Laparoscopic Antireflux Surgery Research Articles

Inflammatory responses in esophageal mucosa before and after laparoscopic antireflux surgery.

Currently, the primary treatment for gastroesophageal reflux is acid suppression with proton pump inhibitors, but they are not a cure, and some patients don't respond well or refuse long-term use. Therefore, alternative therapies are needed to understand the disease and develop better treatments. Laparoscopic anti-reflux surgery (LARS) can resolve symptoms of these patients and plays a significant role in evaluating esophageal healing after preventing harmful effects. Successful LARS improves typical gastroesophageal reflux symptoms in most patients, mainly by reducing the exposure time to gastric contents in the esophagus. Amelioration of the inflammatory response and a recovery response in the esophageal epithelium is expected following the cessation of the noxious attack. To explore the role of inflammatory biomolecules in LARS and assess the time required for esophageal epithelial recovery. Of 22 patients with LARS (pre- and post/5.8 ± 3.8 months after LARS) and 25 healthy controls (HCs) were included. All subjects underwent 24-h multichannel intraluminal impedance-pH monitoring and upper gastrointestinal endoscopy, during which esophageal biopsy samples were collected using endoscopic techniques. Inflammatory molecules in esophageal biopsies were investigated by reverse transcription-polymerase chain reaction and multiplex-enzyme-linked immunosorbent assay. Post-LARS samples showed significant increases in proinflammatory cytokines [interleukin (IL)-1β, interferon-γ, C-X-C chemokine ligand 2 (CXCL2)], anti-inflammatory cytokines [CC chemokine ligand (CCL) 11, CCL13, CCL17, CCL26, CCL1, CCL7, CCL8, CCL24, IL-4, IL-10], and homeostatic cytokines (CCL27, CCL20, CCL19, CCL23, CCL25, CXCL12, migration inhibitory factor) compared to both HCs and pre-LARS samples. CCL17 and CCL21 levels were higher in pre-LARS than in HCs (P < 0.05). The mRNA expression levels of AKT1, fibroblast growth factor 2, HRAS, and mitogen-activated protein kinase 4 were significantly decreased post-LARS vs pre-LARS. CCL2 and epidermal growth factor gene levels were significantly increased in the pre-LARS compared to the HCs (P < 0.05). The presence of proinflammatory proteins post-LARS suggests ongoing inflammation in the epithelium. Elevated homeostatic cytokine levels indicate cell balance is maintained for about 6 months after LARS. The anti-inflammatory response post-LARS shows suppression of inflammatory damage and ongoing postoperative recovery.

The Impact of Obesity on Reflux Recurrence Following Laparoscopic Anti-reflux Surgery: An Evidence-Based Systematic Review and Meta-Analysis.

Gastroesophageal reflux disease (GERD) is frequently seen in the Western population. Laparoscopic anti-reflux surgery (LARS) is effective in managing this condition. Obesity is strongly associated with GERD, and with the rising rate of obesity, there is, therefore, a concurrently increasing frequency of LARS performed. We aim to review the outcomes of LARS in patients with obesity, including the recurrence of GERD symptoms and peri-operative complications. A systematic review and meta-analysis were performed for articles from June 1992 to June 2022. The literature was reviewed for outcomes of LARS in patients with obesity (BMI≥30). Eligibility criteria included specific BMI, study design, type of surgery, and outcomes. The recurrence of symptoms and peri-operative complications were assessed. Thirty-one studies were thoroughly reviewed. Nine studies (five retrospective and four prospective) were selected for meta-analysis using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow, which included 1,499 patients with obesity and 5,521 without. Laparoscopic Nissen fundoplication was the most common procedure performed. The recurrence of symptoms was significantly lower in patients without obesity (p=0.0001). There was no statistically significant difference between patients with and without obesity in peri-operative complications, re-intervention, and early return to theatres. A higher recurrence rate of GERD symptoms post-LARS was reported in patients with obesity. Further research is required to decrease such risks and propose different methods, such as weight loss prior to surgery or Roux-en-Y (R&Y) gastric bypass. Risks and benefits should be considered by clinicians prior to offering LARS to patients with obesity.

