ID

45592

Beschreibung

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

Stichworte

Versionen (1)
  1. 06.02.23 06.02.23 - Dr. Christian Niklas
Rechteinhaber

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

Hochgeladen am

6. Februar 2023

DOI

10.1186/1745-6215-11-47

Lizenz

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

Englisch

Start Questionnaire

7 Formulare  
  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
Randomisation
Beschreibung

Randomisation

Alias
UMLS CUI [1,1]
C0034656
Date of randomisation
Beschreibung

date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0034656
Randomisation number
Beschreibung

number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Randomised intervention
Beschreibung

intervention

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0549433
Operation
Beschreibung

Operation

Alias
UMLS CUI [1,1]
C0543467
Date of Operation
Beschreibung

date

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0543467
Confirmation of Indication
Beschreibung

Confirmation of Indication

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0392360
Intraoperative diagnosis of chronic pancreatitis
Beschreibung

intraop diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0456904
UMLS CUI [1,2]
C0011900
UMLS CUI [1,3]
C0149521
Operation Time
Beschreibung

Operation Time

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0040223
First incision of the skin
Beschreibung

incision

Datentyp

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0191279
Complete closure of wound
Beschreibung

closure

Datentyp

integer

Alias
UMLS CUI[1,1]
C1112446
UMLS CUI[1,2]
C1522314
Performed Surgical Resection and Reconstruction
Beschreibung

Performed Surgical Resection and Reconstruction

Alias
UMLS CUI [1,1]
C0543467
please choose
Beschreibung

choose

Datentyp

integer

Alias
UMLS CUI [1,1]
C1707391
please specify
Beschreibung

specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C1521902
Blood Loss
Beschreibung

Blood Loss

Alias
UMLS CUI [1,1]
C0553700
Intraoperative blood loss assessed by surgeon
Beschreibung

intraop blood loss surgeon

Datentyp

integer

Maßeinheiten
  • ml
Alias
UMLS CUI[1,1]
C5208110
UMLS CUI[1,2]
C0582175
ml
Intraoperative blood loss assessed by anesthesist
Beschreibung

intraop blood loss anesthesist

Datentyp

integer

Maßeinheiten
  • ml
Alias
UMLS CUI[1,1]
C5208110
UMLS CUI[1,2]
C1550495
ml
Serious Adverse Events
Beschreibung

Serious Adverse Events

Alias
UMLS CUI [1,1]
C1519255
Were there any serious adverse events?
Beschreibung

SAE

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
please specify on SAE-form!
Beschreibung

please specify on SAE-form!

Translational Research
Beschreibung

Translational Research

Alias
UMLS CUI[1,1]
C4521202
Blood sample taken
Beschreibung

Blood sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277698
Tissue sample taken
Beschreibung

Tissue sample

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1292533
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Ähnliche Modelle

Start Questionnaire

7 Formulare
  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)
Datentyp
Alias
Item Group
Randomisation
C0034656 (UMLS CUI [1,1])
date
Item
Date of randomisation
date
C0011008 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
number
Item
Randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Randomised intervention
integer
C0034656 (UMLS CUI [1,1])
C0549433 (UMLS CUI [1,2])
CL.5
Code List
Randomised intervention
CL Item
Duodenum preserving pancreatic head resection (DPPHR) (1)
C0400469 (UMLS CUI[1,1])
CL Item
Pancreatic duodenectomy (PD) / classic Whipple (CW) (2)
C0747191 (UMSL CUI[1,1])
C2945589 (UMSL CUI[1,2])
Item Group
Operation
C0543467 (UMLS CUI [1,1])
date
Item
Date of Operation
date
C0011008 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item Group
Confirmation of Indication
C0750484 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
intraop diagnosis
Item
Intraoperative diagnosis of chronic pancreatitis
boolean
C0456904 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C0149521 (UMLS CUI [1,3])
Item Group
Operation Time
C0543467 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
incision
Item
First incision of the skin
time
C1301880 (UMLS CUI [1,1])
C0191279 (UMLS CUI [1,2])
closure
Item
Complete closure of wound
integer
C1112446 (UMLS CUI[1,1])
C1522314 (UMLS CUI[1,2])
Item Group
Performed Surgical Resection and Reconstruction
C0543467 (UMLS CUI [1,1])
Item
please choose
integer
C1707391 (UMLS CUI [1,1])
CL.6
Code List
please choose
CL Item
Pyloruspreserving Whipple (1)
C0400468 (UMLS CUI[1,1])
CL Item
Classical Whipple (2)
C0085162 (UMLS CUI[1,1])
CL Item
Beger Duodenum-preserving pancreatic head resection (3)
C0400469 (UMLS CUI[1,1])
CL Item
Berne Duodenum-preserving pancreatic head resection without dissection of the pancreas above the portal vein (4)
C0400469 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0012737 (UMLS CUI [1,3])
C0030274 (UMLS CUI [1,4])
C0456745 (UMLS CUI [1,5])
C0032718 (UMLS CUI [1,6])
CL Item
Frey Local resection of the pancreatic head combined with longitudinal opening of the pancreatic duct (5)
C0227579 (UMLS CUI [1,1])
C0854522 (UMLS CUI [1,2])
C0205127 (UMLS CUI [1,3])
C0400530 (UMLS CUI [1,4])
CL Item
Other, please specify: (6)
C0205394 (UMLS CUI [1,1])
Item
please specify
integer
C1521902 (UMLS CUI [1,1])
CL.29
Code List
please specify
CL Item
Pancreaticojejunostomy (1)
C0030303 (UMLS CUI[1,1])
CL Item
Pancreaticogastrostomy (2)
C1533621 (UMLS CUI[1,1])
Item Group
Blood Loss
C0553700 (UMLS CUI [1,1])
intraop blood loss surgeon
Item
Intraoperative blood loss assessed by surgeon
integer
C5208110 (UMLS CUI[1,1])
C0582175 (UMLS CUI[1,2])
intraop blood loss anesthesist
Item
Intraoperative blood loss assessed by anesthesist
integer
C5208110 (UMLS CUI[1,1])
C1550495 (UMLS CUI[1,2])
Item Group
Serious Adverse Events
C1519255 (UMLS CUI [1,1])
SAE
Item
Were there any serious adverse events?
boolean
C1519255 (UMLS CUI [1,1])
Item Group
please specify on SAE-form!
Item Group
Translational Research
C4521202 (UMLS CUI[1,1])
Blood sample
Item
Blood sample taken
boolean
C1277698 (UMLS CUI [1,1])
Tissue sample
Item
Tissue sample taken
boolean
C1292533 (UMLS CUI [1,1])
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