Gastroesophageal Reflux Disease Health-related Quality Research Articles

Efficacy of endoscopic radiofrequency ablation for proton pump inhibitor-dependent gastroesophageal reflux disease: Multicenter prospective cohort study.

To evaluate the effects of endoscopic radiofrequency ablation (RFA) on proton pump inhibitor (PPI)-dependent gastroesophageal reflux disease (GERD) in a Chinese population, and to explore the factors associated with favorable efficacy. A multicenter, single-armed prospective cohort study was conducted. PPI-dependent GERD patients were enrolled and underwent RFA. The primary outcome was improvement of GERD health-related quality of life (GERD-HRQL). Secondary outcomes were symptom improvement, satisfaction, PPI use, and the indicators of 24-h pH-impedance monitoring. A nomogram to predict complete remission was constructed. In total, 66 patients were included. The GERD-HRQL score was significantly reduced at the 3 month (mean difference, 14.7 [12.6-16.9]), 6 month (mean difference, 15.9 [13.8-18.1]), 12 month (mean difference, 16.7 [14.4-18.9]), 24 month (mean difference, 18.4 [16.2-20.1]), 36 month (mean difference, 18.2 [16.3-20.4]), and 48 month follow-up (mean difference, 16.1 [14.2-18.3]), all P < 0.001. The esophageal and extra-esophageal symptom scores were all significantly decreased. The proportion of satisfaction and no PPI use were significantly higher. With regard to the indicators of 24-h pH-impedance monitoring, acid exposure time (AET), and DeMeester score, but not lower esophageal sphincter (LES) pressure, decreased significantly at the 12 month follow-up. A nomogram based on age, body mass index (BMI), baseline AET, and LES pressure was then constructed and showed good discrimination in the prediction of complete remission following RFA. This study demonstrated that RFA improved life quality as well as symptoms in PPI-dependent GERD patients in a Chinese population. Younger age, higher BMI, lower baseline AET, and higher baseline LES pressure indicate favorable efficacy of RFA.

BN O03 - Pooled two-year results of the novel RefluxStop implantable device in management of gastroesophageal reflux disease in Germany: Retrospective analysis

Abstract Background The most common gastrointestinal disorder globally is gastroesophageal reflux disease (GERD). Standard-of-care treatments for GERD are medical therapy, via proton pump inhibitors (PPIs), and traditional antireflux surgery (i.e., Nissen fundoplication). Unfortunately, PPI therapy is associated with medication irresponsiveness in up to 40% of cases and Nissen fundoplication results in significant rates of postoperative adverse events (AEs), such as postoperative dysphagia. Notably, patients with large hiatal hernia (&amp;gt;3 cm) are exceedingly difficult to treat with antireflux surgery. This report presents the clinical results of patients treated with an emerging technology, the RefluxStop device, in Germany at our two centers. Method Between July of 2021 and November of 2023, 158 patients were operated on with RefluxStop surgery. This procedure entails correction of a defunct antireflux barrier through cruroplasty (with hiatal hernia reduction, if necessary), limited (90-120°) esophagogastroplication to recreate the acute angle of His and gastroesophageal flap valve, and regional stabilization of newly constructed anatomy with implantation of the RefluxStop device in a fully invaginated fundic pouch. Clinical outcomes included GERD Health-Related Quality of Life (GERD-HRQL) score, PPI use, and perioperative AEs. Results Patients of mean age 49±13.3 years and male (51.3%) had hiatal hernia &amp;gt;3 cm (22.2%). At 20±7-month follow-up, the median (IQR) GERD-HRQL score improved by 90.9% to 2 (0-2) from a baseline of 22 (19-31.5) (p&amp;lt;.001). PPI use decreased by 96.3%. Preoperative dysphagia (n=18) resolved in all patients with five cases (3.2%) of new-onset dysphagia occurring, but none requiring postoperative dilation. Hiatal hernia recurred in two patients (1.3%) and was treated with device repositioning. Device migration presented in two patients (1.3%) from excessively tight suturing of the fundic pouch. One of these patients was converted to Toupet fundoplication. Conclusion This study shows that RefluxStop provides excellent effectiveness and safety outcomes. Quality-of-life improvements were particularly appreciated with a 90.9% reduction in GERD-HRQL score. With the added context of 22.2% of this pooled cohort composed of difficult-to-treat patients (i.e., hiatal hernia &amp;gt;3 cm), RefluxStop surgery provides favorable efficacy in real-world settings with such patients. As with any novel surgical procedure, training is paramount to optimizing surgical outcomes and minimizing unwanted AEs. Further study is required to bolster the evidence supporting this emerging technology.

Transoral Incisionless Fundoplication Leads to Esophageal Mucosa Healing in Responder Patients Followed up to 2 Years, as Documented by Esophageal Mean Nocturnal Baseline Impedance.

