Exploring the feasibility and safety of laparoscopic anti-reflux surgery with the new RefluxStop™ device: a retrospective cohort study of 40 patients.

AIMS OF THE STUDY: Anti-reflux surgery aims to restore the anti-reflux barrier and reduce the retrograde flow of stomach contents. However, traditional surgical techniques generally involve some degree of encircling of the oesophagus, which can result in adverse effects such as dysphagia and the inability to belch or vomit. Based on the first published results, a novel surgical technique - with the RefluxStop™ device - appears promising for treating gastroesophageal reflux disease (GERD) with minimal postoperative dysphagia. This study describes the initial clinical experience with this procedure in a cohort of patients with chronic gastroesophageal reflux disease to evaluate its feasibility and safety in clinical practice. METHODS: This retrospective cohort study examined the first 40 patients who underwent laparoscopic anti-reflux surgery with the RefluxStop™ device at a private hospital in Switzerland. The procedure involves implanting a nonactive device on the outside of the gastric fundus to stabilise a narrow oesophagogastric plication. Feasibility was assessed based on the proportion of patients in whom the device could be successfully implanted, with a discussion of the operative details. Intraoperative and postoperative complications, adverse effects, and changes in gastroesophageal reflux disease-related quality of life (GERD-HRQL questionnaire) are also reported. RESULTS: Between May 2020 and April 2022, 40 patients underwent elective surgery for laparoscopic hiatal hernia repair and RefluxStop™ device implantation. All patients had typical symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation; 20 (50%) had preoperative dysphagia. Laparoscopic surgery was feasible in all patients except one who required laparotomy due to adhesions and associated bleeding when accessing the abdomen. The median operating time was 57.5 minutes (interquartile range = 51.75-64.25 minutes) with no device-related intraoperative or postoperative complications. All patients were imaged one day and three months postoperative, confirming the correct placement of the device. Reflux symptoms (heartburn and acid regurgitation) were significantly improved in all patients at three months (p <0.0001). CONCLUSION: These preliminary results support the feasibility and safety of introducing this novel laparoscopic anti-reflux surgical treatment option in clinical practice.

Treating acid reflux without compressing the food passageway: 4-year safety and clinical outcomes with the RefluxStop device in a prospective multicenter study.

INTRODUCTION: RefluxStop is an implantable device for laparoscopic surgical treatment of gastroesophageal reflux disease (GERD) to restore and maintain lower esophageal sphincter and angle of His anatomy without encircling and putting pressure on the food passageway, thereby avoiding side effects such as dysphagia and bloating seen with traditional fundoplication. This study reports the clinical outcomes with RefluxStop at 4 years following implantation of the device. METHODS: A prospective, single arm, multicenter clinical investigation analyzing safety and effectiveness of the RefluxStop device in 50 patients with chronic GERD. RESULTS: Available data are presented for 44 patients at 4 years with the addition of three patients at 3 years carried forward. At 4 years, median GERD-HRQL score was 90% reduced compared to baseline. Two patients (2/44) used regular daily proton pump inhibitors (PPIs) despite subsequent 24-h pH monitoring off PPI therapy yielding normal results. There were no device-related adverse events (AEs), esophageal dilations, migrations, or explants during the entire study period. AEs reported between 1 and 4 years were as follows: one subject with heartburn and a pathologic pH result with device positioned too low at surgery; one subject with dysphagia, thus, 46/47 patients reported no dysphagia-related AEs between years 1 and 4. Two patients (2/47) were dissatisfied with treatment despite normal 24-h pH monitoring, of whom one had manometry-verified dysmotility at 6 months, indicating dissatisfaction for reasons other than acid reflux. CONCLUSION: These results confirm the excellent and already published 1-year results as stable in the long-term, supporting the safety and effectiveness of the RefluxStop device in treating GERD for over 4 years. GERD-HRQL score, pH testing, and PPI usage indicate treatment success without dysphagia or gas-bloating and only minimal incidence of other AEs. This favorably low rate of AEs is likely attributable to RefluxStop's dynamic physiologic interaction and non-encircling nature.

