Comparison of Extremely Obese Patients Undergoing Gastric Sleeve Surgery

Sponsor

University of Pecs (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05929170

Collaborator

(none)

160

Enrollment

Location

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Morbid Hypertension Diabetes Mellitus, Type 2

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 Design

Study Type:

Observational

Actual Enrollment :

160 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Outcome Measures

Primary Outcome Measures

Assessing the results of gastric sleeve surgery, by weight loss [up to one year]
weight loss (kg)

Secondary Outcome Measures

Assessing the half and one-year results of gastric sleeve surgery, by change in comorbidities [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.)
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]
weight loss (kg)
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]
weight loss (kg)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Obesity (BMI higher than 30 kg/m2)

Exclusion Criteria:

Lack of patient consent to the study, Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Siptár Miklós	Pécs		Hungary	7635

Sponsors and Collaborators

University of Pecs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Siptár Miklós, Anesthesiologist and ICU specialist, University of Pecs

ClinicalTrials.gov Identifier:

NCT05929170

Other Study ID Numbers:

8653-PTE 2021.

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Siptár Miklós, Anesthesiologist and ICU specialist, University of Pecs

gastric sleeve operation

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Obesity, Morbid

Study Results

No Results Posted as of Jul 3, 2023