Fundoplication

胃底折叠术
  • 文章类型: Editorial
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  • 文章类型: Editorial
    在这篇社论中,我们回应了Nabi等人的一篇评论文章,其中作者讨论了经口内镜下肌切开术(POEM)后的胃食管反流(GER)。POEM目前是贲门失弛缓症的主要治疗选择,既安全又有效。POEM后记录了一些不良反应,包括GER。诊断标准不够明确,因为大约60%的患者有很长的酸暴露时间,而只有10%的人出现反流症状。已经确定了高疾病发病率的多个预测因素,包括老年,女性性别,肥胖,基线食管下括约肌压力小于45mmHg。程序中的一些技术步骤,如长时间或全层肌切开术,可能会进一步增强风险。质子泵抑制剂目前是一线治疗。新兴的声音越来越多地提倡将POEM与内窥镜胃底折叠术相结合,如经口内镜胃底折叠术或经口无切口胃底折叠术。然而,需要更多的研究来确定这些手术对接受这些手术的患者的长期安全性和有效性.
    In this editorial, we respond to a review article by Nabi et al, in which the authors discussed gastroesophageal reflux (GER) following peroral endoscopic myotomy (POEM). POEM is presently the primary therapeutic option for achalasia, which is both safe and effective. A few adverse effects were documented after POEM, including GER. The diagnostic criteria were not clear enough because approximately 60% of patients have a long acid exposure time, while only 10% experience reflux symptoms. Multiple predictors of high disease incidence have been identified, including old age, female sex, obesity, and a baseline lower esophageal sphincter pressure of less than 45 mmHg. Some technical steps during the procedure, such as a lengthy or full-thickness myotomy, may further enhance the risk. Proton pump inhibitors are currently the first line of treatment. Emerging voices are increasingly advocating for the routine combining of POEM with an endoscopic fundoplication method, such as peroral endoscopic fundoplication or transoral incisionless fundoplication. However, more research is necessary to determine the safety and effectiveness of these procedures in the long term for patients who have undergone them.
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  • 文章类型: Journal Article
    背景:知情同意对于确保患者了解其医疗状况至关重要,治疗,和潜在风险。这项研究的目的是调查在选定的普通外科手术中,使用视频同意书与标准同意书对患者知识和满意度的影响。
    方法:我们纳入了118例阑尾切除术患者,胆囊切除术,腹股沟疝修补术,奥马哈的两家医院的胃底折叠术,NE.患者被随机分配到标准同意或视频同意。结果包括对其程序的前测和后测客观知识评估,以及在同意后和出院后立即完成的满意度调查。鉴于岗前设计,对两种结局均采用线性混合效应模型进行估计.双向相互作用效应是评估随机分配给标准或视频同意的患者之间结果的前后变化是否不同的主要兴趣。
    结果:除患者性别外,组间基线特征大多相似,p=0.041。从前测到后测,两组知识均有统计学上的显着增加(标准组:0.25,95%CI0.01至0.51,p=0.048;视频组:0.68,95%CI0.36至1.00,p<0.001),视频组显示出显著更大的变化(交互p=0.043),这表明将视频纳入同意过程可以更好地改善患者对拟议程序的了解.Further,两组出院后满意度均有所下降,但两组之间的下降幅度没有统计学上的显着差异(相互作用p=0.309)。
    结论:视频同意可显著改善患者对拟议治疗的认识。尽管患者满意度调查没有显示出显著差异,它确实显示出一种趋势。我们建议将视频纳入常规普外科手术的同意过程。
    BACKGROUND: Informed consent is essential in ensuring patients\' understanding of their medical condition, treatment, and potential risks. The objective of this study was to investigate the impact of utilizing a video consent compared to standard consent for patient knowledge and satisfaction in selected general surgical procedures.
    METHODS: We included 118 patients undergoing appendectomy, cholecystectomy, inguinal hernia repair, and fundoplication at two hospitals in Omaha, NE. Patients were randomized to either a standard consent or a video consent. Outcomes included a pretest and posttest objective knowledge assessment of their procedure, as well as a satisfaction survey which was completed immediately after consent and following discharge. Given the pre-post design, a linear mixed-effect model was estimated for both outcomes. A two-way interaction effect was of primary interest to assess whether pre-to-post change in the outcome differed between patients randomized to standard or video consent.
