Anglais

Visit 2: Surgery

9 Formulaires  
General
Description

General

Alias
UMLS CUI [1,1]
C1508263
Date of Surgery
Description

Date of Surgery

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0543467
Intraoperative Exclusion Criteria (exclusion if "yes" is checked at least for one question)
Description

Intraoperative Exclusion Criteria (exclusion if "yes" is checked at least for one question)

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0456904
1. Incomplete stapling rings
Description

stapling rings incomplete

Type de données

boolean

Alias
UMLS CUI [1,1]
C0206263
UMLS CUI [1,2]
C0205257
2. Positive intraoperative air (bubble) test
Description

air (bubble) test positive

Type de données

boolean

Alias
UMLS CUI [1,1]
C0456904
UMLS CUI [1,2]
C0001863
UMLS CUI [1,3]
C1514241
3. Multivisceral resection
Description

Multivisceral resection

Type de données

boolean

Alias
UMLS CUI [1,1]
C0442045
UMLS CUI [1,2]
C0015252
4. Intraoperative findings that make a loop ileostomy indispensable in the individual surgeon's opinion (e.g. intraoperative diagnosis of liver cirrhosis, acute or chronic Ileus, intraoperative lesion of the rectum, urinary bladder, vagina, etc.)
Description

ileostomy indispensable

Type de données

boolean

Alias
UMLS CUI [1,1]
C0456904
UMLS CUI [1,2]
C0600219
UMLS CUI [1,3]
C0582175
UMLS CUI [1,4]
C0814499
UMLS CUI [1,5]
C0023985
If yes, please specify intraoperative finding
Description

specify

Type de données

integer

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0231286
If other, please specify
Description

specify

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
5. Intrasphincteric resection or transanal coloanal anastomosis
Description

intersphincteric resectio / transanal coloanal anastomosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C5569165
UMLS CUI [1,2]
C0015252
UMLS CUI [2,1]
C0589371
UMLS CUI [2,2]
C2985529
Randomization
Description

Randomization

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

randomization

Type de données

date

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

Randomization number

Type de données

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1300638
Randomization group
Description

Randomization group

Type de données

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0441833
Operation/Surgical procedure
Description

Operation/Surgical procedure

Alias
UMLS CUI [1,1]
C0543467
Start skin incision
Description

skin incision

Type de données

time

Unités de mesure
  • (hh:mm)
Alias
UMLS CUI [1,1]
C0191279
(hh:mm)
End skin closure
Description

skin closure

Type de données

time

Unités de mesure
  • (hh:mm)
Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0185003
(hh:mm)
Minimally invasive surgery
Description

Minimally invasive surgery

Type de données

boolean

Alias
UMLS CUI [1,1]
C0282624
Open surgery
Description

Open surgery

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348025
UMLS CUI [1,2]
C0543467
Intervention performed as randomized
Description

Intervention performed as randomized

Type de données

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1883713
UMLS CUI [1,3]
C0034656
If no, please specify reason
Description

specify

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
Conventional loop ileostomy was necessary after randomization
Description

Conventional loop ileostomy necessary

Type de données

boolean

Alias
UMLS CUI [1,1]
C0023985
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0034656
Decision of surgeon
Description

Decision of surgeon

Type de données

boolean

Alias
UMLS CUI [1,1]
C1709536
UMLS CUI [1,2]
C0582175
Intraoperative complication
Description

Intraoperative complication

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021890
Other
Description

Other

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205394
If other, please specify
Description

specify

Type de données

integer

Alias
UMLS CUI [1,1]
C1521902
Intraoperative Blood loss
Description

Blood loss

Type de données

integer

Alias
UMLS CUI [1,1]
C0456904
UMLS CUI [1,2]
C3163616
Intraoperative blood products
Description

Intraoperative blood products

Type de données

boolean

Alias
UMLS CUI [1,1]
C0456904
UMLS CUI [1,2]
C0456388
PRBC
Description

PRBC

Type de données

boolean

Alias
UMLS CUI [1,1]
C0199962
If yes, amount of packs
Description

amount of packs

Type de données

integer

Alias
UMLS CUI [1,1]
C1265611
Thrombocyte concentrate
Description

Thrombocyte concentrate

Type de données

boolean

Alias
UMLS CUI [1,1]
C1293886
Fresh frozen plasma
Description

Fresh frozen plasma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1293883
Surgeon's expertise (TAR Procedures performed until start of trial participation)
Description

Surgeon's expertise (TAR Procedures performed until start of trial participation)

Alias
UMLS CUI [1,1]
C0582175
UMLS CUI [1,2]
C0870520
UMLS CUI [1,3]
C5441351
≤ 50 procedures
Description

