ID

36693

Description

Gastric Sleeve Pilot Study in Morbidly Obese Undergoing Liver Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT02068872

Link

https://clinicaltrials.gov/show/NCT02068872

Keywords

Versions (1)
  1. 02/06/2019 02/06/2019 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

2 juin 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Obesity NCT02068872

English

Eligibility Obesity NCT02068872

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02068872
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must be willing to give written informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
adult subjects 18-75 years of age of any race or gender who are listed for liver transplantation.
Description

Adult | Age | Racial group | Patient on waiting list Transplantation of liver

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0034510
UMLS CUI [4,1]
C0422768
UMLS CUI [4,2]
C0023911
for consideration of sleeve gastrectomy placement patients must meet the following criteria:
Description

Consideration Sleeve gastrectomy

Data type

boolean

Alias
UMLS CUI [1,1]
C0518609
UMLS CUI [1,2]
C3160799
1. class iii obesity (bmi ≥ 40 kg/m2); or 2. class ii obesity (bmi 35-39.9 kg/m2 in conjunction with any of the following severe obesity related co-morbidities): i. obstructive sleep apnea defined as a formal sleep study consistent with this diagnosis with a) an epworth sleepiness scale ≥ 6 and b) polysomnography with respiratory disturbance index ≥ 10 and/or apneic episodes per hour of sleep; or ii. cardiovascular disease defined as prior history of stroke, myocardial infarction, stable or unstable angina pectoris, or prior coronary artery bypass); or iii. medically refractory hypertension defined as blood pressure greater than 140 mmhg systolic and/or 90 mmhg diastolic despite concurrent use of 3 anti-hypertensive agents of different classes iv. type 2 diabetes mellitus, defined as individuals taking insulin or oral hypoglycemic agents or who have a fasting glucose > 126 mg/dl
Description

Obesity Class | Body mass index | Comorbidity Relationship Severe Obesity | Sleep study Consistent with Obstructive Sleep Apnea | Epworth Sleepiness Scale Questionnaire | Polysomnography: respiratory disturbance index | Apneic episodes hour of sleep | Cardiovascular Disease | Cerebrovascular accident | Myocardial Infarction | Stable angina | Angina, Unstable | Coronary Artery Bypass Surgery | Refractory hypertension | Blood pressure determination | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity Class Different | Diabetes Mellitus, Non-Insulin-Dependent | Insulin | Oral hypoglycemic | Glucose measurement, fasting

Data type

boolean

Alias
UMLS CUI [1,1]
C0028754
UMLS CUI [1,2]
C0456387
UMLS CUI [2]
C1305855
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0028756
UMLS CUI [4,1]
C0162701
UMLS CUI [4,2]
C0332290
UMLS CUI [4,3]
C0520679
UMLS CUI [5]
C3541276
UMLS CUI [6]
C2111853
UMLS CUI [7,1]
C0003578
UMLS CUI [7,2]
C2937255
UMLS CUI [8]
C0007222
UMLS CUI [9]
C0038454
UMLS CUI [10]
C0027051
UMLS CUI [11]
C0340288
UMLS CUI [12]
C0002965
UMLS CUI [13]
C0010055
UMLS CUI [14]
C0860493
UMLS CUI [15]
C0005824
UMLS CUI [16]
C0871470
UMLS CUI [17]
C0428883
UMLS CUI [18,1]
C0003364
UMLS CUI [18,2]
C1265611
UMLS CUI [18,3]
C0456387
UMLS CUI [18,4]
C1705242
UMLS CUI [19]
C0011860
UMLS CUI [20]
C0021641
UMLS CUI [21]
C0359086
UMLS CUI [22]
C0202045
2. have attempted (and failed) previous weight loss efforts over at least a three month period with diet, exercise, lifestyle changes or medications.
Description

Weight loss Effort Attempt | Weight loss Attempt failed | Diet therapy | Exercise | Lifestyle changes | Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0015264
UMLS CUI [1,3]
C1516084
UMLS CUI [2,1]
C1262477
UMLS CUI [2,2]
C1516084
UMLS CUI [2,3]
C0231175
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0015259
UMLS CUI [5]
C0870811
UMLS CUI [6]
C0013227
3. show understanding of the risks and benefits of surgery and side effects of the procedure.
Description