    RESULTS: Baseline characteristics were mostly similar between groups except for patient sex, p = 0.041. Both groups showed a statistically significant increase in knowledge from pretest to posttest (standard group: 0.25, 95% CI 0.01 to 0.51, p = 0.048; video group: 0.68, 95% CI 0.36 to 1.00, p < 0.001), with the video group showing significantly greater change (interaction p = 0.043) indicating that incorporating a video into the consent process resulted in a better improvement in patient\'s knowledge of the proposed procedure. Further, both groups showed a decrease in satisfaction post-discharge, but no statistically significant difference in the magnitude of decrease between the groups (interaction p = 0.309).
    CONCLUSIONS: Video consent lead to a significant improvement in a patient\'s knowledge of the proposed treatment. Although the patient satisfaction survey didn\'t show a significant difference, it did show a trend. We propose incorporating videos into the consent process for routine general surgical procedures.
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  • 文章类型: Review
    经口内镜肌切开术(POEM)手术彻底改变了世界各地许多中心的贲门失弛缓症的管理,因为它为患者提供了由贲门失弛缓症引起的吞咽困难的微创内镜解决方案。除了成功缓解吞咽困难,关于术后胃食管反流病的关注已成为一个相关问题,但尚未完全解决。在这项研究中,纳比等人全面回顾了预测的主题,POEM后胃食管反流的预防和管理。POEM是一种纯粹的内窥镜手术,通常无需任何抗反流手术。某些患者可以通过腹腔镜Heller肌切开术和胃底折叠术得到更好的服务,重要的是胃肠病学家和外科医生提供每种贲门失弛缓症治疗方案的综合风险和益处,以便患者可以决定最适合他们的治疗方法。Nabi等人的这篇文章对这个问题的现状进行了全面的审查,以便进行这些讨论。
    The peroral endoscopic myotomy (POEM) procedure has revolutionized the management of achalasia in many centres around the world as it offers patients a minimally invasive endoscopic solution to their dysphagia caused by achalasia. Alongside its success in alleviating dysphagia, concerns regarding postoperative gastroesophageal reflux disease have emerged as a pertinent issue which are not fully resolved. In this study, Nabi et al have comprehensively reviewed the topic of the prediction, prevention and management of gastroesophageal reflux after POEM. POEM is a purely endoscopic procedure which is usually performed without any anti-reflux procedure. Certain patients may be better served by a laparoscopic Heller\'s myotomy and fundoplication and it is important that gastroenterologists and surgeons provide comprehensive risks and benefits of each achalasia treatment option so that patients can decide what treatment is best for them. This article by Nabi et al provides a comprehensive review of the current status of this issue to allow these discussions to occur.
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  • 文章类型: Journal Article
    背景:带胃底折叠术的视频腹腔镜食管心肌切开术已成为治疗门失弛缓症的一种广泛使用的技术。这项研究分析了该技术在巴西联邦大学公立医院治疗非晚期门失弛缓症(大食道)的安全性和有效性。
    目的:评估巴西公立大学医院电视腹腔镜治疗非晚期大食道的短期和长期结果,采用食管心肌切开术与胃底折叠术。
    方法:在UFU-MG联邦大学临床医院接受非晚期门失弛缓症手术治疗的44例患者的病历,米纳斯吉拉斯州,2001年1月至2021年7月进行了分析。评估了以下数据:性别,年龄,病因学,Rezende-Alves和Ferreira-Santos的放射学分类,即时和晚期并发症(平均随访31.4个月),是否需要转换为开放访问,术后反流,术前是否有内镜下食管扩张,术后死亡率,术前和术后症状的频率(持续性吞咽困难,返流,胃灼热,呕吐,吞咽困难,和体重减轻),手术时间,住院,吞咽困难的持续时间,术前术后体重,和Eckardt得分。
    结果:在分析的患者中,23人(52.3%)为男性,21名(47.7%)为女性,平均年龄50.8岁.未记录到早期并发症,有27.2%的晚期胃食管反流病例。术后体重增加为81.8%,根据Eckardt评分的手术成功率为84.1%。
    结论:食管心肌切开术联合胃底折叠术是治疗非晚期门失弛缓症的一种安全有效的方法。
    BACKGROUND: Videolaparoscopic esophagocardiomyotomy with fundoplication has been a widely used technique for the treatment of achalasia. This study analyzes the safety and effectiveness of the technique in the treatment of non-advanced achalasia (megaesophagus) in a Brazilian federal university public hospital.