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

PurposeIn 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.MethodsRetrospective 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.ResultsBetween 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)).ConclusionRefluxStop 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.

Budget Impact of RefluxStop™ as a Treatment for Patients with Refractory Gastro-oesophageal Reflux Disease in the United Kingdom.

Background: Gastro-oesophageal reflux disease (GORD) is a common condition associated with heartburn and regurgitation. Standard of care for GORD patients in the UK involves initial treatment with proton pump inhibitors (PPIs) and laparoscopic antireflux surgery in patients unwilling to continue or intolerant of long-term PPI treatment. Recently, RefluxStop™, a novel, implantable medical device, has proven to be an efficacious and cost-effective treatment for patients with GORD. The current analysis aimed to describe the budget impact of introducing RefluxStop™ within National Health Service (NHS) England and Wales. Objectives: To estimate the more immediate, short-term clinical and economic effects of introducing RefluxStop™ as a therapeutic option for patients with GORD treated within NHS England and Wales. Methods: A model adherent to international best practice guidelines was developed to estimate the budget impact of introducing RefluxStop™ over a 5-year time horizon, from an NHS perspective. Two hypothetical scenarios were considered, one without RefluxStop™ (comprising PPI treatment, laparoscopic Nissen fundoplication, and magnetic sphincter augmentation using the LINX® system) and one with RefluxStop™ (adding RefluxStop™ to the aforementioned treatment options). Clinical benefits and costs associated with each intervention were included in the analysis. Results: Over 5 years, introducing RefluxStop™ allowed the avoidance of 347 surgical failures, 39 reoperations, and 239 endoscopic esophageal dilations. The financial impact of introducing RefluxStop™ was £3 029 702 in year 5, corresponding to a 1.68% increase in annual NHS spending on GORD treatment in England and Wales. Discussion: While the time horizon was too short to capture some of the adverse events of PPIs and complications of GORD, such as the development of Barrett's esophagus or esophageal cancer, the use of RefluxStop™ was associated with a substantial reduction in surgical complications, including surgical failures, reoperations, and endoscopic esophageal dilations. This favorable clinical profile resulted in cost offsets for the NHS and contributed to the marginal budget impact of RefluxStop™ estimated in the current analysis. Conclusions: Introducing RefluxStop™ as a treatment option for patients with GORD in England and Wales may be associated with clinical benefits at the expense of a marginal budget impact on the NHS.

Budget Impact of RefluxStopTM as a Treatment for Patients with Refractory Gastro-oesophageal Reflux Disease in the United Kingdom

Background: Gastro-oesophageal reflux disease (GORD) is a common condition associated with heartburn and regurgitation. Standard of care for GORD patients in the UK involves initial treatment with proton pump inhibitors (PPIs) and laparoscopic antireflux surgery in patients unwilling to continue or intolerant of long-term PPI treatment. Recently, RefluxStop™, a novel, implantable medical device, has proven to be an efficacious and cost-effective treatment for patients with GORD. The current analysis aimed to describe the budget impact of introducing RefluxStop™ within National Health Service (NHS) England and Wales. Objectives: To estimate the more immediate, short-term clinical and economic effects of introducing RefluxStop™ as a therapeutic option for patients with GORD treated within NHS England and Wales. Methods: A model adherent to international best practice guidelines was developed to estimate the budget impact of introducing RefluxStop™ over a 5-year time horizon, from an NHS perspective. Two hypothetical scenarios were considered, one without RefluxStop™ (comprising PPI treatment, laparoscopic Nissen fundoplication, and magnetic sphincter augmentation using the LINX® system) and one with RefluxStop™ (adding RefluxStop™ to the aforementioned treatment options). Clinical benefits and costs associated with each intervention were included in the analysis. Results: Over 5 years, introducing RefluxStop™ allowed the avoidance of 347 surgical failures, 39 reoperations, and 239 endoscopic esophageal dilations. The financial impact of introducing RefluxStop™ was £3 029 702 in year 5, corresponding to a 1.68% increase in annual NHS spending on GORD treatment in England and Wales. Discussion: While the time horizon was too short to capture some of the adverse events of PPIs and complications of GORD, such as the development of Barrett’s esophagus or esophageal cancer, the use of RefluxStop™ was associated with a substantial reduction in surgical complications, including surgical failures, reoperations, and endoscopic esophageal dilations. This favorable clinical profile resulted in cost offsets for the NHS and contributed to the marginal budget impact of RefluxStop™ estimated in the current analysis. Conclusions: Introducing RefluxStop™ as a treatment option for patients with GORD in England and Wales may be associated with clinical benefits at the expense of a marginal budget impact on the NHS.

