SOOTHER TRIAL: Observational study of an over-the-counter ointment to heal anal itch.

Introduction: Pruritus ani, or rectal or anal itch, is a common perianal disorder that affects ~5% of the population of the developed world. Treatments for this disorder are somewhat limited and include conservative non-medical perianal hygiene care, and topical medical treatments including topical steroids, antibacterial and antifungal agents, and topical anesthetic/analgesics such as lidocaine or capsaicin; astringents and vasoconstrictors such as ephedrine can also be used. Methods: The study was IRB approved. We assessed the efficacy of a novel, composite, over-the-counter, topical lidocaine ointment that included an epidermal barrier and antimicrobial effect along with the typical lidocaine anesthetizing effect, in a single arm, observational, longitudinal, population of 20 ambulatory pruritus ani patients. Patients applied the ointment twice daily, and were studied for 2 weeks; primary outcomes included time to symptom resolution and clinical exam resolution as measured on a 5-point visual analog scale. Results: Twenty-nine consecutive patients were screened and 20 patients (12 males; 8 females) were enrolled in the study. Ninety percent of patients achieved 100% symptom resolution by 2 weeks, and most were improved within 72 h of initiating treatment; 95% of patients had a normal visual exam by the 2 week endpoint. There were no significant adverse events attributable to the therapy. Conclusion: Use of a novel composite topical lidocaine agent, demonstrated rapid and effective relief of pruritus ani in an ambulatory population. Additional studies are underway. Clinical trial registered: Clinicaltrials.gov, identifier NCT05288907.

A novel device for improving visualization in an inadequately prepared colon.

BACKGROUND AND AIMS: Adequate bowel preparation is crucial for a quality colonoscopy. Poor bowel preparation can result in longer procedural times, missed adenomas, earlier repeat procedures, increase costs, and decreased patient satisfaction. Pure-Vu (MOTUS GI, Tirat Carmel, Israel) is a system that facilitates intraprocedural cleaning of a poorly prepared colon during a colonoscopy by irrigating the colon and evacuating the fluid and feces. The study aims were to evaluate Pure-Vu's cleansing capabilities and its usability and safety in a live animal colon. METHODS: The Pure-Vu system was used by 4 experienced gastroenterologists in 35 Yorkshire cross swine (66% female) that received a reduced bowel preparation to ensure an inadequate bowel preparation at baseline. Before colonoscopy the Pure-Vu was attached to the colonoscope, and the baseline prep was assessed during insertion. The Pure-Vu system was then used to cleanse the colon and the prep then assessed after Pure-Vu use. RESULTS: No adverse effects and no failed or prematurely terminated cases were noted. Fourteen percent of the swine colons were adequately prepped at baseline (median Boston Bowel Preparation Scale [BBPS] score = 0 [25th percentile = 0; 75th percentile = 1; interquartile range = 1]) and improved to 100% after use of Pure-Vu (Wilcoxon signed rank test P < .001) (median BBPS score = 3 [25th percentile = 3; 75th percentile = 3; interquartile range = 0]). The physicians found Pure-Vu easy and intuitive to operate. CONCLUSIONS: The Pure-Vu system effectively cleaned inadequately prepped swine colons and proved to be easy to use. The Pure-Vu device, applied in clinical practice, may result in improved overall prep quality and a reduction in repeat examinations because of inadequately prepped colons.

Lower Esophageal Sphincter Augmentation for Gastroesophageal Reflux Disease: The Safety of a Modern Implant.

INTRODUCTION: Use of the magnetic sphincter augmentation device (MSAD) for gastroesophageal reflux disease (GERD) is increasing. As this innovative treatment for GERD gains widespread use and adoption, an assessment of its safety since U.S. market introduction is presented. METHODS: Events were collected from the Manufacturer and User Facility Device Experience (MAUDE) database, which reports events submitted to the Food and Drug Administration (FDA) of suspected device-associated deaths, serious injuries, and malfunctions. The reporting period was from March 22, 2012 (FDA approval) through May 31, 2016, and included only events occurring in the United States. Additional information was provided by the manufacturer, allowing calculation of implant rates and durations. RESULTS: An estimated 3283 patients underwent magnetic sphincter augmentation (165 surgeons at 191 institutions). The median implant duration was 1.4 years, with 1016 patients implanted for at least 2 years. No deaths, life-threatening events, or device malfunctions were reported. The overall rate of device removal was 2.7% (89/3283). The most common reasons for device removal were dysphagia (52/89) and persistent reflux symptoms (19/89). Removal for erosion and migration was 0.15% (5/3283) and 0% (0/3283), respectively. There were no perforations. Of the device removals, 57.3% (51/89) occurred <1 year after implant, 30.3% (27/89) between 1 and 2 years, and 12.4% (11/89) >2 years after implant. The rate of device removal and erosion with an implant duration >2 years were 1.1% (11/1016) and 0.1% (1/1016), respectively. All device removals and erosions were managed nonemergently, with no complications or long-term consequences. CONCLUSIONS: During a 4-year period in more than 3000 patients, no unanticipated MSAD complications have emerged, and there is no data to suggest a trend of increased events over time. The presentation and management of device-related issues have been less complicated than revisions for laparoscopic fundoplication or other interventions for GERD. MSAD is considered safe for the widespread treatment of GERD.