    OBJECTIVE: To evaluate the short- and long-term results of videolaparoscopic treatment of non-advanced megaesophagus in a public university hospital in Brazil, employing the esophagocardiomyotomy technique with fundoplication.
    METHODS: The medical records of 44 patients who underwent surgical treatment for non-advanced achalasia at the Clinical Hospital of Federal University of Uberlândia (UFU-MG), Minas Gerais, from January 2001 to July 2021 were analyzed. The following data were evaluated: gender, age, etiology, radiological classification of Rezende-Alves and Ferreira-Santos, immediate and late complications (mean follow-up of 31.4 months), need or not for conversion to open access, postoperative reflux, performance or not of endoscopic esophageal dilation in the preoperative period, postoperative mortality, frequency of pre and postoperative symptoms (persistent dysphagia, regurgitation, heartburn, vomiting, odynophagia, and weight loss), surgery time, hospital stay, duration of dysphagia, pre and postoperative weight, and Eckardt score.
    RESULTS: Among the analyzed patients, 23 (52.3%) were male, and 21 (47.7%) were female, with a mean age of 50.8 years. No early complications were recorded and there were 27.2% cases of late gastroesophageal reflux. Postoperative weight gain was 81.8% and the success rate of surgery according to the Eckardt score was 84.1%.
    CONCLUSIONS: Esophagocardiomyotomy with fundoplication is an effective and safe technique for the treatment of non-advanced achalasia.
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  • 文章类型: Journal Article
    目标:腹腔镜抗反流手术(LARS)后,食管裂孔疝复发是常见的。有症状复发的患者除了进行颅骨成形术外,通常还需要进行胃底折叠术或转换为磁性括约肌增强术(MSA)。然而,胃底折叠或MSA完整的患者可能只需要重复进行颅骨成形术来修复其复发性食管裂孔疝。这项研究的目的是比较单独的颅骨成形术与完全翻修(即重做胃底折叠术或MSA伴颅骨成形术)治疗复发性食管裂孔疝的结果。
    方法:对2009年2月至2022年10月期间接受有症状的复发性食管裂孔疝手术翻修术的患者进行了回顾性回顾。术前特点,术中细节,我们比较了接受单纯结壳成形术和完全翻修术的患者的术后结局.
    结果:共141例患者纳入分析。93名患者接受了全面翻修,48例患者仅接受了颅骨成形术。初始和修正手术之间的平均时间为8±7.7年。两组间手术时间及术中、术后并发症发生率差异无统计学意义。仅接受颅骨成形术的患者的平均胃食管反流病健康相关生活质量(GERD-HRQL)问卷评分为9.6±10.2,而完全翻修患者的平均评分为8.9±11.2(p=0.829)。单纯患者的修正复发率为10.4%,完全修正患者的复发率为11.8%(p>0.999)。
    结论:在胃底折叠完整或MSA患者中,与完全翻修术治疗复发性食管裂孔疝相比,单独进行颅骨成形术可获得相似的术后结果。
    OBJECTIVE: Following laparoscopic anti-reflux surgery (LARS), recurrence of hiatal hernia is common. Patients with symptomatic recurrence typically undergo revision of the fundoplication or conversion to magnetic sphincter augmentation (MSA) in addition to cruroplasty. However, patients with an intact fundoplication or MSA may only require repeat cruroplasty to repair their recurrent hiatal hernia. The purpose of this study is to compare outcomes following cruroplasty alone compared to full revision (i.e. redo fundoplication or MSA with cruroplasty) for the management of recurrent hiatal hernias.
    METHODS: A retrospective review of patients undergoing surgical revision of a symptomatic recurrent hiatal hernia between February 2009 and October 2022 was performed. Preoperative characteristics, intraoperative details, and postoperative outcomes were compared between patients undergoing cruroplasty alone versus full revision.
