Swedish National Benchmarks in Laparoscopic Bariatric Surgery

Sponsor
Region Östergötland (Other)
Overall Status
Completed
CT.gov ID
NCT05785351
Collaborator
(none)
55,372
119

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic Bariatric Surgery

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 Design

Study Type:
Observational
Actual Enrollment :
55372 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Bariatric Surgery Benchmarks - How Much Do We Bench?
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Outcome Measures

Primary Outcome Measures

  1. 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)

  2. Number of participants with severe postoperative complications [Within 30 days and one year after surgery]

    Severe complication is defined as Clavien-Dindo grade ≥ IIIa

Secondary Outcome Measures

  1. 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

  2. Risk-adjusted benchmark values [Within 30 days and one year after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Region Östergötland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ebba Kihlstedt Pasquier, Principal Investigator, Region Östergötland
ClinicalTrials.gov Identifier:
NCT05785351
Other Study ID Numbers:
  • 2022-04311-01-1
First Posted:
Mar 27, 2023
Last Update Posted:
Mar 27, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ebba Kihlstedt Pasquier, Principal Investigator, Region Östergötland

Study Results

No Results Posted as of Mar 27, 2023