Engelsk

Visit 1: Screening/Enrollment

9 Formulär  
General
Beskrivning

General

Alias
UMLS CUI [1,1]
C1508263
Date of Screening
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0220908
Inclusion criteria
Beskrivning

Inclusion criteria

Alias
UMLS CUI [1,1]
C1512693
Patients undergoing elective low anterior resection for rectal cancer
Beskrivning

elective low anterior resection for rectal cancer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0439608
UMLS CUI [1,2]
C3814448
UMLS CUI [1,3]
C0007113
Ability of subject to understand character and individual consequences of the clinical trial
Beskrivning

ability to understand

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1273101
UMLS CUI [1,2]
C0686907
UMLS CUI [1,3]
C0679823
UMLS CUI [1,4]
C0008976
Age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0001779
Written informed consent
Beskrivning

consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C4082015
Date of written informed consent
Beskrivning

Date consent

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C4082015
Preoperative exclusion criteria
Beskrivning

Preoperative exclusion criteria

Alias
UMLS CUI [1,1]
C0445204
UMLS CUI [1,2]
C0680251
BMI > 30 kg/m²
Beskrivning

BMI

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C0028754
ASA > 3
Beskrivning

ASA

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1531480
Chronic renal failure (necessitating dialysis or GFR<30 ml/min)
Beskrivning

renal failure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022661
Immunosuppression (cortisone ≥ 40 mg/d or equivalent; azathioprine, etc.)
Beskrivning

Immunosuppression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C4048329
Need for therapeutic anticoagulation (any medication)
Beskrivning

therapeutic anticoagulation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003281
Significant cardiac disease: - congestive heart failure of New York Heart Association class ≥ 2 - active coronary artery disease - unstable angina - patients with recent (less than 6 months) myocardial infarction (MI) - or coronary revascularization
Beskrivning

cardiac disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0750502
UMLS CUI [2,1]
C1275491
UMLS CUI [2,2]
C0018802
UMLS CUI [3,1]
C1956346
UMLS CUI [4,1]
C0002965
UMLS CUI [5,1]
C0027051
UMLS CUI [6,1]
C0877341
Liver cirrhosis (of any Child-Pugh grade)
Beskrivning

Liver cirrhosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023890
Ultralow rectal cancer (< 4cm ab ano, or necessitating intersphincteric resection or transanal coloanal anastomosis)
Beskrivning

Ultralow rectal cancer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0442811
Participation in another intervention-trial with interference of intervention and outcome of this study
Beskrivning

Participation in another intervention-trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0814861
Demography
Beskrivning

Demography

Alias
UMLS CUI [1,1]
C0011298
Gender
Beskrivning

Gender

Datatyp

integer

Alias
UMLS CUI [1,1]
C0079399
Age
Beskrivning

Age

Datatyp

integer

Måttenheter
  • Years
Alias
UMLS CUI [1,1]
C0001779
Years
Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1,1]
C0005890
cm
Weight
Beskrivning

Weight

Datatyp

integer

Måttenheter
  • kg
Alias
UMLS CUI [1,1]
C0005910
kg
Medical history
Beskrivning

Medical history

Alias
UMLS CUI [1,1]
C0262926
Previous abdominal surgery
Beskrivning

abdominal surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0198482
UMLS CUI [1,3]
C2062966
If yes, please specify
Beskrivning

specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
ASA status (according to anesthetist's protocol)
Beskrivning

ASA

Datatyp

integer

Alias
UMLS CUI [1,1]
C1531480
Carcinoma histologically proven
Beskrivning

Carcinoma histologically proven

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0456369
UMLS CUI [1,2]
C1516204
Bowel obstruction
Beskrivning

Bowel obstruction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021843
Rectal bleeding
Beskrivning

Rectal bleeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0267596
Hemoglobin
Beskrivning

Hemoglobin

Datatyp

float

Måttenheter
  • g/dl
Alias
UMLS CUI [1,1]
C0518015
g/dl
Height of the tumor from anal verge
Beskrivning

Height tumor

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1,1]
C1300126
cm
Neoadjuvant therapy
Beskrivning

Neoadjuvant therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600558
If yes, please specify
Beskrivning

specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C1521902
Relevant comorbidities/medical history
Beskrivning