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

PURPOSE: In 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. METHODS: Retrospective 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. RESULTS: Between 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)). CONCLUSION: RefluxStop 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.

Laparoscopic Large Hiatal Hernia Repair With RefluxStop: Outcomes of Six Months Follow-up in Thirty Patients.

OBJECTIVE: The antireflux surgical technique with the RefluxStop device is one of the latest approaches to treating patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess the safety and feasibility of laparoscopic hiatal hernia (HH) repair with the RefluxStop device in patients with GERD and concurrent large HH (≥4 cm). PATIENTS AND METHODS: A retrospective chart review was performed for the first 30 patients with a large HH who consented and underwent HH surgery with the RefluxStop device. The operative technique and outcomes were evaluated to assess safety and feasibility, HH recurrence, dysphagia, and patient satisfaction. RESULTS: Between May 2020 and April 2022, 30 patients underwent laparoscopic HH repair with the RefluxStop device. All patients had typical symptoms of GERD, such as heartburn and regurgitation, and 15 patients (50%) had preoperative dysphagia. Median HH size was 5 cm (interquartile range, 4 to 5). Median operating time was 56 minutes (interquartile range, 52 to 63), with no intra and postoperative complications related to the device. One patient required laparotomy due to adhesions and associated bleeding when accessing the abdomen. All patients had postoperative imaging (video fluoroscopy) on postoperative day 1 and at 3 months, confirming the correct location of the RefluxStop device. One patient (3.3%) needed postoperative balloon dilatation due to severe dysphagia. Reflux symptoms (heartburn and acid regurgitation) resolved significantly in all patients ( P < 0.001) at 6 months. One episode of recurrence of HH (3.3%) occurred during the follow-up period of 6 months. CONCLUSION: This study demonstrates the short-term safety and feasibility of laparoscopic HH repair with the RefluxStop device in patients with large HH, with a low rate of postoperative dysphagia and subsequent improvement or resolution of reflux symptoms in all patients.

Counter-regulatory responses to postprandial hypoglycaemia in patients with post-bariatric hypoglycaemia vs surgical and non-surgical control individuals.

AIMS/HYPOTHESIS: Post-bariatric hypoglycaemia is an increasingly recognised complication of bariatric surgery, manifesting particularly after Roux-en-Y gastric bypass. While hyperinsulinaemia is an established pathophysiological feature, the role of counter-regulation remains unclear. We aimed to assess counter-regulatory hormones and glucose fluxes during insulin-induced postprandial hypoglycaemia in patients with post-bariatric hypoglycaemia after Roux-en-Y gastric bypass vs surgical and non-surgical control individuals. METHODS: In this case-control study, 32 adults belonging to four groups with comparable age, sex and BMI (patients with post-bariatric hypoglycaemia, Roux-en-Y gastric bypass, sleeve gastrectomy and non-surgical control individuals) underwent a postprandial hypoglycaemic clamp in our clinical research unit to reach the glycaemic target of 2.5 mmol/l 150-170 min after ingesting 15 g of glucose. Glucose fluxes were assessed during the postprandial and hypoglycaemic period using a dual-tracer approach. The primary outcome was the incremental AUC of glucagon during hypoglycaemia. Catecholamines, cortisol, growth hormone, pancreatic polypeptide and endogenous glucose production were also analysed during hypoglycaemia. RESULTS: The rate of glucose appearance after oral administration, as well as the rates of total glucose appearance and glucose disappearance, were higher in both Roux-en-Y gastric bypass groups vs the non-surgical control group in the early postprandial period (all p<0.05). During hypoglycaemia, glucagon exposure was significantly lower in all surgical groups vs the non-surgical control group (all p<0.01). Pancreatic polypeptide levels were significantly lower in patients with post-bariatric hypoglycaemia vs the non-surgical control group (median [IQR]: 24.7 [10.9, 38.7] pmol/l vs 238.7 [186.3, 288.9] pmol/l) (p=0.005). Other hormonal responses to hypoglycaemia and endogenous glucose production did not significantly differ between the groups. CONCLUSIONS/INTERPRETATION: The glucagon response to insulin-induced postprandial hypoglycaemia is lower in post-bariatric surgery individuals compared with non-surgical control individuals, irrespective of the surgical modality. No significant differences were found between patients with post-bariatric hypoglycaemia and surgical control individuals, suggesting that impaired counter-regulation is not a root cause of post-bariatric hypoglycaemia. TRIAL REGISTRATION: ClinicalTrials.gov NCT04334161.

