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ObesityMGBvsRYGBNCT03045679

One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass

A study testing RYGB and OAGB/MGB in people with Obesity, run by Sana Klinikum Offenbach at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of this prospective randomized controlled trial is to compare the two procedures One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass (RYGB) in relation to intraoperative and postoperative complications (classification of Clavien-Dindo), mortality, metabolic impact… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
RYGB and OAGB/MGB
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteGermany
Study dates
1 Jan 2018to 1 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • primary obesity surgery and indication for gastric bypass
  • age: 18 - 65 years
  • BMI > 40 kg/m² or BMI > 35 kg/m² with obesity related comorbidities
  • informed consent

Who cannot join

  • obesity surgery in the anamnesis
  • visceral surgery in the anamnesis (excluding appendectomy and cholecystectomy)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Sana Klinikum Offenbach

    Offenbach, Hesse, 63069

Other trials in Germany

About this study

Official title: The Evidence of One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass in Metabolic Surgery - a Prospective Randomized Controlled Trial

The aim of this prospective randomized controlled trial is to compare the two procedures One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass (RYGB) in relation to intraoperative and postoperative complications (classification of Clavien-Dindo), mortality, metabolic impact (remission of type 2 diabetes mellitus, hypertonus, gastro-esophageal reflux disease, sleep apnea, dyslipidemia, quality of life, operation time, postoperative excess weight loss, malnutrition and re-do/revisonal surgery.

Read the detailed description

OAGB/MGB is gaining popularity as a primary surgical treatment for morbid obesity due to reduced operation time, a shorter learning curve, better weight loss, higher metabolic impact and fewer major complications compared to RYGB.

In this prospective randomized controlled trial we want to compare OAGB/MGB and RYGB with a FU of up to 24 month.

Patients with indication for gastric bypass get randomized in group A (RYGB, n = 50) or B (OAGB/MGB, n = 50). FU is performed 1, 3, 6, 12 and 24 month after surgery.

Conditions
Obesity
Being tested
RYGB, OAGB/MGB
Keywords
Roux-en Y gastric bypass, One-anastomosis gastric bypass, Mini-gastric bypass, metabolic surgery
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RYGBOther

    laparoscopic RYGB

  • OAGB/MGBOther

    laparoscopic OAGB/MGB

Study groups in NCT03045679
Study groupRoleWhat they receive
RYGB-groupExperimentalPatients who undergo laparoscopic RYGB (150 cm alimentary limb, 50 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50
Receives: Other: RYGB
OAGB/MGB-groupExperimentalPatients who undergo laparoscopic OAGB/MGB (200 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50
Receives: Other: OAGB/MGB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complications

    complications classified next to Clavien-Dindo

    Measured: up to 2 years after surgery

Secondary outcomes (19)

  1. mortality

    death up to 2 years after surgery

    Measured: up to 2 years after surgery

  2. remission of type 2 diabetes mellitus

    HbA1c < 6.5% without medication

    Measured: up to 2 years after surgery

  3. remission of hypertonus

    blood pressure < 140/90 mmHg without medication

    Measured: up to 2 years after surgery

  4. gastro-esophageal reflux disease

    GERD-HRGL Heartburn Scale

    Measured: up to 2 years after surgery

  5. remission of sleep apnea

    presence/absence of CPAP

    Measured: up to 2 years after surgery

  6. remission of hypertrigliceridemia

    triglyceride < 200mg/dl without medication

    Measured: up to 2 years after surgery

  7. remission of hypercholesterinemia

    cholesterin < 155 mg/dl without medication

    Measured: up to 2 years after surgery

  8. quality of life questionnaire

    changing in quality of life measured by questionnaire

    Measured: up to 2 years after surgery

  9. weight loss

    postoperative excess weight loss in %

    Measured: up to 2 years after surgery

  10. operation time

    operation time during surgery in minutes

    Measured: operation time during surgery in minutes

  11. malnutrition 1

    postoperative malnutrition: protein < 64 g/l

    Measured: up to 2 years after surgery

  12. malnutrition 2

    postoperative malnutrition: albumin < 35 g/l

    Measured: up to 2 years after surgery

  13. malnutrition 3

    postoperative malnutrition: ferritin (< 30 µg/l)

