NCT05929170

Brief Summary

By the comparison of the preoperative and postoperative data of approximately 160 patients undergoing gastric sleeve surgery, we try to draw conclusions about the effectiveness of gastric sleeve surgery, expected complication rate.

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
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

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

April 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

2.2 years

First QC Date

June 25, 2023

Last Update Submit

June 30, 2023

Conditions

Obesity, MorbidHypertensionDiabetes Mellitus, Type 2

Keywords

gastric sleeve operation

Outcome Measures

Primary Outcomes (1)

  • Assessing the results of gastric sleeve surgery, by weight loss

    weight loss (kg)

    up to one year

Secondary Outcomes (3)

  • Assessing the half and one-year results of gastric sleeve surgery, by change in comorbidities

    half year, one year

  • Assessing the half and one-year results of gastric sleeve surgery, comparing different groups (male-female, android-gynoid tipe of obesity, ect.)

    half year, one year

  • Assessing the half and one-year results of gastric sleeve surgery, weight loss. (We try to find a confluence between the perioperative parameters and the expected outcome)

    half year, one year

Eligibility Criteria

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

Obese patients (BMI Higher than 30 kg/m2)

You may qualify if:

  • Obesity (BMI higher than 30 kg/m2)

You may not qualify if:

  • Lack of patient consent to the study, Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siptár Miklós

Pécs, 7635, Hungary

Location

MeSH Terms

Conditions

Obesity, MorbidHypertensionDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist and ICU specialist

Study Record Dates

First Submitted

June 25, 2023

First Posted

July 3, 2023

Study Start

April 1, 2021

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)