≤ 50 procedures

Type de données

boolean

Alias
UMLS CUI [1,1]
C0449788
> 50 procedures
Description

> 50 procedures

Type de données

boolean

Alias
UMLS CUI [1,1]
C0449788
Reconstruction technique
Description

Reconstruction technique

Alias
UMLS CUI [1,1]
C0524865
Transverse coloplasty
Description

Transverse coloplasty

Type de données

boolean

Alias
UMLS CUI [1,1]
C0227386
UMLS CUI [1,2]
C0192817
Side-to-end anastomosis
Description

Side-to-end anastomosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392773
Colonic J-pouch
Description

Colonic J-pouch

Type de données

boolean

Alias
UMLS CUI [1,1]
C0086783
UMLS CUI [1,2]
C0086492
Straight coloanal anastomosis
Description

Straight coloanal anastomosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C2985529
UMLS CUI [1,2]
C0445291
Height of anastomosis
Description

Height of anastomosis

Type de données

integer

Unités de mesure
  • cm
Alias
UMLS CUI [1,1]
C0489786
UMLS CUI [1,2]
C0332853
cm
Insertion of drainage
Description

Insertion of drainage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0441587
UMLS CUI [1,2]
C2037866
Complications
Description

Complications

Alias
UMLS CUI [1,1]
C0009566
Did any complication occur during operation
Description

complication occur during operation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0021890
please fill out details in "postoperative complications" form
Description

please fill out details in "postoperative complications" form

Alias
UMLS CUI [1,1]
C3273494
UMLS CUI [1,2]
C0032787
Protocol deviation (since last visit)
Description

Protocol deviation (since last visit)

Alias
UMLS CUI [1,1]
C1705236
Were there any protocol deviations since last visit
Description

protocol deviations since last visit

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205314
UMLS CUI [1,2]
C3872643
UMLS CUI [1,3]
C1705236
If yes, please describe
Description

describe

Type de données

text

Alias
UMLS CUI [1,1]
C1521902
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Similar models

