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

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.

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).

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: Procedure: FundoRingOAGB; Procedure: OAGB

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.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kazakhstan
  • Astana, Kazakhstan, 010000
    • Oral Ospanov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Not fit for bariatric surgery
• Psychiatric illness
• Patients unwilling or unable to provide informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FundoRingOAGB group; laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part (and suture cruroplasty if present hiatal hernia).	Procedure: FundoRingOAGB; laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and with suture cruroplasty if present hiatal hernia
Active Comparator: OAGB group; laparoscopic one anastomosis gastric bypass (and suture cruroplasty if present hiatal hernia).	Procedure: OAGB; laparoscopic one anastomosis gastric bypass with suture cruroplasty if present hiatal hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 12, 24, 36 months after surgery
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; = Symptoms noticeable but not bothersome; = Symptoms noticeable and bothersome but not every day; = Symptoms bothersome every day; = Symptoms affect daily activities; = Symptoms are incapacitating - unable to do daily activities	Baseline, 12, 24, 36 months after surgery
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)	>30 days, at 12, 24, 36 months after surgery
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.	baseline, 1 and 3-year follow-up
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.	Baseline, at 12, 24, 36, 60 months after surgery
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.	60 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral glucose tolerance tests	A standard 3-hour oral glucose tolerance tests performs using 75 g glucose	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
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.	6, 12, 24, 36 months after surgery

Collaborators and Investigators

• Sponsor: The Society of Bariatric and Metabolic Surgeons of Kazakhstan
• Investigators: Principal Investigator: Oral Ospanov, President of Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• 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
• The Surgical Technique of Primary Modified Fundoplication Using the Excluded Stomach with Simultaneous Gastric Bypass
• 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

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): April 5, 2024
• Study Completion (Actual): May 17, 2026

Study Registration Dates

• First Submitted: April 4, 2021
• First Submitted That Met QC Criteria: April 4, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; Fundoplication; Bariatric surgery; One anastomosis gastric bypass; FundoRingOAGB
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Obesity, Morbid
• Other Study ID Numbers: FundoRingOAGB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No