    RESULTS: A total of 141 patients were included in the analysis. 93 patients underwent full revision, and 48 patients underwent cruroplasty alone. The mean time between initial and revisional surgery was 8 ± 7.7 years. There was no significant difference in operative time or rates of intra-operative or post-operative complication between groups. Patients undergoing cruroplasty alone had a mean Gastroesophageal Reflux Disease Health Related Quality Life (GERD-HRQL) Questionnaire score of 9.6 ± 10.2 compared to a mean score of 8.9 ± 11.2 for full revision patients (p = 0.829). Recurrence rates following revision was 10.4% for cruroplasty alone patients and 11.8% in full revision patients (p > 0.999).
    CONCLUSIONS: In patients with intact fundoplication or MSA, cruroplasty alone results in similar post-operative outcomes compared to full revision for recurrent hiatal hernia.
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  • 文章类型: Journal Article
    背景:大多数接受抗反流手术(ARS)的患者都有术前使用质子泵抑制剂(PPI)的病史。众所周知,ARS在恢复抗反流屏障方面是有效的,消除了对昂贵的PPI的持续需求。目前的文献缺乏支持最佳术后PPI停止或断奶策略的客观证据。导致广泛的实践差异。我们试图客观地评估美国专家前肠外科医生和胃肠病学家围绕PPI术后管理的当前实践和观点。
    方法:我们创建了一项关于术后PPI管理方案的调查,强调停止PPI和停止PPI的时机,并旨在确定哪些因素在决策中发挥作用。一种电子调查工具(QualtricsXM,Qualtrics,普罗沃,UT)用于分发调查并匿名记录三个月的答复。
    结果:该调查被373家机构查看了2658次,并与644名成员共享。总的来说,121名受访者参与了调查,111名是外科医生(92%)。50名受访者(42%)总是在ARS后立即停止PPI。其余70名受访者(58%)中,46%的人总是在术后断奶或逐渐变细PPI,47%的人选择性地断奶或逐渐变细。大多数(92%)的从业者在术后3个月内逐渐减少。五名受访者在ARS之后从未停止PPI。总的来说,只有23名受访者(19%)表示他们的方案基于医学文献或循证医学.相反,决策主要基于轶事证据/个人偏好(42%,n=50)或先前的培训/导师(39%,n=47)。
    结论:ARS后停用PPI有两种主要方案:近一半的提供者突然停用PPI,而刚刚超过一半的人逐渐变细,通常在术后早期。这些决定主要是由机构实践和个人偏好驱动的,强调需要以证据为基础的建议。
    BACKGROUND: Most patients undergoing anti-reflux surgery (ARS) have a history of preoperative proton pump inhibitor (PPI) use. It is well-established that ARS is effective in restoring the anti-reflux barrier, eliminating the ongoing need for costly PPIs. Current literature lacks objective evidence supporting an optimal postoperative PPI cessation or weaning strategy, leading to wide practice variations. We sought to objectively gauge current practice and opinion surrounding the postoperative management of PPIs among expert foregut surgeons and gastroenterologists in the United States.
    METHODS: We created a survey of postoperative PPI management protocols, with an emphasis on discontinuation and timing of PPI cessation, and aimed to determine what factors played a role in the decision-making. An electronic survey tool (Qualtrics XM, Qualtrics, Provo, UT) was used to distribute the survey and to record the responses anonymously for a period of three months.
    RESULTS: The survey was viewed 2658 times by 373 institutions and shared with 644 members. In total, 121 respondents participated in the survey and 111 were surgeons (92%). Fifty respondents (42%) always discontinue PPIs immediately after ARS. Of the remaining 70 respondents (58%), 46% always wean or taper PPIs postoperatively and 47% wean or taper them selectively. The majority (92%) of practitioners taper within a 3-month period postoperatively. Five respondents never discontinue PPIs after ARS. Overall, only 23 respondents (19%) stated their protocol is based on medical literature or evidence-based medicine. Instead, decision-making is primarily based on anecdotal evidence/personal preference (42%, n = 50) or prior training/mentors (39%, n = 47).
    CONCLUSIONS: There are two major protocols used for PPI discontinuation after ARS: Nearly half of providers abruptly stop PPIs, while just over half gradually tapers them, most often in the early postoperative period. These decisions are primarily driven by institutional practices and personal preferences, underscoring the need for evidence-based recommendations.
