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. 06-02-23 06-02-23 - 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

6 februari 2023

DOI

10.1186/1745-6215-11-47

Licentie

Creative Commons BY 4.0
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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
Randomisation
Beschrijving

Randomisation

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

date

Datatype

date

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

number

Datatype

integer

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

intervention

Datatype

integer

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

Operation

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

date

Datatype

date

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

Confirmation of Indication

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

intraop diagnosis

Datatype

boolean

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

Operation Time

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

incision

Datatype

time

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

closure

Datatype

integer

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

Performed Surgical Resection and Reconstruction

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

choose

Datatype

integer

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

specify

Datatype

integer

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

Blood Loss

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

intraop blood loss surgeon

Datatype

integer

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

intraop blood loss anesthesist

Datatype

integer

Maateenheden
  • ml
Alias
UMLS CUI[1,1]
C5208110
UMLS CUI[1,2]
C1550495
ml
Serious Adverse Events
Beschrijving

Serious Adverse Events

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

SAE

Datatype

boolean

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

please specify on SAE-form!

Translational Research
Beschrijving

Translational Research

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

Blood sample

Datatype

boolean

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

Tissue sample

Datatype

boolean

Alias
UMLS CUI [1,1]
C1292533
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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
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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