Informações:
Falhas:
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
Link
Palavras-chave
Versões (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
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis
Start Questionnaire
- StudyEvent: Visit 1 : Screening
- StudyEvent: Visit 2 : Operation
- StudyEvent: Visit 3: Discharge
- StudyEvent: Visit 4: 6 +/- 1 Months Post Randomisation
- StudyEvent: Visit 5: 12 +/- 1 Months Post Randomisation
- StudyEvent: Visit 6: 24 +/- 1 Months Post Randomisation
- StudyEvent: End of Study
Similar models
Start Questionnaire
- StudyEvent: Visit 1 : Screening
- StudyEvent: Visit 2 : Operation
- StudyEvent: Visit 3: Discharge
- StudyEvent: Visit 4: 6 +/- 1 Months Post Randomisation
- StudyEvent: Visit 5: 12 +/- 1 Months Post Randomisation
- StudyEvent: Visit 6: 24 +/- 1 Months Post Randomisation
- StudyEvent: End of Study
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
date of Discharge
Item
please enter the date of Discharge
date
C1635072 (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])
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])
C4321457 (UMLS CUI[2,1])
Wound infection
Item
Wound infection (according to the CDC definition)
boolean
C0043241 (UMLS CUI [1,1])
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])
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])
C0013216 (UMLS CUI[1,2])
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])
C2047944 (UMLS CUI[1,2])
CL Item
Still present (3)
C0012634 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
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])
C0948571 (UMLS CUI[1,2])
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])
C0013216 (UMLS CUI[1,2])
CL Item
Still present (3)
C0012634 (UMLS CUI[1,1])
C0150312 (UMLS CUI[1,2])
C0150312 (UMLS CUI[1,2])
SAE
Item
Were there any new serious adverse events since last visit
boolean
C0205314 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Item Group
Investigator's Statement
C0011008 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
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])
C0011008 (UMLS CUI [1,2])