Visit 8: End of trial / postoperative month 6

General
Description

General

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

Date of visit

Data type

date

Alias
UMLS CUI [1,1]
C1320303
Patient discharged after index surgery
Description

Discharge

Data type

boolean

Alias
UMLS CUI [1,1]
C0030685
Date of discharge
Description

Date of discharge

Data type

integer

Alias
UMLS CUI [1,1]
C1635072
Patient readmitted to hospital since last visit
Description

Readmission

Data type

boolean

Alias
UMLS CUI [1,1]
C0600290
Date of readmission to hopital
Description

Date of readmission

Data type

date

Alias
UMLS CUI [1,1]
C0011008
Date of discharge from further inpatient treatment
Description

Date of discharge

Data type

date

Alias
UMLS CUI [1,1]
C1635072
Number of inpatient days, after readmission, if there was more than one readmission
Description

Inpatient days

Data type

integer

Alias
UMLS CUI [1,1]
C3640790
UMLS CUI [1,2]
C5142998
UMLS CUI [1,3]
C0030700
Please describe new complications since last visit
Description

Please describe new complications since last visit

Alias
UMLS CUI [1,1]
C3872643
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0009566
1. Transformation of the ghost ileostomy into protective loop ileostomy
Description

Transformation into protective loop ileostomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0456904
UMLS CUI [1,2]
C4319952
UMLS CUI [1,3]
C0020883
UMLS CUI [1,4]
C0023985
2. Date of transformation
Description

Date of transformation

Data type

integer

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C4319952
3. Reason for transformation
Description

Reason for transformation

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C4319952
Stoma related complications (since last visit)
Description

Stoma related complications (since last visit)

Alias
UMLS CUI [1,1]
C3872643
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0009566
UMLS CUI [1,4]
C1955856
Patient without stoma
Description

Without stoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1955856
UMLS CUI [1,2]
C0549184
1. Parastomal hernia
Description

Parastomal hernia

Data type

boolean

Alias
UMLS CUI [1,1]
C0341539
2. Peristomal wound
Description

Peristomal wound

Data type

boolean

Alias
UMLS CUI [1,1]
C0332798
UMLS CUI [1,2]
C4288405
3. Peristomal abscess
Description

Peristomal abscess

Data type

boolean

Alias
UMLS CUI [1,1]
C0341599
4. Peristomal ulceration
Description

Peristomal ulceration

Data type

boolean

Alias
UMLS CUI [1,1]
C4288405
UMLS CUI [1,2]
C0041582
5. Dehydration/high-output stoma with the need for iv-fluid substitution
Description

Dehydration/high-output stoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0011175
UMLS CUI [2,1]
C0522792
UMLS CUI [2,2]
C0341610
6. Acute kidney injury due to high output
Description

Acute kidney injury

Data type

boolean

Alias
UMLS CUI [1,1]
C2609414
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0341610
If yes, was there need for dialysis?
Description

Need for dialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0686904
7. Other stoma-related complications
Description

Other complications

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1821029
If yes, please continue with postoperative complications
Description

If yes, please continue with postoperative complications

Alias
UMLS CUI [1,1]
C0032787
If at least one complication (1. to 7.) is "yes", please specify in "Postoperative complications"-form
Description

If at least one complication (1. to 7.) is "yes", please specify in "Postoperative complications"-form

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0032787
Postoperative Complications (since last visit)
Description

Postoperative Complications (since last visit)

Alias
UMLS CUI [1,1]
C0032787
UMLS CUI [1,2]
C2047944
UMLS CUI [1,3]
C0205314
UMLS CUI [1,4]
C3872643
1. Anastomotic leakage
Description

Anastomotic leakage

Data type

boolean

Alias
UMLS CUI [1,1]
C0332853
UMLS CUI [1,2]
C4281748
If yes, classification according to ISREC
Description

ISREC

Data type

integer

Alias
UMLS CUI [1,1]
C0008902
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0919691
2. Intraabdominal abscess
Description

Intraabdominal abscess

Data type

boolean

Alias
UMLS CUI [1,1]
C4302732
3. Wound dehiscence
Description

Wound dehiscence

Data type

boolean

Alias
UMLS CUI [1,1]
C0259768
4. Other postoperative complications
Description

Other complications

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0032787
If at least one complication (1. to 4.) is "yes", please specify in "Postoperative complications"-form
Description

