ID

28341

Beschrijving

Trial to Evaluate Laparoscopic Versus Open Surgery in Elderly Colorectal Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01862562

Link

https://clinicaltrials.gov/show/NCT01862562

Trefwoorden

  1. 05-01-18 05-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 januari 2018

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Colorectal Cancer NCT01862562

Eligibility Colorectal Cancer NCT01862562

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age of 75 years old or over
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically proven adenocarcinoma
Beschrijving

Adenocarcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0001418
clinical tumor penetrates visceral peritoneum (t4a), no metastasis (m0) or lower t factor
Beschrijving

Tumor TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3258246
elective operation
Beschrijving

Elective Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1]
C0206058
tolerable surgery under general anesthesia
Beschrijving

Operative Surgical Procedures General Anesthesia Tolerable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0002915
UMLS CUI [1,3]
C4053931
no bulky tumor larger than 8cm in diameter
Beschrijving

Bulky Disease Diameter Size Restricted

Datatype

boolean

Alias
UMLS CUI [1,1]
C1511341
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0456389
UMLS CUI [1,4]
C0443288
no history of laparotomy for colorectal resection except appendectomy
Beschrijving

Absence Laparotomy Colorectal resection | Exception Appendectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0023038
UMLS CUI [1,3]
C0810152
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003611
provided written informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
synchronous or metachronous (within 5 years) malignancy in another organ except carcinoma in situ
Beschrijving

Malignant Neoplasm Synchronous Organ Other | Metachronous Malignant Neoplasm Organ Other | Exception Carcinoma in Situ

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0439580
UMLS CUI [1,3]
C0178784
UMLS CUI [1,4]
C0205394
UMLS CUI [2,1]
C1334703
UMLS CUI [2,2]
C0178784
UMLS CUI [2,3]
C0205394
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
multiple colorectal cancer that needs reconstruction two or more times
Beschrijving

Colorectal Carcinoma multiple | Reconstruction Quantity Needed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0439064
UMLS CUI [2,1]
C0524865
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0027552
acute intestinal obstruction or perforation due to colorectal cancer
Beschrijving

Intestinal Obstruction Due to Colorectal Carcinoma | Intestinal Perforation Due to Colorectal Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021843
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0009402
UMLS CUI [2,1]
C0021845
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0009402
lower rectal cancer that required pelvic side wall lymphadenectomy
Beschrijving

Rectal Carcinoma Lower | Pelvic wall Lymphadenectomy Needed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0007113
UMLS CUI [1,2]
C0441994
UMLS CUI [2,1]
C0230284
UMLS CUI [2,2]
C0024203
UMLS CUI [2,3]
C0027552
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

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

Similar models

Eligibility Colorectal Cancer NCT01862562

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age of 75 years old or over
boolean
C0001779 (UMLS CUI [1])
Adenocarcinoma
Item
histologically proven adenocarcinoma
boolean
C0001418 (UMLS CUI [1])
Tumor TNM clinical staging
Item
clinical tumor penetrates visceral peritoneum (t4a), no metastasis (m0) or lower t factor
boolean
C0027651 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Elective Surgical Procedures
Item
elective operation
boolean
C0206058 (UMLS CUI [1])
Operative Surgical Procedures General Anesthesia Tolerable
Item
tolerable surgery under general anesthesia
boolean
C0543467 (UMLS CUI [1,1])
C0002915 (UMLS CUI [1,2])
C4053931 (UMLS CUI [1,3])
Bulky Disease Diameter Size Restricted
Item
no bulky tumor larger than 8cm in diameter
boolean
C1511341 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
C0443288 (UMLS CUI [1,4])
Absence Laparotomy Colorectal resection | Exception Appendectomy
Item
no history of laparotomy for colorectal resection except appendectomy
boolean
C0332197 (UMLS CUI [1,1])
C0023038 (UMLS CUI [1,2])
C0810152 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0003611 (UMLS CUI [2,2])
Informed Consent
Item
provided written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm Synchronous Organ Other | Metachronous Malignant Neoplasm Organ Other | Exception Carcinoma in Situ
Item
synchronous or metachronous (within 5 years) malignancy in another organ except carcinoma in situ
boolean
C0006826 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C0178784 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1334703 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
Colorectal Carcinoma multiple | Reconstruction Quantity Needed
Item
multiple colorectal cancer that needs reconstruction two or more times
boolean
C0009402 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0524865 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0027552 (UMLS CUI [2,3])
Intestinal Obstruction Due to Colorectal Carcinoma | Intestinal Perforation Due to Colorectal Carcinoma
Item
acute intestinal obstruction or perforation due to colorectal cancer
boolean
C0021843 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
C0021845 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0009402 (UMLS CUI [2,3])
Rectal Carcinoma Lower | Pelvic wall Lymphadenectomy Needed
Item
lower rectal cancer that required pelvic side wall lymphadenectomy
boolean
C0007113 (UMLS CUI [1,1])
C0441994 (UMLS CUI [1,2])
C0230284 (UMLS CUI [2,1])
C0024203 (UMLS CUI [2,2])
C0027552 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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