Decrease of esophageal mean nocturnal baseline impedance reflects loss of mucosal integrity. It can predict response to anti-reflux therapy. Mean nocturnal baseline impedance after transoral incisionless fundoplication for gastroesophageal reflux disease has never been assessed. The aim of the study is to investigate mean nocturnal baseline impedance and conventional pathophysiological parameters following transoral incisionless fundoplication. Patients prospectively treated by transoral incisionless fundoplication in a single center were retrospectively reviewed regarding 1- and 2-year 24-hour pH-metry and multichannel intraluminal impedance with calculation of mean nocturnal baseline impedance, gastroesophageal reflux disease-health related quality of life and reflux symptom index scores. Thirty-eight and 17/38 patients with 1- and 2-year 24-hour pH-multichannel intraluminal impedance assessment and mean nocturnal baseline impedance's calculation after transoral incisionless fundoplication, respectively, were identified. Mean nocturnal baseline impedance significantly increased up to 2-year follow-up (P = 0.033), along with significant decrease in % of acid exposure time (P = 0.003), gastroesophageal reflux disease-health related quality of life score (P < 0.001), and reflux symptom index (P = 0.008), compared with baseline. The longest orthostatic reflux decreased too, approaching statistical significance (P = 0.054). These significant changes occurred in patients experiencing ≥ 50% reduction of symptom questionnaires' scores ("responders"). Conversely, mean nocturnal baseline impedance worsened and no significant changes of 24-hour pH-multichannel intraluminal impedance metrics were observed in "non-responder" patients (symptom questionnaires' scores decrease < 50%).ConclusionIn patients who responded a significant improvement of mean nocturnal baseline impedance and % acid exposure time was observed up to 2-year follow-up, suggesting that transoral incisionless fundoplication achieves an effective esophageal mucosa healing besides symptom improvement.

Efficacy and safety of tegoprazan (LXI-15028) vs. esomeprazole in patients with erosive esophagitis: A multicenter, randomized, double-blind, non-inferiority phase Ⅲ trial.

An evidence gap still exists regarding the efficacy and safety of tegoprazan in Chinese patients with erosive esophagitis (EE) in China. This study aimed to verify the efficacy and safety of tegoprazan vs. esomeprazole in patients with EE in China. This study was a multicenter, randomized, double-blind, parallel, active-controlled, non-inferiority phase III trial of patients with EE randomized 1:1 to tegoprazan 50mg/day vs. esomeprazole 40mg/day. This study was conducted in 32sites between October 24, 2018 and October 18, 2019. The primary endpoint was the cumulative endoscopic healing rate at week 8. The secondary endpoint included endoscopic healing rate at week 4, changes in the reflux disease questionnaire (RDQ) and gastroesophageal reflux disease health-related quality of life (GERD-HRQL) scores, and symptom improvement. A total of 261 patients were randomized: 132 to the tegoprazan group and 129 to the esomeprazole group. The cumulative endoscopic healing rate at 8weeks in the tegoprazan group was non-inferior to that of the esomeprazole group (91.1% vs. 92.8%, difference: -1.7, 95% confidence interval [CI]: -8.5, 5.0, P=0.008). There were no statistically significant differences in the changes in RDQ (total, severity, and frequency) and GERD-HRQL scores between the two groups (all P>0.05). The percentages of days without symptoms, including daytime and nighttime symptoms based on patients' diaries, were similar between the two groups (all P>0.05). In the tegoprazan and esomeprazole groups, 71.5% (93/130) and 61.7% (79/128) of the participants reported adverse events (AEs), 2.3% and 0 experienced serious AEs, while 70.0% and 60.2% had treatment-emergent AEs, respectively. Tegoprazan 50mg/day demonstrated non-inferior efficacy in healing EE, symptom improvement, and quality of life, and it has similar tolerability compared with esomeprazole 40mg/day. ClinicalTrials.gov, NCT03615677.

811. POOLED 1-YEAR SAFETY AND QUALITY-OF-LIFE DATA AFTER REFLUXSTOP SURGERY AT TWO LARGE HOSPITALS IN SWITZERLAND: A RETROSPECTIVE CHART ANALYSIS

