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

Obesity, Morbid Clinical Trial

— FundoRingMGB  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04834635
• Other study ID #: FundoRingOAGB
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: May 10, 2025

Study information

• Verified date: June 2024
• Source: The Society of Bariatric and Metabolic Surgeons of Kazakhstan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: May 10, 2025
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
Kazakhstan	Oral Ospanov	Astana

Sponsors (1)

Lead Sponsor	Collaborator
The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of body mass index	The measure is assessing a change of body mass index. 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
Secondary	Postoperative bile reflux in esophagus	The endoscopic finding of postoperative bile reflux in the esophagus	at 12, 24, 36 months after surgery
Secondary	GERD symptoms	Change og GERD symptoms if present GERD or postoperative de Novo GERD symptoms (GERD-HRQL)	Baseline, 12, 24, 36 months after surgery