Comprehension Risks and Benefits Operative Surgical Procedures | Comprehension Side effects Procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C0687742
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0879626
UMLS CUI [2,3]
C0184661
4. be committed to lifestyle changes. all patients will be evaluated by the transplant psychologist as well as the bariatric surgery psychologist prior to consideration for study enrollment to ensure appropriate psychological motivation.
Description

Commitment Lifestyle changes

Data type

boolean

Alias
UMLS CUI [1,1]
C0870312
UMLS CUI [1,2]
C0870811
5. do not have any medical, psychiatric or emotional condition that would prohibit surgery (e.g. severe irreversible coronary artery disease, untreated schizophrenia, active substance abuse, and/or noncompliance with previous medical care)
Description

Absence Medical condition Preventing Operative Surgical Procedures | Absence Emotional or mental condition Preventing Operative Surgical Procedures | Coronary Artery Disease Severe | Schizophrenia untreated | Substance Use Disorders | Compliance behavior Lacking Medical care

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C3843040
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0543467
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C3843038
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0543467
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0036341
UMLS CUI [4,2]
C0332155
UMLS CUI [5]
C0038586
UMLS CUI [6,1]
C1321605
UMLS CUI [6,2]
C0332268
UMLS CUI [6,3]
C0496675
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
status 1 listing (fulminant hepatic failure) for liver transplant
Description

Fulminant Liver Failure

Data type

boolean

Alias
UMLS CUI [1]
C0162557
active drug abuse or alcohol use within six months
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
positive urine pregnancy test (females)
Description

Urine pregnancy test positive

Data type

boolean

Alias
UMLS CUI [1]
C0430059
diagnosis of active malignancy
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
history of prior bariatric surgery
Description

Bariatric Surgery

Data type

boolean

Alias
UMLS CUI [1]
C1456587
failure to attend the initial patient information sessions or history of noncompliance
Description

Patient Information failed | Compliance behavior Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C1955348
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C0332268
failure to give consent for the study or to understand the proposed consent
Description

Informed Consent failed | Informed Consent Comprehension Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0162340
UMLS CUI [2,3]
C1299582
failure of patient's insurance company to approve surgical intervention so as to avoid extensive cost burden on the patient
Description

Health Insurance failed

Data type

boolean

Alias
UMLS CUI [1,1]
C0021682
UMLS CUI [1,2]
C0231175
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Similar models