Abstract Background The standards of care in reflux disease management are proton pump inhibitor (PPI) therapy and conventional antireflux surgery, however, both options carry the caveats of medication irresponsiveness and troublesome postoperative sequelae, respectively. More specifically, PPIs respond inadequately in up to 40% of cases and Nissen fundoplication is associated with postoperative dysphagia in a significant proportion of patients. RefluxStop is an innovative technology that was adopted at our two respective institutions following promising safety and effectiveness data from its CE mark trial. We present the pooled safety and quality-of-life data of our 1-year experience with RefluxStop surgery. Methods Between September 2018 and August 2023, RefluxStop surgery was performed on 121 patients as part of routine clinical care at two hospitals, both of which are high-volume centers for antireflux surgery. The procedure involves crural repair with hiatal hernia reduction, reconstruction of the flap valve and angle of His, narrow esophagogastric (90-110°) plication, and device implantation in an external pouch on the gastric fundus (Figure 1). A retrospective chart analysis was conducted to document perioperative adverse events (AEs) and quality-of-life improvements via Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) score. Higher GERD-HRQL scores are indicative of more severe disease. Results Baseline patient characteristics included mean age 54.7 years, female sex (52.9%), body mass index 27.2±4.1 kg/m2, large hiatal hernia &amp;gt;3 cm (46.3%) of median (IQR) size 3 (2-5) cm, abnormal esophageal motility (60.3%), and Barrett’s esophagus (27.3%). At 1-year follow-up, patients experienced a median (IQR) reduction of 90.5% (81.4-100%) in total GERD-HRQL score. Intraoperative AEs included conversion to laparotomy for adhesiolysis with bleeding (n=1), bleeding short gastric arteries leading to return to the operating room the next day (n=1), and esophageal perforation repaired intraoperatively (n=1). Postoperative AEs are summarized in Table 1. Conclusion The results of this pooled retrospective chart analysis support the promising early data of the RefluxStop CE mark trial. Few and predictable AEs occurred during the study period while significant improvements in quality of life were observed, as evidenced by 90.5% (81.4-100%) reductions in GERD-HRQL score. Notably, this pooled cohort of patients was comprised of substantial proportions of difficult-to-treat patients (i.e., abnormal esophageal motility in 60.3%, large hiatal hernia &amp;gt;3 cm in 46.3%), providing evidence for wider implementation of RefluxStop surgery in real-world settings. Additional evaluation is required to further delineate the role of this promising innovative antireflux surgery.

213. A NEW MANOMETRIC TOOL TO EVALUATE THE EFFICACY OF LAPAROSCOPIC ANTIREFLUX SURGERY

Abstract Background High resolution manometry (HRM) has been proven able to describe the pathophysiological pathway leading to gastroesophageal reflux disease (GERD). Recently, a new manometric tool, the Milan Score (MS), has been introduced and validated to evaluate the risk of pathologic GERD, defined as Acid Exposure Time (AET) &amp;gt;6% at pH-study. Aim of this study is to validate this score in the post-operative assessment after laparoscopic antireflux surgery (LARS). Methods All patients who underwent HRM after LARS between October 2020 and May 2023 were included. The MS was calculated assessing four manometric variables: esophagogastric junction (EGJ) type, EGJ contractile integral (EGJ-CI), ineffective esophageal motility (IEM) and response to the straight leg raise (SLR) manoeuvre. The MS was considered pathologic if ≥137 (risk of GERD ≥50%). The risk of GERD was categorized into six classes, according to the MS score. The MS was compared with validated questionnaires for reflux symptoms, including GERD Questionnaire (GERD-Q), GERD Health-Related Quality of Life (GERD-HRQL) and Reflux Symptom Index (RSI), and with postoperative endoscopy findings. Results A total of 160 patients were included (63% males, age: 53 years, time from surgery: 30 months). Surgical techniques included magnetic sphincter augmentation in 54% of patients, Toupet fundoplication in 29% and Nissen or Dor fundoplication in 17%. The proportion of patients with MS ≥137 among those with pathologic questionnaires was 73% for GERD-Q (p&amp;lt;0.001), 75% for GERD-HRQL (p&amp;lt;0.001) and 78% for RSI (p&amp;lt;0.001). The rate of pathologic questionnaires increased for higher MSs. A MS ≥137 was related to recurrent hiatal hernia (23%, p=0.046) and esophagitis (21%, p=0.007) at endoscopy. Clinical and manometric outcomes were similar among different surgical techniques. Conclusions The MS is an efficient tool to assess the efficacy of LARS. Various surgical techniques have similar distribution in the different risk classes for GERD identified by MS, and similar clinical results. HRM with MS represent an easy and feasible assessment of surgical outcomes after LARS, providing an objective evaluation of the antireflux barrier after surgery.

481. STRONG SYMPTOMATIC IMPROVEMENT AT 1 YEAR AND BEYOND FOLLOWING REFLUXSTOP SURGERY FOR GASTRO-ESOPHAGEAL REFLUX DISEASE: A 40-PATIENT COHORTT

