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ID

45592

Descrição

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

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Versões (1)
  1. 06/02/2023 06/02/2023 - Dr. Christian Niklas
Titular dos direitos

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

Transferido a

6 de fevereiro de 2023

DOI

10.1186/1745-6215-11-47

Licença

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

    Inglês

    Start Questionnaire

    7 Formulários  
    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
    Descrição

    Date of Visit

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

    Date of Visit

    Tipo de dados

    date

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

    Quality of Life (Primary Endpoint)

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

    QLQ-C30

    Tipo de dados

    boolean

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

    QLQ-PAN26

    Tipo de dados

    boolean

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

    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
    Descrição

    Hospital stay

    Tipo de dados

    boolean

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

    specify days

    Tipo de dados

    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
    Descrição

    Reoperation

    Tipo de dados

    boolean

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

    I.110

    Tipo de dados

    text

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

    first reoperation

    Tipo de dados

    date

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

    second reoperation

    Tipo de dados

    date

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

    Weight

    Tipo de dados

    integer

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

    Diabetes mellitus

    Tipo de dados

    integer

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

    exocrine insufficiency

    Tipo de dados

    integer

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

    Serious Adverse Events

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

    SAE

    Tipo de dados

    integer

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

    please specify on SAE-form!

    Investigator's Statement
    Descrição

    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.
    Descrição

    Investigator's Statement

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
    Voltar ao início da página

    Similar models

    Start Questionnaire

    7 Formulários
    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 dados
    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 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.110
    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
    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 [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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