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Obesity, MorbidFundoRingMGBNCT04834635

The FundoRingOAGB Versus Non-wrapping (Non-banded) Standard Method of Laparoscopic One Anastomosis Gastric Bypass

A study testing FundoRingOAGB and OAGB in people with Obesity, Morbid, 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
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Trial summary

Currently, one anastomosis gastric bypass (OAGB) or mini-gastric bypass (MGB) is a common bariatric procedure for treating obesity. Weight gain after surgery is a big problem in bariatric practice. Therefore, adjustable bands and rings are used, for example, "FobiRing". Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity, Morbid
What is being tested?
FundoRingOAGB and OAGB
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteKazakhstan
Study dates
29 Mar 2021to 17 May 2026
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

  • BMI from 30 to 50 kg / m2.
  • The person is generally fit for anesthesia (ASA grading 1-2) and surgery.
  • The person commits to the need for long-term follow-up.

Who cannot join

  • BMI less than 30 kg / m2 and more than 50 kg / m2.
  • Prosthetic (mesh) Hiatal herniorrhaphy or large hiatal hernia;
  • Esophageal shortening
  • Los Angeles Classification of Oesophagitis (LA grade) C or D reflux esophagitis
  • History of surgery on the stomach or esophagus
  • Less than 18 or more than 60 years of age
Show all 9Show fewer
  • Not fit for bariatric surgery
  • Psychiatric illness
  • Patients unwilling or unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site
  • Oral Ospanov

    Astana, 010000

Other trials in Kazakhstan

About this study

Official title: The Total Wrapping of the Fundus of the Gastric Excluded Part (FundoRing) Versus Non- Wrapping (Non-banded) Standard Method of Laparoscopic One Anastomosis Gastric Bypass/Mini - Gastric Bypass: A Randomized Controlled Trial

Currently, one anastomosis gastric bypass (OAGB) or mini-gastric bypass (MGB) is a common bariatric procedure for treating obesity. Weight gain after surgery is a big problem in bariatric practice. Therefore, adjustable bands and rings are used, for example, "FobiRing". But foreign material can cause complications - the erosion of the stomach wall. For this reason, surgeons avoid the use of various mechanical devices on living tissues.

The greatest criticism is of the OAGB for the likelihood of biliary reflux. In case of reflux of bile into the esophagus after surgery, as a rule, a second operation is required with conversion OAGB to the Roux-en-Y method.

Read more

In addition, along with obesity, 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 in bariatric practice, hiatus cruroraphy is performed, and less often fundoplication using the fundus of the excluded part of the stomach.

We hypothesize that total fundoplication can not only treat GERD but also significant prevent the return of weight like after a banded gastric bypass and prevent postoperative bile reflux in the esophagus.

The aim study is to compare primary outcome as weight loss after total wrapping of the fundus of the gastric excluded part (FundoRing) and non - wrapping (non - banded) standard method of laparoscopic one anastomosis gastric bypass and measure secondary outcome: bile reflux in the esophagus and GERD symptoms.

Methods: Adult participants (n=1000) are randomly allocated to one of two groups:

Experimental surgical bariatric procedure in the first (A) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty if present hiatal hernia (FundoRingOAGB group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass and with only suture cruroplasty if present hiatal hernia (OAGB group).

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 aim study is to compare primary outcome as weight loss after total wrapping of the fundus of the gastric excluded part (FundoRing) and non - wrapping (non - banded) standard method of laparoscopic one anastomosis gastric bypass and measure secondary outcome: bile reflux in the esophagus and GERD symptoms.

Methods: Adult participants (n=1000) are randomly allocated to one of two groups:

Experimental surgical bariatric procedure in the first (A) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and suture cruroplasty if present hiatal hernia (FundoRingOAGB group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=500) undergo the laparoscopic one anastomosis gastric bypass and with only suture cruroplasty if present hiatal hernia (OAGB group). All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index and and measure secondary outcome: bile reflux in the esophagus and GERD symptoms.

Conditions
Obesity, Morbid
Being tested
FundoRingOAGB, OAGB
Keywords
Obesity, Bariatric surgery, One anastomosis gastric bypass, FundoRingOAGB, Fundoplication
Medical subject headings
Obesity, Morbid, Obesity

What participants receive

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

  • FundoRingOAGBProcedure or surgery

    laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and with suture cruroplasty if present hiatal hernia

  • OAGBProcedure or surgery

    laparoscopic one anastomosis gastric bypass with suture cruroplasty if present hiatal hernia

Study groups in NCT04834635
Study groupRoleWhat they receive
FundoRingOAGB groupExperimentallaparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part (and suture cruroplasty if present hiatal hernia).
Receives: Procedure: FundoRingOAGB
OAGB groupActive comparatorlaparoscopic one anastomosis gastric bypass (and suture cruroplasty if present hiatal hernia).
Receives: Procedure: OAGB

What is being measured

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

  1. Change of body mass index

    The measure is assessing a change of body mass index (kg/m2) in groups . 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, 60 months after surgery

  2. Number of participants with bile reflux in esophagus

    Endoscopic assessment of bile reflux in esophagus and 24-hour pH-impedance monitoring to detect number of postoperative esophageal bile reflux (non-acid reflux) in in each group

    Measured: at 12, 24, 36 months after surgery

  3. Number of participants with GERD symptoms

    Change of GERD symptoms (use GERD Health-related Quality of Life (GERD-HRQL) Questionnaire) if present GERD or number of participants with postoperative de Novo GERD.

