Swedish National Benchmarks in Laparoscopic Bariatric Surgery

Study Overview
=================
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.

Official Title
-----------------
Bariatric Surgery Benchmarks - How Much Do We Bench?

Conditions
-----------------
Bariatric Surgery

Intervention / Treatment
-----------------
* Procedure: Laparoscopic Bariatric Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic Bariatric Surgery|Laparoscopic Bariatric Surgery: Gastric Sleeve and Roux-en-Y Gastric Bypass|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | Within 30 days and one year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Within 30 days and one year after surgery | 
| Risk-adjusted benchmark values | ABC method of any identified risk group(s) for complications | Within 30 days and one year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopy, Obesity, Bariatric Surgery, Benchmarking