NCT05785351

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55,372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

9.9 years

First QC Date

January 6, 2023

Last Update Submit

March 24, 2023

Conditions

Bariatric Surgery

Keywords

ObesityBariatric SurgeryLaparoscopyBenchmarking

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Potential risk groups for complications

    Within 30 days and one year after surgery

  • Risk-adjusted benchmark values

    Within 30 days and one year after surgery

Interventions

Laparoscopic Bariatric SurgeryPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with obesity undergoing elective bariatric surgery in order to achieve weight loss.

You may qualify if:

  • adults ≥ 18 years of age
  • primary laparoscopic gastric sleeve or primary laparoscopic roux-en-y gastric bypass

You may not qualify if:

  • other organ surgery at the time of the index operation
  • no data about surgery
  • no data about follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2023

First Posted

March 27, 2023

Study Start

January 1, 2012

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 27, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share