High-resolution 3-dimensional tomography may be a useful tool for understanding the anatomy of hiatal hernias and surgical planning of patients eligible for laparoscopic or robotic antireflux surgery.

3D computed tomography (CT) has been seldom used for the evaluation of hiatal hernias (HH) in surgical patients. This study aims to describe the 3D CT findings in candidates for laparoscopic or robotic antireflux surgery or HH repair and compare them with other tests. Thirty patients with HH and/or gastroesophageal reflux disease (GERD) who were candidates for surgical treatment and underwent high-resolution CT were recruited. The variables studied were distance from the esophagogastric junction (EGJ) to the hiatus; total gastric volume and herniated gastric volume, percentage of herniated volume in relation to the total gastric volume; diameters and area of the esophageal hiatus. HH was diagnosed with CT in 21 (70%) patients. There was no correlation between the distance EGJ-hiatus and the herniated gastric volume. There was a statistically significant correlation between the distance from the EGJ to the hiatus and the area of the esophageal hiatus of the diaphragm. There was correlation between tomographic and endoscopic findings for the presence and size of HH. HH was diagnosed with manometry in 9 (50%) patients. There was no correlation between tomographic and manometric findings for the diagnosis of HH and between hiatal area and lower esophageal sphincter basal pressure. There was no correlation between any parameter and DeMeester score. The anatomy of HH and the hiatus can be well defined by 3D CT. The EGJ-hiatus distance may be equally measured by 3D CT or upper digestive endoscopy. DeMeester score did not correlate with any anatomical parameter.

OGBN P39 Feasibility and Safety of Laparoscopic Anti-Reflux Surgery at a District General Hospital: Matching National Standards and Improving Patient Quality of Life

Abstract Background Gastro-oesophageal Reflux Disease (GORD) affects a substantial proportion of adults in the UK, with surgery offering superior short-to-medium term benefits compared to medical management alone. However, there is significant variation in surgical practice nationwide. This study aimed to assess the feasibility and safety of laparoscopic anti-reflux surgery (LARS) at a District General Hospital (DGH) by aligning outcomes with the national standards set by AUGIS (Association of Upper Gastrointestinal Surgeons). Methods Prospective data from patients who underwent LARS between May 2022 and May 2023 were collected and recorded locally as well as on the National Hiatal Surgery Register (NHSR). Pre-operative symptoms and investigations, intraoperative findings, post-operative short and medium-term outcomes, and patient-reported outcome measures (PROMs) were analyzed. Quality of life (QoL) questionnaires, administered by the NHSR, were collected at 6 months to 1 year post-surgery. AUGIS standards, including a minimum of 5 procedures per year by 2 surgeons, conversion rate below 5%, 30-day return to theatre below 5%, and 30-day readmission rate below 10%, were utilized for comparison. Results In one year, two surgeons performed 41 LARS procedures: 31 Nissen, 4 Toupet, and 2 Dor wraps, with 2 redo surgeries. Minor complications occurred in 3 patients, requiring no intervention. One surgery was converted to open due to bleeding, and hiatal repair performed. Wrap migration led to re-do after 10 months. The 30-day return to theatre rate was 0%, readmission rate 2% (n=1, unremarkable CT scan). One patient discharged as a day case, average stay 4 days. Out of 23 eligible patients, 15 completed post-op questionnaires, showing significant QoL improvement. Additionally, 55% no longer needed anti-reflux meds at 6-month follow-up. Conclusions We significantly increased the number of LARS procedures performed while meeting the national standards set by AUGIS and we observed a significant improvement in our patients' quality of life following surgery. Experienced laparoscopic Upper GI surgeons can safely and effectively offer anti-reflux surgery in a DGH setting. Our commitment to prospective data collection for audit and research purposes has been a major strength. Future objectives include further consolidation of our work and expanding the range of procedures, such as magnetic sphincter augmentation (LINX), to improve day-case rates.