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  • 文章类型: Journal Article
    目的:本研究的目的是比较手术时间,术中并发症,逗留时间,再入院率,整体并发症,死亡率,与机器人手术(RS)和腹腔镜手术(LS)在抗反流和食管裂孔疝手术相关的费用。
    方法:使用MEDLINE(通过PubMed)进行了全面的文献检索,WebofScience和Scopus数据库。纳入了比较RS和LS在抗反流和食管裂孔疝患者中的短期结局和成本的研究。操作时间数据;并发症,逗留时间,再入院率,整体并发症,死亡率,并提取了成本。使用MINORS量表对纳入研究进行质量评估。
    结果:在荟萃分析中纳入了14项回顾性观察研究,共涉及555,368名参与者。结果显示手术时间差异无统计学意义,术中并发症,逗留时间,再入院率,整体并发症,和死亡率介于RS和LS之间。然而,与RS相比,LS的成本较低。
    结论:本系统综述和荟萃分析表明,RS在抗反流和食管裂孔疝手术中的短期预后不差,与LS相比。LS更具成本效益,但RS提供了潜在的好处,如改善的可视化和增强的手术技术.进一步研究,包括随机对照试验和长期结局研究,需要验证和完善这些发现。
    OBJECTIVE: The objective of this study is to compare the operative time, intraoperative complications, length of stay, readmission rates, overall complications, mortality, and cost associated with Robotic Surgery (RS) and Laparascopic Surgery (LS) in anti-reflux and hiatal hernia surgery.
    METHODS: A comprehensive literature search was conducted using MEDLINE (via PubMed), Web of Science and Scopus databases. Studies comparing short-term outcomes and cost between RS and LS in patients with anti-reflux and hiatal hernia were included. Data on operative time, complications, length of stay, readmission rates, overall complications, mortality, and cost were extracted. Quality assessment of the included studies was performed using the MINORS scale.
    RESULTS: Fourteen retrospective observational studies involving a total of 555,368 participants were included in the meta-analysis. The results showed no statistically significant difference in operative time, intraoperative complications, length of stay, readmission rates, overall complications, and mortality between RS and LS. However, LS was associated with lower costs compared to RS.
    CONCLUSIONS: This systematic review and meta-analysis demonstrates that RS has non-inferior short-term outcomes in anti-reflux and hiatal hernia surgery, compared to LS. LS is more cost-effective, but RS offers potential benefits such as improved visualization and enhanced surgical techniques. Further research, including randomized controlled trials and long-term outcome studies, is needed to validate and refine these findings.
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  • 文章类型: Journal Article
    背景:腹腔镜袖状胃切除术联合胃底折叠术(LSGFD)可以显着控制体重并实现有效的抗反流作用。这项研究的目的是调查Ghrelin水平的改变与SGFD后体重减轻之间的相关性。为了比较Ghrelin水平,SG和SGFD之间的体重减轻和代谢改善,目的是为肥胖和胃食管反流病(GERD)患者的治疗提供有关SGFD技术的现有知识。
    方法:对2023年3月至2023年6月在微创外科接受减肥手术的115例肥胖患者的临床资料进行了回顾性分析,疝和腹壁手术,新疆维吾尔自治区人民医院.根据手术方法将受试者分为两组:袖状胃切除术组(SG组,93例)和袖状胃切除术联合胃底折叠术组(SGFD组,22例)。临床数据,例如手术前后的ghrelin水平,两组比较,分析ghrelin水平变化与术后减肥效果的相关性。
    结果:术后3个月,体重没有显着差异,BMI,EWL%,空腹血糖,甘油三酯,胆固醇,SG组和SGFD组之间的尿酸水平(P>0.05)。然而,SGFD组显示体重显著下降,BMI,和尿酸水平与术前相比(P<0.05),而ghrelin水平下降无统计学意义(P>0.05)。Logistic回归分析显示,术后3个月ghrelin水平对术后体重减轻有影响。
    结论:SGFD后患者血浆Ghrelin水平的降低不如SG后患者明显,但它可以使肥胖患者获得与SG后患者相同的良好体重减轻和代谢改善。术后第3个月Ghrelin水平是术后体重减轻的影响因素。
    BACKGROUND: Laparoscopic sleeve gastrectomy combined with fundoplication (LSGFD) can significantly control body weight and achieve effective anti-reflux effects. The aim of this study is to investigate the correlation between the alteration in Ghrelin levels and weight loss following SGFD, and to compare Ghrelin levels, weight loss and metabolic improvements between SG and SGFD, with the objective of contributing to the existing body of knowledge on SGFD technique in the management of patients with obesity and gastroesophageal reflux disease (GERD).
