ID

36836

Description

Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?; ODM derived from: https://clinicaltrials.gov/show/NCT02510911

Link

https://clinicaltrials.gov/show/NCT02510911

Keywords

Versions (1)
  1. 6/14/19 6/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Postoperative Ileus NCT02510911

English

Eligibility Postoperative Ileus NCT02510911

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients scheduled for elective laparoscopic colectomy (right or left hemicolectomy, segmental resection, extended hemicolectomy, sigmoid resection, upper rectum (anastomosis higher than 7 cm ab ano))
Description

Laparoscopic colectomy elective Scheduled | Right colectomy | Left colectomy | Segmentectomy | Partial resection of colon | Sigmoid colectomy | Rectum Upper Anastomosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1517722
UMLS CUI [1,2]
C0439608
UMLS CUI [1,3]
C0205539
UMLS CUI [2]
C0192861
UMLS CUI [3]
C0192865
UMLS CUI [4]
C2987624
UMLS CUI [5]
C0149750
UMLS CUI [6]
C0192866
UMLS CUI [7,1]
C0034896
UMLS CUI [7,2]
C1282910
UMLS CUI [7,3]
C0677554
there will be no upper age limit. if elderly patients are considered fit for surgery, they will be included in the study.
Description

Age | Elderly Fit for surgery

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0001792
UMLS CUI [2,2]
C4075860
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
application of epidural analgesia
Description

Analgesia, Epidural

Data type

boolean

Alias
UMLS CUI [1]
C0002769
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in another concurrent interventional trial
Description

Study Subject Participation Status | Interventional Study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
need for a stoma (colostomy or ileostomy) or reversal of a stoma, if the patient had a complete bowel obstruction
Description

Patient need for Stoma | Colostomy Procedure | Ileostomy | Stoma Reversal | Intestinal Obstruction Complete

Data type

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C1955856
UMLS CUI [2]
C0009410
UMLS CUI [3]
C0020883
UMLS CUI [4,1]
C1955856
UMLS CUI [4,2]
C0443290
UMLS CUI [5,1]
C0021843
UMLS CUI [5,2]
C0205197
known hypersensitivity or allergy to caffeine/coffee
Description

Allergy to caffeine | Hypersensitivity Coffee

Data type

boolean

Alias
UMLS CUI [1]
C0741856
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0009237
expected lack of compliance
Description

Compliance behavior Lacking Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C1517001
american society of anesthesiologists (asa) physical status score of iv or v
Description

ASA physical status classification

Data type

boolean

Alias
UMLS CUI [1]
C0450990
impaired mental state or language problems
Description

Mental state Impaired | Language problems

Data type

boolean

Alias
UMLS CUI [1,1]
C0278060
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C1405458
alcoholism or drug abuse
Description

Alcoholic Intoxication, Chronic | Drug abuse

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0013146
previous extensive abdominal surgery
Description

Operation on abdominal region Extensive

Data type

boolean

Alias
UMLS CUI [1,1]
C0198482
UMLS CUI [1,2]
C0205231
inflammatory bowel disease
Description

Inflammatory Bowel Disease

Data type

boolean

Alias
UMLS CUI [1]
C0021390
clinically significant cardiac arrhythmia
Description

Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
cardiac insufficiency
Description

Heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018801
pregnancy, lactation, or childbearing potential without using adequate contraception
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
intake of opioid analgesics, or steroids >5mg/d for ≥7 days before surgery
Description

Analgesics, Opioid | Steroids Dose

Data type

boolean

Alias
UMLS CUI [1]
C0002772
UMLS CUI [2,1]
C0038317
UMLS CUI [2,2]
C0178602
under anti-depressive medication
Description

Antidepressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0003289
liver cirrhosis or compromised liver function (meld score >15)
Description

Liver Cirrhosis | Liver Dysfunction MELD score

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2,1]
C0086565
UMLS CUI [2,2]
C4048785
emergency procedure
Description

