NCT06664580

Brief Summary

A retrospective study analyzing long-term outcomes of metabolic bariatric surgery (MBS) with a focus on weight loss, nutritional deficiencies, and patient satisfaction over a five-year follow-up. This study evaluates outcomes for different surgical procedures, including Laparoscopic Sleeve Gastrectomy (LSG), Roux-en-Y Gastric Bypass (RYGB), and other MBS techniques. The findings aim to provide insight into optimal nutritional management and patient care following bariatric surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

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, 2017

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

7 years

First QC Date

October 28, 2024

Last Update Submit

October 28, 2024

Conditions

Obesity and OverweightNutritional DeficiencyBariatric Surgery

Keywords

Metabolic Bariatric SurgeryLaparoscopic Sleeve GastrectomyRoux-en-Y Gastric BypassExcess Weight LossIron DeficiencyVitamin D DeficiencyQuality of Life Post-SurgeryTargeted Supplementation

Outcome Measures

Primary Outcomes (1)

  • Percentage of Excess Weight Loss (%EWL)

    5 years post-surgery

    The percentage of excess weight lost relative to baseline, calculated to assess long-term weight maintenance following different metabolic bariatric surgeries.

Secondary Outcomes (2)

  • Incidence of Nutritional Deficiencies

    5 years post-surgery

  • Patient Satisfaction and Quality of Life

    5 years post-surgery

Study Arms (1)

Post-Metabolic Bariatric Surgery Patients

A cohort of 249 patients who underwent metabolic bariatric surgery, including various procedures such as Laparoscopic Sleeve Gastrectomy (LSG) and Roux-en-Y Gastric Bypass (RYGB), with follow-up on long-term outcomes related to weight maintenance, nutritional deficiencies, and patient satisfaction

Other: Metabolic Bariatric Surgery Procedures

Interventions

Metabolic Bariatric Surgery ProceduresOTHER

Observational analysis of various metabolic bariatric surgeries, including LSG, RYGB, and OAGB, focusing on long-term outcomes related to weight maintenance, nutritional health, and patient satisfaction.

Also known as: weight, bariatric, nutrition
Post-Metabolic Bariatric Surgery Patients

Eligibility Criteria

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

Adults who underwent metabolic bariatric surgery, including LSG and RYGB, at a specialized center, with a focus on long-term outcomes in weight maintenance, nutritional health, and patient satisfaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Heusschen L, Berendsen AAM, Deden LN, Hazebroek EJ, Aarts EO. Nutritional Deficiencies 3 Years After Sleeve Gastrectomy Can Be Limited by a Specialized Multivitamin Supplement. Obes Surg. 2022 Nov;32(11):3561-3570. doi: 10.1007/s11695-022-06256-w. Epub 2022 Aug 26.

    PMID: 36018421BACKGROUND

  • Noria SF, Shelby RD, Atkins KD, Nguyen NT, Gadde KM. Weight Regain After Bariatric Surgery: Scope of the Problem, Causes, Prevention, and Treatment. Curr Diab Rep. 2023 Mar;23(3):31-42. doi: 10.1007/s11892-023-01498-z. Epub 2023 Feb 8.

    PMID: 36752995BACKGROUND

  • Gorini S, Camajani E, Franchi A, Cava E, Gentileschi P, Bellia A, Karav S, Sbraccia P, Caprio M, Lombardo M. Enhancing nutritional health and patient satisfaction five years after metabolic bariatric surgery with targeted supplementation. J Transl Med. 2025 Feb 21;23(1):216. doi: 10.1186/s12967-025-06224-9.

    PMID: 39984967DERIVED

Related Links

MeSH Terms

Conditions

ObesityOverweightMalnutritionIron DeficienciesVitamin D Deficiency

Interventions

Bariatric SurgeryWeights and MeasuresNutritional Status

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsIron Metabolism DisordersMetabolic DiseasesAvitaminosisDeficiency Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, OperativeInvestigative TechniquesNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Nutrition Sciences

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 29, 2024

Study Start

January 1, 2017

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy concerns and the retrospective nature of the study, which limits consent for data sharing beyond the initial research purposes. Aggregated study results and relevant findings are available upon reasonable request.