Abstract Background Despite well-established medical and surgical options for gastro-esophageal reflux disease (GERD), there remains a high unmet need for a treatment that improves symptoms without adverse effects. Symptoms of bloating, inability to belch or vomit, and dysphagia are among the more common side effects of standard anti-reflux surgery. RefluxStop is a novel device for the treatment of GERD that does not encircle the food passageway to avoid such side effects. The surgical technique is based on restoration of the normal anatomy of the gastroesophageal junction and maintaining the lower esophageal sphincter within the abdomen. Methods This study presents a case series of 40 patients who underwent RefluxStop surgery between July 2021 and November 2022 reaching at least 12 months of follow-up. A retrospective review of medical records was conducted. Baseline GERD Health-Related Quality of Life (GERD-HRQL) score was reported in addition to demographic and clinical characteristics. At follow-up, GERD-HRQL score, patient-reported GERD symptoms, and proton-pump inhibitor (PPI) use were reported. Peri-operative procedure-related and device-related adverse events (AEs) were recorded. Results Baseline patient characteristics are presented in Table 1. Mean follow-up was 14.5 (range 12-19) months. Mean GERD-HRQL score decreased dramatically from 19.5±3.8 at baseline to 1.1±2.2 at follow-up, reflecting a 91.9% improvement. At follow-up, reflux was reported as a symptom in only two patients (5%) (described as mild and occasional in one of them). None reported regurgitation or dysphagia. Only two patients (5%) reported bloating. The necessity for PPI therapy decreased from 97.5% (n=40) at baseline to 2.5% at follow-up. There were no intra-operative AEs or reoperations. Conclusion These data provide real-world evidence on the performance of RefluxStop in clinical practice. In this series of patients, the outcomes at 1 year and beyond indicate excellent effectiveness in reducing or eliminating GERD symptoms, as demonstrated by spontaneously reported symptoms and the validated, disease-specific, quality-of-life questionnaire. The discontinuation of PPI therapy is an additional indicator of effective symptomatic improvement. Importantly, this treatment did not induce dysphagia, a common consequence of established anti-reflux surgical techniques. RefluxStop is a promising option for patients with chronic GERD seeking definitive treatment while minimizing AEs.

506. CLINICAL OUTCOMES OF A NEW SURGICAL TREATMENT FOR GASTROESOPHAGEAL REFLUX DISEASE: RETROSPECTIVE CHART REVIEW OF 28 PATIENTS FROM GERMANY

Abstract Background Gastroesophageal reflux disease (GERD) is a troublesome gastrointestinal ailment with significant prevalence worldwide. First-line treatment is attempted with proton pump inhibitor (PPI) therapy, but about 40% of patients experience irresponsiveness. Inadequate response, intolerance, or aversion to long-term therapy are indications for anti-reflux surgery. Fundoplication techniques, magnetic sphincter augmentation, and endoscopic techniques are existing surgical options, but are often associated with postoperative complications like dysphagia. The RefluxStop implant is an emerging technology that has demonstrated effectiveness in managing patients with chronic GERD. This report summarizes the clinical outcomes of 28 patients managed with RefluxStop at a German institution. Methods The RefluxStop procedure was performed on 28 patients with chronic GERD in a German center between July 2021 and November 2023. Data was obtained from a retrospective chart review to present the clinical outcomes following RefluxStop surgery, including GERD Health-Related Quality of Life (GERD-HRQL), PPI use, symptom resolution, patient satisfaction, and perioperative adverse events (AEs). Results Twenty-eight patients were followed for 14.1±4.7 months. Baseline patient characteristics are shown in Table 1. Median GERD-HRQL score decreased by 90% from a baseline of 40 (IQR 17) to 4 (IQR 5) at follow-up. PPI use decreased from 96.4% at baseline to 7.1% at follow-up. Almost 93% of reflux symptoms were eliminated. Only one patient (3.6%) was not satisfied with treatment. All patients with dysphagia at baseline (42.9%) experienced complete resolution. No reoperations or esophageal dilations were required. Seven patients experienced minor intraoperative AEs (e.g., neck emphysema) but none were procedure- or device-related. Conclusion This cohort of GERD patients in Germany demonstrated the safety and effectiveness of the RefluxStop procedure. Significant improvements in quality of life, PPI use, and reflux-related symptoms were observed without consequential safety concerns for over one year. Furthermore, this study corroborates the existing evidence of favorable postoperative safety outcomes associated with RefluxStop. Additional study is necessary to continue validation of this promising new treatment option.

Full esophageal mobilization during hiatal hernia repair with concomitant sleeve gastrectomy improves postoperative reflux symptoms for patients with preexisting reflux.

Hiatal hernia repair (HHR) performed concurrently with vertical sleeve gastrectomy (VSG) has been shown to improve postoperative gastroesophageal reflux disease (GERD). However, data on the optimal extent of esophageal mobilization during repair are lacking. Mobilization techniques for HHR during VSG include partial (PM) or full (FM) mobilization of the esophagus. We hypothesize that patients who undergo full mobilization will be less likely to develop postoperative reflux. A single-institution retrospective review of all patients who underwent a VSG with a HHR between 2014 and 2021 was conducted. The primary outcome was postoperative reflux symptoms defined by diagnosis in the medical record, utilization of anti-reflux medications, and GERD health-related quality of life (GERD-HRQL) scores obtained via patient surveys. There were 190 patients included with 80 patients (42.1%) undergoing PM and 110 (57.9%) undergoing FM. Rates of preoperative reflux were similar between the two groups (47.5% vs. 51.8%; p = 0.55). During the GERD-HRQL survey, there were 114 patients (60.0%) contacted with a participation rate of 91.2% (104 patients). Patients with preoperative reflux who underwent PM were found to have a higher rate of reported postoperative reflux (90.0% vs. 62.5%; p = 0.03) and higher GERD-HRQL scores (16.40 ± 9.95 vs. 10.84 ± 9.01; p = 0.04). Patients without preoperative reflux did not have a significant difference in reported reflux (55.0% vs. 51.7%; p = 0.82) or GERD-HRQL scores (12.35 ± 14.14 vs. 9.93 ± 9.46; p = 0.25). Our study found that postoperative GERD was higher in patients with preexisting reflux who underwent partial esophageal mobilization during concurrent hiatal hernia repair with vertical sleeve gastrectomy. In patients without preoperative GERD, our data suggest that postoperative reflux symptoms are not dependent on the extent of esophageal mobilization during hiatal hernia repair with vertical sleeve gastrectomy.

