ObesityFundoRing_RYNCT07486765

FundoRing Roux-en-Y Gastric Bypass Versus FundoRing One Anastomosis Gastric Bypass

A study testing Laparoscopic FundoRing gastric bypass in people with Obesity and Roux-en-y Anastomosis Site, 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

Metabolic and bariatric surgery (MBS) is an effective and durable treatment of severe obesity and its co-morbidities. Gastric bypass is one of the main MBS procedures and is performed using various surgical techniques. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Obesity, Roux-en-y Anastomosis Site, Reflux Gastritis
What is being tested?: Laparoscopic FundoRing gastric bypass
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteKazakhstan
Study dates: 4 Jul 2024to 13 Mar 2026
Phase: Interventional

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 30-50 kg/m2

Who cannot join

BMI <30 and >50 kg/m2

Trial locations and contacts

1 site in 1 country.

Kazakhstan1 site

Oral Ospanov
Astana, Aqmola, 010000

Other trials in Kazakhstan

About this study

Official title: Laparoscopic FundoRing Roux-en-Y Gastric Bypass Versus FundoRingOAGB: a Randomized Clinical Trial

Metabolic and bariatric surgery (MBS) is an effective and durable treatment of severe obesity and its co-morbidities.

Gastric bypass is one of the main MBS procedures and is performed using various surgical techniques. The main postoperative bariatric complication after one anastomosis gastric bypass (OAGB) is bile reflux, and the main disadvantage of traditional Roux-en-Y gastric bypass (RYGB) is dumping syndrome.

The successful strategies for avoiding reflux esophagitis and other complication following gastric bypass is the use FundoRing method for gastric bypass with creation fundoplication employing the excluded (remnant) part of the stomach. Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB. However, the anastomosis after OAGB is constantly bathed in bile. This was previously thought to significantly increase the risk of ulcers, but modern data shows that bile may even have a "protective" buffering effect, neutralizing acid, although the risk of alkaline gastritis remains. The results of trial of consequences of reflux bile flow from the intestine into the gastric pouch after OAGB are controversial. How does this affect the incidence of marginal ulcers due to enterogastric reflux? The answers to these questions remain unclear.

The aim of the study was to compare the incidence of distal gastric pouch inflammation and the likelihood of marginal ulcers in patients treated with the FundoRing Roux-en-Y gastric bypass versus the FundoRing OAGB.

Read the detailed description

Laparoscopic gastric bypass is a minimally invasive weight loss surgery that reduces the stomach's volume to 20 ml and reroutes the small intestine from the gastric pouch, bypassing the duodenum, into the jejunum, limiting food intake and reducing calorie absorption. This technique also involves creating an enteroenterostomy for a variant of the Roux-en-Y procedure. This procedure involves five small incisions, resulting in a faster recovery and fewer complications compared to traditional open surgery.

With an increasing global metabolic and bariatric surgery (MBS) experience, long-term studies have proven it an effective and durable treatment of severe obesity and its co-morbidities. MBS should be considered a safe and effective primary treatment option or when modern pharmacotherapy does not have an optimal clinical response.

The successful strategies for avoiding reflux esophagitis and other complication following gastric bypass is the use FundoRing method for gastric bypass with creation fundoplication employing the excluded (remnant) part of the stomach. Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB at 1 year in a randomized controlled trial]. However, the anastomosis after OAGB is constantly bathed in bile. This was previously thought to significantly increase the risk of ulcers, but modern data shows that bile may even have a "protective" buffering effect, neutralizing acid, although the risk of alkaline gastritis remains. The results of trial of consequences of reflux bile flow from the intestine into the gastric pouch after OAGB are controversial. How does this affect the incidence of marginal ulcers due to enterogastric reflux? The answers to these questions remain unclear.

Therefore, the primary objective of the study was to compare the incidence of distal gastric pouch inflammation and the likelihood of marginal ulcers in patients treated with the FundoRing Roux-en-Y gastric bypass versus the FundoRing OAGB.

Conditions: Obesity, Roux-en-y Anastomosis Site, Reflux Gastritis, Reflux Esophagitis
Being tested: Laparoscopic FundoRing gastric bypass
Medical subject headings: Obesity, Esophagitis, Peptic

What participants receive

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

Laparoscopic FundoRing gastric bypassProcedure or surgery
Also called FundoRing
Laparoscopic gastric bypass is a minimally invasive weight loss surgery that reduces the stomach's volume to 20 ml (separated stomach to gastric pouch (small part) and remnant (excluded, large) part) and reroutes the small intestine from the gastric pouch, bypassing the duodenum, into the jejunum, limiting food intake and reducing calorie absorption.
Additionally, the esophagus and the upper part of the gastric pouch were wrapped with the upper part (fundus) of the excluded (remnant) part of stomach using the FundoRing method.

Study groups in NCT07486765
Study group	Role	What they receive
FundoRingRoux-en-Y	Experimental	Laparoscopic FundoRing Roux-en-Y gastric bypass includes two anastomosis: gastroenterostomy and enter-enteroanastomosis. Receives: Procedure: Laparoscopic FundoRing gastric bypass
FundoRingOAGB	Active comparator	Laparoscopic FundoRing one anastomosis gastric bypass includes only single gastro-enterostomy. Unlike the Roux-en-Y procedure, this technique does not require the creation of an enteroenterostomy. Receives: Procedure: Laparoscopic FundoRing gastric bypass

What is being measured

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

Compare the number of participants with postoperative reflux gastritis in each groups
Compare the number of participants with endoscopically detected incidence of postoperative reflux gastritis in each group.
Measured: 1, 3, 6, 12, 24, 36 month after surgery
Compare the number of participants with marginal ulcers of gastroenteroanastomosis in each groups
Number of participants with endoscopic Identification of the frequency of marginal ulcers in gastroenteroanastomosis in two groups
Measured: 1, 3, 6, 12, 24, 36 month after surgery
Change of body masse index (BMI) in two groups
Weight (kg) and height (meter) will reported combined as mean BMI in kg/m2 in each groups
Measured: 1, 2, 3 year after surgery

Timeline

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

4 Jul 202413 Mar 2026

First posted20 Mar 2026
Study start4 Jul 2024
Primary completion12 Mar 2026
Study completion13 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07486765
Sponsor's protocol ID: FundoRingRoux-en-Y
Acronym: FundoRing_RY
Status last verified: Mar 2026
First submitted: 13 Mar 2026
Last updated: 20 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

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?

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