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NCT Number: NCT04812132

RCT Comparing OAGB and Long Limb Roux Gastric Bypass

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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)

Treatment and study plan

One-Anastomosis Gastric Bypass

Procedure

One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)

Long biliary limb Roux gastric bypass

Procedure

Other group is planned to receive a long biliary limb Roux gastric bypass

Primary outcomes

  1. Excess weight loss %

    Time frame: 10 years

    Calculated loss of the excess weight

  2. Impact on type 2 diabetes mellitus

    Time frame: 10 years

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

  3. Impact on type 2 diabetes mellitus

    Time frame: 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)

  4. Impact on hypertensive disease

    Time frame: 10 years

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

  5. Impact on total cholesterol

    Time frame: 10 years

    Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).

  6. Impact on hyperlipidemia

    Time frame: 10 years

    Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L)

  7. Impact on hyperlipidemia

    Time frame: 10 years

    Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L)

  8. Impact on hyperlipidemia

    Time frame: 10 years

    Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L)

  9. Impact on hyperlipidemias

    Time frame: 10 years

    Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides

Secondary outcomes

  1. Nutritional deficiencies: anemia

    Time frame: 10 years

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

  2. Nutritional deficiencies

    Time frame: 10 years

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

  3. GERD

    Time frame: 10 years

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

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Collaborators

  • Fertilitas (private clinic)
  • North Estonia Medical Centre

Registry information

Official study title

A Multicentre Randomized Controlled Trial Comparing Outcome of Laparoscopic One-anastomosis Gastric Bypass and Laparoscopic Long Biliopancreatic Limb Roux Gastric Bypass for Treatment of Morbid Obesity.

Acronym: OAGBvsLLbypass

Important dates

Study start
2021
Primary completion
2031
Study completion
2036
First posted
Mar 23, 2021
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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