NCT04852198

Brief Summary

The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
42mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Dec 2021Nov 2029

First Submitted

Initial submission to the registry

October 6, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

December 13, 2021

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2027

Expected
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

5.5 years

First QC Date

October 6, 2020

Last Update Submit

April 22, 2024

Conditions

Bariatric Surgery CandidateObesityObesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • Percentage excess BMI loss at 2 years (%EBMIL)

    Percentage excess BMI loss after 2 years of follow-up

    2 years

Study Arms (2)

OAGB

ACTIVE COMPARATOR

149 patients receiving one anastomosis gastric bypass (OAGB) with a Biliopancreatic-limb of 150cm

Procedure: OAGB

RYGB

ACTIVE COMPARATOR

149 patients receiving Roux-en-Y gastric bypass (RYGB) with a Biliopancreatic-limb of 150cm

Procedure: RYGB

Interventions

OAGBPROCEDURE

Simplified gastric bypass procedure

Also known as: Mini gastric bypass, Omega loop gastric bypass
OAGB
RYGBPROCEDURE

Roux-en-Y gastric bypass. Standard procedure in the Netherlands

RYGB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • body-mass index (BMI) of 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee)
  • a positive evaluation by our BMDT

You may not qualify if:

  • Presence of H. Pylori, resistant to eradication therapy
  • chronic diarrhoea
  • history of previous bariatric or extensive abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Flevoziekenhuis

Almere Stad, 1315RA, Netherlands

RECRUITING

OLVG

Amsterdam, 1061AE, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

ObesityObesity, Morbid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stef JM Smeets, MD PhD

    Flevoziekenhuis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stef JM Smeets, MD PhD

CONTACT

0031368688888ssmeets@flevoziekenhuis.nl

Floris Bruinsma, Student

CONTACT

0031368688888fbruinsma@flevoziekenhuis.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with 2 groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2020

First Posted

April 21, 2021

Study Start

December 13, 2021

Primary Completion (Estimated)

June 13, 2027

Study Completion (Estimated)

November 1, 2029

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)