If at least one complication (1. to 4.) is "yes", please specify in "Postoperative complications"-form

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0032787
Reoperation and reintervention (since last visit)
Description

Reoperation and reintervention (since last visit)

Alias
UMLS CUI [1,1]
C5452916
UMLS CUI [1,2]
C0035110
UMLS CUI [1,3]
C3872643
UMLS CUI [1,4]
C0205314
1. Reoperation
Description

1. Reoperation

Alias
UMLS CUI [1,1]
C0035110
Did the patient undergo reoperation
Description

Reoperation

Data type

boolean

Alias
UMLS CUI [1,1]
C0035110
If yes, reason for reoperation (Please specify in "Postoperative complications"-form
Description

Reason

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0035110
Date of reoperation
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0035110
UMLS CUI [1,2]
C0011008
Specification of surgical procedure
Description

specify

Data type

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C3173307
Did the patient undergo terminal ostomy
Description

Terminal ostomy

Data type

boolean

Alias
UMLS CUI [1,1]
C1705315
UMLS CUI [1,2]
C0029473
Please specify procedure
Description

specify

Data type

integer

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C3173307
Date of terminal ostomy
Description

Date

Data type

integer

Alias
UMLS CUI [1,1]
C0011008
2. Reintervention
Description

2. Reintervention

Alias
UMLS CUI [1,1]
C5452916
Did the patient have a therapeutic intervention
Description

Intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0808232
Interventional drainage
Description

Drainage

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0013103
If yes, reason for interventional drainage (Please specify in "Postoperative complications"-form)
Description

Reason

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0013103
UMLS CUI [1,3]
C0566251
If yes, date of insertion of drainage
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0013103
Endoscopic intervention
Description

Endoscopic intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0014245
If yes, reason for endoscopic intervention (Please specify in "Postoperative complications"-form)
Description

Reason

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C0184661
UMLS CUI [1,4]
C0014245
If yes, specification of endoscopic intervention
Description

specify

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0014245
UMLS CUI [1,3]
C0184661
Date of endoscopic intervention
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0014245
Ileostomy closure
Description

Ileostomy closure

Alias
UMLS CUI [1,1]
C0192775
Stoma closure performed
Description

Stoma closure

Data type

boolean

Alias
UMLS CUI [1,1]
C3665863
If yes, date of stoma closure
Description

Date stoma closure

Data type

date

Alias
UMLS CUI [1,1]
C0011008
If no, please continue with comprehensive complication index below
Description

If no, please continue with comprehensive complication index below

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0918012
UMLS CUI [1,3]
C0009566
Complications after ileostomy closure
Description

Complications after ileostomy closure

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C0192775
1. Anastomotic leakage
Description

Anastomotic leakage

Data type

boolean

Alias
UMLS CUI [1,1]
C0332853
UMLS CUI [1,2]
C4281748
2. Prolonged postoperative ileus
Description

Prolonged ileus

Data type

boolean

Alias
UMLS CUI [1,1]
C0400877
UMLS CUI [1,2]
C0439590
3. Wound dehiscence
Description

Wound dehiscence

Data type

boolean

Alias
UMLS CUI [1,1]
C0259768
4. Surgical site infection
Description

Surgical site infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0038941
5. Burst abdomen (dehiscence of abdominal fascia)
Description

Burst abdomen

Data type

boolean

Alias
UMLS CUI [1,1]
C0929287
UMLS CUI [1,2]
C1739397
UMLS CUI [1,3]
C2711727
6. Incisional hernia
Description

Incisional hernia

Data type

boolean

Alias
UMLS CUI [1,1]
C0267716
7. Other complications related to ileostomy closure
Description

Other complications

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
8. Reoperation due to complication after ileostomy closure
Description

Reoperation

Data type

boolean

Alias
UMLS CUI [1,1]
C0035110
If yes, documented in section reoperation and intervention
Description

Documented

Data type

boolean

Alias
UMLS CUI [1,1]
C1301725
If at least one complication (1. to 8.) is "yes", please specify in "Postoperative complications"-form
Description

If at least one complication (1. to 8.) is "yes", please specify in "Postoperative complications"-form

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0032787
Comprehensive complication index (complications up to POD 30)
Description

Comprehensive complication index (complications up to POD 30)

Alias
UMLS CUI [1,1]
C1880156
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0918012
UMLS CUI [2,1]
C4524868
Grade I
Description

