Magnetic Sphincter Augmentation Superior to Proton Pump Inhibitors for Regurgitation in a 1-Year Randomized Trial.

BACKGROUND & AIMS: Regurgitative gastroesophageal reflux disease (GERD) refractive to medical treatment is common and caused by mechanical failure of the anti-reflux barrier. We compared the effects of magnetic sphincter augmentation (MSA) with those of proton-pump inhibitors (PPIs) in a randomized trial. METHODS: Patients with moderate to severe regurgitation (assessed by the foregut symptom questionnaire) despite once-daily PPI therapy (n = 152) were randomly assigned to groups given twice-daily PPIs (n = 102) or laparoscopic MSA (n = 50) at 20 sites, from July 2015 through February 2017. Patients answered questions from the foregut-specific reflux disease questionnaire and GERD health-related quality of life survey about regurgitation, heartburn, dysphagia, bloating, diarrhea, flatulence, and medication use, at baseline and 6 and 12 months after treatment. Six months after PPI therapy, MSA was offered to patients with persistent moderate to severe regurgitation and excess reflux episodes during impedance or pH testing on medication. Regurgitation, foregut scores, esophageal acid exposure, and adverse events were evaluated at 1 year. RESULTS: Patients in the MSA group and those who crossed over to the MSA group after PPI therapy (n = 75) had similar outcomes. MSA resulted in control of regurgitation in 72/75 patients (96%); regurgitation control was independent of preoperative response to PPIs. Only 8/43 patients receiving PPIs (19%) reported control of regurgitation. Among the 75 patients who received MSA, 61 (81%) had improvements in GERD health-related quality of life improvement scores (greater than 50%) and 68 patients (91%) discontinued daily PPI use. Proportions of patients with dysphagia decreased from 15% to 7% (P < .005), bloating decreased from 55% to 25%, and esophageal acid exposure time decreased from 10.7% to 1.3% (P < .001) from study entry to 1-year after MSA (Combined P < .001). Seventy percent (48/69) of patients had pH normalization at study completion. MSA was not associated with any peri-operative events, device explants, erosions, or migrations. CONCLUSIONS: In a prospective study, we found MSA to reduce regurgitation in 95% of patients with moderate to severe regurgitation despite once-daily PPI therapy. MSA is superior to twice-daily PPIs therapy in reducing regurgitation. Relief of regurgitation is sustained over 12 months. ClinicalTrials.gov no: NCT02505945.

Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial.

BACKGROUND AND AIMS: GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, because PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy. METHODS: One hundred fifty-two patients with GERD, aged ≥21 years with moderate-to-severe regurgitation despite 8 weeks of once-daily PPI therapy, were prospectively enrolled at 21 U.S. sites. Participants were randomized 2:1 to treatment with twice-daily (BID) PPIs (N = 102) or to laparoscopic MSA (N = 50). Standardized foregut symptom questionnaires and ambulatory esophageal reflux monitoring were performed at baseline and at 6 months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy. RESULTS: Per protocol, 89% (42/47) of treated patients with MSA reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (P < .001) at the 6-month primary endpoint. By intention-to-treat analysis, 84% (42/50) of patients in the MSA group and 10% (10/102) in the BID PPI group met this primary endpoint (P < .001). Eighty-one percent (38/47) of patients with MSA versus 8% (7/87) of patients with BID PPI had ≥50% improvement in GERD-health-related quality of life scores (P < .001), and 91% (43/47) remained off of PPI therapy. A normal number of reflux episodes and acid exposures was observed in 91% (40/44) and 89% (39/44) of MSA patients, respectively, compared with 58% (46/79) (P < .001) and 75% (59/79) (P = .065) of BID PPI patients at 6 months. No significant safety issues were observed. In MSA patients, 28% reported transient dysphagia; 4% reported ongoing dysphagia. CONCLUSION: Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.).

Comparison of outcomes for single-incision laparoscopic inguinal herniorrhaphy and traditional three-port laparoscopic herniorrhaphy at a single institution.

