NCT05710913

Brief Summary

This Study aims to develop machine learning models with the ability to predict patients' BMI and complications after Bariatric Surgery (CABS-Score). This Study also aims to develop machine learning models with the ability to predict diabetic (DM II)patients' remission rate after Bariatric Surgery. The service mentioned above will be publicly available as a web-based application

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
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration 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 5, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

3 years

First QC Date

January 15, 2023

Last Update Submit

January 25, 2023

Conditions

Keywords

Bariatric SurgeryMachine learningClinical prediction modellingArtificial intelligence

Outcome Measures

Primary Outcomes (3)

  • Complication after surgery

    [Time Frame: From index surgery up to 3 months postoperatively]

  • Body mass Index (KG/m2) after surgery

    [Time Frame: From index surgery up to 1 year postoperatively]

  • Diabetes mellitus type II remission rate postoperatively

    [Time Frame: From index surgery up to 2 year postoperatively]

Eligibility Criteria

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

Patients undergoing bariatric surgery

You may qualify if:

  • Patients undergoing bariatric surgery
  • Patients \>18 years

You may not qualify if:

  • Patients \<18 years
  • Patients who cannot be followed up on for more than 6 month after surgery
  • Patients who are unable to provide informed approval to participate according to each centre's rules will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel - Department of Biomedical Engineering

Basel, Switzerland

RECRUITING

MeSH Terms

Conditions

Body WeightPostoperative ComplicationsHernia, HiatalGastroesophageal RefluxInternal HerniaIntussusceptionDiabetes Mellitus, Type 2Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesHernia, DiaphragmaticHerniaPathological Conditions, AnatomicalEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesIntestinal ObstructionIntestinal DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Bassey Enodien, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

January 15, 2023

First Posted

February 2, 2023

Study Start

January 5, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 2, 2023

Record last verified: 2023-01

Locations