Short-term symptomatic outcomes of GERD in patients with gastroparesis after gastric per oral endoscopic pyloromyotomy.

Gastroparesis (Gp) patients often have gastroesophageal reflux disease (GERD). Management of GERD in Gp patients is a challenge. Many studies have shown that gastric peroral endoscopic pyloromyotomy (G-POEM or POP) is moderately effective in reducing nausea and vomiting in patients with Gp. This study aims to determine whether G-POEM can improve GERD in Gp Patients. Patients who underwent G-POEM from July 2021 to October 2022 were enrolled in the study. GERD Health-Related Quality of Life (GERD HRQL) and Reflux Symptom Index (RSI) were used to assess patients' GERD before and after G-POEM. The use of proton pump inhibitors (PPIs) before and after G-POEM were also documented. The Gastroparesis Cardinal Symptom Index (GCSI) was used to assess the severity of Gp before and after G-POEM. A 'Welch two-sample t-test' was used to find differences in GERD HRQL (health-related quality of life) and RSI scores before and after the procedure. Pearson's chi-square test was used to find differences for use of PPI before and after G-POEM. Twenty-three consecutive refractory Gp patients with 30% male (average age 63.2) and 70% female patients (average age 53.9) were enrolled. Of these, 14 had diabetes, 3 had a history of surgery, and 6 had idiopathic Gp. The mean follow-up was 41days (range 7-61days). There was a significant decrease in the mean GERD HRQL score from 16.5 to 6.5 after G POEM with a P-value <0.0001 (95% level of significance) and a significant decrease in mean RSI score from 15.3 to 5.2 after G-POEM with P-value <0.0001 (95% level of significance). The proportion of use of PPI before GPOEM was 0.91, and the proportion of PPI use after GPOEM was 0.43 (P = 0.0008). The mean GCSI pre- and post-GPOEM were 3.53 and 1.59, respectively. Eighteen had clinical success in Gp as defined by decreased mean GCSI score greater than 1. In this short-term outcome study, 87% of patients' GERD HRQL scores and RSI scores decreased after G-POEM. These findings indicate that GPOEM not only effectively reduces Gp symptoms but also improves GERD symptoms leading to decreased or more effective use of PPI in these patients. To our knowledge, this is the first study to comprehensively show G-POEM significantly improves GERD. Further studies with a larger patient population and long-term outcomes are needed.

Safety and efficacy of robotic anti-reflux surgery in geriatric patients: a comparative analysis.

As our population ages, older adults are being considered for anti-reflux surgery (ARS). Geriatric patients typically have heightened surgical risk, and literature has shown mixed results regarding postoperative outcomes. We sought to evaluate the safety and efficacy of robotic ARS in the geriatric population. We conducted a single-institution review of ARS procedures performed between 2009 and 2023. Patients ≥ 65 were assigned to the geriatric cohort. We compared operative details, lengths of stay (LOS), readmissions, reoperations, and complications between the two cohorts. The gastroesophageal reflux disease health-related quality of life (GERD-HRQL) survey and review of clinic notes were used to evaluate ARS efficacy. 628 patients were included, with 190 in the geriatric cohort. This cohort had a higher frequency of diabetes (16.3% vs 5.9% p < 0.0001), hypertension (50.0% vs 21.5% p < 0.0001), and heart disease (17.9% vs 2.3% p < 0.0001). Geriatric patients were more likely to exhibit hiatal hernias on imaging (51.6% vs 34.2% p < 0.0001) and were more likely to have large hernias (30.0% vs 7.1% p < 0.0001). Older adults were more likely to undergo Toupet fundoplications (58.4% vs 41.3%, p < 0.0001), Collis gastroplasties (9.5% vs 2.7% p < 0.0001), and relaxing incisions (11.6% vs 1.4% p < 0.0001). Operative time was longer for geriatric patients (132.0min vs 104.5min p < 0.0001). There were no significant differences in LOS, readmissions, or reoperations between cohorts. Geriatric patients exhibited lower rates of complications (7.4% vs. 14.6%, p = 0.011), but similar complication grades. Both groups had significant reduction in symptom scores from preoperative values. There were no significant differences in the reported symptoms between cohorts at any follow-up timepoint. Geriatric robotic ARS patients tend to do as well as younger adults regarding postoperative and symptomatic outcomes, despite presenting with larger hiatal hernias and shorter esophagi. Clinicians should be aware of possible need for lengthening procedures or relaxing incisions in this population.

