ID
Bron
Verkorte titel
Aandoening
Uncomplicated cholecystolithiasis
Gallstones
Cholecystectomy
Post-cholecystectomy symptoms
Ongecompliceerde cholecystolithiasis
Galstenen
Cholecystectomie
Symptomen na cholecystectomie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The predictive validity, external validity and the sensitivity and specificity of the decision rule with as outcome a pain-free patient after 6 months.
Achtergrond van het onderzoek
This study is a prospective, multicentre cohort study. In which we validate the decision rule for surgery indication in patients with uncomplicated cholecystolithiasis;
All adult patients referred to the surgical outpatient clinic for gallstones will be considered for inclusion. Patients will all be recruited in The Netherlands.
They will be phoned by one of our researchers and asked if they want to participate in the study.
After the first outpatient clinic visit (t=0), the patient characteristics, EQ-5D, Short Form - Health and Labour Questionnaire, Izbicki Pain Score, Gastro-Intestinal Quality of Life Index and Gallstone Symptom List will be taken via e-mail.
After 3 (t=3) and 6 months (t=6) the patients will receive the questionnaires again. In between some patients will be treated by means of a cholecystecomy and others won't get treatment (still observational).
After this, data management and statistical analysis will be carried out using IBM SPSS statistical software package version 22.0 (SPSS inc., Chicago, IL).
Onderzoeksopzet
t=0 months
-Patient characteristics:
- sex
- age
- BMI
- ethnic background
- smoking (packages per week)
- alcohol use (glasses per week)
- use of painkillers
- history or current treatment of: high blood pressure, high cholesterol or diabetes.
- other diseases
- history of operations or gastroscopy
- other medicine used besides painkillers
EQ-5D
Short Form - Health and Labour Questionnaire
Izbicki Pain Score
Gastro-Intestinal Quality of Life Index
Gallstone Symptom List
t = 3 months
EQ-5D
Short Form - Health and Labour Questionnaire
Izbicki Pain Score
Gastro-Intestinal Quality of Life Index
Gallstone Symptom List
t=6 months
Treatment, operation report, pathology, report
EQ-5D
Short Form - Health and Labour Questionnaire
Izbicki Pain Score
Gastro-Intestinal Quality of Life Index
Gallstone Symptom List
Onderzoeksproduct en/of interventie
Questionnaires:
EQ-5D
Short Form - Health and Labour Questionnaire
Izbicki Pain Score
Gastro-Intestinal Quality of Life Index
Gallstone Symptom List
Publiek
Carmen Latenstein
Nijmegen 6500 HB
The Netherlands
06-19402554
carmen.latenstein@radboudumc.nl
Wetenschappelijk
Carmen Latenstein
Nijmegen 6500 HB
The Netherlands
06-19402554
carmen.latenstein@radboudumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 18 years of age or older, and
- with ultrasonically proven, uncomplicated cholecystolithiasis, and
- referred for surgical consultation
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- History of complicated cholelithiasis (i.e. choledocholithiasis, acute cholecystitis, biliary
pancreatitis or cholangitis)
- Current schizophrenia, memory deficiency, or any other disorder that predispose them to
unreliable questionnaire responses;
- Mentally incompetent;
- Insufficient knowledge of the Dutch language;
- Known pregnancy
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7069 |
| NTR-old | NTR7267 |
| Ander register | Commissie Mensgebonden Onderzoek : 2017 3306 |