ID

23190

Beschrijving

Responsible Party: Dirk R. Bulian, Principal Investigator, University of Witten/Herdecke ClinicalTrials.gov Identifier: NCT01685775 History of Changes Other Study ID Numbers: U1111-1114-7386 DRKS00000341 ( Registry Identifier: DRKS-ID ) Study First Received: September 4, 2012 Last Updated: October 12, 2013 Needlescopic Versus Transvaginal/Transumbilical Cholecystectomy (NATCH) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01685775

Link

https://clinicaltrials.gov/ct2/show/NCT01685775

Trefwoorden

Versies (1)
  1. 27-06-17 27-06-17 -
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27 juni 2017

DOI

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Creative Commons BY 4.0
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Eligibility Cholecystectomy NCT01685775 DRKS00000341 DRKS00000341

Engels

Eligibility Cholecystectomy NCT01685775 DRKS00000341

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Gender: Female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
Minimum Age: 18 Years Maximum Age: 80 Years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
Indication for elective cholecystectomy on account of symptomatic cholecystolithiasis
Beschrijving

Elective cholecystectomy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008320
UMLS CUI [1,2]
C0206058
Legal competence
Beschrijving

Legal competence

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301860
UMLS CUI [1,2]
C0086035
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Acute cholecystitis or locally complicated disease (gallbladder empyema, choledocholithiasis, pancreatitis, etc.)
Beschrijving

Acute cholecystitis or locally complicated disease

Datatype

boolean

Alias
UMLS CUI [1]
C0149520
UMLS CUI [2,1]
C0231242
UMLS CUI [2,2]
C0008325
Liver cirrhosis (Child Pugh A, B, C)
Beschrijving

Child Pugh Score

Datatype

boolean

Alias
UMLS CUI [1]
C4055253
Severe comorbidity, class IV or V as defined by the American Society for Anesthesiologists (ASA)
Beschrijving

ASA

Datatype

boolean

Alias
UMLS CUI [1]
C1531480
Intact hymen
Beschrijving

Hymen

Datatype

boolean

Alias
UMLS CUI [1]
C0020412
Acute vaginal infection
Beschrijving

Vaginal infection

Datatype

text

Alias
UMLS CUI [1]
C0404521
Lacking visibility of the uterine orifice
Beschrijving

Uterine orifice

Datatype

boolean

Alias
UMLS CUI [1]
C0736443
Endometriosis
Beschrijving

Endometriosis

Datatype

boolean

Alias
UMLS CUI [1]
C0014175
Malignoma
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
Obesity with a Body Mass Index (BMI) > 40 kg/m2
Beschrijving

BMI

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
Chronic abuse of analgesics or alcohol
Beschrijving

Substance Use Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
Neuromuscular disease that could interfere treatment or measures of pain
Beschrijving

Neuromuscular disease

Datatype

boolean

Alias
UMLS CUI [1]
C0027868
History of major abdominal surgery with a high risk of intraperitoneal adhesions (minor operations such as an appendectomy, inguinal hernia repair, minor gynaecological surgery, etc. will not be considered exclusion criteria)
Beschrijving

Major abdominal surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0455612
Gravidity or breastfeeding
Beschrijving

Gynaecological Status

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Allergy against analgesics
Beschrijving

Hypersensitivity to Analgesics

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0002771
Patients who are dependent on or employed by the trial sponsor or physicians
Beschrijving

Relationship

Datatype

boolean

Alias
UMLS CUI [1]
C0439849
Institutionalisation for legal reasons
Beschrijving

Institutionalization

Datatype

boolean

Alias
UMLS CUI [1]
C0021629
Participation in other clinical studies that could interfere with the present trial
Beschrijving

Study Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
No written informed consent signed
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Healthy Volunteers
Beschrijving

Control Group

Datatype

boolean

Alias
UMLS CUI [1]
C0009932
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Similar models

Eligibility Cholecystectomy NCT01685775 DRKS00000341

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Gender
Item
Gender: Female
boolean
C0079399 (UMLS CUI [1])
Age
Item
Minimum Age: 18 Years Maximum Age: 80 Years
boolean
C0001779 (UMLS CUI [1])
Elective cholecystectomy
Item
Indication for elective cholecystectomy on account of symptomatic cholecystolithiasis
boolean
C0008320 (UMLS CUI [1,1])
C0206058 (UMLS CUI [1,2])
Legal competence
Item
Legal competence
boolean
C1301860 (UMLS CUI [1,1])
C0086035 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Acute cholecystitis or locally complicated disease
Item
Acute cholecystitis or locally complicated disease (gallbladder empyema, choledocholithiasis, pancreatitis, etc.)
boolean
C0149520 (UMLS CUI [1])
C0231242 (UMLS CUI [2,1])
C0008325 (UMLS CUI [2,2])
Child Pugh Score
Item
Liver cirrhosis (Child Pugh A, B, C)
boolean
C4055253 (UMLS CUI [1])
ASA
Item
Severe comorbidity, class IV or V as defined by the American Society for Anesthesiologists (ASA)
boolean
C1531480 (UMLS CUI [1])
Hymen
Item
Intact hymen
boolean
C0020412 (UMLS CUI [1])
Vaginal infection
Item
Acute vaginal infection
text
C0404521 (UMLS CUI [1])
Uterine orifice
Item
Lacking visibility of the uterine orifice
boolean
C0736443 (UMLS CUI [1])
Endometriosis
Item
Endometriosis
boolean
C0014175 (UMLS CUI [1])
Malignant Neoplasms
Item
Malignoma
boolean
C0006826 (UMLS CUI [1])
BMI
Item
Obesity with a Body Mass Index (BMI) > 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Substance Use Disorder
Item
Chronic abuse of analgesics or alcohol
boolean
C0038586 (UMLS CUI [1])
Neuromuscular disease
Item
Neuromuscular disease that could interfere treatment or measures of pain
boolean
C0027868 (UMLS CUI [1])
Major abdominal surgery
Item
History of major abdominal surgery with a high risk of intraperitoneal adhesions (minor operations such as an appendectomy, inguinal hernia repair, minor gynaecological surgery, etc. will not be considered exclusion criteria)
boolean
C0455612 (UMLS CUI [1])
Gynaecological Status
Item
Gravidity or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity to Analgesics
Item
Allergy against analgesics
boolean
C0020517 (UMLS CUI [1,1])
C0002771 (UMLS CUI [1,2])
Relationship
Item
Patients who are dependent on or employed by the trial sponsor or physicians
boolean
C0439849 (UMLS CUI [1])
Institutionalization
Item
Institutionalisation for legal reasons
boolean
C0021629 (UMLS CUI [1])
Study Participation Status
Item
Participation in other clinical studies that could interfere with the present trial
boolean
C2348568 (UMLS CUI [1])
Informed Consent
Item
No written informed consent signed
boolean
C0021430 (UMLS CUI [1])
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
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