FundoRing Roux-en-Y Gastric Bypass Versus FundoRing One Anastomosis Gastric Bypass (FundoRing_RY)

March 17, 2026 updated by: The Society of Bariatric and Metabolic Surgeons of Kazakhstan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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 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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
    • Aqmola
      • Astana, Aqmola, Kazakhstan, 010000
        • Oral Ospanov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • BMI 30-50 kg/m2

Exclusion Criteria:

  • BMI <30 and >50 kg/m2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FundoRingRoux-en-Y
Laparoscopic FundoRing Roux-en-Y gastric bypass includes two anastomosis: gastroenterostomy and enter-enteroanastomosis.
Procedure: Laparoscopic FundoRing gastric bypass

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.

Other Names:
  • FundoRing
Active Comparator: FundoRingOAGB
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.
Procedure: Laparoscopic FundoRing gastric bypass

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.

Other Names:
  • FundoRing

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Investigators

  • Principal Investigator: Oral Ospanov, Professor, The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2024

Primary Completion (Actual)

March 12, 2026

Study Completion (Actual)

March 13, 2026

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FundoRingRoux-en-Y

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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