A Modern Magnetic Implant for Gastroesophageal Reflux Disease.

A magnetic implant for the treatment of gastroesophageal reflux disease (GERD) was Food and Drug Administration-approved in 2012 and has been extensively evaluated. The device is a ring of magnets that are placed around the gastroesophageal junction, augmenting the native lower esophageal sphincter and preventing reflux yet preserving lower esophageal sphincter physiologic function and allowing belching and vomiting. Magnetic force is advantageous, being permanent and precise, and forces between magnets decrease with esophageal displacement. Multiple patient cohorts have been studied using the magnetic device, and trials establish consistent, long-term improvement in pH data, GERD symptom scores, and proton-pump inhibitor use. A 5-year Food and Drug Administration trial demonstrated that most patients achieved normal pH scores, 85% stopped proton-pump inhibitors, and GERD health-related quality of life symptom scores improved from 27 to 4 at 5 years. Seven studies have compared magnetic augmentation with laparoscopic Nissen fundoplication and demonstrated that the magnetic device achieved comparable efficacy with regard to proton-pump inhibitor cessation, GERD symptom score improvement, and heartburn and regurgitation scores. However, to date there have been no randomized, controlled trials comparing the 2 techniques, and the study cohorts are not necessarily comparable regarding hiatal hernia size, severity of reflux, body mass index scores, or esophagitis scores. Dysphagia incidence was similar in both groups. Reoperation rates and safety profiles were also comparable, but the magnetic device demonstrated significant beneficial differences in allowing belching and vomiting. The magnetic device is safe, with the main adverse event being dysphagia with an approximate 3%-5% chronic incidence. Device removals in clinical trials have been between 0% and 7% and were uneventful. There have been no erosions, perforations, or infections in FDA clinical trials; erosions have rarely been noted in practice. Magnetic augmentation of the lower esophageal sphincter is a safe and effective operation for GERD, and should be considered a surgical option for those seeking a fundic-sparing operation, particularly those with parameters consistent with study cohorts. Additional randomized, controlled trials are underway.

A Review of New Surgical and Endoscopic Therapies for Gastroesophageal Reflux Disease.

Treatment of gastroesophageal reflux disease in the United States today is binary, with the majority of patients with gastroesophageal reflux disease being treated with antisecre-tory medications and a minority of patients, typically those with volume regurgitation, undergoing Nissen fundoplication. However, there has been increasing dissatisfaction with proton pump inhibitor therapy among a significant number of patients with gastroesophageal reflux disease owing to cost, side effects, and refractory symptoms, and there has been a general reluctance to undergo surgical fundoplication due to its attendant side-effect profile. As a result, a therapy gap exists for many patients with gastroesophageal reflux disease. Alternative techniques are available for these gap patients, including 2 endoscopic fundoplication techniques, an endoscopic radiofrequency energy delivery technique, and 2 minimally invasive surgical procedures. These alternative techniques have been extensively evaluated; however, there are limitations to published studies, including arbitrary definitions of success, variable efficacy measurements, deficient reporting tools, inconsistent study designs, inconsistent lengths of follow-up postintervention, and lack of comparison data across techniques. Although all of the techniques appear to be safe, the endoscopic techniques lack demonstrable reflux control and show variable symptom improvement and variable decreases in proton pump inhibitor use. The surgical techniques are more robust, with evidence for adequate reflux control, symptom improvement, and decreased proton pump inhibitor use; however, these techniques are more difficult to perform and are more intrusive. Additionally, these alternative techniques have only been studied in patients with relatively normal anatomy. The field of gastroesophageal reflux disease treatment is in need of consistent definitions of efficacy, standardized study design and outcome measurements, and improved reporting tools before the role of these techniques can be fully ascertained.

Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux.

