ID

45592

Description

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

Keywords

Versions (1)
  1. 2/6/23 2/6/23 - Dr. Christian Niklas
Copyright Holder

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

Uploaded on

February 6, 2023

DOI

10.1186/1745-6215-11-47

License

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

English

Start Questionnaire

7 forms  
  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
Description

Randomisation

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

date

Data type

date

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

number

Data type

integer

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

intervention

Data type

integer

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

Operation

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

date

Data type

date

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

Confirmation of Indication

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

intraop diagnosis

Data type

boolean

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

Operation Time

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

incision

Data type

time

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

closure

Data type

integer

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

Performed Surgical Resection and Reconstruction

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

choose

Data type

integer

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

specify

Data type

integer

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

Blood Loss

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

intraop blood loss surgeon

Data type

integer

Measurement units
  • ml
Alias
UMLS CUI[1,1]
C5208110
UMLS CUI[1,2]
C0582175
ml
Intraoperative blood loss assessed by anesthesist
Description

intraop blood loss anesthesist

Data type

integer

Measurement units
  • ml
Alias
UMLS CUI[1,1]
C5208110
UMLS CUI[1,2]
C1550495
ml
Serious Adverse Events
Description

Serious Adverse Events

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

SAE

Data type

boolean

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

please specify on SAE-form!

Translational Research
Description

Translational Research

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

Blood sample

Data type

boolean

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

Tissue sample

Data type

boolean

Alias
UMLS CUI [1,1]
C1292533
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Similar models

Start Questionnaire

7 forms
  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)
Data type
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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