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

NCT07486765 — Not applicable, Completed, 200 participants, The Society of Bariatric and Metabolic Surgeons of Kazakhstan

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

RegistryNCT07486765, acronym FundoRing_RY
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment200 (Actual)
SponsorThe Society of Bariatric and Metabolic Surgeons of Kazakhstan (Other)
ConditionsObesity, Roux-en-y Anastomosis Site, Reflux Gastritis, Reflux Esophagitis
InterventionsLaparoscopic FundoRing gastric bypass (Procedure)
Datesstart 2024-07-04, primary completion 2026-03-12, completion 2026-03-13, first posted 2026-03-20, last updated 2026-03-20
Locations1 site in Kazakhstan

Related Papers Related Patents Related Grants Related Experts
All trials for Obesity All trials for Roux-en-y Anastomosis Site All trials of Laparoscopic FundoRing gastric bypass

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
FundoRingRoux-en-YExperimentalProcedure: Laparoscopic FundoRing gastric bypassLaparoscopic FundoRing Roux-en-Y gastric bypass includes two anastomosis: gastroenterostomy and enter-enteroanastomosis.
FundoRingOAGBActive comparatorProcedure: Laparoscopic FundoRing gastric bypassLaparoscopic 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.
  • Laparoscopic FundoRing gastric bypass (Procedure), also known as 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.

+Outcome measures

Primary outcomes

  • Compare the number of participants with postoperative reflux gastritis in each groups [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.
  • Compare the number of participants with marginal ulcers of gastroenteroanastomosis in each groups [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
  • Change of body masse index (BMI) in two groups [1, 2, 3 year after surgery]: Weight (kg) and height (meter) will reported combined as mean BMI in kg/m2 in each groups

+Eligibility

Sex: All, ages: 18 Years to 60 Years

Inclusion Criteria:

* BMI 30-50 kg/m2

Exclusion Criteria:

* BMI <30 and >50 kg/m2

+Locations (1)

FacilityCityCountryStatus
Oral OspanovAstana, AqmolaKazakhstan

+Investigators