    METHODS: A retrospective analysis was conducted on the clinical data of 115 obese patients who underwent bariatric surgery between March 2023 and June 2023 at the Department of Minimally Invasivew Surgery, Hernia and Abdominal Wall Surgery, People\'s Hospital of Xinjiang Uygur Autonomous Region. The subjects were divided into two groups based on surgical methods: sleeve gastrectomy group (SG group, 93 cases) and sleeve gastrectomy combined with fundoplication group (SGFD group, 22 cases). Clinical data, such as ghrelin levels before and after the operation, were compared between the two groups, and the correlation between changes in ghrelin levels and weight loss effectiveness after the operation was analyzed.
    RESULTS: Three months after the operation, there was no significant difference in body mass, BMI, EWL%, fasting blood glucose, triglyceride, cholesterol, and uric acid levels between the SG and SGFD groups (P > 0.05). However, the SGFD group exhibited a significant decrease in body weight, BMI, and uric acid levels compared to preoperative levels (P < 0.05), while the decrease in ghrelin levels was not statistically significant (P > 0.05). Logistic regression analysis indicated that ghrelin levels three months after the operation were influential in postoperative weight loss.
    CONCLUSIONS: The reduction of plasma Ghrelin level in patients after SGFD is not as obvious as that in patients after SG, but it can make obese patients get the same good weight loss and metabolic improvement as patients after SG. Ghrelin level at the third month after operation is the influencing factor of postoperative weight loss.
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  • 文章类型: Journal Article
    简介:西方社会最普遍的疾病之一是胃食管反流病(GERD)。在瑞士,GERD的标准治疗是基于质子泵抑制剂(PPI)的医疗管理,但Nissen胃底折叠术和MSA系统等手术选择是可用的。RefluxStop是一种新颖的设备,提供了一种替代解决方案。本报告的目的是评估RefluxStop与PPI和现有手术治疗相比的成本效益。方法:使用瑞士医疗保健支付者的观点开发了一个模型(马尔可夫),一个月的周期长度,以及每年3%的成本和收益折现率。纳入治疗组特有的不良事件,和益处以质量调整寿命年(QALYs)衡量。RefluxStop的临床疗效数据来自其CE标记研究,和比较治疗基于已发表的文献。使用确定性和概率敏感性分析来探索不确定性。由于RefluxStop和PPI治疗之间没有正面研究,尼森胃底折叠术,或MSA,这项研究的一个局限性是使用天真,间接比较研究的治疗方案之间的临床有效性。结果:与Nissen胃底折叠术和LINX系统相比,RefluxStop提供了更高的QALY和更低的成本。与基于PPI的医疗管理相比,RefluxStop的增量成本效益比(ICER)为2,116瑞士法郎。在获得的每QALY100,000瑞士法郎的成本效益阈值下,RefluxStop具有成本效益的可能性很高,概率为100%,97%,100%反对基于PPI的医疗管理,尼森胃底折叠术,和MSA,分别。通过确定性和概率敏感性分析提供了分析的稳健性。结论:这项成本效益分析表明,与瑞士其他可用的治疗方案相比,RefluxStop很有可能成为GERD成人患者的一种具有成本效益的治疗方式。
    胃食管反流病(GERD)是西方社会最普遍的疾病之一。瑞士的标准治疗需要基于质子泵抑制剂(PPI)的医疗管理或手术选择(即,Nissen胃底折叠术和磁性括约肌增强[MSA])。RefluxStop是一项用于GERD手术治疗的新技术,可恢复抗反流屏障的正常解剖结构。RefluxStop的临床益处和货币成本必须与可用的治疗方案进行权衡,以确定这项新技术在瑞士的作用。成本效益分析比较了在患者旅程中采用不同路径时疾病管理的相对成本和临床结果。按质量调整寿命年(QALYs)衡量。在本研究中,RefluxStop与Nissen胃底折叠术相比,和MSA,提供更高的QALY和更低的成本。反对PPI治疗,成本略高,但QALY也更高,产生有利的增量成本效益比。此外,在每QALY获得100,000瑞士法郎的成本效益阈值下,与PPI治疗相比,RefluxStop极有可能具有成本效益,尼森胃底折叠术,概率为100%的MSA,97%,100%,分别。最终,这种成本效益分析表明,RefluxStop作为GERD治疗在瑞士与其他治疗方案相比,具有很高的成本效益。即使在额外的敏感性分析中考虑了不确定性,结果也是稳健的。
    UNASSIGNED: One of the most prevalent conditions in Western societies is gastroesophageal reflux disease (GERD). In Switzerland, the standard treatment for GERD is proton pump inhibitor (PPI)-based medical management, but surgical options such as Nissen fundoplication and magnetic sphincter augmentation (MSA) are available. RefluxStop is a novel device that offers an alternative solution. The purpose of this report is to evaluate the cost-effectiveness of RefluxStop compared to PPIs and existing surgical treatments.
