Current practice variation in selection of patients with gallbladder stones and abdominal complaints for cholecystectomy is not efficient. Here we evaluate stepwise selection for surgery to improve patient outcome and to reduce the number of…
ID
Source
Brief title
Condition
- Gallbladder disorders
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The percentage of patients pain-free at 12 months of follow-up. Pain free is
defined as a visual analogue scale (VAS;
validated pain score) less than or equal to 4 over the last four weeks before
evaluation.
Secondary outcome
A comparison of usual care with the restrictive strategy on:
(a) The proportion of patients being pain-free after cholecystectomy
(b) The proportion of cholecystectomies
(c) The proportion of patients with complications (i.e. choledocholithiasis,
acute cholecystitis, biliary pancreatitis or cholangitis) due to gallstones.
(d) Changes in health status and valuation over time. Health status will be
measured using generic and disease specific health status questionnaires after
informed consent and after 3, 6 and 12 months.
(e) Time to pain free
(f) The relation between the patients* symptoms and treatment and work
performance
(g) Cost-effectiveness
(h) The proportion of complications due to the cholecystectomy.
(i) Patient satisfaction on result of treatment
(j) Alternative diagnostic test and treatment (additional to or replacing
cholecystectomy)
Background summary
Five to 22 percent of the adult Western population has gallstones. Among them,
13 to 22 percent becomes symptomatic during their lifetime. Cholecystectomy
(gallbladder removal) is the preferred treatment option for symptomatic
cholecystolithiasis (painful gallstones) today. In The Netherlands, with 16
million inhabitants, annually more than 20,000 cholecystectomies are performed
against direct hospital-related costs of 80 million euro. Remarkably,
gallbladder removal appears to be ineffective in 30-40% of patients. In
addition, the Dutch health care insurance companies have noted a considerable
practice variation in gallbladder removals in The Netherlands, attributable to
a lack of evidence and to preferences that differ by surgeon.
Study objective
Current practice variation in selection of patients with gallbladder stones and
abdominal complaints for cholecystectomy is not efficient. Here we evaluate
stepwise selection for surgery to improve patient outcome and to reduce the
number of cholecystectomies.
Study design
Randomized controlled trial
Intervention
Patients will be randomized into 2 groups. The first group comprises usual care
with practice variation in performing laparoscopic cholecystectomy. The second
group comprises a restrictive strategy with standardized work-up and interval
evaluation with stepwise selection for laparoscopic cholecystectomy.
Study burden and risks
The gallbladder will be removed in both groups if there is a clear medical
reason. A disadvantage may be that a subject prefers to be operated
immediately, but because be do not know if we help the subject to get rid of
his symptoms there will be a possibility that we postpone the eventual
operation or drop it if the symptoms have disappeared. Another possible
disadvantage of this study is that the completion of the questionnaires may
require some extra time of the subject. Subject will receive the same
questionnaires at home before treatment and at 3, 6, 9 and 12 months and will
be asked to return the completed questionnaires. These questionnaires relate to
symptoms and wellbeing of the subjects. This will take about 15 minutes a time.
Amendement: Five years after inclusion, patients will be approached to fill-out
a long term follow-up questionnaire. Only patients who gave permission on the
informed consent form to be contacted again (after intitial 12 months
follow-up) will be send this questionnaire. The content of the questionnaire
will be the same as the 12 month follow-up questionnaire supplemented with
questions on (health care consumption) for gallstone symptoms or persistent
symptoms after cholecystectomy.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1. Referred to a surgeon with abdominal complaints and who have ultrasound proven gallstones or sludge (proven before or after referral)
2. Patients age 18 years or older
3. Availability of informed consent.
Exclusion criteria
1. A history of complicated cholecystolithiasis
2. Indication for primary open cholecystectomy
3. Current treatment for malignancy
4. Expected short life span of less than 12 months
5. ASA score 3 or 4
6. Pregnancy
7. Insufficient knowledge of the Dutch language
8. Mentally incompentent
9. Residence in a federal correctional institution
10. Known cirrhosis of the liver
11. Current schizophrenia, memory deficiency, or any other disorder that predispose them to unreliable questionnaire responses
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 |
|---|---|
| CCMO | NL43810.018.13 |