Endoscopic full-thickness plication along with argon plasma coagulation for treatment of proton pump inhibitor dependent gastroesophageal reflux disease

BACKGROUND Most endoscopic anti-reflux interventions for gastroesophageal reflux disease (GERD) management are technically challenging to practice with inadequate data to support it utility. Therefore, this study was carried to evaluate the effectiveness and safety newer endoscopic full-thickness fundoplication (EFTP) device along with Argon Plasma Coagulation to treat individuals with GERD. AIM To evaluate the effectiveness and safety newer EFTP device along with Argon Plasma Coagulation to treat individuals with GERD. METHODS This study was a single-center comparative analysis conducted on patients treated at a Noble Institute of Gastroenterology, Ahmedabad, hospital between 2020 and 2022. The research aimed to retrospectively analyze patient data on GERD symptoms and proton pump inhibitor (PPI) dependence who underwent EFTP using the GERD-X system along with argon plasma coagulation (APC). The primary endpoint was the mean change in the total gastroesophageal reflux disease health-related quality of life (GERD-HRQL) score compared to the baseline measurement at the 3-month follow-up. Secondary endpoints encompassed enhancements in the overall GERD-HRQL score, improvements in GERD symptom scores at the 3 and changes in PPI usage at the 3 and 12-month time points. RESULTS In this study, patients most were in Hill Class II, and over half had ineffective esophageal motility. Following the EFTP procedure, there were significant improvements in heartburn and regurgitation scores, as well as GERD-HRQL scores (P &lt; 0.001). PPI use significantly decreased, with 82.6% not needing PPIs or prokinetics at end of 1 year. No significant adverse events related to the procedures were observed in either group. CONCLUSION The EFTP along with APC procedure shows promise in addressing GERD symptoms and improving patients' quality of life, particularly for suitable candidates. Moreover, the application of a lone clip with APC yielded superior outcomes and exhibited greater cost-effectiveness.

Predictability of magnetic sphincter augmentation device explantation: a nomogram-based scoring tool from an experienced quaternary center

BackgroundMagnetic sphincter augmentation (MSA) explantation is an uncommon occurrence, and there are limited studies characterizing factors predictive of MSA explantation. This study aimed to create a nomogram to aid in determining the probability of explantation in patients before MSA implantation. MethodsAn institutional review board–approved, prospectively maintained database was retrospectively reviewed for all patients undergoing antireflux surgery between February 2015 and May 2023. All patients who underwent MSA-related procedures were included. Patients were divided into 2 groups, explant group and nonexplant group, and differences were analyzed. A multivariable logistic regression model was fitted to identify independent risk factors for predicting MSA explantation, and a nomogram-based scoring tool was developed. ResultsThere were 227 patients (134 females and 93 males) with a mean age of 51.4 years. The explant group included 28 patients (12.3%), whereas the nonexplant group included 199 patients (87.7%). Patient sociodemographic characteristics, medical comorbidities, preoperative testing results, and surgical history were included in the analysis. The multivariable regression model resulted in 4 significant variables that were included in the nomogram. These included preoperative DeMeester score, preoperative gastroesophageal reflux disease health–related quality of life score, preoperative distal contractile integral value on manometry, and body mass index. Based on these variables, a scoring nomogram was developed with values ranging from 0 to 18. ConclusionOur data were used to develop a scoring calculator capable of predicting the probability of MSA explantation. This scoring tool can guide preoperative patient selection and treatment decisions.

Validity and reliability of the Persian version of the Gastroesophageal Reflux Disease Health-Related Quality of Life questionnaire

ObjectiveThe Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) is one of the most widely used questionnaires for assessing typical gastro-oesophageal reflux disease (GORD) symptoms. It is simple, concise, and...

Does crural repair with biosynthetic mesh improve outcomes of revisional surgery for recurrent hiatal hernia?