I

Data type

integer

Alias
UMLS CUI [1,1]
C4049998
Grade II
Description

II

Data type

integer

Alias
UMLS CUI [1,1]
C4049999
Grade IIIa
Description

IIIa

Data type

integer

Alias
UMLS CUI [1,1]
C4050000
Grade IIIb
Description

IIIb

Data type

integer

Alias
UMLS CUI [1,1]
C4050000
Grade IVa
Description

IVa

Data type

integer

Alias
UMLS CUI [1,1]
C4050001
Grade IVb
Description

IVb

Data type

integer

Alias
UMLS CUI [1,1]
C4050001
Grade V
Description

V

Data type

integer

Alias
UMLS CUI [1,1]
C4050002
CCI
Description

CCI

Data type

integer

Alias
UMLS CUI [1,1]
C0009566
UMLS CUI [1,2]
C4524868
Quality of Life and functional questionnaires
Description

Quality of Life and functional questionnaires

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0281588
EORTC QLQ-C30 completed
Description

EORTC QLQ-C30

Data type

boolean

Alias
UMLS CUI [1,1]
C3641780
CR29 completed
Description

CR 29

Data type

boolean

Alias
UMLS CUI [1,1]
C5418603
Wexner score completed
Description

Wexner score

Data type

boolean

Alias
UMLS CUI [1,1]
C0015732
UMLS CUI [1,2]
C0449820
Anorectal function: Wexner Score
Description

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
Description

Solid

Data type

integer

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

Liquid

Data type

integer

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

Gas

Data type

integer

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

Pad

Data type

integer

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

Lifestyle

Data type

integer

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

Wexner Score

Data type

integer

Alias
UMLS CUI [1,1]
C0021167
UMLS CUI [1,2]
C0449820
Perioperative or adjuvant chemotherapy
Description

Perioperative or adjuvant chemotherapy

Alias
UMLS CUI [1,1]
C0392920
Adjuvant therapy planned
Description

Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C0085533
If yes, please specify
Description

specify

Data type

integer

Alias
UMLS CUI [1,1]
C1521902
Start of adjuvant therapy
Description

Date

Data type

boolean

Alias
UMLS CUI [1,1]
C0439659
UMLS CUI [1,2]
C0085533
If yes, please specify therapy
Description

If yes, please specify therapy

Alias
UMLS CUI [1,1]
C1521902
Radiochemotherapy
Description

Radiochemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0436307
Chemotherapy
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
If yes, could all cycles of adjuvant therapy be completed as intended (dose adaption / reduction excluded)?
Description

All cycles completed

Data type

boolean

Alias
UMLS CUI [1,1]
C0580352
UMLS CUI [1,2]
C1556116
Protocol deviation (since last visit)
Description

Protocol deviation (since last visit)

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C3872643
Were there any protocol deviations since last visit?
Description

protocol deviations

Data type

boolean

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

specify

Data type

text

Alias
UMLS CUI [1,1]
C1521902
End of Study
Description

End of Study

Alias
UMLS CUI [1,1]
C0444930
UMLS CUI [1,2]
C2603343
Did the patient complete the trial regularly?
Description

Regularly

Data type

boolean

Alias
UMLS CUI [1,1]
C2348577
If no, please specify reason for premature trial termination
Description

If no, please specify reason for premature trial termination

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C5669243
1. Patient died
Description

Patient died

Data type

boolean

Alias
UMLS CUI [1,1]
C1306577
If yes, date of death
Description

Date of death

Data type

date

Alias
UMLS CUI [1,1]
C1148348
If yes, reason of death
Description

Reason of death

Data type

text

Alias
UMLS CUI [1,1]
C0007465
2. Lost to follow up
Description

Lost to follow up

Data type

boolean

Alias
UMLS CUI [1,1]
C1302313
If yes, date of last contact
Description

Date of last contact

Data type

date

Alias
UMLS CUI [1,1]
C0805839
3. Withdrawal informed consent
Description

Withdrawal informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C1707492
If yes, date of withdrawal
Description

Date of withdrawal

Data type

date

Alias
UMLS CUI [1,1]
C0011008
4. other
Description

Other

Data type

boolean

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

specify

Data type

integer

Alias
UMLS CUI [1,1]
C1521902
Date
Description

Date

Alias
UMLS CUI [1,1]
C0011008
Date
Description

Date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
Investigator
Description