    UNASSIGNED: A model (Markov) was developed using the Swiss healthcare payer perspective with a lifetime horizon, 1-month cycle length, and a 3% annual discount rate for costs and benefits. Adverse events specific to treatment arms were incorporated, and benefits were measured in quality-adjusted life-years (QALYs). Clinical efficacy data for RefluxStop was obtained from its CE mark study, and comparator treatments were based on published literature. Deterministic and probabilistic sensitivity analyses were used to explore uncertainty. Since there are no head-to-head studies between RefluxStop and PPI therapy, Nissen fundoplication, or MSA, a limitation of this study is the use of naïve, indirect comparison of clinical effectiveness between the studied treatment options.
    UNASSIGNED: Higher QALYs and lower costs were provided by RefluxStop compared to Nissen fundoplication and the MSA system. The incremental cost-effectiveness ratio (ICER) for RefluxStop was CHF 2,116 in comparison to PPI-based medical management. At a cost-effectiveness threshold of CHF 100,000 per QALY gained, the probability of RefluxStop being cost-effective was high, with probabilities of 100%, 97%, and 100% against PPI-based medical management, Nissen fundoplication, and MSA, respectively. The robustness of the analysis was provided by deterministic and probabilistic sensitivity analyses.
    UNASSIGNED: This cost-effectiveness analysis demonstrates that there is a high likelihood of RefluxStop being a cost-effective treatment modality in adults with GERD when compared with other treatment options available in Switzerland.
    Gastroesophageal reflux disease (GERD) is one of the most prevalent conditions in Western societies. Standard treatment in Switzerland entails proton pump inhibitor (PPI)-based medical management or surgical options (i.e., Nissen fundoplication and magnetic sphincter augmentation [MSA]) in selected cases. RefluxStop is a new technology indicated for the surgical treatment of GERD that restores the normal anatomy of the anti-reflux barrier. The clinical benefits and monetary costs of RefluxStop must be weighed against available treatment options to determine the role of this new technology in Switzerland. Cost-effectiveness analyses compare the relative costs and clinical outcomes of disease management when pursuing different paths in the patient journey landscape, as measured by quality-adjusted life-years (QALYs). In the present study, RefluxStop in comparison to Nissen fundoplication, and MSA, provided higher QALYs and lower costs. Against PPI therapy, the costs were slightly higher but the QALYs were also higher, generating a favourable Incremental cost-effectiveness ratio. Furthermore, at the cost-effectiveness threshold of CHF 100,000 per QALY gained, RefluxStop was highly likely to be cost-effective in comparison to PPI therapy, Nissen fundoplication, and MSA with probabilities of 100%, 97%, and 100%, respectively. Ultimately, this cost-effectiveness analysis showed that RefluxStop has a high likelihood of cost-effectiveness as a GERD treatment in Switzerland against other treatment options, with results being robust even with uncertainties considered in additional sensitivity analyses.
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