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NCT05929170 Clinical Trial

Comparison of Extremely Obese Patients Undergoing Gastric Sleeve Surgery

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05929170
Other study ID # 8653-PTE 2021.
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date July 2023

Study information
Verified date June 2023
Source University of Pecs
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.,

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 160
Est. completion date July 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Obesity (BMI higher than 30 kg/m2) Exclusion Criteria: Lack of patient consent to the study, Pregnancy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Hungary Siptár Miklós Pécs

Sponsors (1)
Lead Sponsor Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessing the results of gastric sleeve surgery, by weight loss weight loss (kg) up to one year
Secondary Assessing the half and one-year results of gastric sleeve surgery, by change in comorbidities 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
Secondary Assessing the half and one-year results of gastric sleeve surgery, comparing different groups (male-female, android-gynoid tipe of obesity, ect.) weight loss (kg) half year, one year
Secondary 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) weight loss (kg) half year, one year
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