Investigator

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

Name

Data type

text

Alias
UMLS CUI [1,1]
C2826892
Signature
Description

Signature

Data type

text

Alias
UMLS CUI [1,1]
C2346576

Similar models

Visit 8: End of trial / postoperative month 6

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General
C1508263 (UMLS CUI [1,1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
Discharge
Item
Patient discharged after index surgery
boolean
C0030685 (UMLS CUI [1,1])
Date of discharge
Item
Date of discharge
integer
C1635072 (UMLS CUI [1,1])
Readmission
Item
Patient readmitted to hospital since last visit
boolean
C0600290 (UMLS CUI [1,1])
Date of readmission
Item
Date of readmission to hopital
date
C0011008 (UMLS CUI [1,1])
Date of discharge
Item
Date of discharge from further inpatient treatment
date
C1635072 (UMLS CUI [1,1])
Inpatient days
Item
Number of inpatient days, after readmission, if there was more than one readmission
integer
C3640790 (UMLS CUI [1,1])
C5142998 (UMLS CUI [1,2])
C0030700 (UMLS CUI [1,3])
Item Group
Please describe new complications since last visit
C3872643 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
Transformation into protective loop ileostomy
Item
1. Transformation of the ghost ileostomy into protective loop ileostomy
boolean
C0456904 (UMLS CUI [1,1])
C4319952 (UMLS CUI [1,2])
C0020883 (UMLS CUI [1,3])
C0023985 (UMLS CUI [1,4])
Date of transformation
Item
2. Date of transformation
integer
C0011008 (UMLS CUI [1,1])
C4319952 (UMLS CUI [1,2])
Reason for transformation
Item
3. Reason for transformation
text
C0392360 (UMLS CUI [1,1])
C4319952 (UMLS CUI [1,2])
Item Group
Stoma related complications (since last visit)
C3872643 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
C1955856 (UMLS CUI [1,4])
Without stoma
Item
Patient without stoma
boolean
C1955856 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
Parastomal hernia
Item
1. Parastomal hernia
boolean
C0341539 (UMLS CUI [1,1])
Peristomal wound
Item
2. Peristomal wound
boolean
C0332798 (UMLS CUI [1,1])
C4288405 (UMLS CUI [1,2])
Peristomal abscess
Item
3. Peristomal abscess
boolean
C0341599 (UMLS CUI [1,1])
Peristomal ulceration
Item
4. Peristomal ulceration
boolean
C4288405 (UMLS CUI [1,1])
C0041582 (UMLS CUI [1,2])
Dehydration/high-output stoma
Item
5. Dehydration/high-output stoma with the need for iv-fluid substitution
boolean
C0011175 (UMLS CUI [1,1])
C0522792 (UMLS CUI [2,1])
C0341610 (UMLS CUI [2,2])
Acute kidney injury
Item
6. Acute kidney injury due to high output
boolean
C2609414 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0341610 (UMLS CUI [1,3])
Need for dialysis
Item
If yes, was there need for dialysis?
boolean
C0011946 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Other complications
Item
7. Other stoma-related complications
boolean
C0205394 (UMLS CUI [1,1])
C1821029 (UMLS CUI [1,2])
Item Group
If yes, please continue with postoperative complications
C0032787 (UMLS CUI [1,1])
Item Group
If at least one complication (1. to 7.) is "yes", please specify in "Postoperative complications"-form
C1521902 (UMLS CUI [1,1])
C0032787 (UMLS CUI [1,2])
Item Group
Postoperative Complications (since last visit)
C0032787 (UMLS CUI [1,1])
C2047944 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,3])
C3872643 (UMLS CUI [1,4])
Anastomotic leakage
Item
1. Anastomotic leakage
boolean
C0332853 (UMLS CUI [1,1])
C4281748 (UMLS CUI [1,2])
Item
If yes, classification according to ISREC
integer
C0008902 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0919691 (UMLS CUI [1,3])
Code List
If yes, classification according to ISREC
CL Item
Grade A (1)
CL Item
Grade B (2)
CL Item
Grade C (3)
Intraabdominal abscess
Item
2. Intraabdominal abscess
boolean
C4302732 (UMLS CUI [1,1])
Wound dehiscence
Item
3. Wound dehiscence
boolean
