Bariatric SurgeryNCT05785351
Swedish National Benchmarks in Laparoscopic Bariatric Surgery
An observational study of Bariatric Surgery, run by Region Östergötland.
Trial summary
The aim of this observational study is to define national reference values, according to the achievable benchmarks of care method (ABC™), for laparoscopic bariatric surgery in Sweden. The primary outcome is to identify the best possible, yet achievable, results during and after bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Laparoscopic Bariatric Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 55,372 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with obesity undergoing elective bariatric surgery in order to achieve weight loss.
Who may be able to join
- adults ≥ 18 years of age
- primary laparoscopic gastric sleeve or primary laparoscopic roux-en-y gastric bypass
Who cannot join
- other organ surgery at the time of the index operation
- no data about surgery
- no data about follow-up
About this study
Official title: Bariatric Surgery Benchmarks - How Much Do We Bench?
The aim of this observational study is to define national reference values, according to the achievable benchmarks of care method (ABC™), for laparoscopic bariatric surgery in Sweden. The primary outcome is to identify the best possible, yet achievable, results during and after bariatric surgery. The second outcome to investigate if there are risk groups for complications, and if so perform risk-adjusted benchmark-calculations.
Read the detailed description
The data source will be the Scandinavian Obesity Surgery Registry (SOReg), a prospective quality registry for obesity surgery. The time frame will be 2012-2021. The techniques to be investigated are laparoscopic roux-en-y gastric bypass and laparoscopic gastric sleeve respectively. Register variables related to surgical quality will be analyzed, and related to risk of peroperative and postoperative complications. The study will analyze data for the time of surgery and up to one year after surgery.
- Conditions
- Bariatric Surgery
- Being tested
- Laparoscopic Bariatric Surgery
- Keywords
- Obesity, Bariatric Surgery, Laparoscopy, Benchmarking
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Bariatric SurgeryProcedure or surgery
Laparoscopic Bariatric Surgery: Gastric Sleeve and Roux-en-Y Gastric Bypass
What is being measured
The primary outcome is the main question the study is designed to answer.
Benchmark values of variables related to surgical quality
ABC method of variables related to surgical quality (duration of surgery (minutes), complications (percentage), reoperations (percentage), weight loss at one year (percentage) etc)
Measured: Surgical intervention and up to one year after surgery
Number of participants with severe postoperative complications
Severe complication is defined as Clavien-Dindo grade ≥ IIIa
Measured: Within 30 days and one year after surgery
Secondary outcomes (2)
Potential risk groups for complications
Estimated with multivariable regression analysis looking at BMI (kg/m^2), age categories, gender, waist line category, occurrence of dyspepsia, hypertension, previous thrombo-embolism or diabetes
Measured: Within 30 days and one year after surgery
Risk-adjusted benchmark values
ABC method of any identified risk group(s) for complications
Measured: Within 30 days and one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study startJan 2012
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebba Kihlstedt Pasquier, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785351
- Sponsor's protocol ID
- 2022-04311-01-1
- Status last verified
- Mar 2023
- First submitted
- 6 Jan 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery Benchmarks - How Much Do We Bench?
- ClinicalTrials.gov ID
- NCT05785351
- Acronym / sponsor ID
- 2022-04311-01-1
- Conditions
- Bariatric Surgery
- Keywords
- Obesity, Bariatric Surgery, Laparoscopy, Benchmarking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55,372 participants (actual)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 27 Mar 2023 (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.
The aim of this observational study is to define national reference values, according to the achievable benchmarks of care method (ABC™), for laparoscopic bariatric surgery in Sweden. The primary outcome is to identify the best possible, yet achievable, results during and after bariatric surgery. The second outcome to investigate if there are risk groups for complications, and if so perform risk-adjusted benchmark-calculations.
Detailed description
The data source will be the Scandinavian Obesity Surgery Registry (SOReg), a prospective quality registry for obesity surgery. The time frame will be 2012-2021. The techniques to be investigated are laparoscopic roux-en-y gastric bypass and laparoscopic gastric sleeve respectively. Register variables related to surgical quality will be analyzed, and related to risk of peroperative and postoperative complications. The study will analyze data for the time of surgery and up to one year after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with obesity undergoing elective bariatric surgery in order to achieve weight loss.
Key inclusion criteria (2 listed)
- adults ≥ 18 years of age
- primary laparoscopic gastric sleeve or primary laparoscopic roux-en-y gastric bypass
Key exclusion criteria (3 listed)
- other organ surgery at the time of the index operation
- no data about surgery
- no data about follow-up
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 |
|---|---|---|
| Laparoscopic Bariatric SurgeryLaparoscopic Bariatric Surgery: Gastric Sleeve and Roux-en-Y Gastric Bypass | Procedure or surgery | – |
Primary outcome
Benchmark values of variables related to surgical quality
Time frame: Surgical intervention and up to one year after surgery
ABC method of variables related to surgical quality (duration of surgery (minutes), complications (percentage), reoperations (percentage), weight loss at one year (percentage) etc)
Number of participants with severe postoperative complications
Time frame: Within 30 days and one year after surgery
Severe complication is defined as Clavien-Dindo grade ≥ IIIa
2 secondary outcomes
Potential risk groups for complications
Time frame: Within 30 days and one year after surgery
Risk-adjusted benchmark values
Time frame: Within 30 days and one year after surgery
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 27 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery, run by Region Östergötland.
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 3 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 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Benchmark values of variables related to surgical quality (time frame: Surgical intervention and up to one year after surgery). 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 27 Mar 2023.