One- and 2-year evaluation of a feasibility trial (clinicaltrials.gov registration numbers NCT01057992, NCT01058070, and 01058564) to assess the safety and efficacy of a laparoscopically implanted sphincter augmentation device for the treatment of gastroesophageal reflux disease (GERD). A sphincter augmentation device (LINX Reflux Management System; Torax Medical, Shoreview, MN), designed to prevent reflux due to abnormal opening of the lower esophageal sphincter (LES), was laparoscopically implanted at the gastroesophageal junction in 44 patients. At baseline, all patients had abnormal esophageal acid exposure on 24-hour pH monitoring and improved, but persistent, typical GERD symptoms while on acid suppression therapy with proton pump inhibitors (PPIs). The device comprises a miniature string of interlinked titanium beads, with magnetic cores, placed around the gastroesophageal junction. The magnetic bond between adjacent beads augments sphincter competence. The beads temporarily separate to accommodate a swallowed bolus, allow belching or vomiting, and reapproximate to augment the LES in the closed position. Patients were evaluated after surgery by GERD Health-Related Quality of Life symptom score, PPI usage, endoscopy, esophageal manometry, and 24-hour esophageal pH monitoring. The total mean GERD Health-Related Quality of Life symptom scores improved from a mean baseline value of 25.7 to 3.8 and 2.4 at 1- and 2-year follow-up, representing an 85% and 90% reduction, respectively (P < 0.0001). Complete cessation of PPI use was reported by 90% of patients at 1 year and by 86% of patients at 2 years. Early dysphagia occurred in 43% of the patients and self-resolved by 90 days. One device was laparoscopically explanted for persistent dysphagia without disruption of the anatomy or function of the cardia. There were no device migrations, erosions, or induced mucosal injuries. At 1 and 2 years, 77% and 90% of patients had a normal esophageal acid exposure. The mean percentage time pH was less than 4 decreased from a baseline of 11.9% to 3.1% (P < 0.0001) at 1 year and to 2.4% (P < 0.0001) at 2 years. Patient satisfaction was 87% at 1 year and 86% at 2 years. The new laparoscopically implanted sphincter augmentation device eliminates GERD symptoms without creating undue side effects and is effective at 1 and 2 years of follow-up.

This study was undertaken to evaluate our clinical experience during a 6-year period with an implantable device that augments the lower esophageal sphincter for gastroesophageal reflux disease (GERD). The device uses magnetic sphincter augmentation (MSA) to strengthen the antireflux barrier. In a single-center, prospective case series, 100 consecutive patients underwent laparoscopic MSA for GERD between March 2007 and February 2012. Clinical outcomes for each patient were tracked post implantation and compared with presurgical data for esophageal pH measurements, symptom scores, and proton pump inhibitor (PPI) use. Median implant duration was 3 years (range 378 days to 6 years). Median total acid exposure time was reduced from 8.0% before implant to 3.2% post implant (p < 0.001). The median GERD Health Related Quality of Life score at baseline was 16 on PPIs and 24 off PPIs and improved to a score of 2 (p < 0.001). Freedom from daily dependence on PPIs was achieved in 85% of patients. There have been no long-term complications, such as device migrations or erosions. Three patients had the device laparoscopically removed for persistent GERD, odynophagia, or dysphagia, with subsequent resolution of symptoms. Magnetic sphincter augmentation for GERD in clinical practice provides safe and long-term reduction of esophageal acid exposure, substantial symptom improvement, and elimination of daily PPI use. For candidates of antireflux surgery who have been carefully evaluated before surgery to confirm indication for MSA, MSA has become a standard treatment at our institution because control of reflux symptoms and pH normalization can be achieved with minimal side effects and preservation of gastric anatomy.

Purpose: To examine the updated evidence on safety, effectiveness, and outcomes of the totally extraperitoneal (TEP) versus the laparoscopic transabdominal preperitoneal (TAPP) repair and to explore the timely tendency variations favoring one treatment over another. Methods: Systematic review and trial sequential analysis (TSA) of randomized controlled trials (RCTs). MEDLINE, Scopus, Web of Science, Cochrane Central Library, and ClinicalTrials.gov were consulted. Risk Ratio (RR), weighted mean difference (WMD), and 95% confidence intervals (CI) were used as pooled effect size measures. Results: Fifteen RCTs were included (1359 patients). Of these, 702 (51.6%) underwent TAPP and 657 (48.4%) TEP repair. The age of the patients ranged from 18 to 92 years and 87.9% were males. The estimated pooled RR for hernia recurrence (RR = 0.83; 95% CI 0.35–1.96) and chronic pain (RR = 1.51; 95% CI 0.54–4.22) were similar for TEP vs. TAPP. The TSA shows a cumulative z-curve without crossing the monitoring boundaries line (Z = 1.96), thus supporting true negative results while the information size was calculated as adequate for both outcomes. No significant differences were found in term of early postoperative pain, operative time, wound-related complications, hospital length of stay, return to work/daily activities, and costs. Conclusions: TEP and TAPP repair seems comparable in terms of postoperative hernia recurrence and chronic pain. The cumulative evidence and information size are sufficient to provide a conclusive evidence on recurrence and chronic pain. Similar trials or meta-analyses seem unlikely to show diverse results and should be discouraged.

The treatment of periampullary and pancreatic head neoplasms is evolving. While minimally invasive Pancreaticoduodenectomy (PD) has gained worldwide interest, there has been a debate on its related outcomes. The purpose of this paper was to provide an updated evidence comparing short-term surgical and oncologic outcomes within Open Pancreaticoduodenectomy (OpenPD), Laparoscopic Pancreaticoduodenectomy (LapPD), and Robotic Pancreaticoduodenectomy (RobPD). MEDLINE, Web of Science, PubMed, Cochrane Central Library, and ClinicalTrials.gov were referred for systematic search. A Bayesian network meta-analysis was executed. Forty-one articles (56,440 patients) were included; 48,382 (85.7%) underwent OpenPD, 5570 (9.8%) LapPD, and 2488 (4.5%) RobPD. Compared to OpenPD, LapPD and RobPD had similar postoperative mortality [Risk Ratio (RR) = 1.26; 95%CrI 0.91–1.61 and RR = 0.78; 95%CrI 0.54–1.12)], clinically relevant (grade B/C) postoperative pancreatic fistula (POPF) (RR = 1.12; 95%CrI 0.82–1.43 and RR = 0.87; 95%CrI 0.64–1.14, respectively), and severe (Clavien-Dindo ≥ 3) postoperative complications (RR = 1.03; 95%CrI 0.80–1.46 and RR = 0.93; 95%CrI 0.65–1.14, respectively). Compared to OpenPD, both LapPD and RobPD had significantly reduced hospital length-of-stay, estimated blood loss, infectious, pulmonary, overall complications, postoperative bleeding, and hospital readmission. No differences were found in the number of retrieved lymph nodes and R0. OpenPD, LapPD, and RobPD seem to be comparable across clinically relevant POPF, severe complications, postoperative mortality, retrieved lymphnodes, and R0. LapPD and RobPD appears to be safer in terms of infectious, pulmonary, and overall complications with reduced hospital readmission We advocate surgeons to choose their preferred surgical approach according to their expertise, however, the adoption of minimally invasive techniques may possibly improve patients’ outcomes.