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NCT Number: NCT04834635

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

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).

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral Ospanov

Astana, 010000, Kazakhstan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FundoRingOAGB

Procedure

laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and with suture cruroplasty if present hiatal hernia

OAGB

Procedure

laparoscopic one anastomosis gastric bypass with suture cruroplasty if present hiatal hernia

Primary outcomes

  1. Change of body mass index

    Time frame: Baseline, at 12, 24, 36, 60 months after surgery

    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.

  2. Number of participants with bile reflux in esophagus

    Time frame: at 12, 24, 36 months after surgery

    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

  3. Number of participants with GERD symptoms

    Time frame: Baseline, 12, 24, 36 months after surgery

    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

  4. Frequency of late (>30 day) postoperative complication in each groups

    Time frame: >30 days, at 12, 24, 36 months after surgery

    Namber participants with late postoperative complication ( dumping syndrome, marginal ulcer, food intolerance, protein malnutrition, anemia, thiamine deficiency)

  5. Chance of the components of Metabolic Syndrome (MetS) after surgery

    Time frame: baseline, 1 and 3-year follow-up

    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.

  6. Cases of recurrent weight gain (The percentage total weight loss (%TWL) lower than 35%)

    Time frame: 60 months after surgery

    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.

Secondary outcomes

  1. Oral glucose tolerance tests

    Time frame: 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

    A standard 3-hour oral glucose tolerance tests performs using 75 g glucose

  2. Sigstad score

    Time frame: 6, 12, 24, 36 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Other

Registry information

Official study title

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

Acronym: FundoRingMGB

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Apr 8, 2021
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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