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

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
One-anastomosis gastric bypass
Long biliary limb Roux gastric bypass
Sponsored by
Tartu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring OAGB, Long biliary limb Roux gastric bypass, Metabolic surgery, Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Tartu University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Women

Men

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2021
Last Updated
March 21, 2021
Sponsor
Tartu University Hospital
Collaborators
North Estonia Medical Centre, Fertilitas (private clinic)
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1. Study Identification

Unique Protocol Identification Number
NCT04812132
Brief Title
RCT Comparing OAGB and Long Limb Roux Gastric Bypass
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2031 (Anticipated)
Study Completion Date
December 31, 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tartu University Hospital
Collaborators
North Estonia Medical Centre, Fertilitas (private clinic)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
OAGB, Long biliary limb Roux gastric bypass, Metabolic surgery, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women
Arm Type
Active Comparator
Arm Title
Men
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
One-anastomosis gastric bypass
Intervention Description
One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)
Intervention Type
Procedure
Intervention Name(s)
Long biliary limb Roux gastric bypass
Intervention Description
Other group is planned to receive a long biliary limb Roux gastric bypass
Primary Outcome Measure Information:
Title
Excess weight loss %
Description
Calculated loss of the excess weight
Time Frame
10 years
Title
Impact on type 2 diabetes mellitus
Description
Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %
Time Frame
10 years
Title
Impact on type 2 diabetes mellitus
Description
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
Title
Impact on hypertensive disease
Description
Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)
Time Frame
10 years
Title
Impact on total cholesterol
Description
Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).
Time Frame
10 years
Title
Impact on hyperlipidemia
Description
Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L)
Time Frame
10 years
Title
Impact on hyperlipidemia
Description
Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L)
Time Frame
10 years
Title
Impact on hyperlipidemia
Description
Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L)
Time Frame
10 years
Title
Impact on hyperlipidemias
Description
Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Nutritional deficiencies: anemia
Description
% of subjects having hemoglobin below sex adjusted reference (g/L) and ferritin below sex adjusted references (ug/L)
Time Frame
10 years
Title
Nutritional deficiencies
Description
Occurrence of B12 deficiency, measured in % of subjects with vitamin B12 below reference (measures in pmol/L)
Time Frame
10 years
Title
GERD
Description
% of subjects reporting reflux disease symptoms and/or PPI usage after the surgery
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva-Maria Kikkas, Dr
Phone
+37258162720
Email
evamariakikkas@gmail.com
First Name & Middle Initial & Last Name & Degree
Toomas Sillakivi, Dr, PhD
Email
toomas.sillakivi@kliinikum.ee

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

RCT Comparing OAGB and Long Limb Roux Gastric Bypass

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