ObesityFundoRingNCT04828733

One Anastomosis Gastric Bypass With Excluded Stomach Fundoplication: FundoRing vs Nissen vs OAGB Without Fundoplication

A study testing laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty, laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty and Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication. in people with Obesity and GERD, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Background and study aims: Currently, one anastomosis Gastric Bypass (OAGB) is a common bariatric procedure. Obesity and gastroesophageal reflux disease (GERD) are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Obesity, GERD
What is being tested?: laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty, laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty and Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteKazakhstan
Study dates: 29 Mar 2019to 10 May 2024
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Class I- III obesity (BMI 30.0-50.0 kg/m)
Patients with GERD A or B grade of reflux esophagitis (LA grade) after treatment PPI
Hiatal hernia (HH) <5 cm
ASA grading 1-2
Age 18-60 years old.

Who cannot join

Giant hiatal hernia (HH) >5 cm
Esophageal shortening
Patients with C or D grade of RE (reflux esophagitis)
Previously surgery on the stomach or esophagus
Psychiatric illness

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

Oral Ospanov
Astana, 020000

Other trials in Kazakhstan

About this study

Official title: A Randomized Controlled Trial of Laparoscopic One Anastomosis Gastric Bypass With Excluded Stomach Fundoplication: FundoRingOAGB Versus NissenOAGB Versus OAGB Without Fundoplication for Treating Morbid Obesity and GERD

Background and study aims:

Currently, one anastomosis Gastric Bypass (OAGB) is a common bariatric procedure.

Obesity and gastroesophageal reflux disease (GERD) are steadily increasing world weight and antireflux surgery must be performed simultaneously with bariatric surgery in obese patients. In these cases, most often for GERD patients OAGB procedures only with hiatus cruroraphy is performed.

The goal of this randomized controlled clinical trial is to compare bariatric and antireflux results after OAGB plus suture cruroplasty with FundoRing (n=50) versus Nissen fundoplication (n=50) and versus without total fundoplication (n=50) for patients with morbid obesity and GERD.

The main questions it aims to answer are:

What is the impact of wrapping the fundus of the excluded part of the stomach use FundoRing method in the experimental group against developing reflux esophagitis compare impact standard Nissen in OAGB?
What is the impact of excluded stomach fundoplication on weight loss in FundoRing group versus standard Nissen group in OAGB?

Methods: Adult participants (n=150) are randomly allocated to one of three groups:

Experimental surgical bariatric procedure in the first (A) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty (OAGB + SCP + FundoRing); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty (OAGB + SCP +NF).

Active comparator surgical bariatric procedure in the second (C) group: patients (n=50) undergo laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty (OAGB + SCP). All patients are then followed up 12, 24, and 36 months after surgery where the changing body mass index and change of GERD symptoms (GERD-HRQL).

Read the detailed description

One anastomosis Gastric Bypass/Mini Gastric Bypass (OAGB/MGB) is gaining popularity as a primary surgical treatment for morbid obesity. The total fundoplication is the gold standard for treating GERD. Morbid obesity and GERD require simultaneous surgical treatment.

The aim study is to compare bariatric and antireflux results after OAGB/MGB plus suture cruroplasty (SCP) with FundoRing versus Nissen fundoplication and versus without total fundoplication.

Adult participants (n=150) are randomly allocated to one of three groups:

Active comparator surgical bariatric procedure in the second (C) group: patients (n=50) undergo laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty (OAGB + SCP). All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index and change of GERD symptoms (GERD-HRQL).

Conditions: Obesity, GERD
Being tested: laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty, laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty, Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.
Keywords: Obesity, GERD, Gastric bypass, Fundoplication, Nissen, FundoRing
Medical subject headings: Obesity, Gastroesophageal Reflux

What participants receive

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

laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplastyProcedure or surgery
Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use FundoRing method.
laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplastyProcedure or surgery
Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use the Nissen method.
Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.Procedure or surgery
Laparoscopic gastric bypass with only suture cruroplasty without fundoplication

Study groups in NCT04828733
Study group	Role	What they receive
OAGB + SCP + FundoRing	Experimental	laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty Receives: Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty
OAGB + SCP + NF	Active comparator	laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty Receives: Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty
OAGB + SCP	Active comparator	laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty Receives: Procedure: Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.