    Scoring Scale 0 = No symptoms

    1. = Symptoms noticeable but not bothersome
    2. = Symptoms noticeable and bothersome but not every day
    3. = Symptoms bothersome every day
    4. = Symptoms affect daily activities
    5. = Symptoms are incapacitating - unable to do daily activities

    Measured: Baseline, 12, 24, 36 months after surgery

  4. Frequency of late (>30 day) postoperative complication in each groups

    Namber participants with late postoperative complication ( dumping syndrome, marginal ulcer, food intolerance, protein malnutrition, anemia, thiamine deficiency)

    Measured: >30 days, at 12, 24, 36 months after surgery

  5. Chance of the components of Metabolic Syndrome (MetS) after surgery

    Chance of level of HbA1c (<5,7%), level of HOMA-IR (<2.7) , < number participants with type 2 diabetes and arterial hypertension and chanqe of Lipid profile (Total Cholesterol: <200 mg/dL, LDL Cholesterol: <100 mg/dL (optimal), HDL Cholesterol: >60 mg/dL (desirable), Triglycerides: <150 mg/dL) at 1 and 3-year follow-up.

    Measured: baseline, 1 and 3-year follow-up

  6. Cases of recurrent weight gain (The percentage total weight loss (%TWL) lower than 35%)

    Maintenance of a weight loss of 35% or more after weight loss surgery at 5 years was classified as superior weight loss (no significant weight regain). Patients with a weight loss of less than 35% at 60 months after surgery were classified as having weight regain (recurence). For comparison with earlier studies, the percentage of excess weight loss (%EWL) was also calculated for each time point using the following formula: (baseline weight - weight at follow-up)/(baseline weight - ideal body weight) × 100. Ideal body weight was set at a BMI of 25, resulting in the following formula: weight (kg) = 25 × height (m)².

    Measured: 60 months after surgery

Secondary outcomes (2)
  1. Oral glucose tolerance tests

    A standard 3-hour oral glucose tolerance tests performs using 75 g glucose

    Measured: Blood samples for glucose collects at 0, 15, 30, 60, 120, 150 and 180 minutes, while those for insulin collects at 0, 30, 60, 120 and 180 minutes

  2. Sigstad score

    Sigstad score for questionnaire of diagnostic the dumping syndrome. The Sigstad score is a diagnostic index for dumping syndrome, with a score >7 indicating a high probability of the condition, while a score < 4 suggests alternative diagnoses.

    Key Elements of the Sigstad Scoring System:

    • Thresholds: < or =3 (Negative), 4-7 (Doubtful), >7 (Positive for dumping).
    • Key Symptoms Evaluated: Shock (+5), almost fainting/syncope (+4), desire to lie/sit down (+4), sweating/pallor (+4), palpitations (+2), nausea, and abdominal fullness.

    Measured: 6, 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.

  1. First posted8 Apr 2021
  2. Study start29 Mar 2021
  3. Primary completion5 Apr 2024
  4. Study completion17 May 2026

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
Masking
None (open label)
Enrolment
1,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04834635
Sponsor's protocol ID
FundoRingOAGB
Acronym
FundoRingMGB
Status last verified
May 2026
First submitted
4 Apr 2021
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ospanov O, Yeleuov G, Fursov A, Yelembayev B, Fursov R, Sergazin Z, Mustafin A. A laparoscopic one anastomosis gastric bypass with wrapping versus nonwrapping fundus of the excluded part of the stomach to treat obese patients (FundoRingOAGB trial): study protocol for a randomized controlled trial. Trials. 2022 Apr 7;23(1):264. doi: 10.1186/s13063-022-06252-6.

    PubMed 35392958
  • Ospanov O. The Surgical Technique of Primary Modified Fundoplication Using the Excluded Stomach with Simultaneous Gastric Bypass. Obes Surg. 2023 Apr;33(4):1311-1313. doi: 10.1007/s11695-023-06505-6. Epub 2023 Feb 17.

    PubMed 36800158
  • Ospanov O, Yeleuov G, Buchwald JN, Zharov N, Yelembayev B, Sultanov K. A Randomized Controlled Trial of Acid and Bile Reflux Esophagitis Prevention by Modified Fundoplication of the Excluded Stomach in One-Anastomosis Gastric Bypass: 1-Year Results of the FundoRing Trial. Obes Surg. 2023 Jul;33(7):1974-1983. doi: 10.1007/s11695-023-06618-y. Epub 2023 Apr 26.

    PubMed 37099252
  • Ospanov O, Yelembayev B, Buchwald JN, Sultanov K, Rakhmetov M, Duysenov G, Tuleuov B. Comparative endoscopic ultrasound assessment of the gastric pouch after FundoRing-OAGB and OAGB. BMC Surg. 2025 Dec 2;26(1):23. doi: 10.1186/s12893-025-03386-7.

    PubMed 41331600
  • Ospanov OB. The Gastric Bypass and Fundoplication in Bariatric Surgery: the Comments on Published Papers and Our Classification of Combination Procedures. Obes Surg. 2021 Oct;31(10):4643-4644. doi: 10.1007/s11695-021-05505-8. Epub 2021 Jun 1.

    PubMed 34059995

Questions about this trial

What is this clinical trial studying?

A study testing FundoRingOAGB and OAGB in people with Obesity, Morbid, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.

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 3 inclusion and 9 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 19 May 2026. 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, 60 months after surgery). The study lists 6 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 NCT04834635, 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 19 May 2026.

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