OGBN P15 The cost-effectiveness of a novel implantable device for treating gastro-oesophageal reflux disease in the United Kingdom

Abstract Background Gastro-oesophageal reflux disease (GORD) is a common gastrointestinal condition characterized by heartburn, chest pain, and regurgitation. Chronic treatment with proton pump inhibitor (PPI)-based medical management is the current standard of care, with antireflux surgery considered in selected patients. RefluxStop is a novel implantable device indicated for patients eligible for laparoscopic anti-reflux surgery. The purpose of this analysis was to assess the cost-effectiveness of RefluxStop against other GORD treatment options in the UK. Methods A Markov model was developed to assess the cost-effectiveness of RefluxStop compared with PPI-based medical management, laparoscopic Nissen fundoplication, and magnetic sphincter augmentation (MSA) for management of GORD. The UK National Health Service perspective was adopted, with clinical outcomes and costs estimated over a lifetime horizon and an annual discount rate of 3.5% applied. Clinical efficacy data for RefluxStop was obtained from its CE mark study, and comparator treatments were based on published literature. Results RefluxStop demonstrated favorable surgical outcomes compared to both laparoscopic Nissen fundoplication and MSA. The base case incremental cost-effectiveness ratios (ICERs) compared with PPIs, laparoscopic Nissen fundoplication, and MSA were £4,156, £6,517, and £249 per quality-adjusted life-year (QALY) gained, respectively. With a UK cost-effectiveness threshold of £20,000 per QALY gained, the probabilities that RefluxStop was cost-effective compared with PPIs, laparoscopic Nissen fundoplication, and MSA were 100%, 93%, and 100%, respectively. Conclusions Based on this analysis, RefluxStop was estimated to improve quality of life and extend life expectancy in GORD patients when compared to PPIs, laparoscopic Nissen fundoplication, and MSA. Furthermore, this analysis demonstrated that RefluxStop is highly likely to be a cost-effective option for treating GORD in the UK.

Refractory esophageal anastomotic stricture after esophageal atresia surgery improved with retrograde balloon dilatation through gastrostomy followed by laparoscopic fundoplication: a case report

BackgroundAn esophageal anastomotic stricture (EAS) after an esophageal atresia surgery occurs in approximately 4–60% of the cases, and its first-line therapy includes balloon dilatation. Oral balloon dilatation cannot be performed in some EAS cases; conversely, even if dilatation is possible, these strictures recur in some cases, necessitating a surgical procedure for repairing the stenosis. However, these procedures are invasive and have short- and long-term complications. If an EAS recurs repeatedly after multiple balloon dilations, gastroesophageal reflux disease (GERD) may be the underlying cause. A fundoplication procedure may be effective for treating a refractory EAS, as in the present case.Case presentationA neonatal patient with type D esophageal atresia underwent thoracoscopic esophago-esophageal anastomosis at the age of 1 day, and her postoperative course was uneventful. Thereafter, the patient underwent gastrostomy for poor oral intake at the age of 3 months. After gastrostomy, the patient presented with a complete obstructive EAS. Balloon dilatation via the oral route was attempted; however, a guidewire could not be inserted into the EAS site. Hence, retrograde balloon dilatation via gastrostomy was performed successfully. However, the EAS recurred easily thereafter, and laparoscopic anti-reflux surgery was performed to prevent GERD. The anti-reflux surgery cured the otherwise refractory EAS and prevented its recurrence.ConclusionsRetrograde balloon dilatation is another treatment option for an EAS. When an EAS recurs soon after dilatation, the patient must be evaluated for GERD; if severe GERD is observed, an appropriate anti-reflux surgery is required before dilating the EAS.

