PDF(Pubmed)
Abstract：
OBJECTIVE: 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)).
CONCLUSIONS: 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.
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)).
CONCLUSIONS: 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.
摘要：
目的：在需要手术治疗的胃食管反流病（GERD）中，伴随无效的食管运动（IEM）是手术计划的决定性因素，因为担心吞咽困难.使用RefluxStop装置的抗反流手术是一种有前途的技术。我们评估了GERD和IEM患者RefluxStop手术的初始可行性和临床结果。
方法：GERD患者的回顾性分析，食管裂孔疝（HH），和IEM,他们在我们的机构接受了RefluxStop手术，并获得了12个月的随访。评估了技术可行性，除了症状缓解（GERD-HRQL问卷），不良事件,HH复发,吞咽困难,患者满意度。在术后第1天以及第3个月和第12个月通过视频透视检查确认装置的放置。
结果：在2020年6月至2022年11月之间，20例IEM患者接受了RefluxStop手术并完成了12个月的随访。所有患者都报告了GERD的典型症状，12例术前吞咽困难。HH长度中位数为4.5cm(IQR，3.75-5).中位手术时间为59.5分钟(IQR，50.25-64），无植入物相关的术中或术后并发症。未观察到HH复发。一名患者在术后11个月时报告了持续的左侧胸痛，这需要诊断性腹腔镜检查和粘连松解术。三名患者报告了严重的术后吞咽困难：进行了球囊扩张以解决。平均GERD-HRQL评分改善(从基线时的40.7至3个月时的4.8和12个月时的5.7(p<0.001))。
结论：RefluxStop手术是可行的，并为该组GERD和IEM患者提供了有效的治疗。所有患者GERD症状完全缓解或显著改善，90％的患者对术后1年的生活质量感到满意。
方法：GERD患者的回顾性分析，食管裂孔疝（HH），和IEM,他们在我们的机构接受了RefluxStop手术，并获得了12个月的随访。评估了技术可行性，除了症状缓解（GERD-HRQL问卷），不良事件,HH复发,吞咽困难,患者满意度。在术后第1天以及第3个月和第12个月通过视频透视检查确认装置的放置。
结果：在2020年6月至2022年11月之间，20例IEM患者接受了RefluxStop手术并完成了12个月的随访。所有患者都报告了GERD的典型症状，12例术前吞咽困难。HH长度中位数为4.5cm(IQR，3.75-5).中位手术时间为59.5分钟(IQR，50.25-64），无植入物相关的术中或术后并发症。未观察到HH复发。一名患者在术后11个月时报告了持续的左侧胸痛，这需要诊断性腹腔镜检查和粘连松解术。三名患者报告了严重的术后吞咽困难：进行了球囊扩张以解决。平均GERD-HRQL评分改善(从基线时的40.7至3个月时的4.8和12个月时的5.7(p<0.001))。
结论：RefluxStop手术是可行的，并为该组GERD和IEM患者提供了有效的治疗。所有患者GERD症状完全缓解或显著改善，90％的患者对术后1年的生活质量感到满意。
