RCT Comparing OAGB and Long Limb Roux Gastric Bypass

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Procedure: One-anastomosis gastric bypass; Procedure: Long biliary limb Roux gastric bypass

• Registration Number: NCT04812132
• Lead Sponsor: Tartu University Hospital

Brief Summary

A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass.

We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea.

Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life.

There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts.

There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-02-27
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-21
• Last Update Submitted: 2021-03-21
• Study First Posted: 2021-03-23
• Last Update Posted: 2021-03-23
• Primary Completion: 2031-12-31
• Study Completion: 2036-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• BMI over 35 and obesity related disease
• BMI over 40
• age between 18-60 years
• agrees to participate in the study

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Exclusion Criteria

• age under 18 years or over 60 years
• abundant adhesions discovered during the surgery
• active upper gastrointestinal ulcer disease
• prior bariatric surgery
• active symptomatic reflux disease
• active psychiatric disease (eg psychosis)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Men	One-anastomosis gastric bypass	-
Women	Long biliary limb Roux gastric bypass	-
Men	Long biliary limb Roux gastric bypass	-
Women	One-anastomosis gastric bypass	-

Primary Outcome Measures

Name	Time	Method
Impact on total cholesterol	10 years	Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).
Impact on hypertensive disease	10 years	Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)
Impact on type 2 diabetes mellitus	10 years	Outcome of type 2 diabetes mellitus after the surgery, measured in usage of medication (same dosage, decreased dosage, insulin to peroral, ended all medication)
Impact on hyperlipidemia	10 years	Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L)
Impact on hyperlipidemias	10 years	Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides
Excess weight loss %	10 years	Calculated loss of the excess weight

Secondary Outcome Measures

Name	Time	Method
Nutritional deficiencies: anemia	10 years	% of subjects having hemoglobin below sex adjusted reference (g/L) and ferritin below sex adjusted references (ug/L)
GERD	10 years	% of subjects reporting reflux disease symptoms and/or PPI usage after the surgery
Nutritional deficiencies	10 years	Occurrence of B12 deficiency, measured in % of subjects with vitamin B12 below reference (measures in pmol/L)

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Estonia