480. ANTIREFLUX SURGERY’S LIFESPAN: 20 YEARS AFTER LAPAROSCOPIC FUNDOPLICATION

Abstract Background Laparoscopic Fundoplication (LF) is the surgical technique of choice for treating GERD, but only few studies report a follow-up beyond 15 years. The aim was to evaluate the results at least 20 years after laparoscopic fundoplication at a single national referral center for esophageal diseases. Methods We prospectively collected data on a cohort of consecutive patients who underwent LF between 1992–2001. Patients were divided into two groups: a GERD group (patients with pathological esophageal acid exposure and hiatal hernias &amp;lt;3 cm) and a large hiatal hernia (HH) group (patients having type I &amp;gt; 3 cm and types II-IV hiatal hernias). Patients were followed up for at least 20 years using endoscopy, barium-swallow, esophageal manometry, and pH monitoring. LF was defined failed in case of: GERD symptom recurrence (SS &amp;gt; 10); recurrence of esophagitis; HH recurrence or slipped-fundoplication; pathological pH-monitoring; BE progression or adenocarcinoma onset. Results The study population consisted of 142 patients: 112 in the GERD group and 30 in the HH group. The characteristics of patients are shown on Figure 1. Conversion to open surgery proved necessary in 8 patients (5.6%). At a median follow-up of 22 years, 80.4% of the GERD patients and 63.3% of the HH patients were failure-free. Revisional surgery was necessary in 14 (9.8%) patients (9 GERD and 5 HH patients); indications were dysphagia (5 cases), slipped fundoplication or hernia recurrence (6 cases), abnormal pH-monitoring or esophagitis resistant to medical therapy (2 cases), and telescoping (one case). Two decades after LARS, 87.6% of GERD patients and 76.7% of HH patients were satisfied with the procedure. Conclusions The present study concerns one of the largest populations of patients who had undergone LF to have been followed up for more than 20 years at a single center. The findings showed that laparoscopic antireflux surgery is effective and durable (for &amp;gt;20 years) in patients with uncomplicated GERD and, to a lesser extent, in those with a large hiatal hernia. The satisfaction rate more than 20 years after surgery almost reached 90% in the GERD group.

341 Safe and Effective Delivery of Anti-Reflux Surgical Standards at a District General Hospital

Abstract Aim Up to 20% of adults in UK suffer from Gastro-oesophageal Reflux Disease (GORD). Surgery offers better short-to-medium term benefit compared to sole medical management. However, practice varies significantly nationwide. The volume of cases performed in our district general hospital (DGH) has increased from one in 2015, to 24 in 2022. We aimed to establish feasibility and safety of laparoscopic anti-reflux surgery (LARS) at a DGH, by matching our outcomes with the AUGIS national standards. Method Data from patients undergoing LARS between January - December 2022 have been collected prospectively and recorded both locally and on National Hiatal Surgery Register (NHSR). Pre-operative symptoms and investigations, intraoperative findings and post-operative short and medium-term outcomes were analysed. Average follow up was 6 weeks. Results 24 laparoscopic anti-reflux procedures were performed (21 Nissen and 3 Toupet), including 6 paraoesophageal hernia repairs. All patients underwent primary repair and fundoplication. Average length of hiatus hernia preoperatively was 4.1cm for sliding, and 7.6cm for para oesophageal. 23/24 patients were inpatients, 1 was a day case. Mean length of stay was 4 days. Conversion to open rate was 0%. 22 patients had no complications. One patient experienced a mediastinal collection, another patient had post-operative hypotension, both not requiring intervention (Clavien-Dindo 2). 30-day return to theatre rate was 0%, as was 30-day readmission rate. Conclusions At our DGH, we significantly increased the volume of LARS performed whilst achieving AUGIS national standards. Anti-reflux surgery can be offered safely and effectively by experienced laparoscopic Upper GI surgeons in a DGH.