BackgroundLaparoscopic revisional surgery for recurrent hiatal hernia (HH) is technically demanding. Re-recurrences are common and esophageal hiatus mesh reinforcement might improve durability of the repair, thus minimizing the risk of re-herniation.PurposeAssess safety and effectiveness of simple suture repair (no mesh group) vs. crural augmentation with a biosynthetic absorbable mesh (mesh group) in patients with recurrent HH.MethodsObservational retrospective study from September 2012 to December 2022. Only patients undergoing redo surgery for previous failures of hiatal hernia repair were enrolled. Surgical failure was defined as symptomatic recurrent HH with > 2 cm of gastric tissue above the diaphragmatic impression at upper gastrointestinal endoscopy and/or swallow study. Gastro-Esophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) and Short Form-36 (SF-36) questionnaires were used to assess and preoperative and postoperative symptoms and quality of life.ResultsOne hundred four patients were included. Overall, 60 patients (57.7%) underwent mesh-reinforced cruroplasty, whereas 44 (42.3%) underwent simple suture cruroplasty. Mesh and no mesh groups had similar baseline demographics, symptoms, prevalence of esophagitis and Barrett’s esophagus, and HH size. A composite crural repair was most commonly performed in the mesh group (38.3% vs. 20.5%; p = 0.07). In addition to cruroplasty, most patients (91%) underwent a Toupet fundoplication. The 90-day postoperative complication rate was 8.6%, and there was no mortality. Recurrent HH was diagnosed in 21 patients (20.2%) with a clinical trend toward reduced incidence in the mesh group (16.7% vs. 25%; p = 0.06). Compared to baseline, there was a statistically significant improvement of median GERD-HRQL score (p < 0.01) and all SF-36 items (p < 0.01).ConclusionsLaparoscopic revisional surgery for recurrent HH is safe and effective. Selective use of biosynthetic mesh may protect from early recurrence and has the potential to reduce re-herniation in the long-term.

The role of transoral incisionless fundoplication (TIF) in the management of gastroesophageal reflux disease (GERD) following peroral endoscopic myotomy (POEM): A pilot, prospective, patient-driven study.

Gastroesophageal reflux (GERD) is a concern after peroral endoscopic myotomy (POEM). Transoral incisionless fundoplication (TIF) has been recently described as a possible therapy for post-POEM GERD in case series. We prospectively enrolled patients undergoing POEM who agreed to participate in objective post-procedure GERD evaluation. Patients with objective evidence of GERD and suitable anatomy were offered TIF vs. proton pump inhibitor (PPI) only. Patients who underwent TIF were compared to those on PPI-only therapy after follow-up. Of 21 enrolled POEM patients with objective testing, GERD was found in 11 (52%). Of those eligible for TIF, 4 (40%) opted to pursue TIF and were compared to those on PPI-only therapy ( n = 6). Three months post-TIF, 75% of patients had discontinued or significantly decreased PPI. There were no adverse events. GERD health-related quality of life scores were low and comparable between TIF (3.75 ± 6.2) and those who remained on PPI-only therapy (4.1 ± 5). In this pilot, patient-driven prospective study, 75% of patients with post-POEM GERD undergoing TIF had stopped or significantly reduced PPI use. Post-POEM TIF is safe and effective and may be a viable alternative to PPI for POEM-related GERD; however, future studies should include a control arm and post-intervention pH monitoring.

Efficacy and safety of endoscopic cardia peripheral tissue scar formation (ECSF) for the treatment of refractory gastroesophageal reflux disease: A systematic review with meta-analysis.

Endoscopic treatment is increasingly used for refractory gastroesophageal reflux disease (rGERD). Unlike the mechanism of conventional surgical fundoplication, gastroesophageal junction ligation, anti-reflux mucosal intervention, and radiofrequency ablation have extremely similar anti-reflux mechanisms; hence, we collectively refer to them as endoscopic cardia peripheral tissue scar formation (ECSF). We conducted a systematic review and meta-analysis to assess the safety and efficacy of ECSF in treating rGERD. We performed a comprehensive search of several databases, including PubMed, Embase, Medline, China Knowledge Network, and Wanfang, to ensure a systematic approach for data collection between January 2011 and July 2023. Forest plots were used to summarize and combine the GERD-health-related quality of life (HRQL), gastroesophageal reflux questionnaire score, and DeMeester scores, acid exposure time, lower esophageal sphincter pressure, esophagitis, proton pump inhibitors use, and patient satisfaction. This study comprised 37 studies, including 1732 patients. After ECSF, significant improvement in gastroesophageal reflux disease health-related quality of life score (mean difference [MD] = 18.27 95% CI: 14.81-21.74), gastroesophageal reflux questionnaire score (MD = 4.85 95% CI: 3.96-5.75), DeMeester score (MD = 42.34, 95% CI: 31.37-53.30), acid exposure time (MD = 7.98, 95% CI: 6.03-9.92), and lower esophageal sphincter pressure was observed (MD = -5.01, 95% CI: -8.39 to 1.62). The incidence of serious adverse effects after ECSF was 1.1% (95% CI: 0.9%-1.2%), and postoperatively, 67.4% (95% CI: 66.4%-68.2%) of patients could discontinue proton pump inhibitor-like drugs, and the treatment outcome was observed to be satisfactory in over 80% of the patients. Subgroup analyses of the various procedures showed that all 3 types improved several objective or subjective patient indicators. Based on the current meta-analysis, we conclude that rGERD can be safely and effectively treated with ECSF as an endoscopic procedure.

Efficacy of abdominal breathing on sleep and quality of life among patients with non-erosive gastroesophageal reflux.

