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Completed

NCT Number: NCT05785351

Swedish National Benchmarks in Laparoscopic Bariatric Surgery

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.

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Key information

Conditions

Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic Bariatric Surgery

Procedure

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

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. Potential risk groups for complications

    Time frame: 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

  2. Risk-adjusted benchmark values

    Time frame: Within 30 days and one year after surgery

    ABC method of any identified risk group(s) for complications

Sponsors and collaborators

Lead sponsor

Region Östergötland

Other

Registry information

Official study title

Bariatric Surgery Benchmarks - How Much Do We Bench?

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2023
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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