Purpose: In gastro-esophageal reflux disease (GERD) requiring surgical treatment, concomitant ineffective esophageal motility (IEM) is a decisive factor in surgical planning, due to concern regarding dysphagia. Anti-reflux surgery with the RefluxStop device is a promising technique. We assessed initial feasibility and clinical outcomes of RefluxStop surgery in patients with GERD and IEM.
Methods: Retrospective analysis of patients with GERD, hiatal hernia (HH), and IEM, who underwent surgery with RefluxStop at our institution and achieved 12-month follow-up. Technique feasibility was assessed, in addition to symptom resolution (GERD-HRQL questionnaire), adverse events, HH recurrence, dysphagia, and patient satisfaction. Placement of the device was confirmed by video fluoroscopy on postoperative day 1, and at 3 and 12 months.
Results: Between June 2020 and November 2022, 20 patients with IEM underwent surgery with RefluxStop and completed 12-month follow-up. All patients reported typical symptoms of GERD, and 12 had preoperative dysphagia. The median HH length was 4.5 cm (IQR, 3.75-5). The median operating time was 59.5 min (IQR, 50.25-64) with no implant-related intra- or postoperative complications. No HH recurrence was observed. One patient reported persistent left-sided thoracic pain at 11 months post-surgery, which required diagnostic laparoscopy and adhesiolysis. Three patients reported severe postoperative dysphagia: balloon dilatation was performed towards resolution. The mean GERD-HRQL scores improved (from 40.7 at baseline to 4.8 at 3 months and 5.7 at 12 months (p <0.001)).
Conclusion: RefluxStop surgery was feasible and offered effective treatment for this group of patients with GERD and IEM. All patients had complete resolution or significant improvement of GERD symptoms, and 90% of them were satisfied with their quality of life 1 year after surgery.
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http://dx.doi.org/10.1007/s00423-024-03264-5 | DOI Listing |
Surg Open Sci
January 2025
Klinikum Friedrichshafen GmbH, Department of Visceral Surgery, Röntgenstraße 2, 88048 Friedrichshafen, Germany.
Background: This study reports outcomes of the RefluxStop procedure treating gastroesophageal reflux disease (GERD) in clinical practice at a high-volume regional hospital in Germany.
Methods: A retrospective analysis was conducted on 79 patients with chronic GERD that underwent the RefluxStop procedure, comprising high mediastinal dissection, loose cruroplasty, esophagogastroplication between vagal trunks, and fundus invagination of the RefluxStop implant. The primary outcome was GERD Health-Related Quality-of-Life (GERD-HRQL) score and improvement from baseline.
Dig Dis Sci
December 2024
Surgical Department, Fejér County Szent György University Teaching Hospital, Székesfehérvár, Hungary.
Background: RefluxStop is a unique implant for laparoscopic treatment of gastroesophageal reflux disease (GERD). It restores normal function of the gastroesophageal junction without the unwanted effects of encircling the esophagus, circumventing adverse events (AEs) associated with conventional anti-reflux surgeries.
Methods: Three-year follow-up of 50 patients with chronic GERD treated by RefluxStop was achieved in a prospective, single-arm, multicentric clinical trial analyzing safety and effectiveness of the procedure.
Expert Rev Pharmacoecon Outcomes Res
October 2024
Division of Surgery and Oncology, Karolinska Institutet, Stockholm, Sweden.
Visc Med
October 2024
Division of Visceral Surgery, Department of General Surgery, Medical University of Vienna, Vienna, Austria.
Background: Gastroesophageal reflux disease is one of the most common chronic diseases, affecting up to 28% of the western population. Therapeutic management ranges from conservative measures to endoscopic or surgical interventions. Laparoscopic Nissen fundoplication (LNF) still is considered as gold standard, but alternative procedures have been developed and evaluated within the past years.
View Article and Find Full Text PDFPharmacoecon Open
November 2024
Division of General and Foregut Surgery, IRCCS Policlinico San Donato, University of Milan Medical School, Milan, Italy.
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