BACKGROUND & AIMS: Based on results from year 2 of a 5-year trial, in 2012 the US Food and Drug Administration approved the use of a magnetic device to augment lower esophageal sphincter function in patients with gastroesophageal reflux disease (GERD). We report the final results of 5 years of follow-up evaluation of patients who received this device. METHODS: We performed a prospective study of the safety and efficacy of a magnetic device in 100 adults with GERD for 6 months or more, who were partially responsive to daily proton pump inhibitors (PPIs) and had evidence of pathologic esophageal acid exposure, at 14 centers in the United States and The Netherlands. The magnetic device was placed using standard laparoscopic tools and techniques. Eighty-five subjects were followed up for 5 years to evaluate quality of life, reflux control, use of PPIs, and side effects. The GERD-health-related quality of life (GERD-HRQL) questionnaire was administered at baseline to patients on and off PPIs, and after placement of the device; patients served as their own controls. A partial response to PPIs was defined as a GERD-HRQL score of 10 or less on PPIs and a score of 15 or higher off PPIs, or a 6-point or more improvement when scores on vs off PPI were compared. RESULTS: Over the follow-up period, no device erosions, migrations, or malfunctions occurred. At baseline, the median GERD-HRQL scores were 27 in patients not taking PPIs and 11 in patients on PPIs; 5 years after device placement this score decreased to 4. All patients used PPIs at baseline; this value decreased to 15.3% at 5 years. Moderate or severe regurgitation occurred in 57% of subjects at baseline, but only 1.2% at 5 years. All patients reported the ability to belch and vomit if needed. Bothersome dysphagia was present in 5% at baseline and in 6% at 5 years. Bothersome gas-bloat was present in 52% at baseline and decreased to 8.3% at 5 years. CONCLUSIONS: Augmentation of the lower esophageal sphincter with a magnetic device provides significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a 5-year follow-up period. These findings validate the long-term safety and efficacy of the magnetic sphincter augmentation device for patients with GERD. ClinicalTrials.gov no: NCT00776997.

Magnetic Sphincter Augmentation for Gastroesophageal Reflux at 5 Years: Final Results of a Pilot Study Show Long-Term Acid Reduction and Symptom Improvement.

BACKGROUND: As previously reported, the magnetic sphincter augmentation device (MSAD) preserves gastric anatomy and results in less severe side effects than traditional antireflux surgery. The final 5-year results of a pilot study are reported here. PATIENTS AND METHODS: A prospective, multicenter study evaluated safety and efficacy of the MSAD for 5 years. Prior to MSAD placement, patients had abnormal esophageal acid and symptoms poorly controlled by proton pump inhibitors (PPIs). Patients served as their own control, which allowed comparison between baseline and postoperative measurements to determine individual treatment effect. At 5 years, gastroesophageal reflux disease (GERD)-Health Related Quality of Life (HRQL) questionnaire score, esophageal pH, PPI use, and complications were evaluated. RESULTS: Between February 2007 and October 2008, 44 patients (26 males) had an MSAD implanted by laparoscopy, and 33 patients were followed up at 5 years. Mean total percentage of time with pH <4 was 11.9% at baseline and 4.6% at 5 years (P < .001), with 85% of patients achieving pH normalization or at least a 50% reduction. Mean total GERD-HRQL score improved significantly from 25.7 to 2.9 (P < .001) when comparing baseline and 5 years, and 93.9% of patients had at least a 50% reduction in total score compared with baseline. Complete discontinuation of PPIs was achieved by 87.8% of patients. No complications occurred in the long term, including no device erosions or migrations at any point. CONCLUSIONS: Based on long-term reduction in esophageal acid, symptom improvement, and no late complications, this study shows the relative safety and efficacy of magnetic sphincter augmentation for GERD.

Update in procedural therapy for GERD--magnetic sphincter augmentation, endoscopic transoral incisionless fundoplication vs laparoscopic Nissen fundoplication.

Gastroesophageal reflux disease (GERD) is a common and progressive condition manifested by heartburn or regurgitation. Though Nissen fundoplication has been and remains the gold standard for procedural therapy for GERD, two newer interventions have gained popularity: magnetic sphincter augmentation (MSA), which entails the placement of a self expanding magnetic ring around the gastroesophageal (GE) junction, and transoral incisionless fundoplication (TIF), an endoscopic approach that creates a neogastroesophageal valve near the fundus. Collective data gathered from four studies published within the past year suggest that the three modalities share comparable effectiveness in pH monitoring and patient satisfaction, TIF may have a lower proton pump inhibitor cessation rate, and Nissen fundoplication required longer recovery time and had a more serious adverse effects profile. Large, prospective, randomized controlled studies are needed to reliably compare the three procedures.

A pilot study of endoluminal US for stool liquefaction.