Role of Mesh in the Reinforcement of the Primary Repair of Large Hiatal Hernia

Abstract Background The incidence of hiatal hernias increases with age. Approximately 55%-60% of individuals over the age of 50 have a hiatal hernia. However, only about 9% have symptoms, and it depends on the type and competency of the lower esophageal sphincter. Aim of the Work In our study, an objective observational study was made regarding post operative short term mesh related complications possible to develop in patients underwent hiatal repair of large hiatal hernia with mesh rienforcement. Patients and Methods An observational cohort (retrospective and prospective) study regarding the post operative mesh related complications in patients who underwent Large diaphragmatic hernia repair with mesh application. The study was conducted at Ain Shams University Hospitals, Al-Demerdash, Department of General surgery. Approval of the research ethics Committee of medicine and general surgery department at faculty of medicine, Ain Shams University as well as a written informed consent from all participants was obtained. The study was conducted on 15 patients over a period of six months, starting from date of approval of the protocol by the faculty and the university committee at 10/7/2021. Results Five patients (33.3%) complained about dysphagia postoperatively. In one case, the symptoms declined spontaneously within 6 months was grade 1. Another patient successfully underwent esophageal dilatation of a stenosis 2 months postoperatively was grade 2. Up to this date, two patients (13.3%) still report mild dysphagia but maintain normal body weight were grade 3. Three cases report persistent intraabdominal discomfort without weight loss described as bloating. Two patients experienced heartburn, while another patient reported respiratory compromise in the form dyspnea due to already huge hiatal defect with lung collapse present preoperatively. Conclusion Laparoscopic large hiatal/paraesophageal hernia repair with prosthetic meshes as well as laparoscopic antireflux surgery with prosthetic hiatal closure are safe and effective procedures to prevent hiatal hernia recurrence and/or postoperative intrathoracic wrap migration, with low complication rates and mesh fixation is indicated in patients with large hiatal hernial defect &amp;gt; 5 cm.

WTP5.9 Does anti-reflux surgery offer durable symptom remission in a tertiary centre?

Abstract Aims Anti-reflux surgery success can be affected by multiple factors. We sought to evaluate pre-operative and technical factors influencing medium-term outcomes. Methods A retrospective analysis of laparoscopic anti-reflux surgery in a tertiary centre between 2016 and 2019. Patients were identified through clinical coding. Electronic patient records were reviewed with minimum follow up of 3 years. Outcomes analysed included pre-operative work-up, type of fundoplication, remission and relapse of symptoms at follow up and revision surgery. Results 104 patients underwent fundoplication. The majority were Nissen 68 (65%) and the remaining were partial wrap configuration.18 (19%) of these patients were revisional anti-reflux procedures. Pre-operative investigations noted most underwent endoscopy 85 (81.7%) and oesophageal physiology in 74 (71.2%) with barium swallow in 34 (32.7%). 15/104 (14%) underwent all three studies. 50 (48.1%) patients were symptomatic at initial follow up with dysphagia (21.3%) and dyspepsia (13.5%) most prevalent. Of these 104 patients, 15 (14.4%) required revisional surgery. 6/36 (17%) partial and 9/68 Nissen (13.2%) fundoplications underwent re-operation. Timing of revision varied: 8 (53.3%) within one year including early 30-day re-operation for complications. 3 (20%) at 1-3years and 4 (26.7%) after 3 years. Subsequent revision rate was higher for revisional patients: 4/18 (22.2%) compared to primary 11/86 (12.7%). Conclusion Almost half of the patients had at least one symptom at initial follow up, however only 14.4% patients required revisional surgery by 3 years follow up. Partial fundoplication and previous fundoplication surgery had higher revision surgery rates.

Methods of quality assurance in multicenter trials in laparoscopic fundoplication for gastroesophageal reflux disease.