Abdominal breathing recently has demonstrated an important role in managing symptoms of Gastroesophageal Reflux Disease (GERD), improving quality of life, medication adherence, and sleep quality. This study aimed to evaluate the effectiveness of abdominal breathing on sleep and quality of life in patients with non-erosive gastroesophageal reflux. A Quasi-experimental design was used. A purposive sample of 100 patients was selected from the medical outpatient clinics of Menoufia University Hospital and the outpatient clinics of the National Liver Institute in Menoufia Governorate, Egypt. A Structured interview questionnaire was used to collect data on patients' sociodemographic characteristics, belly breathing exercise performance and self-reported compliance, GERD symptoms severity and frequency, Pittsburgh Sleep Quality Index, and GERD Health-Related Quality of Life. The frequency of GERD symptoms decreased from 26.64 pre-intervention to 17.61 and 9.58, respectively, at two- and four-months post-intervention. Antacid consumption among patients taking it 7 days/week was reduced from 34% pre-intervention to 2% and 0% post-intervention by two and four months, respectively. Good sleepers were 24% pre-intervention then increased to 62% and 90% post-intervention by 2 and 4 months, respectively. Regarding GERD related quality of life, only 1% was satisfied pre-intervention, which increased to 32% and 72% post-intervention by 2 and 4 months, respectively. Abdominal breathing offers better therapeutic improvements in all patients' outcomes such as reduced severity and frequency of GERD symptoms, reduced antacid consumption, increased sleep quality, and increased satisfaction with life quality. Healthcare professionals are encouraged to incorporate abdominal breathing into treatment protocols for patients with non-erosive GERD.

Overlap Between Gastroesophageal Reflux Disease and Irritable Bowel Syndrome and Its Impact on Quality of Life.

Background Gastroesophageal reflux disease (GERD) and irritable bowel syndrome (IBS) are common gastrointestinal disorders that can negatively affect quality of life and healthcare costs. The co-occurrence of these conditions can lead to more complex symptomatology and therapeutic challenges. Therefore, understanding the extent of overlap between GERD and IBS is paramount. This study aims to estimate the overlap between GERD and IBS in Saudi Arabia and its impact on quality of life. Methods Patients with GERD at primary care clinics at King Khalid University Hospital in Riyadh, Saudi Arabia, were the subjects of cross-sectional research. The patients were selected using a simple random sampling technique, and an electronic questionnaire was utilized to collect data. Symptoms of IBS were assessed based on Rome IV criteria, and quality of life was evaluated using the GERD quality of life tool. Results Of the 293 GERD patients, the prevalence of co-occurrence of IBS among GERD patients was 35.8%. The GERD health-related quality of life (GERD- HRQL) scores ranged from 0 to 50, with a median and interquartile range (IQR) of 14 (8.5-20). Those with GERD and IBS had a significantly higher GERD-HRQL score than the patients with GERD alone (11 vs. 9, p-value: 0.049). Furthermore, patients with GERD and IBS had a significantly higher GERD-HRQL score than the patients with IBS alone (15 vs. 11, p-value: 0.001). Of the total participants, 29.4% reported having abdominal pain in the last three months. The majority of the participants (55.6%) reported experiencing abdominal pain one to two times per week, while 22.2% reported experiencing it two to three days per month. Conclusion The high prevalence of IBS co-existence among GERD patients highlights the importance of considering both diseases in clinical practice to improve patient outcomes. The study also found that patients with both GERD and IBS had a significantly lower quality of life than those with GERD or IBS alone.

On-demand Versus Continuous Maintenance Treatment With a Proton Pump Inhibitor for Mild Gastroesophageal Reflux Disease: A Prospective Randomized Multicenter Study.

It remains unclear which maintenance treatment modality is most appropriate for mild gastroesophageal reflux disease (GERD). We aimed to compare on-demand treatment with continuous treatment using a proton pump inhibitor (PPI) in the maintenance treatment for patients with non-erosive GERD or mild erosive esophagitis. Patients whose GERD symptoms improved after 4 weeks of standard dose PPI treatment were prospectively enrolled at 25 hospitals. Subsequently, the enrolled patients were randomly assigned to either an on-demand or a continuous maintenance treatment group, and followed in an 8-week interval for up to 24 weeks. A total of 304 patients were randomized to maintenance treatment (continuous, n = 151 vs on-demand, n = 153). The primary outcome, the overall proportion of unwillingness to continue the assigned maintenance treatment modality, failed to confirm the non-inferiority of on-demand treatment (45.9%) compared to continuous treatment (36.1%). Compared with the on-demand group, the GERD symptom and health-related quality of life scores significantly more improved and the overall satisfaction score was significantly higher in the continuous treatment group, particularly at week 8 and week 16 of maintenance treatment. Work impairment scores were not different in the 2 groups, but the prescription cost was less in the on-demand group. Serum gastrin levels significantly elevated in the continuous treatment group, but not in the on-demand group. Continuous treatment seems to be more appropriate for the initial maintenance treatment of non-erosive GERD or mild erosive esophagitis than on-demand treatment. Stepping down to on-demand treatment needs to be considered after a sufficient period of continuous treatment.