No registrations found.
ID
Source
Brief title
Health condition
Gallstones, Cholecystolithiasis, Dyspepsia, Irritable Bowel Syndrome, Cholecystectomy.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence of Functional Dyspepsia (FD) and Irritable Bowel Syndrome (IBS) according to the ROME IV criteria.
Secondary outcome
- What is the prevalence of gastroduodenal disorders and bowel disorders separately?
- What is the prevalence of overweight and obesity in the study population?
- Is the prevalence of patients with FGID that are scheduled for cholecystectomy different from those not scheduled?
- Which additional diagnostic tests are performed in patients not scheduled for surgery?
- Which therapeutic interventions are performed in patients not scheduled for surgery?
- Has symptom severity changed six months after the visit to the outpatient clinic and what is the influence of cholecystectomy on symptom severity?
- Is there a correlation between aspects (such as wall thickness) and motility of the gallbladder on ultrasonic and pathological examination, and the presence of FGID?
Background summary
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).
Study objective
The prevelance of FGID in patients with uncomplicated gallstones is higher compared to the general population
Study design
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)
Intervention
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)
Carmen Latenstein
Nijmegen 6500 HB
The Netherlands
06-19402554
carmen.latenstein@radboudumc.nl
Carmen Latenstein
Nijmegen 6500 HB
The Netherlands
06-19402554
carmen.latenstein@radboudumc.nl
Inclusion criteria
- 18 years of age or older, and
- with ultrasonically proven, uncomplicated cholecystolithiasis, and
- referred for surgical consultation
Exclusion criteria
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7101 |
| NTR-old | NTR7307 |
| Other | Commissie Mensgebonden Onderzoek : 2017 3783 |