BACKGROUND: Evidence in the literature regarding the potential of single-incision laparoscopic (SILS) inguinal herniorrhaphy currently is limited. A retrospective comparison of SILS and traditional multiport laparoscopic (MP) inguinal hernia repair was conducted to assess the safety and feasibility of the minimally invasive laparoscopic technique. METHODS: All laparoscopic inguinal hernia repairs performed by three surgeons at a single institution during 4 years were reviewed. Statistical evaluation included descriptive analysis of demographics including age, gender, body mass index (BMI), and hernia location (uni- or bilateral), in addition to bivariate and multivariate analyses of surgical technique and outcomes including operative times, conversions, and complications. RESULTS: The study compared 129 patients who underwent SILS inguinal hernia repair and 76 patients who underwent MP inguinal hernia repair. The cases included 190 men (92.68 %) with a mean age of 55.36 ± 18.01 years (range, 8-86 years) and a mean BMI of 26.49 ± 4.33 kg/m(2) (range, 17.3-41.7 kg/m(2)). These variables did not differ significantly between the SILS and MP cohorts. The average operative times for the SILS and MP unilateral cases were respectively 57.51 and 66.96 min. For the bilateral cases, the average operative times were 81.07 min for SILS and 81.38 min for MP. A multivariate analysis using surgical approach, BMI, case complexity, and laterality as the covariates demonstrated noninferiority of the SILS technique in terms of operative time (p = 0.031). No conversions from SILS to MP occurred, and the rates of conversion to open procedure did not differ significantly between the cohorts (p = 1.00, Fisher's exact test), nor did the complication rates (p = 0.65, χ (2)). CONCLUSIONS: As shown by the findings, SILS inguinal herniorrhaphy is a safe and feasible alternative to traditional MP inguinal hernia repair and can be performed successfully with similar operative times, conversion rates, and complication rates. Prospective trials are essential to confirm equivalence in these areas and to detect differences in patient-centered outcomes.

Single-incision laparoscopic appendectomy versus traditional three-port laparoscopic appendectomy: an analysis of outcomes at a single institution.

BACKGROUND: Questions have emerged as to whether single-incision laparoscopy has reproducible or superior patient outcomes compared with traditional laparoscopy. A retrospective review comparing single-incision laparoscopic (SILS) appendectomy and traditional multiport laparoscopic (MP) appendectomy was conducted to assess the safety and feasibility of the less invasive laparoscopic technique. METHODS: All SILS and MP appendectomies performed by three surgeons at a single institution during 43 months were reviewed. Statistical evaluation included descriptive analysis of demographic data including age and gender, as well as bi- and multi-variate analyses of operative outcomes including operative time, conversions, complications, and hospital length of stay. RESULTS: The study reviewed 168 patients who underwent SILS appendectomy and 108 patients who underwent MP appendectomy. No statistically significant difference was found between the mean SILS and MP operative times (43.63 vs. 40.95 min; p = 0.29). Additionally, no statistically significant association was noted between surgical approach and length of hospital stay. Although 0.93 % of MP appendectomies and 2.38 % of SILS appendectomies were converted to open procedure, this difference was not statistically significant (p = 0.65, Fisher's exact test). After exclusion of cases converted to open procedure from the study, the findings showed that 3.66 % of SILS cases were converted to multiport laparoscopy. No increase in the overall complication rate was associated with SILS compared with MP appendectomy. The wound complications documented included one incisional hernia for SILS appendectomy and two wound infections for MP appendectomy. CONCLUSION: The findings showed SILS appendectomy to be a safe and feasible alternative to traditional MP appendectomy that can be conducted with operative times, lengths of stay, and complication rates similar to those of the standardized technique. This review is a precursor to prospective studies, which are warranted to demonstrate conclusively the equivalence of operative times, complications, and lengths of hospital stay, as well as to elucidate differences in patient-centered outcomes including postoperative pain, cosmesis, and quality of life.

Magnetic sphincter augmentation: Optimal patient selection and referral care pathways.

Outcomes associated with magnetic sphincter augmentation (MSA) in patients with gastroesophageal reflux disease (GERD) have been reported, however the optimal population for MSA and the related patient care pathways have not been summarized. This Minireview presents evidence that describes the optimal patient population for MSA, delineates diagnostics to identify these patients, and outlines opportunities for improving GERD patient care pathways. Relevant publications from MEDLINE/EMBASE and guidelines were identified from 2000-2018. Clinical experts contextualized the evidence based on clinical experience. The optimal MSA population may be the 2.2-2.4% of GERD patients who, despite optimal medical management, continue experiencing symptoms of heartburn and/or uncontrolled regurgitation, have abnormal pH, and have intact esophageal function as determined by high resolution manometry. Diagnostic work-ups include ambulatory pH monitoring, high-resolution manometry, barium swallow, and esophagogastroduodenoscopy. GERD patients may present with a range of typical or atypical symptoms. In addition to primary care providers (PCPs) and gastroenterologists (GIs), other specialties involved may include otolaryngologists, allergists, pulmonologists, among others. Objective diagnostic testing is required to ascertain surgical necessity for GERD. Current referral pathways for GERD management are suboptimal. Opportunities exist for enabling patients, PCPs, GIs, and surgeons to act as a team in developing evidence-based optimal care plans.