What is being measured

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

Change of body mass index
The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2.
Measured: Baseline, at 12, 24, 36 months after surgery
Change of GERD symptoms (GERD-HRQL)
Success; ≥50% improvement in the baseline GERD-HRQL score Failure; <50% improvement in the baseline GERD-HRQL score at 12,24, 36 months.
Measured: 12, 24, 36 months after surgery

Timeline

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

29 Mar 201910 May 2024

First posted2 Apr 2021
Study start29 Mar 2019
Primary completion5 Dec 2021
Study completion10 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Masking: None (open label)
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04828733
Sponsor's protocol ID: FundoRing vs Nissen
Acronym: FundoRing
Status last verified: Jan 2025
First submitted: 30 Mar 2021
Last updated: 3 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ospanov O, Zharov N, Yelembayev B, Duysenov G, Volchkova I, Sultanov K, Mustafin A. A Three-Arm Randomized Controlled Trial of Primary One-Anastomosis Gastric Bypass: With FundoRing or Nissen Fundoplications vs. without Fundoplication for the Treatment of Obesity and Gastroesophageal Reflux Disease. Medicina (Kaunas). 2024 Feb 27;60(3):405. doi: 10.3390/medicina60030405.
PubMed 38541131
Ospanov O. Standardization of surgical technique of the fundoring method for laparoscopic gastric bypass. Sci Rep. 2025 Dec 29;15(1):44941. doi: 10.1038/s41598-025-29153-5.
PubMed 41462511

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial of Laparoscopic One Anastomosis Gastric Bypass With Excluded Stomach Fundoplication: FundoRingOAGB Versus NissenOAGB Versus OAGB Without Fundoplication for Treating Morbid Obesity and GERD
ClinicalTrials.gov ID: NCT04828733
Acronym / sponsor ID: FundoRing / FundoRing vs Nissen
Conditions: Obesity, GERD
Keywords: Obesity, GERD, Gastric bypass, Fundoplication, Nissen, FundoRing
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: The Society of Bariatric and Metabolic Surgeons of KazakhstanUniversity, hospital or other
Study start: 29 Mar 2019 (actual)
Primary completion: 5 Dec 2021 (actual)
Study completion: 10 May 2024 (actual)
First posted: 2 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background and study aims:

Currently, one anastomosis Gastric Bypass (OAGB) is a common bariatric procedure.

The main questions it aims to answer are:

What is the impact of wrapping the fundus of the excluded part of the stomach use FundoRing method in the experimental group against developing reflux esophagitis compare impact standard Nissen in OAGB?
What is the impact of excluded stomach fundoplication on weight loss in FundoRing group versus standard Nissen group in OAGB?

Methods: Adult participants (n=150) are randomly allocated to one of three groups:

Detailed description

The aim study is to compare bariatric and antireflux results after OAGB/MGB plus suture cruroplasty (SCP) with FundoRing versus Nissen fundoplication and versus without total fundoplication.

Adult participants (n=150) are randomly allocated to one of three groups:

Active comparator surgical bariatric procedure in the second (C) group: patients (n=50) undergo laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty (OAGB + SCP). All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index and change of GERD symptoms (GERD-HRQL).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
OAGB + SCP + FundoRing	Experimental	Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplastylaparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty
OAGB + SCP + NF	Active comparator	Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplastylaparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty
OAGB + SCP	Active comparator	Procedure: Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Class I- III obesity (BMI 30.0-50.0 kg/m)
Patients with GERD A or B grade of reflux esophagitis (LA grade) after treatment PPI
Hiatal hernia (HH) <5 cm
ASA grading 1-2
Age 18-60 years old.

Key exclusion criteria (5 listed)

Giant hiatal hernia (HH) >5 cm
Esophageal shortening
Patients with C or D grade of RE (reflux esophagitis)
Previously surgery on the stomach or esophagus
Psychiatric illness

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplastyLaparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use FundoRing method.	Procedure or surgery	OAGB + SCP + FundoRing
laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplastyLaparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use the Nissen method.	Procedure or surgery	OAGB + SCP + NF
Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.Laparoscopic gastric bypass with only suture cruroplasty without fundoplication	Procedure or surgery	OAGB + SCP

Primary outcome

Change of body mass index
Time frame: Baseline, at 12, 24, 36 months after surgery
The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2.
Change of GERD symptoms (GERD-HRQL)
Time frame: 12, 24, 36 months after surgery
Success; ≥50% improvement in the baseline GERD-HRQL score Failure; <50% improvement in the baseline GERD-HRQL score at 12,24, 36 months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Results publication: PubMed 38541131Ospanov O, Zharov N, Yelembayev B, Duysenov G, Volchkova I, Sultanov K, Mustafin A. A Three-Arm Randomized Controlled Trial of Primary One-Anastomosis Gastric Bypass: With FundoRing or Nissen Fundoplications vs. without Fundoplication for the Treatment of Obesity and Gastroesophageal Reflux Disease. Medicina (Kaunas). 2024 Feb 27;60(3):405. doi: 10.3390/medicina60030405.
Derived from this study: PubMed 41462511Ospanov O. Standardization of surgical technique of the fundoring method for laparoscopic gastric bypass. Sci Rep. 2025 Dec 29;15(1):44941. doi: 10.1038/s41598-025-29153-5.
Individual participant dataSharing planned: No

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Oral Ospanov, Professor principal investigator

President of Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 5 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: finished, as of the sponsor's last update on 3 Jan 2025. 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 Kazakhstan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change of body mass index (time frame: Baseline, at 12, 24, 36 months after surgery). The study lists 2 primary outcomes in all. 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 NCT04828733, which also lists 2 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 3 Jan 2025.