One Anastomosis Gastric Bypass With Excluded Stomach Fundoplication: FundoRing vs Nissen vs OAGB Without Fundoplication

NCT04828733 | Completed

• 1 other identifier: FundoRing vs Nissen
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Background and study aims: Currently, one anastomosis Gastric Bypass (OAGB) is a common bariatric procedure. Obesity and 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 for GERD patients OAGB procedures only with hiatus cruroraphy is performed. The goal of this randomized controlled clinical trial is to compare bariatric and antireflux results after OAGB plus suture cruroplasty with FundoRing (n=50) versus Nissen fundoplication (n=50) and versus without total fundoplication (n=50) for patients with morbid obesity and GERD. The main questions it aims to answer are:

• What is the impact of wrapping the fundus of the excluded part of the stomach use FundoRing method in the experimental group against developing reflux esophagitis compare impact standard Nissen in OAGB?
• What is the impact of excluded stomach fundoplication on weight loss in FundoRing group versus standard Nissen group in OAGB? Methods: Adult participants (n=150) are randomly allocated to one of three groups: Experimental surgical bariatric procedure in the first (A) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty (OAGB + SCP + FundoRing); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) undergo the laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty (OAGB + SCP +NF). Active comparator surgical bariatric procedure in the second (C) group: patients (n=50) undergo laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty (OAGB + SCP). All patients are then followed up 12, 24, and 36 months after surgery where the changing body mass index and change of GERD symptoms (GERD-HRQL).

Conditions

Obesity; GERD

Keywords

Obesity; GERD; Gastric bypass; Fundoplication; Nissen; FundoRing

Outcome Measures

Primary Outcomes (2)

• 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

• Change of GERD symptoms (GERD-HRQL)

  Success; ≥50% improvement in the baseline GERD-HRQL score Failure; \<50% improvement in the baseline GERD-HRQL score at 12,24, 36 months.

  12, 24, 36 months after surgery

Study Arms (3)

OAGB + SCP + FundoRing

EXPERIMENTAL

laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty

Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty

OAGB + SCP + NF

ACTIVE COMPARATOR

laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty

Procedure: laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty

OAGB + SCP

ACTIVE COMPARATOR

laparoscopic one anastomosis gastric bypass without excluded stomach fundoplication and only suture cruroplasty

Procedure: Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication.

Interventions

laparoscopic one anastomosis gastric bypass with excluded stomach fundoplication: FundoRingOAGB and suture cruroplasty PROCEDURE

Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use FundoRing method.

OAGB + SCP + FundoRing

laparoscopic one anastomosis gastric bypass with excluded stomach Nissen fundoplication and suture cruroplasty PROCEDURE

Laparoscopic gastric bypass with suture cruroplasty and excluded stomach fundoplication use the Nissen method.

OAGB + SCP + NF

Standard laparoscopic one anastomosis gastric bypass with cruroplasty. Not used fundoplication. PROCEDURE

Laparoscopic gastric bypass with only suture cruroplasty without fundoplication

OAGB + SCP

Eligibility Criteria

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

You may qualify if:

• Class I- III obesity (BMI 30.0-50.0 kg/m)
• Patients with GERD A or B grade of reflux esophagitis (LA grade) after treatment PPI
• Hiatal hernia (HH) \<5 cm
• ASA grading 1-2
• Age 18-60 years old.

You may not qualify if:

• Giant hiatal hernia (HH) \>5 cm
• Esophageal shortening
• Patients with C or D grade of RE (reflux esophagitis)
• Previously surgery on the stomach or esophagus
• Psychiatric illness

Sponsors & Collaborators

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

Study Sites (1)

Oral Ospanov

Astana, 020000, Kazakhstan

Location

Related Publications (1)

• Ospanov O, Zharov N, Yelembayev B, Duysenov G, Volchkova I, Sultanov K, Mustafin A. A Three-Arm Randomized Controlled Trial of Primary One-Anastomosis Gastric Bypass: With FundoRing or Nissen Fundoplications vs. without Fundoplication for the Treatment of Obesity and Gastroesophageal Reflux Disease. Medicina (Kaunas). 2024 Feb 27;60(3):405. doi: 10.3390/medicina60030405.

  PMID: 38541131 RESULT

MeSH Terms

Conditions

Obesity; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Oral Ospanov, Professor

  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: March 30, 2021
• First Posted: April 2, 2021
• Study Start: March 29, 2019
• Primary Completion: December 5, 2021
• Study Completion: May 10, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)