Relevant comorbidities/medical history

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0009488
Cardiac
Beskrivning

Cardiac

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
Pulmonary
Beskrivning

Pulmonary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024115
Renal
Beskrivning

Renal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022658
Hepatic
Beskrivning

Hepatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023895
If yes, please specify
Beskrivning

specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
Diabetes mellitus
Beskrivning

Diabetes mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
Insulin dependent
Beskrivning

Insulin dependent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011854
Other comorbidities
Beskrivning

Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0009488
If yes, please specify
Beskrivning

specify

Datatyp

text

Alias
UMLS CUI [1,1]
C1521902
Prior imaging studies
Beskrivning

Prior imaging studies

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C1881134
CT
Beskrivning

CT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040405
MRT
Beskrivning

MRT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
EUS
Beskrivning

EUS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0376443
Quality of Life
Beskrivning

Quality of Life

Alias
UMLS CUI [1,1]
C0034380
QLQ C-30 completed
Beskrivning

QLQ C-30

Datatyp

boolean

Alias
UMLS CUI [1,1]
C5205956
UMLS CUI [1,2]
C1271978
CR29 completed
Beskrivning

CR29

Datatyp

boolean

Alias
UMLS CUI [1,1]
C5418603
UMLS CUI [1,2]
C1271978
Anorectal function: Wexner Score
Beskrivning

Anorectal function: Wexner Score

Alias
UMLS CUI [1,1]
C3870603
UMLS CUI [1,2]
C0542341
UMLS CUI [2,1]
C0015732
UMLS CUI [2,2]
C0449820
Solid incontinence
Beskrivning

Solid

Datatyp

integer

Alias
UMLS CUI [1,1]
C0021167
UMLS CUI [1,2]
C0205208
Liquid incontinence
Beskrivning

Liquid

Datatyp

integer

Alias
UMLS CUI [1,1]
C0021167
UMLS CUI [1,2]
C0302908
Gas incontinence
Beskrivning

Gas

Datatyp

integer

Alias
UMLS CUI [1,1]
C0021167
UMLS CUI [1,2]
C0017110
Wear Pad
Beskrivning

Pad

Datatyp

integer

Alias
UMLS CUI [1,1]
C0182158
Lifestyle altered
Beskrivning

Lifestyle

Datatyp

integer

Alias
UMLS CUI [1,1]
C0870811
Sum Wexner Score
Beskrivning

Wexner Score

Datatyp

integer

Alias
UMLS CUI [1,1]
C0021167
UMLS CUI [1,2]
C0449820
Date
Beskrivning

Date

Alias
UMLS CUI [1,1]
C0011008
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
Investigator
Beskrivning

Investigator

Alias
UMLS CUI [1,1]
C0035173
Name of investigator
Beskrivning

Name

Datatyp

text

Alias
UMLS CUI [1,1]
C2826892
Signature
Beskrivning

Signature

Datatyp

text

Alias
UMLS CUI [1,1]
C2346576
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Similar models

