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

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ClinicalTrials.gov Identifier: NCT04834635
Recruitment Status : Active, not recruiting
First Posted : April 8, 2021
Last Update Posted : January 4, 2022
Sponsor:
Information provided by (Responsible Party):
The Society of Bariatric and Metabolic Surgeons of Kazakhstan

Study Description
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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=100) are randomly allocated to one of two groups:

Experimental surgical bariatric procedure in the first (A) group: patients (n=50) 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=50) undergo the laparoscopic one anastomosis gastric bypass and with only suture cruroplasty if present hiatal hernia (OAGB group).


Condition or disease Intervention/treatment Phase
Obesity, Morbid Procedure: FundoRingOAGB Procedure: OAGB Not Applicable

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=100) are randomly allocated to one of two groups:

Experimental surgical bariatric procedure in the first (A) group: patients (n=50) 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=50) 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : April 5, 2024
Estimated Study Completion Date : May 10, 2024
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change of body mass index [ Time Frame: Baseline, at 12, 24, 36 months after surgery ]
    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.


Secondary Outcome Measures :
  1. Postoperative bile reflux in esophagus [ Time Frame: at 12, 24, 36 months after surgery ]
    The endoscopic finding of postoperative bile reflux in the esophagus

  2. GERD symptoms [ Time Frame: Baseline, 12, 24, 36 months after surgery ]
    Change og GERD symptoms if present GERD or postoperative de Novo GERD symptoms (GERD-HRQL)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04834635


Locations
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Kazakhstan
Oral Ospanov
Astana, Kazakhstan, 010000
Sponsors and Collaborators
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
Investigators
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Principal Investigator: Oral Ospanov President of Society of Bariatric and Metabolic Surgeons of Kazakhstan" (SBMSK)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: The Society of Bariatric and Metabolic Surgeons of Kazakhstan
ClinicalTrials.gov Identifier: NCT04834635    
Other Study ID Numbers: FundoRingOAGB
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Society of Bariatric and Metabolic Surgeons of Kazakhstan:
Obesity
Bariatric surgery
One anastomosis gastric bypass
FundoRingOAGB
Fundoplication
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight