RCT Comparing OAGB and Long Limb Roux Gastric Bypass

ConditionObesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-60

SponsorTartu University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI over 35 and obesity related disease

BMI over 40

age between 18-60 years

agrees to participate in the study

Disqualifiers

age under 18 years or over 60 years

abundant adhesions discovered during the surgery

active upper gastrointestinal ulcer disease

prior bariatric surgery

Trial design

Design model

Parallel

Treatments tested in this trial

One-anastomosis gastric bypass
Procedure/Surgery
One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)
Long biliary limb Roux gastric bypass
Procedure/Surgery
Other group is planned to receive a long biliary limb Roux gastric bypass

Treatment groups

500 Participants

are divided into 2 treatment groups

Group A: WomenActive comparator 2 interventions

Group B: MenActive comparator 2 interventions

Trial outcomes

Primary outcomes

Excess weight loss %

Calculated loss of the excess weight

Time frame

10 years

Impact on type 2 diabetes mellitus

Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %

Time frame

10 years

Impact on type 2 diabetes mellitus

Outcome of type 2 diabetes mellitus after the surgery, measured in usage of medication (same dosage, decreased dosage, insulin to peroral, ended all medication)

Time frame

10 years

Impact on hypertensive disease

Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)

Time frame

10 years

Secondary outcomes

Nutritional deficiencies: anemia

% of subjects having hemoglobin below sex adjusted reference (g/L) and ferritin below sex adjusted references (ug/L)

Time frame

10 years

Nutritional deficiencies

Occurrence of B12 deficiency, measured in % of subjects with vitamin B12 below reference (measures in pmol/L)

Time frame

10 years

GERD

% of subjects reporting reflux disease symptoms and/or PPI usage after the surgery

Time frame

10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tartu University Hospital

Lead sponsor

North Estonia Medical Centre

Collaborator

Fertilitas (private clinic)

Collaborator

Source ClinicalTrials.gov

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