Visit 1: Screening/Enrollment

9 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
General
C1508263 (UMLS CUI [1,1])
Date
Item
Date of Screening
date
C0011008 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Item Group
Inclusion criteria
C1512693 (UMLS CUI [1,1])
elective low anterior resection for rectal cancer
Item
Patients undergoing elective low anterior resection for rectal cancer
boolean
C0439608 (UMLS CUI [1,1])
C3814448 (UMLS CUI [1,2])
C0007113 (UMLS CUI [1,3])
ability to understand
Item
Ability of subject to understand character and individual consequences of the clinical trial
boolean
C1273101 (UMLS CUI [1,1])
C0686907 (UMLS CUI [1,2])
C0679823 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
Age
Item
Age ≥ 18 years
boolean
C0001675 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C4082015 (UMLS CUI [1,2])
Date consent
Item
Date of written informed consent
date
C0011008 (UMLS CUI [1,1])
C4082015 (UMLS CUI [1,2])
Item Group
Preoperative exclusion criteria
C0445204 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
BMI
Item
BMI > 30 kg/m²
boolean
C1305855 (UMLS CUI [1,1])
C0028754 (UMLS CUI [1,2])
ASA
Item
ASA > 3
boolean
C1531480 (UMLS CUI [1,1])
renal failure
Item
Chronic renal failure (necessitating dialysis or GFR<30 ml/min)
boolean
C0022661 (UMLS CUI [1,1])
Immunosuppression
Item
Immunosuppression (cortisone ≥ 40 mg/d or equivalent; azathioprine, etc.)
boolean
C0021079 (UMLS CUI [1,1])
C4048329 (UMLS CUI [1,2])
therapeutic anticoagulation
Item
Need for therapeutic anticoagulation (any medication)
boolean
C0003281 (UMLS CUI [1,1])
cardiac disease
Item
Significant cardiac disease: - congestive heart failure of New York Heart Association class ≥ 2 - active coronary artery disease - unstable angina - patients with recent (less than 6 months) myocardial infarction (MI) - or coronary revascularization
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2,1])
C0018802 (UMLS CUI [2,2])
C1956346 (UMLS CUI [3,1])
C0002965 (UMLS CUI [4,1])
C0027051 (UMLS CUI [5,1])
C0877341 (UMLS CUI [6,1])
Liver cirrhosis
Item
Liver cirrhosis (of any Child-Pugh grade)
boolean
C0023890 (UMLS CUI [1,1])
Ultralow rectal cancer
Item
Ultralow rectal cancer (< 4cm ab ano, or necessitating intersphincteric resection or transanal coloanal anastomosis)
boolean
C0007113 (UMLS CUI [1,1])
C0442811 (UMLS CUI [1,2])
Participation in another intervention-trial
Item
Participation in another intervention-trial with interference of intervention and outcome of this study
boolean
C2348568 (UMLS CUI [1,1])
C0814861 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI [1,1])
Item
Gender
integer
C0079399 (UMLS CUI [1,1])
CL.1
Code List
Gender
CL Item
Female (1)
CL Item
Male (2)
Age
Item
Age
integer
C0001779 (UMLS CUI [1,1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1,1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1,1])
Item Group
Medical history
C0262926 (UMLS CUI [1,1])
abdominal surgery
Item
Previous abdominal surgery
boolean
C0205156 (UMLS CUI [1,1])
C0198482 (UMLS CUI [1,2])
C2062966 (UMLS CUI [1,3])
specify
Item
If yes, please specify
text
C1521902 (UMLS CUI [1,1])
Item
ASA status (according to anesthetist's protocol)
integer
C1531480 (UMLS CUI [1,1])
CL.2
Code List
ASA status (according to anesthetist's protocol)
CL Item
i (1)
CL Item
ii (2)
CL Item
iii (3)
Carcinoma histologically proven
Item
Carcinoma histologically proven
boolean
C0456369 (UMLS CUI [1,1])
C1516204 (UMLS CUI [1,2])
Bowel obstruction
Item
Bowel obstruction
boolean
C0021843 (UMLS CUI [1,1])
Rectal bleeding
Item
Rectal bleeding
boolean
C0267596 (UMLS CUI [1,1])
Hemoglobin
Item
Hemoglobin
float
C0518015 (UMLS CUI [1,1])
Height tumor
Item
Height of the tumor from anal verge
