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. 2/6/23 2/6/23 - 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

February 6, 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
Date of Visit
Beskrivning

Date of Visit

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

Date of Visit

Datatyp

date

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

Quality of Life (Primary Endpoint)

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

QLQ-C30

Datatyp

boolean

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

QLQ-PAN26

Datatyp

boolean

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

Study-Related Examination (Secondary Endpoints)

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

Wound infection

Datatyp

boolean

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

specify

Datatyp

string

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

Pulmonary infection

Datatyp

boolean

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

Pancreatic fistula

Datatyp

boolean

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

specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C1521902
Hospital stay due to chronic pancreatitis since last visit
Beskrivning

Hospital stay

Datatyp

boolean

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

specify days

Datatyp

integer

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

Reoperation

Datatyp

boolean

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

I.100

Datatyp

text

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

first reoperation

Datatyp

date

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

second reoperation

Datatyp

date

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

Weight

Datatyp

integer

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

Diabetes mellitus

Datatyp

integer

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

exocrine insufficiency

Datatyp

integer

Alias
UMLS CUI[1,1]
C0267963
UMLS CUI[1,2]
C0948571
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
Tillbaka till toppen

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
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])
Wound infection
Item
Wound infection (according to the CDC definition)
boolean
C0043241 (UMLS CUI [1,1])
specify
Item
please specify:
string
C1521902 (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.13
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])
Hospital stay
Item
Hospital stay due to chronic pancreatitis since last visit
boolean
C3489408 (UMLS CUI [1,1])
C2047944 (UMLS CUI [1,2])
C0149521 (UMLS CUI [1,3])
specify days
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.100
Item
please specify
text
C1521902 (UMLS CUI[1,1])
first reoperation
Item
Date of first reoperation
date
C0205435 (UMLS CUI [1,1])
C0035110 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
second reoperation
Item
Date of second reoperation
date
C0205436 (UMLS CUI [1,1])
C0035110 (UMLS CUI [1,2])
C0011008 (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 [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])
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