BACKGROUND: There is a need to cleanse patients who are poorly prepared for colonoscopy safely and efficiently during the procedure to minimize rescheduling. US is already being used in catheter-based intravascular thrombolysis, and time-reversal acoustic (TRA) has been explored in assisting drug delivery to the brain. OBJECTIVE: To explore the efficacy and safety of a miniaturized endoluminal US device in stool dissolution as a means to salvage poor bowel preparation. DESIGN: Proof of concept experimental study. SETTINGS: Animal laboratory. INTERVENTIONS: Low-frequency US and TRAs. MAIN OUTCOME MEASUREMENTS: Feasibility, efficacy, and safety of US to liquefy stools ex vivo. RESULTS: Depending on parameters, such as pulse rate, acoustic intensity, and duration, increases in liquefaction speeds by a factor of 50 and 100 times were obtained. There was a significant difference in weight change between the 20-kHz-treated sample compared with controls (P ≤ .0001). There was no difference in sloughing of mucosa and mechanical injury among the US, water spray, and control groups. LIMITATIONS: Animal model. CONCLUSION: Endoluminal US can liquefy stools at acoustic exposure levels that do not damage ex vivo colonic mucosa. Endoluminal US should be able to dissolve stools more rapidly than water spray alone, thereby optimizing colonoscopic evaluation in vivo.

Barrett's esophagus is frequently overdiagnosed in clinical practice: results of the Barrett's Esophagus Endoscopic Revision (BEER) study.

BACKGROUND: The published prevalence of Barrett's esophagus (BE) varies from 0.9% to 25%, in part because of differences in the endoscopic interpretation of the disease. OBJECTIVE: We studied the accuracy of diagnosis in 130 patients previously labeled as having BE. Our aim was to determine the interobserver consistency of endoscopic findings and assess the percentage of patients with confirmed BE versus those with a revised diagnosis. DESIGN/SETTING/PATIENTS: Patients previously diagnosed with BE of any length and due for surveillance endoscopy were eligible for study. INTERVENTIONS: After intensive consensus anatomic and endoscopic review, study patients underwent endoscopy and biopsy by 1 of 3 endoscopists. BE was defined as any length of columnar-lined esophagus with goblet cells. MAIN OUTCOME MEASUREMENTS: Patients were photographed/videotaped for review by the other 2 endoscopists, and BE was either confirmed or revised. RESULTS: Eighty-eight patients (67.7%) had confirmed BE, and 42 (32.3%) had their diagnosis revised to no BE (95% confidence interval, 24.4%-41.1%) because there was no visible columnar-lined esophagus proximal to the gastric folds or no goblet cells were found on biopsy. BE length, site of previous endoscopy, age, sex, and hiatal hernia size were predictors of revision. All 3 endoscopists agreed on all confirmed BE cases and 38 of 42 of those revised. LIMITATIONS: Retrospective analysis, possible sampling error. CONCLUSIONS: BE is overdiagnosed in clinical practice with important implications for patient care including increased costs, reduced insurability, and psychological stress. The true BE cancer risk may also be underestimated. This study suggests the need for a better definition of the gastroesophageal junction, stricter accountability for BE diagnosis, and improved endoscopic education.

Esophageal sphincter device for gastroesophageal reflux disease.

BACKGROUND: Patients with gastroesophageal reflux disease who have a partial response to proton-pump inhibitors often seek alternative therapy. We evaluated the safety and effectiveness of a new magnetic device to augment the lower esophageal sphincter. METHODS: We prospectively assessed 100 patients with gastroesophageal reflux disease before and after sphincter augmentation. The study did not include a concurrent control group. The primary outcome measure was normalization of esophageal acid exposure or a 50% or greater reduction in exposure at 1 year. Secondary outcomes were 50% or greater improvement in quality of life related to gastroesophageal reflux disease and a 50% or greater reduction in the use of proton-pump inhibitors at 1 year. For each outcome, the prespecified definition of successful treatment was achievement of the outcome in at least 60% of the patients. The 3-year results of a 5-year study are reported. RESULTS: The primary outcome was achieved in 64% of patients (95% confidence interval [CI], 54 to 73). For the secondary outcomes, a reduction of 50% or more in the use of proton-pump inhibitors occurred in 93% of patients, and there was improvement of 50% or more in quality-of-life scores in 92%, as compared with scores for patients assessed at baseline while they were not taking proton-pump inhibitors. The most frequent adverse event was dysphagia (in 68% of patients postoperatively, in 11% at 1 year, and in 4% at 3 years). Serious adverse events occurred in six patients, and in six patients the device was removed. CONCLUSIONS: In this single-group evaluation of 100 patients before and after sphincter augmentation with a magnetic device, exposure to esophageal acid decreased, reflux symptoms improved, and use of proton-pump inhibitors decreased. Follow-up studies are needed to assess long-term safety. (Funded by Torax Medical; ClinicalTrials.gov number, NCT00776997.).