integer
C1300126 (UMLS CUI [1,1])
Neoadjuvant therapy
Item
Neoadjuvant therapy
boolean
C0600558 (UMLS CUI [1,1])
Item
If yes, please specify
integer
C1521902 (UMLS CUI [1,1])
CL.3
Code List
If yes, please specify
CL Item
Radiotherapy (1)
C1522449 (UMLS CUI [1,1])
CL Item
Radiochemotherapy (2)
C0436307 (UMLS CUI [1,1])
Item Group
Relevant comorbidities/medical history
C0262926 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Cardiac
Item
Cardiac
boolean
C0018799 (UMLS CUI [1,1])
Pulmonary
Item
Pulmonary
boolean
C0024115 (UMLS CUI [1,1])
Renal
Item
Renal
boolean
C0022658 (UMLS CUI [1,1])
Hepatic
Item
Hepatic
boolean
C0023895 (UMLS CUI [1,1])
specify
Item
If yes, please specify
text
C1521902 (UMLS CUI [1,1])
Diabetes mellitus
Item
Diabetes mellitus
boolean
C0011849 (UMLS CUI [1,1])
Insulin dependent
Item
Insulin dependent
boolean
C0011854 (UMLS CUI [1,1])
Other
Item
Other comorbidities
boolean
C0205394 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
specify
Item
If yes, please specify
text
C1521902 (UMLS CUI [1,1])
Item Group
Prior imaging studies
C0332152 (UMLS CUI [1,1])
C1881134 (UMLS CUI [1,2])
CT
Item
CT
boolean
C0040405 (UMLS CUI [1,1])
MRT
Item
MRT
boolean
C0024485 (UMLS CUI [1,1])
EUS
Item
EUS
boolean
C0376443 (UMLS CUI [1,1])
Item Group
Quality of Life
C0034380 (UMLS CUI [1,1])
QLQ C-30
Item
QLQ C-30 completed
boolean
C5205956 (UMLS CUI [1,1])
C1271978 (UMLS CUI [1,2])
CR29
Item
CR29 completed
boolean
C5418603 (UMLS CUI [1,1])
C1271978 (UMLS CUI [1,2])
Item Group
Anorectal function: Wexner Score
C3870603 (UMLS CUI [1,1])
C0542341 (UMLS CUI [1,2])
C0015732 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
Item
Solid incontinence
integer
C0021167 (UMLS CUI [1,1])
C0205208 (UMLS CUI [1,2])
CL.4
Code List
Solid incontinence
CL Item
Never (0)
C2003901 (UMLS CUI [1,1])
CL Item
Rarely (1)
C0522498 (UMLS CUI [1,1])
CL Item
Sometimes (2)
C1998882 (UMLS CUI [1,1])
CL Item
Usually (3)
C3888388 (UMLS CUI [1,1])
CL Item
Always (4)
C2003902 (UMLS CUI [1,1])
Item
Liquid incontinence
integer
C0021167 (UMLS CUI [1,1])
C0302908 (UMLS CUI [1,2])
CL.4
Code List
Liquid incontinence
CL Item
Never (0)
C2003901 (UMLS CUI [1,1])
CL Item
Rarely (1)
C0522498 (UMLS CUI [1,1])
CL Item
Sometimes (2)
C1998882 (UMLS CUI [1,1])
CL Item
Usually (3)
C3888388 (UMLS CUI [1,1])
CL Item
Always (4)
C2003902 (UMLS CUI [1,1])
Item
Gas incontinence
integer
C0021167 (UMLS CUI [1,1])
C0017110 (UMLS CUI [1,2])
CL.4
Code List
Gas incontinence
CL Item
Never (0)
C2003901 (UMLS CUI [1,1])
CL Item
Rarely (1)
C0522498 (UMLS CUI [1,1])
CL Item
Sometimes (2)
C1998882 (UMLS CUI [1,1])
CL Item
Usually (3)
C3888388 (UMLS CUI [1,1])
CL Item
Always (4)
C2003902 (UMLS CUI [1,1])
Item
Wear Pad
integer
C0182158 (UMLS CUI [1,1])
CL.4
Code List
Wear Pad
CL Item
Never (0)
C2003901 (UMLS CUI [1,1])
CL Item
Rarely (1)
C0522498 (UMLS CUI [1,1])
CL Item
Sometimes (2)
C1998882 (UMLS CUI [1,1])
CL Item
Usually (3)
C3888388 (UMLS CUI [1,1])
CL Item
Always (4)
C2003902 (UMLS CUI [1,1])
Item
Lifestyle altered
integer
C0870811 (UMLS CUI [1,1])
CL.4
Code List
Lifestyle altered
CL Item
Never (0)
C2003901 (UMLS CUI [1,1])
CL Item
Rarely (1)
C0522498 (UMLS CUI [1,1])
CL Item
Sometimes (2)
C1998882 (UMLS CUI [1,1])
CL Item
Usually (3)
C3888388 (UMLS CUI [1,1])
CL Item
Always (4)
C2003902 (UMLS CUI [1,1])
Wexner Score
Item
Sum Wexner Score
integer
C0021167 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
Item Group
Date
C0011008 (UMLS CUI [1,1])
Date
Item
Date
date
C0011008 (UMLS CUI [1,1])
Item Group
Investigator
C0035173 (UMLS CUI [1,1])
Name
Item
Name of investigator
text
C2826892 (UMLS CUI [1,1])
Signature
Item
Signature
text
C2346576 (UMLS CUI [1,1])
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