NCT06081413

Brief Summary

A retrospective multicenter study that will analyze the results of surgical treatment of obesity in patients over 65 years of age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 2, 2023

Last Update Submit

October 6, 2023

Conditions

ObesityDiabetes Mellitus, Type 2Hypertension

Keywords

bariatric surgeryelderly patientsobesity-related diseases

Outcome Measures

Primary Outcomes (2)

  • weight loss after bariatric surgery

    how much weight patients lost, determined by BMI

    until December 31, 2022

  • improvement in obesity-related diseases

    changes in the treatment of hypertension and diabetes type 2 - whether the diseases resolved completely or whether there was a change in medications (in accordance with the guidelines of the American Society for Metabolic and Bariatric Surgery ASMBS)

    until December 31, 2022

Interventions

bariatric surgeryPROCEDURE

bariatric surgeries - sleeve gastrectomy, roux-en-Y gastric bypass, one anastomosis gastric bypass, adjustable gastric band

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients over 65 years of age who underwent bariatric procedures

You may qualify if:

  • years of age and more
  • undergone bariatric surgery

You may not qualify if:

  • lost to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UWM

Olsztyn, 10-045, Poland

Location

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Hypertension

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 13, 2023

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)