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      Short-term results of laparoscopic anti-reflux surgery with the RefluxStop device in patients with gastro-esophageal reflux disease and ineffective esophageal motility

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          Abstract

          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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          Most cited references17

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          Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.

          Daniel Dindo, Nicolas Demartines, Pierre-Alain Clavien (2004)
          Although quality assessment is gaining increasing attention, there is still no consensus on how to define and grade postoperative complications. This shortcoming hampers comparison of outcome data among different centers and therapies and over time. A classification of complications published by one of the authors in 1992 was critically re-evaluated and modified to increase its accuracy and its acceptability in the surgical community. Modifications mainly focused on the manner of reporting life-threatening and permanently disabling complications. The new grading system still mostly relies on the therapy used to treat the complication. The classification was tested in a cohort of 6336 patients who underwent elective general surgery at our institution. The reproducibility and personal judgment of the classification were evaluated through an international survey with 2 questionnaires sent to 10 surgical centers worldwide. The new ranking system significantly correlated with complexity of surgery (P < 0.0001) as well as with the length of the hospital stay (P < 0.0001). A total of 144 surgeons from 10 different centers around the world and at different levels of training returned the survey. Ninety percent of the case presentations were correctly graded. The classification was considered to be simple (92% of the respondents), reproducible (91%), logical (92%), useful (90%), and comprehensive (89%). The answers of both questionnaires were not dependent on the origin of the reply and the level of training of the surgeons. The new complication classification appears reliable and may represent a compelling tool for quality assessment in surgery in all parts of the world.
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            Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification.

            L. R. Lundell, J. Dent, J Bennett … (1999)
            Endoscopic oesophageal changes are diagnostically helpful and identify patients exposed to the risk of disease chronicity. However, there is a serious lack of agreement about how to describe and classify the appearance of reflux oesophagitis To examine the reliability of criteria that describe the circumferential extent of mucosal breaks and to evaluate the functional and clinical correlates of patients with reflux disease whose oesophagitis was graded according to the Los Angeles system. Forty six endoscopists from different countries used a detailed worksheet to evaluate endoscopic video recordings from 22 patients with the full range of severity of reflux oesophagitis. In separate studies, Los Angeles system gradings were correlated with 24 hour oesophageal pH monitoring (178 patients), and with clinical trials of omeprazole treatment (277 patients). Evaluation of circumferential extent of oesophagitis by the criterion of whether mucosal breaks extended between the tops of mucosal folds, gave acceptable agreement (mean kappa value 0.4) among observers. This approach is used in the Los Angeles system. An alternative approach of grouping the circumferential extent of mucosal breaks as occupying 0-25%, 26-50%, 51-75%, 76-99%, or 100% of the oesophageal circumference, gave unacceptably high interobserver variation (mean kappa values 0-0.15) for all but the lowest category of extent (mean kappa value 0.4). Severity of oesophageal acid exposure was significantly (p<0.001) related to the severity grade of oesophagitis. Preteatment oesophagitis grades A-C were related to heartburn severity (p<0.01), outcomes of omeprazole (10 mg daily) treatment (p<0.01), and the risk for symptom relapse off therapy over six months (p<0.05). Results add further support to previous studies for the clinical utility of the Los Angeles system for endoscopic grading of oesophagitis.
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              Ineffective esophageal motility: Concepts, future directions, and conclusions from the Stanford 2018 symposium.

              C Gyawali, Daniel Sifrim, Dustin A Carlson … (2019)
              Ineffective esophageal motility (IEM) is a heterogenous minor motility disorder diagnosed when ≥50% ineffective peristaltic sequences (distal contractile integral <450 mm Hg cm s) coexist with normal lower esophageal sphincter relaxation (integrated relaxation pressure < upper limit of normal) on esophageal high-resolution manometry (HRM). Ineffective esophageal motility is not consistently related to disease states or symptoms and may be seen in asymptomatic healthy individuals.
              Article 0 comments Cited 28 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Joerg Zehetner:
                ORCID: http://orcid.org/0000-0001-6530-8012
                joerg.zehetner@hirslanden.ch
                Journal
                Journal ID (nlm-ta): Langenbecks Arch Surg
                Journal ID (iso-abbrev): Langenbecks Arch Surg
                Title: Langenbeck's Archives of Surgery
                Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )
                ISSN (Print): 1435-2443
                ISSN (Electronic): 1435-2451
                Publication date (Electronic): 29 February 2024
                Publication date PMC-release: 29 February 2024
                Publication date (Print): 2024
                Volume: 409
                Issue: 1
                Electronic Location Identifier: 78
                Affiliations
                [1 ]Department of Visceral Surgery, Hirslanden Clinic Beau-Site, 3013 Bern, Switzerland
                [2 ]Department of Gastroenterology, Hirslanden Clinic Beau-Site, 3013 Bern, Switzerland
                Author information
                http://orcid.org/0000-0002-9888-0987
                http://orcid.org/0000-0001-9804-2935
                http://orcid.org/0000-0002-9547-9426
                http://orcid.org/0000-0001-6530-8012
                Article
                Publisher ID: 3264
                DOI: 10.1007/s00423-024-03264-5
                PMC ID: 10901965
                PubMed ID: 38418718
                SO-VID: 034fc256-0a74-4e60-9d88-da2763eff7c5
                Copyright © © The Author(s) 2024
                License:

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                Date received : 11 September 2023
                Date accepted : 17 February 2024
                Categories
                Subject: Research
                Custom metadata
                issue-copyright-statement © Springer-Verlag GmbH Germany, part of Springer Nature 2024

                ScienceOpen disciplines: Surgery
                Keywords: gastro-esophageal reflux disease,ineffective esophageal motility,esophageal dysmotility,hiatal hernia,anti-reflux surgery,refluxstop
                Data availability:
                ScienceOpen disciplines: Surgery
                Keywords: gastro-esophageal reflux disease, ineffective esophageal motility, esophageal dysmotility, hiatal hernia, anti-reflux surgery, refluxstop

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