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.9
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])
gastric emptying
Item
Delayed gastric emptying (according to Wente definition)
boolean
C0740411 (UMLS CUI [1,1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1,1])
Item
Diabetes mellitus (under current oral or s.c. medication)
integer
C0011849 (UMLS CUI[1,1])
C0013216 (UMLS CUI[1,2])
CL.10
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)
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Item
Development of exocrine insufficiency (continuous supplement of enzymes necessary)
integer
C0267963 (UMLS CUI[1,1])
C0948571 (UMLS CUI[1,2])
CL.11
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
boolean
C0205314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
please specify on SAE-form!
Item Group
Investigator's Statement
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Investigator's Statement
Item
With this electronic signature, I acknowledge that ALL REPORTED eFORMS (Cover, Eligibility Criteria, Screening1, Screening2, Operation, and Discharge) for this patient have 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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