Primary objective is to gain insight into risk acceptation of serious adverse events (
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Health condition
Morbide Obesitas en bariatrische chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is the maximum accepted risk on serious adverse events
(<30 days).
Secondary outcome
Secondary study parameters are expected weight loss and maximum accepted risk
on mortality, long-term complications and side effects and associations with
specific patient characteristics.
Background summary
Bariatric surgery and its golden standard, the laparoscopic Roux-en-Y gastric
bypass (LRYGB) is currently the only sustainable way to reduce mortality in
morbidly obese patients. Like with any other surgical procedure, its risk is
predominantly expressed in percentage chance of peri-surgical mortality. Over
the course of years, mortality in LRYGB surgery has decreased to less than 1%,
which is very low for abdominal surgery of this extent. Therefore, surgical
outcome is better expressed in *adverse outcomes*, which has a higher
prevalence up to about 4%. Patients seldom have knowledge about long-term
complications. Long-term complications and complaints such as abdominal pain,
nausea and vomiting lead to emergency department visits in >30% of all patients
within 3 years after surgery. Side effects are even more common: 42% of all
LRYGB will experience at least one episode of *dumping syndrome* within their
first postsurgical year. Ninety-one percent of all female and 67% of all male
patients report feeling unattractive due to their surgery. Moreover, more than
60% of the female and 40% of the male patients experience skin problems
(rashes, fungal) due to their excess skin. One-third of the female and
one-quarter of the male patients experience pain due to their excess skin. One
third of all patients have psychological problems due to their surplus skin.
There is some evidence that patients are well aware of the low mortality risk,
there are no studies reporting on willingness to accept serious adverse events,
long-term complications and the side effects of LRYGB.
We hypothesize that patients accept unrealistic high risks.
Five to 10% total body weight loss (TBWL) has been proven to be enough to have
a diminishing effect on comorbidities. Studies reveal that short-term weight
loss outcome is generally 31-38% TWBL and long term TWBL is 25-29%. However,
patients expect to lose 38% TBWL in the long term and have indicated to be
disappointed with a long term TBWL of 26% or less. We hypothesize that patients
overestimate the outcomes of bariatric surgery.
Study objective
Primary objective is to gain insight into risk acceptation of serious adverse
events (<30 days) in bariatric surgery. Secondary objectives are the expected
weight loss, risk acceptation of mortality, risk acceptation of serious adverse
events (< 30 days), risk acceptation of long-term complications, risk
acceptation of side effects and if high risk acceptation is associated with
specific patient characteristics.
Study design
Cross-sectional, non-interventional study using standard gamble and treatment
trade off methods.
Study burden and risks
The interview will take one hour and will be scheduled at the day of the
patient*s last routine screening visits. The patient will not benefit from
participation, except for being very well informed about the outcomes of LRYGB.
The interview contains sensitive topics such as mortality and adverse outcomes;
the patient might experience discussing these matters as a burden. We emphasize
that facts and figures about the results of the operation are a mandatory
component of every informed consent. If we gain more knowledge on the
willingness to accept a certain risk in patients seeking weight loss surgery
and by which factors this accepted risk is influenced, we might be able to
inform patients better. This way, we will be able to limit the naïve acceptance
of a certain surgical risk for a possibly disappointing outcome.
Louwesweg 6
Amsterdam 1066 EC
NL
Louwesweg 6
Amsterdam 1066 EC
NL
Listed location countries
Age
Inclusion criteria
Age 18-65
Seeking weight loss surgery
written informed consent
Exclusion criteria
Incapability to complete Dutch questionnaires or to engage in a Dutch interview due to insufficient ability to understand or speak the Dutch language
No written informed consent
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 | NL55344.048.15 |