RCT Comparing OAGB and Long Limb Roux Gastric Bypass (OAGBvsLLbypass)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Procedure: One-anastomosis gastric bypass; Procedure: Long biliary limb Roux gastric bypass

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Estonia
  • Tartu, Estonia, 50406
    • Recruiting
    • Tartu University Hospital
    • Contact: Eva-Maria Kikkas, Dr; Phone Number: +37258162720; Email: evamariakikkas@gmail.com
    • Contact: Toomas Sillakivi, Dr, PhD; Email: toomas.sillakivi@kliinikum.ee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Men	Procedure: One-anastomosis gastric bypass; One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass); Procedure: Long biliary limb Roux gastric bypass; Other group is planned to receive a long biliary limb Roux gastric bypass
Active Comparator: Women	Procedure: One-anastomosis gastric bypass; One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass); Procedure: Long biliary limb Roux gastric bypass; Other group is planned to receive a long biliary limb Roux gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excess weight loss %	Calculated loss of the excess weight	10 years
Impact on type 2 diabetes mellitus	Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %	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)	10 years
Impact on hypertensive disease	Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)	10 years
Impact on total cholesterol	Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).	10 years
Impact on hyperlipidemia	Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L)	10 years
Impact on hyperlipidemia	Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L)	10 years
Impact on hyperlipidemia	Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L)	10 years
Impact on hyperlipidemias	Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides	10 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tartu University Hospital
• Collaborators: North Estonia Medical Centre; Fertilitas (private clinic)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2031
• Study Completion (Anticipated): December 31, 2036

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: March 21, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 21, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; OAGB; Metabolic surgery; Long biliary limb Roux gastric bypass
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: TartuUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No