Comparison of Extremely Obese Patients Undergoing Gastric Sleeve Surgery

June 30, 2023 updated by: Siptár Miklós, University of Pecs

Comparison of Different Tipe Extremely Obese Patients Undergoing Gastric Sleeve Surgery in Terms of Perioperative Risk (Cardiopulmonary Parameters and Other Perioperative Risk Factors) and Effectiveness of the Intervention

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

We plan to compare the preoperative and postoperative data of approximately 160 patients undergoing gastric sleeve surgery (android-gynoid, male-female, comparison of patients with different degree of obesity, age comparison, etc.) Many preoperative and postoperative data are known about the patients (weight, height, BMI, preoperative comorbidities, heart ultrasound values, respiratory function values, laboratory parameters, smoking habits, rate of weight loss in half a year and one year, etc.). By statistical analysis of these data, we try to draw conclusions about the effectiveness of gastric sleeve surgery, expected complication rate, etc.,

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Pécs, Hungary, 7635
        • Siptár Miklós

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Obese patients (BMI Higher than 30 kg/m2)

Description

Inclusion Criteria:

Obesity (BMI higher than 30 kg/m2)

Exclusion Criteria:

Lack of patient consent to the study, Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the results of gastric sleeve surgery, by weight loss
Time Frame: up to one year
weight loss (kg)
up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the half and one-year results of gastric sleeve surgery, by change in comorbidities
Time Frame: half year, one year
change in comorbidities (the clinical improvement of the given comorbidity, for example in the case of hypertension, the patient's antihypertensive medications can be reduced or completely omitted, ect.)
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.)
Time Frame: half year, one year
weight loss (kg)
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)
Time Frame: half year, one year
weight loss (kg)
half year, one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Estimated)

June 1, 2023

Study Completion (Estimated)

July 1, 2023

Study Registration Dates

First Submitted

June 25, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 30, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8653-PTE 2021.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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