Swedish National Benchmarks in Laparoscopic Bariatric Surgery

Bariatric Surgery Clinical Trial

Official title:

Bariatric Surgery Benchmarks - How Much Do We Bench?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05785351
• Other study ID #: 2022-04311-01-1
• Status: Completed
• Start date: January 2012
• Est. completion date: December 2021

Study information

• Verified date: March 2023
• Source: Region Östergötland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The second outcome to investigate if there are risk groups for complications, and if so perform risk-adjusted benchmark-calculations.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55372
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Östergötland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Risk-adjusted benchmark values	ABC method of any identified risk group(s) for complications	Within 30 days and one year after surgery