Outcomes of magnetic sphincter augmentation - A community hospital perspective.

BACKGROUND: Magnetic sphincter augmentation (MSA) is FDA approved for the surgical treatment of GERD. While multiple reports from academic settings exist, we report the early experience from two community-based health systems. METHODS: The first 102 post-trial cases of MSA were reviewed. Outcomes were compared to those in the initial clinical trial. RESULTS: Mean follow-up duration was 7.6 months. GERD medication use decreased from 98% preoperative to 8% postoperative (P<0.001). Median GERD health-related quality of life (HRQL) improved from 27 preoperative to 5 postoperative (P<0.001). Patient satisfaction increased from 8% preoperative to 84% postoperative (P<0.001). Results were similar to the trial data. CONCLUSIONS: MSA is a safe and effective treatment for GERD, with significant improvement in quality of life. GERD-HRQL, medication reduction, operative times, and dysphagia rates were similar to other reports, demonstrating the reproducibility of MSA. Lower dilation rates may be due to refinements in technique and postoperative dietary management.

Spontaneous chylous ascites, chylomediastinum and bilateral chylothoraces encountered during laparoscopic incarcerated paraesophageal hernia repair.

Chylous ascites is an accumulation of milky lipid-rich lymph in the peritoneal cavity. Spontaneous chyle leak is a rare occurrence, often associated with malignancy or cirrhosis. This is a report of spontaneous chylous ascites, chylomediastinum and chylothoraces encountered in the setting of an incarcerated paraesophageal hernia. A 60-year-old female presented to the emergency department with epigastric pain, dysphagia and vomiting. Clinical presentation and imaging were concerning for an incarcerated paraesophageal hernia, and the patient was taken to the operating room. During laparoscopic reduction of the hernia and repair, chyle was encountered in the peritoneal cavity, mediastinum and pleural spaces. Postoperatively, the chyle leak resolved with a nonfat diet. The unusual occurrence of a chyle leak in this case may have been due to compression of the thoracic duct within the chest by the incarcerated paraesophageal hernia.

Single-site Nissen fundoplication versus laparoscopic Nissen fundoplication.

BACKGROUND: Advances in minimally invasive surgery have led to the emergence of single-incision laparoscopic surgery (SILS). The purpose of this study is to assess the feasibility of SILS Nissen fundoplication and compare its outcomes with traditional laparoscopic Nissen fundoplication. METHODS: This is a retrospective study of 33 patients who underwent Nissen fundoplication between January 2009 and September 2010. RESULTS: There were 15 SILS and 18 traditional laparoscopic Nissen fundoplication procedures performed. The mean operative time was 129 and 182 minutes in the traditional laparoscopic and single-incision groups, respectively (P=.019). There were no conversions in the traditional laparoscopic group, whereas 6 of the 15 patients in the SILS group required conversion by insertion of 2 to 4 additional ports (P=.0004). At short-term follow-up, recurrence rates were similar between both groups. To date, there have been no reoperations. CONCLUSIONS: SILS Nissen fundoplication is both safe and feasible. Short-term outcomes are comparable with standard laparoscopic Nissen fundoplication. Challenges related to the single-incision Nissen fundoplication include overcoming the lengthy learning curve and decreasing the need for additional trocars.

Single-incision laparoscopic Ladd's procedure for intestinal malrotation.

INTRODUCTION: The potential of single-incision laparoscopic surgery (SILS) as a less invasive and more cosmetically appealing technique has prompted the expansion of its adoption. SILS has been shown to be a safe and feasible alternative to traditional multiport cholecystectomy, appendectomy, colectomy, and many other laparoscopic procedures. The objective of this study is to provide an initial report of the feasibility of correcting intestinal malrotation via a single-incision laparoscopic transumbilical approach. CASE DESCRIPTION: A 29-year-old woman presented with symptomatic congenital intestinal malrotation. She elected to undergo a Ladd's procedure using a single-incision laparoscopic approach with a SILS port and standard laparoscopic instruments. The procedure was accomplished without additional ports or conversion to laparotomy, and no intraoperative or postoperative complications were noted. Total operative time was 106 minutes. The patient had minimal postoperative pain and was satisfied with the cosmetic outcome. CONCLUSION: When performed by a surgeon experienced in the SILS technique, single-incision laparoscopic Ladd's procedure for symptomatic intestinal malrotation in an adult is feasible and safe, with minimal postoperative pain and favorable cosmetic outcome.