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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04812132
Other study ID # TartuUH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2036

Study information

Verified date March 2021
Source Tartu University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2036
Est. primary completion date December 31, 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Estonia Tartu University Hospital Tartu

Sponsors (3)

Lead Sponsor Collaborator
Tartu University Hospital Fertilitas (private clinic), North Estonia Medical Centre

Country where clinical trial is conducted

Estonia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Excess weight loss % Calculated loss of the excess weight 10 years
Primary Impact on type 2 diabetes mellitus Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c % 10 years
Primary 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) 10 years
Primary Impact on hypertensive disease Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended) 10 years
Primary Impact on total cholesterol Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L). 10 years
Primary Impact on hyperlipidemia Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L) 10 years
Primary Impact on hyperlipidemia Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L) 10 years
Primary Impact on hyperlipidemia Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L) 10 years
Primary Impact on hyperlipidemias Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides 10 years
Secondary Nutritional deficiencies: anemia % of subjects having hemoglobin below sex adjusted reference (g/L) and ferritin below sex adjusted references (ug/L) 10 years
Secondary Nutritional deficiencies Occurrence of B12 deficiency, measured in % of subjects with vitamin B12 below reference (measures in pmol/L) 10 years
Secondary GERD % of subjects reporting reflux disease symptoms and/or PPI usage after the surgery 10 years
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