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

NCT04834635 | Completed

• 1 other identifier: FundoRingOAGB
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obesity, Morbid

Keywords

Obesity; Bariatric surgery; One anastomosis gastric bypass; FundoRingOAGB; Fundoplication

Outcome Measures

Primary Outcomes (5)

• 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 months after surgery

• 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 1. = Symptoms noticeable but not bothersome 2. = Symptoms noticeable and bothersome but not every day 3. = Symptoms bothersome every day 4. = Symptoms affect daily activities 5. = 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

Secondary Outcomes (2)

• Oral glucose tolerance tests

  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

  6, 12, 24, 36 months after surgery

Study Arms (2)

FundoRingOAGB group

EXPERIMENTAL

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

OAGB group

ACTIVE COMPARATOR

laparoscopic one anastomosis gastric bypass (and suture cruroplasty if present hiatal hernia).

Procedure: OAGB

Interventions

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

FundoRingOAGB group

OAGB PROCEDURE

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

OAGB group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Oral Ospanov

Astana, 010000, Kazakhstan

Location

Related Publications (4)

• 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.

  PMID: 35392958 RESULT

• 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.

  PMID: 36800158 RESULT

• 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.

  PMID: 37099252 RESULT

• 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.

  PMID: 34059995 DERIVED

Related 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

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Oral Ospanov

  President of Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)

  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: April 4, 2021
• First Posted: April 8, 2021
• Study Start: March 29, 2021
• Primary Completion: April 5, 2024
• Study Completion: December 31, 2024
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)