Emergency procedure

Data type

boolean

Alias
UMLS CUI [1]
C1298802
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Similar models

Eligibility Postoperative Ileus NCT02510911

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Laparoscopic colectomy elective Scheduled | Right colectomy | Left colectomy | Segmentectomy | Partial resection of colon | Sigmoid colectomy | Rectum Upper Anastomosis
Item
patients scheduled for elective laparoscopic colectomy (right or left hemicolectomy, segmental resection, extended hemicolectomy, sigmoid resection, upper rectum (anastomosis higher than 7 cm ab ano))
boolean
C1517722 (UMLS CUI [1,1])
C0439608 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0192861 (UMLS CUI [2])
C0192865 (UMLS CUI [3])
C2987624 (UMLS CUI [4])
C0149750 (UMLS CUI [5])
C0192866 (UMLS CUI [6])
C0034896 (UMLS CUI [7,1])
C1282910 (UMLS CUI [7,2])
C0677554 (UMLS CUI [7,3])
Age | Elderly Fit for surgery
Item
there will be no upper age limit. if elderly patients are considered fit for surgery, they will be included in the study.
boolean
C0001779 (UMLS CUI [1])
C0001792 (UMLS CUI [2,1])
C4075860 (UMLS CUI [2,2])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Analgesia, Epidural
Item
application of epidural analgesia
boolean
C0002769 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Interventional Study
Item
participation in another concurrent interventional trial
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
Patient need for Stoma | Colostomy Procedure | Ileostomy | Stoma Reversal | Intestinal Obstruction Complete
Item
need for a stoma (colostomy or ileostomy) or reversal of a stoma, if the patient had a complete bowel obstruction
boolean
C0686904 (UMLS CUI [1,1])
C1955856 (UMLS CUI [1,2])
C0009410 (UMLS CUI [2])
C0020883 (UMLS CUI [3])
C1955856 (UMLS CUI [4,1])
C0443290 (UMLS CUI [4,2])
C0021843 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
Allergy to caffeine | Hypersensitivity Coffee
Item
known hypersensitivity or allergy to caffeine/coffee
boolean
C0741856 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0009237 (UMLS CUI [2,2])
Compliance behavior Lacking Expected
Item
expected lack of compliance
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
ASA physical status classification
Item
american society of anesthesiologists (asa) physical status score of iv or v
boolean
C0450990 (UMLS CUI [1])
Mental state Impaired | Language problems
Item
impaired mental state or language problems
boolean
C0278060 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1405458 (UMLS CUI [2])
Alcoholic Intoxication, Chronic | Drug abuse
Item
alcoholism or drug abuse
boolean
C0001973 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Operation on abdominal region Extensive
Item
previous extensive abdominal surgery
boolean
C0198482 (UMLS CUI [1,1])
C0205231 (UMLS CUI [1,2])
Inflammatory Bowel Disease
Item
inflammatory bowel disease
boolean
C0021390 (UMLS CUI [1])
Cardiac Arrhythmia
Item
clinically significant cardiac arrhythmia
boolean
C0003811 (UMLS CUI [1])
Heart failure
Item
cardiac insufficiency
boolean
C0018801 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
pregnancy, lactation, or childbearing potential without using adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Analgesics, Opioid | Steroids Dose
Item
intake of opioid analgesics, or steroids >5mg/d for ≥7 days before surgery
boolean
C0002772 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Antidepressive Agents
Item
under anti-depressive medication
boolean
C0003289 (UMLS CUI [1])
Liver Cirrhosis | Liver Dysfunction MELD score
Item
liver cirrhosis or compromised liver function (meld score >15)
boolean
C0023890 (UMLS CUI [1])
C0086565 (UMLS CUI [2,1])
C4048785 (UMLS CUI [2,2])
Emergency procedure
Item
emergency procedure
boolean
C1298802 (UMLS CUI [1])
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