NCT05336331

Brief Summary

This study compared differences in weight loss, comorbidity resolution and complications and reoperations between a recently established sleeve gastrectomy (SG) and prior laparoscopic Rox-en-Y gastric bypass (RYGB).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,015

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

February 14, 2022

Last Update Submit

April 12, 2022

Conditions

Postoperative Complications

Keywords

bariatric surgerylaparoscopic Roux-en-Y gastric bypasslaparoscopic sleeve gastrectomyMorbid obesityWeight lossMetabolic controlMetabolic syndromeComplication risk

Outcome Measures

Primary Outcomes (17)

  • Weight loss

    weight and height will be combined to report various measurements of BMI in kg/m\^2

    after 6 weeks

  • Weight loss

    weight and height will be combined to report various measurements of BMI in kg/m\^2

    after 1 year

  • Weight loss

    weight and height will be combined to report various measurements of BMI in kg/m\^2

    after 2 years

  • Changes in Diabetes

    measured as fasting plasma glucose and/or Hemoglobin A1c

    after 1 year

  • Changes in Diabetes

    measured as fasting plasma glucose and/or Hemoglobin A1c

    after 2 years

  • Changes in Hypertension

    measured as Systolic- and Diastolic Blood Pressure

    after 1 year

  • Changes in Hypertension

    measured as Systolic- and Diastolic Blood Pressure

    after 2 years

  • Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l)

    measured as hypertriglyceridaemia (plasma-level \>1.7 mmol/l)

    after 1 year

  • Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l)

    measured as hypertriglyceridaemia (plasma-level \>1.7 mmol/l)

    after 2 year

  • Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L).

    Measured as Hypercholesterolemia (Plasma concentration of LDL \>3.0 mmol/L and/or of HDL \< 1.0 mmol/L).

    after 1 years

  • Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L).

    Measured as Hypercholesterolemia (Plasma concentration of LDL \>3.0 mmol/L and/or of HDL \< 1.0 mmol/L).

    after 2 years

  • Duration of surgery

    Operation time in minutes

    From the start of the operation until completion, in average 62 minutes

  • Duration of hospital stay

    Duration of hospital stay in days

    From time of operation until discharge, in average 1.7 days

  • Early complications

    Complications occurred until six weeks from operation

    At six weeks

  • Early reoperations

    Reoperations occurred until six weeks from operation

    At six weeks

  • Late complications

    Complications occurred from six weeks until 2 years from operation

    From six weeks until 2 years from operation

  • Late reoperations

    Reoperations occurred from six weeks until 2 years from operation

    From six weeks until 2 years from operation

Study Arms (2)

laparoscopic sleeve gastrectomy (SG)

Patients operated on with a SG

Procedure: SG or a RYGB

laparoscopic Roux-en-Y gastric bypass (RYGB)

patients operated on with aRYGB

Procedure: SG or a RYGB

Interventions

SG or a RYGBPROCEDURE

operation type differed between a partial gastrectomy (SG)or a combined restrictive/malabsorptive

laparoscopic Roux-en-Y gastric bypass (RYGB)laparoscopic sleeve gastrectomy (SG)

Eligibility Criteria

Age18 Years - 60 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Morbid obesity patients found suitable for a SG or RYGB

You may qualify if:

  • Patients with either a BMI 35 or higher with comorbidity, or patients with a BMI of 40 or more without known comorbidity associated, undergoing a primary laparoscopic bariatric surgery in Sundsvall,Sweden 2010-01-01 to 2018-06-10.

You may not qualify if:

  • All other patients undergoing a bariatric surgery during this time frame

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sundsvall Hospital

Sundsvall, Sweden

Location

MeSH Terms

Conditions

Postoperative ComplicationsObesity, MorbidWeight LossMetabolic Syndrome

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsBody Weight ChangesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2022

First Posted

April 20, 2022

Study Start

January 1, 2021

Primary Completion

January 1, 2022

Study Completion

December 31, 2025

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)