Gastric electric stimulator versus gastrectomy for the treatment of medically refractory gastroparesis.

BACKGROUND: Gastric electrical stimulation (GES) and laparoscopic gastrectomy (LG) are known therapeutic options for medically refractory gastroparesis (MRG) although there are limited data comparing their outcomes. We aim to compare clinical outcomes between patients undergoing GES vs upfront LG for the treatment of MRG while examining factors associated with GES failure and conversion to LG. METHODS: We retrospectively analyzed 181 consecutive patients who underwent GES or LG for MRG at our institution from January 2003 to December 2017. Data collection consisted of chart review and follow-up telephone survey. Statistical analysis utilized Chi-squared, ANOVA, and multivariable logistic regression. RESULTS: Overall, 130 (72%) patients underwent GES and 51 (28%) LG as primary intervention. GES patients were more likely to have diabetic gastroparesis (GES 67% vs LG 39%, p < 0.001), while primary LG patients were more likely to have post-surgical gastroparesis (GES 5% vs LG 43%, p < 0.001). Postoperatively, primary LG patients had higher rates of major in-hospital morbidity events (GES 5% vs LG 18%, p = 0.017) and longer hospital stays (GES 3 vs LG 9 days, p < 0.001). However, over a mean 35-month follow-up period, there were no differences in the rates of major morbidity, readmissions, or mortality. Multivariable regression analysis revealed patients undergoing GES as a primary intervention were less likely to report improvement in symptoms on follow-up compared to primary LG patients OR 0.160 (95% CI 0.048-0.532). Additionally, patients who converted to LG from GES were more likely to have post-surgical gastroparesis as the primary etiology. CONCLUSION: GES as a first-line surgical treatment of MRG was associated with worse outcomes compared to LG. Post-surgical etiology was associated with an increased likelihood of GES failure, and in such patients, upfront gastrectomy may be a superior alternative to GES. Further studies are needed to determine patient selection for operative treatment of MRG.

Postoperative Dysphagia Following Magnetic Sphincter Augmentation for Gastroesophageal Reflux Disease.

The addition of posterior cruroplasty to magnetic sphincter augmentation (MSA-PC) has been shown to be effective in treating gastroesophageal reflux disease (GERD). This study evaluates the predictors of persistent postoperative dysphagia, one of the major complaints after MSA-PC. From August 2015 to February 2018 the medical records of 118 patients (male=59, female=59) receiving MSA-PC for GERD were reviewed. Postoperative dysphagia was present in 80 patients (67.8%), with 20 (16.9%) requiring dilation for persistent dysphagia. Three patients (2.5%) had the magnetic sphincter augmentation device removed for persistent dysphagia, one was converted to a Nissen fundoplication. The median number of dilations was 1, mean time from surgery to dilation was 5.6 months, and 15/20 (75%) had symptom resolution after 1 to 2 dilations. Dilated patients were more likely than nondilated patients to have atypical GERD symptoms preoperatively (70% vs. 44.7%, P=0.042). After dilation, 93.3% of patients reported a good quality of life.

Short-term outcomes of endoscopic gastro-jejunal revisions for treatment of dumping syndrome after Roux-En-Y gastric bypass.

