Comparison of Extremely Obese Patients Undergoing Gastric Sleeve Surgery

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2; Obesity, Morbid; Hypertension

• Registration Number: NCT05929170
• Lead Sponsor: University of Pecs

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.

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 Timeline

• Study Start: 2021-04-01
• Status Verified: 2023-06
• Primary Completion: 2023-06
• Study First Submitted: 2023-06-25
• Study First Submitted QC: 2023-06-30
• Last Update Submitted: 2023-06-30
• Study Completion: 2023-07
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Obesity (BMI higher than 30 kg/m2)

Exclusion Criteria

Lack of patient consent to the study, Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessing the results of gastric sleeve surgery, by weight loss	up to one year	weight loss (kg)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Siptár Miklós; 🇭🇺 Pécs, Hungary