Operative performance may affect the internal and external validity of randomized trials. The aim of this study was to review the use of surgical quality assurance mechanisms of published trials on laparoscopic anti-reflux surgery, with the objective to appraise their internal (research quality) and external validity (applicability to the clinical setting). Building upon a previous systematic review and network meta-analysis published by the authors, Medline, Embase, AMED, CINAHL, CENTRAL, and OpenGrey databases were searched for randomized control trials comparing different methods of laparoscopic anti-reflux surgery for the management of gastroesophageal disease. Quality assurance in individual studies was appraised using a specified framework addressing surgeon accreditation, procedure standardization, and performance monitoring. In total, 2276 articles were screened to obtain 43 publications reporting 29 randomized controlled trials. Twenty-five out of 43 (58.1%) articles reported the number of participating centers and surgeons involved. Additionally, only 21/43 (48.8%) of articles reported consistent use of a bougie, while 23/43 (53.5%) of articles reported consistent division of the short gastric arteries during fundoplication. Surgical experience and credentials were stated in half of the studies. Standardization of the technique was reported in almost 70% of cases, whereas operative notes or video was submitted in one fourth of the studies. Monitoring of the operative performance during the trial was not documented in most of the trials (62%). Surgical quality assurance in randomized trials on laparoscopic anti-reflux surgery is insufficient, which does not allow appraisal of the internal and external validity of this research. With improved reporting, trials assessing the use of laparoscopic anti-reflux surgery will enable surgeons to make informed treatment decisions to enhance patient care in the surgical management of GERD.

МИНИИНВАЗИВНОЕ ХИРУРГИЧЕСКОЕ ЛЕЧЕНИЕ ПАЦИЕНТОВ С ГРЫЖЕЙ ПИЩЕВОДНОГО ОТВЕРСТИЯ ДИАФРАГМЫ

The article is devoted to the description of own observations and treatment of patients with hiatal hernias. It was noted that approaches to the surgical treatment of patients with hiatal hernias require an increase in efficiency and safety, which makes this issue relevant, despite the accumulated experience of treatment. Attention is focused on endosurgical technologies in the form of laparoscopic fundoplication and laparoscopic chiatoplasty. It has been established that the main indications for surgical treatment of hiatal hernias are: severe reflux esophagitis, development of extraesophageal complications, lack of the effect from pharmacological therapy. Laparoscopic Nissen antireflux surgery in combination with crurorrhaphy meets the requirements for surgical correction of this pathology. It is effective, well tolerated by patients, has a low percentage of complications, which allows us to consider it the "gold standard".

Long-term patient-reported outcomes after anti-reflux surgery for gastroesophageal reflux disease and hiatal hernia repair: a single-center experience.

Patients with gastroesophageal reflux disease (GERD) and hiatal hernia who are candidates for surgery should be treated with minimally invasive partial or total fundoplication. As data on long-term clinical and functional outcomes after laparoscopic surgery for GERD are limited, the aim of this study was to evaluate the long-term effectiveness of fundoplication in terms of patient-reported symptoms and proton pump inhibitor (PPI) use. The data of 88 patients who underwent laparoscopic anti-reflux surgery for GERD between January 2007 and September 2020 were retrospectively reviewed. Preoperative and postoperative patient-reported outcomes were investigated after surgery using a 13-items Likert-Scale questionnaire based on the frequency (events/week) and severity of typical and atypical symptoms, dysphagia, and dyspepsia. Furthermore, variations in the use of PPIs were investigated as a secondary endpoint. A total of 76 patients participated in the questionnaire survey. The median follow-up duration was 77 (2-165) months. The postoperative rate of mild and severe typical symptoms was significantly lower than the preoperative rate (P<0.01). Similarly, the atypical symptom rates decreased after surgery (P<0.05). Dysphagia was more frequent after fundoplication (P<0.01). Before the anti-reflux surgery, 94.7% of the patients were prescribed a PPI. At the time of follow-up, this proportion had decreased to 73.7% (P<0.01). However, the PPI intake rate was 90.9% in the group of patients interviewed >10 years after surgery. In this cohort of patients, laparoscopic anti-reflux fundoplication reduced the rate typical and atypical symptoms of GERD. However, surgery appeared to have no impact on PPI intake over time.

Robotic-assisted versus laparoscopic redo antireflux surgery in children: A cost-effectiveness study.