Eligibility Obesity NCT02068872

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT02068872
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
subjects must be willing to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Adult | Age | Racial group | Patient on waiting list Transplantation of liver
Item
adult subjects 18-75 years of age of any race or gender who are listed for liver transplantation.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0034510 (UMLS CUI [3])
C0422768 (UMLS CUI [4,1])
C0023911 (UMLS CUI [4,2])
Consideration Sleeve gastrectomy
Item
for consideration of sleeve gastrectomy placement patients must meet the following criteria:
boolean
C0518609 (UMLS CUI [1,1])
C3160799 (UMLS CUI [1,2])
Obesity Class | Body mass index | Comorbidity Relationship Severe Obesity | Sleep study Consistent with Obstructive Sleep Apnea | Epworth Sleepiness Scale Questionnaire | Polysomnography: respiratory disturbance index | Apneic episodes hour of sleep | Cardiovascular Disease | Cerebrovascular accident | Myocardial Infarction | Stable angina | Angina, Unstable | Coronary Artery Bypass Surgery | Refractory hypertension | Blood pressure determination | Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Quantity Class Different | Diabetes Mellitus, Non-Insulin-Dependent | Insulin | Oral hypoglycemic | Glucose measurement, fasting
Item
1. class iii obesity (bmi ≥ 40 kg/m2); or 2. class ii obesity (bmi 35-39.9 kg/m2 in conjunction with any of the following severe obesity related co-morbidities): i. obstructive sleep apnea defined as a formal sleep study consistent with this diagnosis with a) an epworth sleepiness scale ≥ 6 and b) polysomnography with respiratory disturbance index ≥ 10 and/or apneic episodes per hour of sleep; or ii. cardiovascular disease defined as prior history of stroke, myocardial infarction, stable or unstable angina pectoris, or prior coronary artery bypass); or iii. medically refractory hypertension defined as blood pressure greater than 140 mmhg systolic and/or 90 mmhg diastolic despite concurrent use of 3 anti-hypertensive agents of different classes iv. type 2 diabetes mellitus, defined as individuals taking insulin or oral hypoglycemic agents or who have a fasting glucose > 126 mg/dl
boolean
C0028754 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C1305855 (UMLS CUI [2])
C0009488 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0028756 (UMLS CUI [3,3])
C0162701 (UMLS CUI [4,1])
C0332290 (UMLS CUI [4,2])
C0520679 (UMLS CUI [4,3])
C3541276 (UMLS CUI [5])
C2111853 (UMLS CUI [6])
C0003578 (UMLS CUI [7,1])
C2937255 (UMLS CUI [7,2])
C0007222 (UMLS CUI [8])
C0038454 (UMLS CUI [9])
C0027051 (UMLS CUI [10])
C0340288 (UMLS CUI [11])
C0002965 (UMLS CUI [12])
C0010055 (UMLS CUI [13])
C0860493 (UMLS CUI [14])
C0005824 (UMLS CUI [15])
C0871470 (UMLS CUI [16])
C0428883 (UMLS CUI [17])
C0003364 (UMLS CUI [18,1])
C1265611 (UMLS CUI [18,2])
C0456387 (UMLS CUI [18,3])
C1705242 (UMLS CUI [18,4])
C0011860 (UMLS CUI [19])
C0021641 (UMLS CUI [20])
C0359086 (UMLS CUI [21])
C0202045 (UMLS CUI [22])
Weight loss Effort Attempt | Weight loss Attempt failed | Diet therapy | Exercise | Lifestyle changes | Pharmaceutical Preparations
Item
2. have attempted (and failed) previous weight loss efforts over at least a three month period with diet, exercise, lifestyle changes or medications.
boolean
C1262477 (UMLS CUI [1,1])
C0015264 (UMLS CUI [1,2])
C1516084 (UMLS CUI [1,3])
C1262477 (UMLS CUI [2,1])
C1516084 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0012159 (UMLS CUI [3])
C0015259 (UMLS CUI [4])
C0870811 (UMLS CUI [5])
C0013227 (UMLS CUI [6])
Comprehension Risks and Benefits Operative Surgical Procedures | Comprehension Side effects Procedure
Item
3. show understanding of the risks and benefits of surgery and side effects of the procedure.
boolean
C0162340 (UMLS CUI [1,1])
C0687742 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0162340 (UMLS CUI [2,1])
C0879626 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
Commitment Lifestyle changes
Item
4. be committed to lifestyle changes. all patients will be evaluated by the transplant psychologist as well as the bariatric surgery psychologist prior to consideration for study enrollment to ensure appropriate psychological motivation.
boolean
C0870312 (UMLS CUI [1,1])
C0870811 (UMLS CUI [1,2])
Absence Medical condition Preventing Operative Surgical Procedures | Absence Emotional or mental condition Preventing Operative Surgical Procedures | Coronary Artery Disease Severe | Schizophrenia untreated | Substance Use Disorders | Compliance behavior Lacking Medical care
Item
5. do not have any medical, psychiatric or emotional condition that would prohibit surgery (e.g. severe irreversible coronary artery disease, untreated schizophrenia, active substance abuse, and/or noncompliance with previous medical care)
boolean
C0332197 (UMLS CUI [1,1])
C3843040 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C3843038 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0543467 (UMLS CUI [2,4])
C1956346 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0036341 (UMLS CUI [4,1])
C0332155 (UMLS CUI [4,2])
C0038586 (UMLS CUI [5])
C1321605 (UMLS CUI [6,1])
C0332268 (UMLS CUI [6,2])
C0496675 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Fulminant Liver Failure
Item
status 1 listing (fulminant hepatic failure) for liver transplant
boolean
C0162557 (UMLS CUI [1])
Substance Use Disorders
Item
active drug abuse or alcohol use within six months
boolean
C0038586 (UMLS CUI [1])
Urine pregnancy test positive
Item
positive urine pregnancy test (females)
boolean
C0430059 (UMLS CUI [1])
Malignant Neoplasms
Item
diagnosis of active malignancy
boolean
C0006826 (UMLS CUI [1])
Bariatric Surgery
Item
history of prior bariatric surgery
boolean
C1456587 (UMLS CUI [1])
Patient Information failed | Compliance behavior Lacking
Item
failure to attend the initial patient information sessions or history of noncompliance
boolean
C1955348 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Informed Consent failed | Informed Consent Comprehension Unable
Item
failure to give consent for the study or to understand the proposed consent
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0162340 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Health Insurance failed
Item
failure of patient's insurance company to approve surgical intervention so as to avoid extensive cost burden on the patient
boolean
C0021682 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
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