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

NCT07486765 | Completed

• 1 other identifier: FundoRingRoux-en-Y
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Roux-en-y Anastomosis Site; Reflux Gastritis; Reflux Esophagitis

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  1, 2, 3 year after surgery

Study Arms (2)

FundoRingRoux-en-Y

EXPERIMENTAL

Laparoscopic FundoRing Roux-en-Y gastric bypass includes two anastomosis: gastroenterostomy and enter-enteroanastomosis.

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.

Procedure: Laparoscopic FundoRing gastric bypass

Interventions

Laparoscopic FundoRing gastric bypass PROCEDURE

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.

Also known as: FundoRing

FundoRingOAGB; FundoRingRoux-en-Y

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 30-50 kg/m2

You may not qualify if:

• BMI \<30 and \>50 kg/m2

Sponsors & Collaborators

• The Society of Bariatric and Metabolic Surgeons of Kazakhstan: lead

Study Sites (1)

Oral Ospanov

Astana, Aqmola, 010000, Kazakhstan

Location

MeSH Terms

Conditions

Obesity; Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Study Officials

• Oral Ospanov, Professor

  The Society of Bariatric and Metabolic Surgeons of Kazakhstan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 20, 2026
• Study Start: July 4, 2024
• Primary Completion: March 12, 2026
• Study Completion: March 13, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

KA (1)