Visit 2: Surgery

9 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
General
C1508263 (UMLS CUI [1,1])
Date of Surgery
Item
Date of Surgery
date
C0011008 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Item Group
Intraoperative Exclusion Criteria (exclusion if "yes" is checked at least for one question)
C0680251 (UMLS CUI [1,1])
C0456904 (UMLS CUI [1,2])
stapling rings incomplete
Item
1. Incomplete stapling rings
boolean
C0206263 (UMLS CUI [1,1])
C0205257 (UMLS CUI [1,2])
air (bubble) test positive
Item
2. Positive intraoperative air (bubble) test
boolean
C0456904 (UMLS CUI [1,1])
C0001863 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
Multivisceral resection
Item
3. Multivisceral resection
boolean
C0442045 (UMLS CUI [1,1])
C0015252 (UMLS CUI [1,2])
ileostomy indispensable
Item
4. Intraoperative findings that make a loop ileostomy indispensable in the individual surgeon's opinion (e.g. intraoperative diagnosis of liver cirrhosis, acute or chronic Ileus, intraoperative lesion of the rectum, urinary bladder, vagina, etc.)
boolean
C0456904 (UMLS CUI [1,1])
C0600219 (UMLS CUI [1,2])
C0582175 (UMLS CUI [1,3])
C0814499 (UMLS CUI [1,4])
C0023985 (UMLS CUI [1,5])
Item
If yes, please specify intraoperative finding
integer
C1521902 (UMLS CUI [1,1])
C0231286 (UMLS CUI [1,2])
CL.5
Code List
If yes, please specify intraoperative finding
CL Item
intraoperative diagnosis of liver cirrhosis (1)
C0231286 (UMLS CUI [1,1])
C0023890 (UMLS CUI [1,2])
CL Item
intraoperative lesion of the urinary bladder (2)
C1558210 (UMLS CUI [1,1])
C0005682 (UMLS CUI [1,2])
CL Item
intraoperative lesion of the vagina (3)
C1558210 (UMLS CUI [1,1])
C0042232 (UMLS CUI [1,2])
CL Item
intraoperative lesion of the rectum (5)
C1558210 (UMLS CUI [1,1])
C0034896 (UMLS CUI [1,2])
CL Item
acute or chronic ileus (4)
C1258215 (UMLS CUI [1,1])
CL Item
other (6)
C0205394 (UMLS CUI [1,1])
specify
Item
If other, please specify
text
C1521902 (UMLS CUI [1,1])
intersphincteric resectio / transanal coloanal anastomosis
Item
5. Intrasphincteric resection or transanal coloanal anastomosis
boolean
C5569165 (UMLS CUI [1,1])
C0015252 (UMLS CUI [1,2])
C0589371 (UMLS CUI [2,1])
C2985529 (UMLS CUI [2,2])
Item Group
Randomization
C0034656 (UMLS CUI [1,1])
randomization
Item
Date of randomization
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Randomization number
Item
Randomization number
integer
C0034656 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item
Randomization group
integer
C0034656 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
CL.10
Code List
Randomization group
CL Item
Ghost Ileostomy (1)
C5444416 (UMLS CUI [1,1])
C0020883 (UMLS CUI [1,2])
CL Item
Conventional Loop Ileostomy (2)
C0023985 (UMLS CUI [1,1])
Item Group
Operation/Surgical procedure
C0543467 (UMLS CUI [1,1])
skin incision
Item
Start skin incision
time
C0191279 (UMLS CUI [1,1])
skin closure
Item
End skin closure
time
C1522314 (UMLS CUI [1,1])
C0185003 (UMLS CUI [1,2])
Minimally invasive surgery
Item
Minimally invasive surgery
boolean
C0282624 (UMLS CUI [1,1])
Open surgery
Item
Open surgery
boolean
C0348025 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Intervention performed as randomized
Item
Intervention performed as randomized
boolean
C0184661 (UMLS CUI [1,1])
C1883713 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
specify
Item
If no, please specify reason
text
C1521902 (UMLS CUI [1,1])
Conventional loop ileostomy necessary
Item
Conventional loop ileostomy was necessary after randomization
boolean
C0023985 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
Decision of surgeon
Item
Decision of surgeon
boolean
C1709536 (UMLS CUI [1,1])
C0582175 (UMLS CUI [1,2])
Intraoperative complication
Item
Intraoperative complication
boolean
C0021890 (UMLS CUI [1,1])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
specify
Item
If other, please specify
integer
C1521902 (UMLS CUI [1,1])
Blood loss
Item
Intraoperative Blood loss
integer
C0456904 (UMLS CUI [1,1])
C3163616 (UMLS CUI [1,2])
Intraoperative blood products
Item
Intraoperative blood products
boolean
C0456904 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
PRBC
Item
PRBC
boolean
C0199962 (UMLS CUI [1,1])
amount of packs
Item
If yes, amount of packs
integer
C1265611 (UMLS CUI [1,1])
Thrombocyte concentrate
Item
Thrombocyte concentrate
boolean
C1293886 (UMLS CUI [1,1])
Fresh frozen plasma
Item
Fresh frozen plasma
boolean
C1293883 (UMLS CUI [1,1])
Item Group
Surgeon's expertise (TAR Procedures performed until start of trial participation)
C0582175 (UMLS CUI [1,1])
C0870520 (UMLS CUI [1,2])
C5441351 (UMLS CUI [1,3])
≤ 50 procedures
Item
≤ 50 procedures
boolean
C0449788 (UMLS CUI [1,1])
> 50 procedures
Item
> 50 procedures
boolean
C0449788 (UMLS CUI [1,1])
Item Group
Reconstruction technique
C0524865 (UMLS CUI [1,1])
Transverse coloplasty
Item
Transverse coloplasty
boolean
C0227386 (UMLS CUI [1,1])
C0192817 (UMLS CUI [1,2])
Side-to-end anastomosis
Item
Side-to-end anastomosis
boolean
C0392773 (UMLS CUI [1,1])
Colonic J-pouch
Item
Colonic J-pouch
boolean
C0086783 (UMLS CUI [1,1])
C0086492 (UMLS CUI [1,2])
Straight coloanal anastomosis
Item
Straight coloanal anastomosis
boolean
C2985529 (UMLS CUI [1,1])
C0445291 (UMLS CUI [1,2])
Height of anastomosis
Item
Height of anastomosis
integer
C0489786 (UMLS CUI [1,1])
C0332853 (UMLS CUI [1,2])
Insertion of drainage
Item
Insertion of drainage
boolean
C0441587 (UMLS CUI [1,1])
C2037866 (UMLS CUI [1,2])
Item Group
Complications
C0009566 (UMLS CUI [1,1])
complication occur during operation
Item
Did any complication occur during operation
boolean
C0021890 (UMLS CUI [1,1])
Item Group
please fill out details in "postoperative complications" form
C3273494 (UMLS CUI [1,1])
C0032787 (UMLS CUI [1,2])
Item Group
Protocol deviation (since last visit)
C1705236 (UMLS CUI [1,1])
protocol deviations since last visit
Item
Were there any protocol deviations since last visit
boolean
C0205314 (UMLS CUI [1,1])
C3872643 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
describe
Item
If yes, please describe
text
C1521902 (UMLS CUI [1,1])
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