BACKGROUND: Dumping syndrome is a known long-term complication of Roux-en-Y gastric bypass (RYGB). Most cases can be avoided with dietary and lifestyle changes. Severe dumping is characterized by multiple daily episodes with significant impact on quality-of-life. As dumping correlates with rapid pouch emptying through a dilated gastro-jejunal anastomosis (GJA), the aim was to assess endoscopic gastro-jejunal revisions (EGR) regarding feasibility, safety, and outcome. METHODS: From January 2016 to August 2018, we reviewed the electronic records of all patients with dumping syndrome undergoing EGR with the Apollo OverStitch suturing device (Apollo Endosurgery, Austin, Texas, USA). Demographics, procedure details, and outcome variables were recorded. Sigstad questionnaire was administered before and after surgery to assess symptomatic response. RESULTS: There were 40 patients (M:F = 13:27) treated with EGR for dumping. Mean procedure time was 18.5 min (12-41) with a median number of 1 suture (range 1-3) used. Mean anastomotic diameter was 22.6 mm (R 18-35) at the beginning and 6.2 mm (R 4-13) at the end of the procedure, with 100% technical success in narrowing the GJA. There were no intra-operative or 30-day complications. Repeat EGR was required in 9 patients (22.5%) for persistent/recurrent dumping. Two patients (5%) required a laparoscopic pouch revision. For patients with minimum 1-month follow-up who were treated only endoscopically, 33/37 (89.2%) had improved or resolved symptoms during the follow-up period. Mean follow-up time was 12.5 months (R1-33.8). Survey responses were available for 25/34 (73.5%) patients. Mean Sigstad score decreased from 13.9 (R 0-28) pre-operatively to 8.6 (R 0-28) after EGR. CONCLUSION: EGR of the dilated GJA is a highly effective treatment option for dumping syndrome after RYGB. Due to its endoluminal approach, it is a feasible and safe procedure, and effective for immediate symptom resolution in most patients. In some patients, repeat narrowing of the anastomosis is necessary for the maintenance of symptom resolution.

Clinical Significance of Esophageal Outflow Resistance Imposed by a Nissen Fundoplication.

BACKGROUND: Attention has been focused on the amplitude of esophageal body contraction to avoid persistent dysphagia after a Nissen fundoplication. The current recommended level is a contraction amplitude in the distal third of esophagus above the fifth percentile. We hypothesized that a more physiologic approach is to measure outflow resistance imposed by a fundoplication, which needs to be overcome by the esophageal contraction amplitude. STUDY DESIGN: The esophageal outflow resistance, as reflected by the intra-bolus pressure (iBP) measured 5 cm above the lower esophageal sphincter (LES), was measured in 53 normal subjects and 37 reflux patients with normal esophageal contraction amplitude, before and after a standardized Nissen fundoplication. All were free of postoperative dysphagia. A test population of 100 patients who had a Nissen fundoplication was used to validate the threshold of outflow resistance to avoid persistent postoperative dysphagia. RESULTS: The mean (SD) amplitude of the iBP in normal subjects was 6.8 (3.7) mmHg and in patients before fundoplication was 3.6 (7.0) mmHg (p = 0.003). After Nissen fundoplication, the mean (SD) amplitude of the iBP increased to 12.0 (3.2) mmHg (p < 0.0001 vs normal subjects or preoperative values). The 95th percentile value for iBP after a Nissen fundoplication was 20.0 mmHg and was exceeded by esophageal contraction in all patients in the validation population, and 97% of these patients were free of persistent postoperative dysphagia at a median 50-month follow-up. CONCLUSIONS: Nissen fundoplication increases the outflow resistance of the esophagus and should be constructed to avoid an iBP > 20 mmHg. Patients whose distal third esophageal contraction amplitude is >20 mmHg have a minimal risk of dysphagia after a tension-free Nissen fundoplication.

Endoscopic Closure of Gastro-gastric Fistula After Gastric Bypass: a Technically Feasible Procedure but Associated with Low Success Rate.

