Swedish National Benchmarks in Laparoscopic Bariatric Surgery

Completed

• Conditions: Bariatric Surgery

• Registration Number: NCT05785351
• Lead Sponsor: Region Östergötland

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Study First Submitted: 2023-01-06
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-24
• Last Update Submitted: 2023-03-24
• Study First Posted: 2023-03-27
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55372

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with severe postoperative complications	Within 30 days and one year after surgery	Severe complication is defined as Clavien-Dindo grade ≥ IIIa
Benchmark values of variables related to surgical quality	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)

Secondary Outcome Measures

Name	Time	Method
Potential risk groups for complications	Within 30 days and one year after surgery	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
Risk-adjusted benchmark values	Within 30 days and one year after surgery	ABC method of any identified risk group(s) for complications