C0259768 (UMLS CUI [1,1])
Other complications
Item
4. Other postoperative complications
boolean
C0205394 (UMLS CUI [1,1])
C0032787 (UMLS CUI [1,2])
Item Group
If at least one complication (1. to 4.) is "yes", please specify in "Postoperative complications"-form
C1521902 (UMLS CUI [1,1])
C0032787 (UMLS CUI [1,2])
Item Group
Reoperation and reintervention (since last visit)
C5452916 (UMLS CUI [1,1])
C0035110 (UMLS CUI [1,2])
C3872643 (UMLS CUI [1,3])
C0205314 (UMLS CUI [1,4])
Item Group
1. Reoperation
C0035110 (UMLS CUI [1,1])
Reoperation
Item
Did the patient undergo reoperation
boolean
C0035110 (UMLS CUI [1,1])
Reason
Item
If yes, reason for reoperation (Please specify in "Postoperative complications"-form
text
C1521902 (UMLS CUI [1,1])
C0035110 (UMLS CUI [1,2])
Date
Item
Date of reoperation
date
C0035110 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
specify
Item
Specification of surgical procedure
text
C2348235 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C3173307 (UMLS CUI [1,3])
Terminal ostomy
Item
Did the patient undergo terminal ostomy
boolean
C1705315 (UMLS CUI [1,1])
C0029473 (UMLS CUI [1,2])
Item
Please specify procedure
integer
C2348235 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C3173307 (UMLS CUI [1,3])
Code List
Please specify procedure
CL Item
Hatmann procedure (1)
CL Item
Abdomino-perineal extirpation (2)
Date
Item
Date of terminal ostomy
integer
C0011008 (UMLS CUI [1,1])
Item Group
2. Reintervention
C5452916 (UMLS CUI [1,1])
Intervention
Item
Did the patient have a therapeutic intervention
boolean
C0808232 (UMLS CUI [1,1])
Drainage
Item
Interventional drainage
boolean
C0184661 (UMLS CUI [1,1])
C0013103 (UMLS CUI [1,2])
Reason
Item
If yes, reason for interventional drainage (Please specify in "Postoperative complications"-form)
text
C1521902 (UMLS CUI [1,1])
C0013103 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Date
Item
If yes, date of insertion of drainage
date
C0011008 (UMLS CUI [1,1])
C0013103 (UMLS CUI [1,2])
Endoscopic intervention
Item
Endoscopic intervention
boolean
C0184661 (UMLS CUI [1,1])
C0014245 (UMLS CUI [1,2])
Reason
Item
If yes, reason for endoscopic intervention (Please specify in "Postoperative complications"-form)
text
C0566251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0014245 (UMLS CUI [1,4])
specify
Item
If yes, specification of endoscopic intervention
text
C1521902 (UMLS CUI [1,1])
C0014245 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Date
Item
Date of endoscopic intervention
date
C0011008 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0014245 (UMLS CUI [1,3])
Item Group
Ileostomy closure
C0192775 (UMLS CUI [1,1])
Stoma closure
Item
Stoma closure performed
boolean
C3665863 (UMLS CUI [1,1])
Date stoma closure
Item
If yes, date of stoma closure
date
C0011008 (UMLS CUI [1,1])
Item Group
If no, please continue with comprehensive complication index below
C1521902 (UMLS CUI [1,1])
C0918012 (UMLS CUI [1,2])
C0009566 (UMLS CUI [1,3])
Item Group
Complications after ileostomy closure
C0009566 (UMLS CUI [1,1])
C0192775 (UMLS CUI [1,2])
Anastomotic leakage
Item
1. Anastomotic leakage
boolean
C0332853 (UMLS CUI [1,1])
C4281748 (UMLS CUI [1,2])
Prolonged ileus
Item
2. Prolonged postoperative ileus
boolean
C0400877 (UMLS CUI [1,1])
C0439590 (UMLS CUI [1,2])
Wound dehiscence
Item
3. Wound dehiscence
boolean
C0259768 (UMLS CUI [1,1])
Surgical site infection
Item
4. Surgical site infection
boolean
C0038941 (UMLS CUI [1,1])
Burst abdomen
Item
5. Burst abdomen (dehiscence of abdominal fascia)
boolean
C0929287 (UMLS CUI [1,1])
C1739397 (UMLS CUI [1,2])
C2711727 (UMLS CUI [1,3])
Incisional hernia
Item
6. Incisional hernia
boolean
C0267716 (UMLS CUI [1,1])
Other complications
Item
7. Other complications related to ileostomy closure
boolean
C0205394 (UMLS CUI [1,1])
Reoperation
Item
