ID

28323

Beschrijving

Resorbable Barrier for the Prevention of Abdominal and Peri-hepatic Adhesion Formation; ODM derived from: https://clinicaltrials.gov/show/NCT01262417

Link

https://clinicaltrials.gov/show/NCT01262417

Trefwoorden

Versies (1)
  1. 04-01-18 04-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT01262417

Engels

Eligibility Colorectal Cancer NCT01262417

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
women and men aged ≥ 18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
colorectal cancer with synchronous or metachronous hepatic metastases
Beschrijving

Colorectal Carcinoma | Secondary malignant neoplasm of liver Synchronous | Secondary malignant neoplasm of liver Metachronous

Datatype

boolean

Alias
UMLS CUI [1]
C0009402
UMLS CUI [2,1]
C0494165
UMLS CUI [2,2]
C0439580
UMLS CUI [3,1]
C0494165
UMLS CUI [3,2]
C0085183
patients requiring two-stage surgery with laparotomy for the resection of hepatic metastases
Beschrijving

Operative Surgical Procedure Two stage Patient need for | Laparotomy | Excision Secondary malignant neoplasm of liver

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0574055
UMLS CUI [1,3]
C0686904
UMLS CUI [2]
C0023038
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C0494165
the 2 operations should be scheduled in the same centre
Beschrijving

Operative Surgical Procedures Quantity Scheduled | Medical center Same

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0565990
UMLS CUI [2,2]
C0445247
the 2 operations should be scheduled at an interval of 1 to 6 months
Beschrijving

Operative Surgical Procedures Quantity Scheduled | Interval

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0205539
UMLS CUI [2]
C1272706
patient affiliated with social security
Beschrijving

Social security recipient

Datatype

boolean

Alias
UMLS CUI [1]
C0682299
patient able to read and write french
Beschrijving

Able to read French language | Able to write French language

Datatype

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376246
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0376246
written, voluntary, informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with previous hepatic or biliary surgery through supra-umbilical incision (except biliary surgery with laparotomy more than 6 months previously)
Beschrijving

Operation on liver Surgical Incision Supraumbilical | Biliary Surgical Procedures Incision Supraumbilical

Datatype

boolean

Alias
UMLS CUI [1,1]
C0193373
UMLS CUI [1,2]
C0184898
UMLS CUI [1,3]
C0442196
UMLS CUI [2,1]
C0005427
UMLS CUI [2,2]
C0184898
UMLS CUI [2,3]
C0442196
patient with previous major surgery except colorectal surgery for resection of primitive tumour
Beschrijving

Major surgery | Exception Colorectal Surgery Tumors Simple

Datatype

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2608114
UMLS CUI [2,3]
C0027651
UMLS CUI [2,4]
C0205352
metastasis removable in one surgical procedure
Beschrijving

Neoplasm Metastasis Removable Operative Surgical Procedure Single

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1882925
UMLS CUI [1,3]
C0543467
UMLS CUI [1,4]
C0205171
non resectable metastasis
Beschrijving

Neoplasm Metastasis unresectable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1519810
follow-up impossible for social, geographical, familial or psychological reasons
Beschrijving

Follow-up Unsuccessful Due to Social factor | Follow-up Unsuccessful Due to Geographic Factors | Follow-up Unsuccessful Due to Factor Familial | Follow-up Unsuccessful Due to Psychological Factors

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1272705
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0337460
UMLS CUI [2,1]
C3274571
UMLS CUI [2,2]
C1272705
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0017444
UMLS CUI [3,1]
C3274571
UMLS CUI [3,2]
C1272705
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C1521761
UMLS CUI [3,5]
C0241888
UMLS CUI [4,1]
C3274571
UMLS CUI [4,2]
C1272705
UMLS CUI [4,3]
C0678226
UMLS CUI [4,4]
C0033898
patient deprived of freedom
Beschrijving

Prisoner

Datatype

boolean

Alias
UMLS CUI [1]
C0033167
patient enrolled in another experimental surgery trial
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
pregnant or lactating woman
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Colorectal Cancer NCT01262417

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
women and men aged ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Colorectal Carcinoma | Secondary malignant neoplasm of liver Synchronous | Secondary malignant neoplasm of liver Metachronous
Item
colorectal cancer with synchronous or metachronous hepatic metastases
boolean
C0009402 (UMLS CUI [1])
C0494165 (UMLS CUI [2,1])
C0439580 (UMLS CUI [2,2])
C0494165 (UMLS CUI [3,1])
C0085183 (UMLS CUI [3,2])
Operative Surgical Procedure Two stage Patient need for | Laparotomy | Excision Secondary malignant neoplasm of liver
Item
patients requiring two-stage surgery with laparotomy for the resection of hepatic metastases
boolean
C0543467 (UMLS CUI [1,1])
C0574055 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0023038 (UMLS CUI [2])
C0728940 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
Operative Surgical Procedures Quantity Scheduled | Medical center Same
Item
the 2 operations should be scheduled in the same centre
boolean
C0543467 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0565990 (UMLS CUI [2,1])
C0445247 (UMLS CUI [2,2])
Operative Surgical Procedures Quantity Scheduled | Interval
Item
the 2 operations should be scheduled at an interval of 1 to 6 months
boolean
C0543467 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C1272706 (UMLS CUI [2])
Social security recipient
Item
patient affiliated with social security
boolean
C0682299 (UMLS CUI [1])
Able to read French language | Able to write French language
Item
patient able to read and write french
boolean
C0586740 (UMLS CUI [1,1])
C0376246 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376246 (UMLS CUI [2,2])
Informed Consent
Item
written, voluntary, informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Operation on liver Surgical Incision Supraumbilical | Biliary Surgical Procedures Incision Supraumbilical
Item
patient with previous hepatic or biliary surgery through supra-umbilical incision (except biliary surgery with laparotomy more than 6 months previously)
boolean
C0193373 (UMLS CUI [1,1])
C0184898 (UMLS CUI [1,2])
C0442196 (UMLS CUI [1,3])
C0005427 (UMLS CUI [2,1])
C0184898 (UMLS CUI [2,2])
C0442196 (UMLS CUI [2,3])
Major surgery | Exception Colorectal Surgery Tumors Simple
Item
patient with previous major surgery except colorectal surgery for resection of primitive tumour
boolean
C0679637 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2608114 (UMLS CUI [2,2])
C0027651 (UMLS CUI [2,3])
C0205352 (UMLS CUI [2,4])
Neoplasm Metastasis Removable Operative Surgical Procedure Single
Item
metastasis removable in one surgical procedure
boolean
C0027627 (UMLS CUI [1,1])
C1882925 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0205171 (UMLS CUI [1,4])
Neoplasm Metastasis unresectable
Item
non resectable metastasis
boolean
C0027627 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
Follow-up Unsuccessful Due to Social factor | Follow-up Unsuccessful Due to Geographic Factors | Follow-up Unsuccessful Due to Factor Familial | Follow-up Unsuccessful Due to Psychological Factors
Item
follow-up impossible for social, geographical, familial or psychological reasons
boolean
C3274571 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0337460 (UMLS CUI [1,4])
C3274571 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0017444 (UMLS CUI [2,4])
C3274571 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C1521761 (UMLS CUI [3,4])
C0241888 (UMLS CUI [3,5])
C3274571 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0678226 (UMLS CUI [4,3])
C0033898 (UMLS CUI [4,4])
Prisoner
Item
patient deprived of freedom
boolean
C0033167 (UMLS CUI [1])
Study Subject Participation Status
Item
patient enrolled in another experimental surgery trial
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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