Bariatric Surgery CandidateNCT03105050
Access to Bariatric Surgery In Europe
An observational study of Bariatric Surgery Candidate, run by Rijnstate Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Access to bariatric surgery
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Apr 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Representatives of bariatric communities per country in Europe
Who may be able to join
- Representative must be member of scientific community of his/her country for bariatric surgery
- All data of 2015 must be available for each country
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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
- To gain insight into the referral system for bariatric surgery in each European country for morbidly obese patients
- To investigate the differences in inclusion criteria and registries for bariatric surgery per European country
- To investigate the funding of bariatric and contouring surgery in each European country
- To identify the differences in the multidisciplinary team providing care for bariatric patients
- To identify the differences in the number of operations per surgeon and per hospital
In more detail:
- Money:
- 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.
- 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
- Guideline differences and Evidence)
- How does the country comply with the evidence and/or International Federation for Surgery on Obesity (IFSO) Consensus Statement?
- Are there specific national Guidelines?
- What are the criteria for reimbursement? Do they comply to national Guidelines?
- Evaluation of the patient's journey:
- First contact to the bariatric surgeon... to bariatric surgery. (Differences in the system (self-referral, General Practitioner (GP) referral, etc.)
- Time interval from first contact to surgery
- Waiting time for elective surgery?
- Quality:
- Patient collective (Are there differences? Baseline BMI / Co-morbidities?)
- Outcome (register: no register)
- How many patients undergo surgery in a centre
- How many patients undergo surgery in an University Hospital?
- Plastic surgery
- How is referral arranged?
- 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.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Access to bariatric surgery
- Keywords
- access, policy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to bariatric surgeryOther
All countries representatives will be interviewed on their Healthcare systems
| Study group | Role | What they receive |
|---|---|---|
| Countries in Europe | All 51 countries will fill out their unique data on access to bariatric surgery in Europe Receives: Other: Access to bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access to bariatric surgery per country (using a validated questionnaire)
Inventory accessibility
Measured: 6 months
Quality of care per country (using a validated questionnaire)
Inventory quality of care
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start9 Apr 2017
- Primary completion1 Oct 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin, Sint Franciscus Gasthuis, University Hospital, Ghent, Lithuanian University of Health Sciences, Göteborg University
- Responsible party
- Sponsor
- Investigators
- Yves van Nieuwenhove, MD, PhD, Study chair, University of GentAlmantas Maleckas, MD, PhD, Study chair, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105050
- Sponsor's protocol ID
- 2017-0976
- Status last verified
- Jun 2024
- First submitted
- 27 Mar 2017
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will become available for other researchers in the form of articles, presentations and if requested
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Access to Bariatric Surgery In Europe
- ClinicalTrials.gov ID
- NCT03105050
- Acronym / sponsor ID
- 2017-0976
- Conditions
- Bariatric Surgery Candidate
- Keywords
- access, policy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- University College Dublin, Sint Franciscus Gasthuis, University Hospital, Ghent, Lithuanian University of Health Sciences, Göteborg University
- Study start
- 9 Apr 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- To gain insight into the referral system for bariatric surgery in each European country for morbidly obese patients
- To investigate the differences in inclusion criteria and registries for bariatric surgery per European country
- To investigate the funding of bariatric and contouring surgery in each European country
- To identify the differences in the multidisciplinary team providing care for bariatric patients
- To identify the differences in the number of operations per surgeon and per hospital
In more detail:
- Money:
- 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.
- 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
- Guideline differences and Evidence)
- How does the country comply with the evidence and/or International Federation for Surgery on Obesity (IFSO) Consensus Statement?
- Are there specific national Guidelines?
- What are the criteria for reimbursement? Do they comply to national Guidelines?
- Evaluation of the patient's journey:
- First contact to the bariatric surgeon... to bariatric surgery. (Differences in the system (self-referral, General Practitioner (GP) referral, etc.)
- Time interval from first contact to surgery
- Waiting time for elective surgery?
- Quality:
- Patient collective (Are there differences? Baseline BMI / Co-morbidities?)
- Outcome (register: no register)
- How many patients undergo surgery in a centre
- How many patients undergo surgery in an University Hospital?
- Plastic surgery
- How is referral arranged?
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Countries in Europe | – | Other: Access to bariatric surgeryAll 51 countries will fill out their unique data on access to bariatric surgery in Europe |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Representatives of bariatric communities per country in Europe
Key inclusion criteria (2 listed)
- Representative must be member of scientific community of his/her country for bariatric surgery
- All data of 2015 must be available for each country
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to bariatric surgeryAll countries representatives will be interviewed on their Healthcare systems | Other | Countries in Europe |
Primary outcome
Access to bariatric surgery per country (using a validated questionnaire)
Time frame: 6 months
Inventory accessibility
Quality of care per country (using a validated questionnaire)
Time frame: 6 months
Inventory quality of care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Yes. Data will become available for other researchers in the form of articles, presentations and if requested
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves van Nieuwenhove, MD, PhD study chair
University of Gent
Almantas Maleckas, MD, PhD study chair
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery Candidate, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access to bariatric surgery per country (using a validated questionnaire) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.