8. Reoperation due to complication after ileostomy closure
boolean
C0035110 (UMLS CUI [1,1])
Documented
Item
If yes, documented in section reoperation and intervention
boolean
C1301725 (UMLS CUI [1,1])
Item Group
If at least one complication (1. to 8.) is "yes", please specify in "Postoperative complications"-form
C1521902 (UMLS CUI [1,1])
C0032787 (UMLS CUI [1,2])
Item Group
Comprehensive complication index (complications up to POD 30)
C1880156 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0918012 (UMLS CUI [1,3])
C4524868 (UMLS CUI [2,1])
I
Item
Grade I
integer
C4049998 (UMLS CUI [1,1])
II
Item
Grade II
integer
C4049999 (UMLS CUI [1,1])
IIIa
Item
Grade IIIa
integer
C4050000 (UMLS CUI [1,1])
IIIb
Item
Grade IIIb
integer
C4050000 (UMLS CUI [1,1])
IVa
Item
Grade IVa
integer
C4050001 (UMLS CUI [1,1])
IVb
Item
Grade IVb
integer
C4050001 (UMLS CUI [1,1])
V
Item
Grade V
integer
C4050002 (UMLS CUI [1,1])
CCI
Item
CCI
integer
C0009566 (UMLS CUI [1,1])
C4524868 (UMLS CUI [1,2])
Item Group
Quality of Life and functional questionnaires
C0034394 (UMLS CUI [1,1])
C0281588 (UMLS CUI [1,2])
EORTC QLQ-C30
Item
EORTC QLQ-C30 completed
boolean
C3641780 (UMLS CUI [1,1])
CR 29
Item
CR29 completed
boolean
C5418603 (UMLS CUI [1,1])
Wexner score
Item
Wexner score completed
boolean
C0015732 (UMLS CUI [1,1])
C0449820 (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])
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])
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])
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])
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])
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
Perioperative or adjuvant chemotherapy
C0392920 (UMLS CUI [1,1])
Adjuvant therapy
Item
Adjuvant therapy planned
boolean
C1301732 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
specify
Item
If yes, please specify
integer
C1521902 (UMLS CUI [1,1])
Date
Item
Start of adjuvant therapy
boolean
C0439659 (UMLS CUI [1,1])
C0085533 (UMLS CUI [1,2])
Item Group
If yes, please specify therapy
C1521902 (UMLS CUI [1,1])
Radiochemotherapy
Item
Radiochemotherapy
boolean
C0436307 (UMLS CUI [1,1])
Chemotherapy
Item
Chemotherapy
boolean
C3665472 (UMLS CUI [1,1])
All cycles completed
Item
If yes, could all cycles of adjuvant therapy be completed as intended (dose adaption / reduction excluded)?
boolean
C0580352 (UMLS CUI [1,1])
C1556116 (UMLS CUI [1,2])
Item Group
Protocol deviation (since last visit)
C1705236 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C3872643 (UMLS CUI [1,3])
protocol deviations
Item
Were there any protocol deviations since last visit?
boolean
C1705236 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C3872643 (UMLS CUI [1,3])
specify
Item
If yes, please describe
text
C1521902 (UMLS CUI [1,1])
Item Group
End of Study
C0444930 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Regularly
Item
Did the patient complete the trial regularly?
boolean
C2348577 (UMLS CUI [1,1])
Item Group
If no, please specify reason for premature trial termination
C1521902 (UMLS CUI [1,1])
C5669243 (UMLS CUI [1,2])
Patient died
Item
1. Patient died
boolean
C1306577 (UMLS CUI [1,1])
Date of death
Item
If yes, date of death
date
C1148348 (UMLS CUI [1,1])
Reason of death
Item
If yes, reason of death
text
C0007465 (UMLS CUI [1,1])
Lost to follow up
Item
2. Lost to follow up
boolean
C1302313 (UMLS CUI [1,1])
Date of last contact
Item
If yes, date of last contact
date
C0805839 (UMLS CUI [1,1])
Withdrawal informed consent
Item
3. Withdrawal informed consent
boolean
C1707492 (UMLS CUI [1,1])
Date of withdrawal
Item
If yes, date of withdrawal
date
C0011008 (UMLS CUI [1,1])
Other
Item
4. other
boolean
C0205394 (UMLS CUI [1,1])
specify
Item
If yes, please specify
integer
C1521902 (UMLS CUI [1,1])
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])