No registrations found.
ID
Source
Brief title
Health condition
Uncomplicated cholecystolithiasis
Gallstones
Cholecystectomy
Post-cholecystectomy symptoms
Ongecompliceerde cholecystolithiasis
Galstenen
Cholecystectomie
Symptomen na cholecystectomie
Sponsors and support
Intervention
Outcome measures
Primary outcome
The predictive validity, external validity and the sensitivity and specificity of the decision rule with as outcome a pain-free patient after 6 months.
Secondary outcome
- The proportion of patients fulfilling 3 or more criteria of the decision rule and scheduled for cholecystectomy and the proportion in those not scheduled.
- The proportion of patients fullfilling 3, 4 or 5 criteria of the decision rule, scheduled for cholecystectomy and pain-free.
- The symptoms of patients at baseline prediciting to be painfree after cholecystectomy.
- The proportion of patients with uncomplicated cholecystolithiasis and abdominal symptoms
that has a BMI >25 and the proportion with BMI >30
- The difference in symptom change, after six months follow-up between the group of patients that received cholecystectomy and those without
operation
- Description of additional health care consumption in patients not scheduled for surgery, i.e.
diagnostic tests and therapeutic interventions within six months of first outpatient clinic visit
- Description of the aspect and wall thickness of the gallbladder wall at ultrasound
- Description of the pathological report of the gallbladder (providing that the patient had an
operation and pathological examination of the gallbladder is done)
Background summary
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).
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
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
Intervention
Questionnaires:
EQ-5D
Short Form - Health and Labour Questionnaire
Izbicki Pain Score
Gastro-Intestinal Quality of Life Index
Gallstone Symptom List
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 | NL7069 |
| NTR-old | NTR7267 |
| Other | Commissie Mensgebonden Onderzoek : 2017 3306 |