    Measured: up to 2 years after surgery

  14. malnutrition 4

    postoperative malnutrition: vitamin E < 12 µmol/l

    Measured: up to 2 years after surgery

  15. malnutrition 5

    postoperative malnutrition: vitamin K < 90 ng/l

    Measured: up to 2 years after surgery

  16. malnutrition 6

    postoperative malnutrition: vitamin 25-OH- Vitamin D3 < 50 nmol/l

    Measured: up to 2 years after surgery

  17. malnutrition 7

    postoperative malnutrition: vitamin A < 1.05 µmol/l

    Measured: up to 2 years after surgery

  18. malnutrition 8

    postoperative malnutrition: vitamin B12 < 145 pmol/l

    Measured: up to 2 years after surgery

  19. revisional surgery

    revisional surgery during follow up

    Measured: up to 2 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2017 (estimated)
  2. Study start1 Jan 2018
  3. Primary completion1 Dec 2020
  4. Study completion1 Dec 2020

Why it stopped: Hospital changed in 2019, no recruitment performed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
prospective randomized controlled trial: RYGB (group A) vs OAGB/MGB (group B)
Masking
Single blind
Who is masked
Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03045679
Sponsor's protocol ID
FF 74/2016
Acronym
MGBvsRYGB
Status last verified
Jan 2023
First submitted
5 Feb 2017
Last updated
17 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chevallier JM, Arman GA, Guenzi M, Rau C, Bruzzi M, Beaupel N, Zinzindohoue F, Berger A. One thousand single anastomosis (omega loop) gastric bypasses to treat morbid obesity in a 7-year period: outcomes show few complications and good efficacy. Obes Surg. 2015 Jun;25(6):951-8. doi: 10.1007/s11695-014-1552-z.

    PubMed 25585612

  • Jammu GS, Sharma R. A 7-Year Clinical Audit of 1107 Cases Comparing Sleeve Gastrectomy, Roux-En-Y Gastric Bypass, and Mini-Gastric Bypass, to Determine an Effective and Safe Bariatric and Metabolic Procedure. Obes Surg. 2016 May;26(5):926-32. doi: 10.1007/s11695-015-1869-2.

    PubMed 26337694

  • Musella M, Apers J, Rheinwalt K, Ribeiro R, Manno E, Greco F, Cierny M, Milone M, Di Stefano C, Guler S, Van Lessen IM, Guerra A, Maglio MN, Bonfanti R, Novotna R, Coretti G, Piazza L. Efficacy of Bariatric Surgery in Type 2 Diabetes Mellitus Remission: the Role of Mini Gastric Bypass/One Anastomosis Gastric Bypass and Sleeve Gastrectomy at 1 Year of Follow-up. A European survey. Obes Surg. 2016 May;26(5):933-40. doi: 10.1007/s11695-015-1865-6.

    PubMed 26341086

  • Guenzi M, Arman G, Rau C, Cordun C, Moszkowicz D, Voron T, Chevallier JM. Remission of type 2 diabetes after omega loop gastric bypass for morbid obesity. Surg Endosc. 2015 Sep;29(9):2669-74. doi: 10.1007/s00464-014-3987-7. Epub 2015 Jan 1.

    PubMed 25552228

  • Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. doi: 10.1097/01.sla.0000167762.46568.98.

    PubMed 15973097

Questions about this trial

What is this clinical trial studying?

A study testing RYGB and OAGB/MGB in people with Obesity, run by Sana Klinikum Offenbach at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Hospital changed in 2019, no recruitment performed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complications (time frame: up to 2 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03045679, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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