Robotic-assisted redo fundoplication has some advantages compared to the laparoscopic approach in adults, although to date there are no studies in children. A retrospective case-control study was performed among consecutive children who underwent redo antireflux surgery between 2004 and 2020, divided into two groups: LAF group (laparoscopic redo-fundoplication) and RAF group (robotic-assisted redo-fundoplication). Demographics, clinical, intraoperative, postoperative and economic data were compared. A total of 24 patients were included (10 LAF group; 14 RAF group) without demographic or clinical differences. The RAF group presented lower intraoperative blood loss (52±19 vs. 145±69mL; p<0.021), shorter surgery time (135±39 vs. 179±68min; p=0.009) and shorter length of hospital stay (median 3days [2-4] vs. 5days [3-7]; p=0.002). The RAF group presented a higher rate of symptom improvement (85.7% vs. 60%; p=0.192) and lower overall associated economic costs (25800$ vs. 45500$; p=0.012). Robotic-assisted redo antireflux surgery may offer several benefits over the laparoscopic approach. Prospective studies are still needed.

Inflammatory responses in esophageal mucosa before and after laparoscopic antireflux surgery

Inflammatory responses in esophageal mucosa before and after laparoscopic antireflux surgery

American Foregut Society White Paper on Transoral Incisionless Fundoplication

Gastroesophageal reflux disease (GERD) is a chronic disease on a spectrum that has an array of management options ranging from lifestyle changes, acid suppressive therapy to laparoscopic anti-reflux surgery (LARS). Transoral incisionless fundoplication (TIF) is an endoscopic procedure in the management of GERD that re-establishes and augments the gastroesophageal flap valve (GEFV). TIF is appropriate for patients that do not have a hiatal hernia greater than 2 cm. Patients with a hiatal hernia greater than 2 cm have the option to have either a conventional LARS (laparoscopic hiatal hernia repair with complete or partial fundoplication) or a concomitant laparoscopic hiatal hernia repair with TIF, known as concomitant TIF (cTIF). This white paper summarizes the published outcome data for TIF 2.0 and cTIF to date and outline the best practice approaches including patient assessment, selection, and management for TIF and cTIF.

Cost-effectiveness of a novel, non-active implantable device as a treatment for refractory gastro-esophageal reflux disease

AimsGastro-esophageal reflux disease (GERD) is a common, chronic gastrointestinal condition characterized by heartburn, chest pain, regurgitation, and bloating. The current standard of care includes chronic treatment with proton pump inhibitors (PPIs) or, in selected patients, laparoscopic anti-reflux surgery. RefluxStop is a novel implantable device indicated for GERD patients eligible for laparoscopic surgical treatment. The aim of this analysis was to assess the cost-effectiveness of RefluxStop against available treatment options for GERD.Material and methodsA Markov model was developed to assess the cost-effectiveness of RefluxStop compared with PPI-based medical management (MM) and two surgical management options, LNF and magnetic sphincter augmentation (MSA, LINX system), in people with GERD. Clinical outcomes and costs were estimated over a lifetime horizon from the UK National Health Service perspective and an annual discount rate of 3.5% was applied.ResultsRefluxStop showed favorable surgical outcomes compared with both LNF and MSA. The base case incremental cost-effectiveness ratios compared with MM, LNF, and MSA were £4,156, £6,517, and £249 per QALY gained, respectively. At the UK cost-effectiveness threshold of £20,000 per QALY gained, the probability that RefluxStop was cost-effective against MM, LNF, and MSA was 100%, 93%, and 100%, respectively.LimitationsThe model presented the results of a comparison, with evidence for RefluxStop derived from its single-arm CE mark trial and that for comparators from the literature. The varied clinical care pathway of individual GERD patients was necessarily simplified for modeling purposes, and necessary assumptions were made; however, the model results proved robust to sensitivity analyses.ConclusionsIntroduction of RefluxStop was estimated to extend life expectancy and improve quality-of-life of GERD patients when compared with MM, LNF, and MSA. The results of the cost-effectiveness analysis demonstrated that RefluxStop is highly likely to be a cost-effective treatment option within NHS England.