ID

23190

Beschreibung

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

Stichworte

Versionen (1)
  1. 27.06.17 27.06.17 -
Hochgeladen am

27. Juni 2017

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Cholecystectomy NCT01685775 DRKS00000341 DRKS00000341

Englisch

Eligibility Cholecystectomy NCT01685775 DRKS00000341

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Gender: Female
Beschreibung

Gender

Datentyp

boolean

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

Age

Datentyp

boolean

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

Elective cholecystectomy

Datentyp

boolean

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

Legal competence

Datentyp

boolean

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

Exclusion Criteria

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

Acute cholecystitis or locally complicated disease

Datentyp

boolean

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

Child Pugh Score

Datentyp

boolean

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

ASA

Datentyp

boolean

Alias
UMLS CUI [1]
C1531480
Intact hymen
Beschreibung

Hymen

Datentyp

boolean

Alias
UMLS CUI [1]
C0020412
Acute vaginal infection
Beschreibung

Vaginal infection

Datentyp

text

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

Uterine orifice

Datentyp

boolean

Alias
UMLS CUI [1]
C0736443
Endometriosis
Beschreibung

Endometriosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0014175
Malignoma
Beschreibung

Malignant Neoplasms

Datentyp

boolean

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

BMI

Datentyp

boolean

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

Substance Use Disorder

Datentyp

boolean

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

Neuromuscular disease

Datentyp

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)
Beschreibung

Major abdominal surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0455612
Gravidity or breastfeeding
Beschreibung

Gynaecological Status

Datentyp

boolean

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

Hypersensitivity to Analgesics

Datentyp

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
Beschreibung

Relationship

Datentyp

boolean

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

Institutionalization

Datentyp

boolean

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

Study Participation Status

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Healthy Volunteers
Beschreibung

Control Group

Datentyp

boolean

Alias
UMLS CUI [1]
C0009932
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Cholecystectomy NCT01685775 DRKS00000341

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video