The prevelance of FGID in patients with uncomplicated gallstones is higher compared to the general population
ID
Bron
Verkorte titel
Aandoening
Gallstones, Cholecystolithiasis, Dyspepsia, Irritable Bowel Syndrome, Cholecystectomy.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The prevalence of Functional Dyspepsia (FD) and Irritable Bowel Syndrome (IBS) according to the ROME IV criteria.
Achtergrond van het onderzoek
This study is a prospective, multicentre cohort study. In which we determine the prevalence of dyspepsia and IBS 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.
Before the first outpatient clinic visit (t=0), the patient characteristics, Rome IV Questionnaire, PAGI-SYM, Izbicki Pain Score, Gallstone Symptom List and Hospital Anxiety and Depression Scale will be taken.
After 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).
Doel van het onderzoek
The prevelance of FGID in patients with uncomplicated gallstones is higher compared to the general population
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
Gastrointestinal Disorders in Adults (R4DQ)
PAGI-SYM
Izbicki Pain Score (IPS)
Gallstone Symptom List (GSL)
Hospital Anxiety and Depression Scale (HADS)
t=6 months
Treatment, operation report, pathology, report
Gastrointestinal Disorders in Adults (R4DQ)
PAGI-SYM
Izbicki Pain Score (IPS)
Gallstone Symptom List (GSL)
Hospital Anxiety and Depression Scale (HADS)
Onderzoeksproduct en/of interventie
Questionnaires:
Rome IV Diagnostic Questionnaire for Functional Gastrointestinal Disorders in Adults (R4DQ)
PAGI-SYM
Izbicki Pain Score (IPS)
Gallstone Symptom List (GSL)
Hospital Anxiety and Depression Scale (HADS)
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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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7101 |
| NTR-old | NTR7307 |
| Ander register | Commissie Mensgebonden Onderzoek : 2017 3783 |