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Swedish National Benchmarks in Laparoscopic Bariatric Surgery

Bariatric Surgery Benchmarks - How Much Do We Bench?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05785351
Enrollment
55372
Registered
2023-03-27
Start date
2012-01-31
Completion date
2021-12-31
Last updated
2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery

Keywords

Obesity, Bariatric Surgery, Laparoscopy, Benchmarking

Brief 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. 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.

Interventions

PROCEDURELaparoscopic Bariatric Surgery

Laparoscopic Bariatric Surgery: Gastric Sleeve and Roux-en-Y Gastric Bypass

Sponsors

Region Östergötland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adults ≥ 18 years of age * primary laparoscopic gastric sleeve or primary laparoscopic roux-en-y gastric bypass

Exclusion criteria

* other organ surgery at the time of the index operation * no data about surgery * no data about follow-up

Design outcomes

Primary

MeasureTime frameDescription
Benchmark values of variables related to surgical qualitySurgical intervention and up to one year after surgeryABC 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 complicationsWithin 30 days and one year after surgerySevere complication is defined as Clavien-Dindo grade ≥ IIIa

Secondary

MeasureTime frameDescription
Potential risk groups for complicationsWithin 30 days and one year after surgeryEstimated 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
Risk-adjusted benchmark valuesWithin 30 days and one year after surgeryABC method of any identified risk group(s) for complications

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026