RCT Comparing OAGB and Long Limb Roux Gastric Bypass

Obesity Clinical Trial

— OAGBvsLLbypass  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04812132
• Other study ID #: TartuUH
• Status: Recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Obesity

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