ID

45592

Beschrijving

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

Trefwoorden

Versies (1)
  1. 2/6/23 2/6/23 - Dr. Christian Niklas
Houder van rechten

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

Geüploaded op

February 6, 2023

DOI

10.1186/1745-6215-11-47

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis

Engels

Start Questionnaire

7 Formulieren  
  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
Beschrijving

Date of Visit

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

Date of Visit

Datatype

date

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

Quality of Life (Primary Endpoint)

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

QLQ-C30

Datatype

boolean

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

QLQ-PAN26

Datatype

boolean

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

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
Beschrijving

Hospital stay

Datatype

boolean

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

specify

Datatype

integer

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

Reoperation

Datatype

boolean

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

I.82

Datatype

text

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

first reoperation

Datatype

date

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

second reoperation

Datatype

date

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

Weight

Datatype

integer

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

Diabetes mellitus

Datatype

integer

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

exocrine insufficiency

Datatype

integer

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

Serious Adverse Events

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

SAE

Datatype

integer

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

please specify on SAE-form!

Investigator's Statement
Beschrijving

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.
Beschrijving

Investigator's Statement

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Terug naar het begin van de pagina

Similar models

Start Questionnaire

7 Formulieren
  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)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial