Laparascopic Sleeve Gastrectomy vs. Endoscopic Gastric Plication in Obesity (SLAVIA)

Institute for Clinical and Experimental Medicine

Status: Not yet enrolling

Conditions: Obesity

Treatments: Device: endoscopic gastric plication; Other: conservative treatment of obesity; Device: laparoscopic sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05259644

NU21-01-00096

Details and patient eligibility

About

The project will describe the efficacy and safety of laparoscopic sleeve gastrectomy and endoscopic gastric plication procedures as compared to conservative therapy and clarify the mechanisms of action of these treatments. The project will also contribute to more precise indications of bariatric or endoscopic methods in clinical practice and enable personalized choice of therapy for particular patient.

Full description

Bariatric surgery is the most efficacious treatment of obesity and type 2 diabetes mellitus. Novel endoscopic methods based on the principles of bariatric surgery are also highly effective. No direct randomized comparison of both types of treatment has been performed to date and the mechanisms of action of both procedures are still only partially clarified. The aim of the project is to perform a randomized trial comparing efficacy and safety of three treatment options in patients with obesity: laparoscopic sleeve gastrectomy, endoscopic gastric plication and conservative treatment. A further aim is to characterize the influence of the three treatments on subclinical inflammation, gut microbiota composition and changes of gastrointestinal hormones. The results of the project will describe the efficacy and safety of these procedures as compared to conservative therapy and clarify the mechanisms of action of these treatments. The project will also contribute to more precise indications of bariatric or endoscopic methods in clinical practice and enable personalized choice of therapy for particular patient.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. BMI > 35 kg/m2
2. For patients with type 2 diabetes - stable antidiabetic medication > 1 month
3. Age 18-60 years

Exclusion criteria

1. Other diabetes mellitus types (type 1 DM, monogenic DM, secondary DM)

2. Prior gastrointestinal (GIT) surgery interfering with study procedure

3. Severe gastroesophageal reflux, severe GIT motility disorder

4. Active malignancy

5. Acute myocardial infarction, unstable angina pectoris, acute stroke 3 months prior to enrolment

6. Acute liver or kidney failure

7. Transplantation of insulin producing tissue

8. Gravidity or lactation

9. Mental disorder

10. Inability to sign informed consent

11. Any other contraindication of bariatric surgery or bariatric endoscopy procedure

12. Acute liver or kidney failure 7. Transplantation of insulin producing tissue 8. Gravidity or lactation 9. Mental disorder 10. Inability to sign informed consent 11. Any other contraindication of bariatric surgery or bariatric endoscopy procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Conservative treatment group

Active Comparator group

Description:

Obese patients treated with conservative approach - diet.

Treatment:

Other: conservative treatment of obesity

Laparoscopic sleeve gastrectomy

Active Comparator group

Description:

Obese patients treated with laparoscopic sleeve gastrectomy.

Treatment:

Device: laparoscopic sleeve gastrectomy

endoscopic gastric plication

Active Comparator group

Description:

Obese patients treated with endoscopic gastric plication.

Treatment:

Device: endoscopic gastric plication