Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03105050 |
| Other study ID # |
2017-0976 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 9, 2017 |
| Est. completion date |
December 1, 2017 |
Study information
| Verified date |
June 2024 |
| Source |
Rijnstate Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In recent years more and more collaboration between hospitals performing bariatric surgery
occur and more exchange of knowledge on pre and postoperative care is shared. Different
countries have many different protocols to select and guide patients through bariatric
surgery, and even within countries differences exist. These are most commonly based on expert
opinions and cultural influences. Although many outcomes of the different approaches are
known, the pathways the patient has to take and the accessibility to bariatric surgery are
unclear for each country as well as how the care for these patients is financially arranged.
As a progressive research collaboration, we would like to gain more insight into these
different approaches. With this study we would like to gain more insight into the
accessibility and restrictions to accessibility to both bariatric surgery and body contouring
surgery after massive weight loss that exists in all 51 European countries, as well as why
this disparity exists.
Description:
Introduction
Bariatric surgery not only gives patients a new chance in life, but also facilitates
improvements in social and mental status. Initially, guidance towards this life-changing
surgery was often performed by the surgeons themselves. Before surgery, the patient had a
short consultation and was given only limited information about the surgery and the expected
results. The surgeon was often the only health care professional who made a judgment on
whether a patient was suitable for bariatric surgery. On average, patients had annual or
bi-annual postoperative follow-up. These visits focused in particular on weight loss and
reduction in comorbidities. Today we know that this way of selecting and preparing patients
for bariatric operations was inadequate. Many questions remained unanswered and patients did
not know what to expect. In particular, many patients were unable to cope with the
psychological adaptation required to undertake dietary and lifestyle changes to maximise
weight loss. Because the number of follow-up visits were limited, many problems were not
overcome.
There is a strong need for patients to have access to specialized professionals. In addition,
it is very important to have patients screened by a multidisciplinary team before undergoing
bariatric surgery. This team can quickly identify problems and can give advice on how to
manage these. Although we all agree that morbid obese patients should have access to
professional healthcare, we do not know the pathways the patient has to go to gain access. It
seems logical that each country in Europe has his own pathways, but which one results in the
best outcomes? As described above, there has been rapid growth in the number of patients
undergoing bariatric surgery. Proper regulation of screening, follow-up and frequent
counselling seems to strongly influence outcomes, like average weight loss. In the long term,
a continuous supply of care is important to prevent weight gain. This has resulted in
significant logistical issues for many hospitals, as care for each patient must be properly
regulated and guaranteed. This care should be given for life, to identify and manage problems
as quickly as possible.
In recent years more and more collaboration between hospitals occur and more exchange of
knowledge on pre and postoperative care is shared. Different countries have many different
protocols to select and guide patients through bariatric surgery, and even within countries
differences exist. These are most commonly based on expert opinions and cultural influences.
Although many outcomes of the different approaches are known, the pathways the patient has to
take and the accessibility to bariatric surgery are unclear for each country as well as how
the care for these patients is financially arranged. As a progressive research collaboration,
we would like to gain more insight into these different approaches. With this study we would
like to gain more insight into the accessibility and restrictions to access to both bariatric
surgery and body contouring surgery after massive weight loss that exists in the different
European countries, as well as why this disparity exists.
Research aim
To explore accessibility to bariatric surgery and quality of care in different European
countries
Research objectives
1. To gain insight into the referral system for bariatric surgery in each European country
for morbidly obese patients
2. To investigate the differences in inclusion criteria and registries for bariatric
surgery per European country
3. To investigate the funding of bariatric and contouring surgery in each European country
4. To identify the differences in the multidisciplinary team providing care for bariatric
patients
5. To identify the differences in the number of operations per surgeon and per hospital
In more detail:
1. Money:
1. The amount of money which is used for reimbursement of bariatric surgery / Total
amount of money in each healthcare system . This needs to be set in context with
the population who does fulfil the criteria to undergo bariatric surgery according
to (inter?)national guidelines.
2. Methods to calculate reimbursement data: (Data from insurance companies: How much
on average for a procedure? x Procedures (number and type) being performed a year
(data from official register or society) per country
2. Guideline differences and Evidence)
1. How does the country comply with the evidence and/or International Federation for
Surgery on Obesity (IFSO) Consensus Statement?
2. Are there specific national Guidelines?
3. What are the criteria for reimbursement? Do they comply to national Guidelines?
3. Evaluation of the patient's journey:
1. First contact to the bariatric surgeon... to bariatric surgery. (Differences in the
system (self-referral, General Practitioner (GP) referral, etc.)
2. Time interval from first contact to surgery
3. Waiting time for elective surgery?
4. Quality:
1. Patient collective (Are there differences? Baseline BMI / Co-morbidities?)
2. Outcome (register: no register)
3. How many patients undergo surgery in a centre
4. How many patients undergo surgery in an University Hospital?
5. Plastic surgery
1. How is referral arranged?
2. Is it reimbursed and secondly how?
Methods
This study will be performed by the six researchers mentioned above. A questionnaire has been
specifically designed for the purpose of this study (see appendix 1). Also, an inventory will
be made as to who the national representatives for bariatric surgery are who can be
interviewed.
The 51 countries have been divided between the six participants in this study and each
participant will within six months gather the data required per country. Data will digitally
be send to the research coordinator.
The IFSO secretary will be contacted to ask them to participate in this study and let us sent
the questionnaire to all members. Secondly, the industry (Johnson and Johnson) will be asked
to contact their connections on a nationwide scale to also sent the same questionnaire. If
these are insufficient, we will try to contact insurance companies and/or patient groups to
gain more data.
