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.
Acid and bile reflux esophagitis
Bariatric surgery
FundoRingOAGB
Fundoplication
Modified fundoplication of the OAGB-excluded stomach
Obesity
One-anastomosis gastric bypass
Journal
Obesity surgery
ISSN: 1708-0428
Titre abrégé: Obes Surg
Pays: United States
ID NLM: 9106714
Informations de publication
Date de publication:
07 2023
07 2023
Historique:
received:
19
02
2023
accepted:
19
04
2023
revised:
14
04
2023
medline:
26
6
2023
pubmed:
26
4
2023
entrez:
26
4
2023
Statut:
ppublish
Résumé
The advantages and disadvantages of one-anastomosis gastric bypass (OAGB) with primary modified fundoplication using the excluded stomach ("FundoRing") is unclear. We aimed to assess the impact of this operation in a randomized controlled trial (RCT) and answer the next questions: (1) What the impact of wrapping the fundus of the excluded part of the stomach in OAGB on protection in the experimental group against developing de novo reflux esophagitis? (2) If preoperative RE could be improved in the experimental group? (3) Can preoperative acid reflux as measured by PH impedance, be treated by the addition of the "FundoRing"? The study design was a single-center prospective, interventional, open-label (no masking) RCT (FundoRing Trial) with 1-year follow-up. Endpoints were body mass index (BMI, kg/m One hundred patients (n = 50 FundoRingOAGB (f-OAGB) vs n = 50 standard OAGB (s-OAGB)) with complete follow-up data were included in the study. During OAGB procedures, patients with hiatal hernia underwent cruroplasty (29/50 f-OAGB; 24/50 s-OAGB). There were no leaks, bleeding, or deaths in either group. At 1 year, BMI in the f-OAGB group was 25.3 ± 2.77 (19-30) vs 26.48 ± 2.8 (21-34) s-OAGB group (p = 0.03). In f-OAGB vs s-OAGB groups, respectively, acid RE was seen in 1 vs 12 patients (p = 0.001) and bile RE in 0 vs 4 patients (p < 0.05). Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB at 1 year in a randomized controlled trial. ClinicalTrials.gov Identifier: NCT04834635.
Sections du résumé
BACKGROUND
The advantages and disadvantages of one-anastomosis gastric bypass (OAGB) with primary modified fundoplication using the excluded stomach ("FundoRing") is unclear. We aimed to assess the impact of this operation in a randomized controlled trial (RCT) and answer the next questions: (1) What the impact of wrapping the fundus of the excluded part of the stomach in OAGB on protection in the experimental group against developing de novo reflux esophagitis? (2) If preoperative RE could be improved in the experimental group? (3) Can preoperative acid reflux as measured by PH impedance, be treated by the addition of the "FundoRing"?
METHODS
The study design was a single-center prospective, interventional, open-label (no masking) RCT (FundoRing Trial) with 1-year follow-up. Endpoints were body mass index (BMI, kg/m
RESULTS
One hundred patients (n = 50 FundoRingOAGB (f-OAGB) vs n = 50 standard OAGB (s-OAGB)) with complete follow-up data were included in the study. During OAGB procedures, patients with hiatal hernia underwent cruroplasty (29/50 f-OAGB; 24/50 s-OAGB). There were no leaks, bleeding, or deaths in either group. At 1 year, BMI in the f-OAGB group was 25.3 ± 2.77 (19-30) vs 26.48 ± 2.8 (21-34) s-OAGB group (p = 0.03). In f-OAGB vs s-OAGB groups, respectively, acid RE was seen in 1 vs 12 patients (p = 0.001) and bile RE in 0 vs 4 patients (p < 0.05).
CONCLUSION
Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB at 1 year in a randomized controlled trial.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04834635.
Identifiants
pubmed: 37099252
doi: 10.1007/s11695-023-06618-y
pii: 10.1007/s11695-023-06618-y
doi:
Banques de données
ClinicalTrials.gov
['NCT04834635']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1974-1983Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
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