BACKGROUND: Gastro-gastric fistulas (GGF) are reported to be as high as 12% after gastric bypass for treatment of morbid obesity. While different endoscopic methods are described, the management traditionally consists of surgical revision with high associated morbidity. The aim of the study was to assess feasibility, safety and success rate of endoscopic closure using an endoscopic suturing device. METHODS: From January 2016 to March 2018, we reviewed the electronic records of all patients undergoing endoscopic closure of a GGF with the Apollo Overstitch system (Apollo Endosurgery, Austin, Texas, USA). Demographic details, procedure details, and outcome variables were recorded. RESULTS: A total of six patients (M:F = 5:1) underwent endoscopic fistula closure. Five patients (83.3%) had a prior banded gastric bypass (with subsequent band removal). The median number of prior abdominal surgeries was 3, the mean time from bypass to endoscopic fistula closure was 5 years (range 1.1-10.4). While immediate complete endoscopic fistula closure was possible in 10 of 12 attempts in those six patients (83%), all patients had recurrent (persistent) fistulas at follow-up. After a mean follow-up time of 12 months, 83.3% had further laparoscopic converted to open (n = 2) or laparoscopic (n = 3) revisions with complete fistula closure. One patient is refusing further intervention. CONCLUSION: Endoscopic gastro-gastric fistula closure with an endoscopic suturing device is feasible and safe. Unfortunately, due to the nature of gastro-gastric fistulas, permanent successful closure is rare. Therefore, the approach should be reserved for patients in whom a laparoscopic or open surgical attempt is impossible due to prior abdominal revisions.

Endoscopic Gastrojejunal Revisions Following Gastric Bypass: Lessons Learned in More Than 100 Consecutive Patients.

BACKGROUND: Weight regain and dumping after Roux-en-Y gastric bypass (RYGB) are long-term challenges thought to be due to dilation of the gastrojejunal anastomosis. The aim of this study was to analyze the feasibility, safety, and outcomes of endoscopic gastrojejunal revisions (EGRs) after its introduction in a tertiary bariatric surgery center. METHODS: From January 2016 to March 2018, we reviewed the electronic records of all patients undergoing EGR with the OverStitch suturing device. Demographics, procedure details, and outcomes were recorded. RESULTS: There were 107 patients (M:F = 29:78) treated with 133 EGR procedures for weight regain (n = 81), dumping syndrome (n = 13), or both (n = 13) with mean age 47.3 years (R 22.0-72.9) and mean BMI 32.9 kg/m2 (R 22.2-49.8) at time of procedure. Mean procedure time was 17.8 min (R 12-41), with median 1 suture used (R 1-2). No intra-operative or 30-day complications were recorded. Mean follow-up time was 9.2 months (R 1-26.8). Patients lost a mean of 4.1, 5.8, and 8.0 kg at 3, 6, and 12 months, respectively, after the procedure. Weight loss outcomes were significantly better when two compared to one suture was used (p = 0.036), and for patients with higher starting BMI (p = 0.047). For patients with dumping syndrome, 90-100% had treatment response after one or two EGRs. CONCLUSION: EGR is feasible and safe for weight regain and dumping syndrome after RYGB. It can stabilize weight regain and improve dumping symptoms. Around 20% of patients will need repeat EGR within 1 year to achieve sufficient narrowing of the anastomosis.

Hiatal hernia recurrence following magnetic sphincter augmentation and posterior cruroplasty: intermediate-term outcomes.

BACKGROUND: We have previously reported short-term outcomes after hiatal hernia repair (HHR) at the time of magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease (GERD). Here we report intermediate-term outcomes and hernia recurrence rate after concomitant MSA and HHR. METHODS: This is a retrospective cohort study of patients who underwent repair of a hiatal hernia 3 cm or larger at the time of MSA implantation between May 2009 and December 2015. The primary endpoint was hiatal hernia recurrence identified by routine postoperative videoesophagography or endoscopy. Recurrence was defined by a 2 cm or greater upward displacement of the stomach through the diaphragmatic esophageal hiatus. Secondary endpoints included cessation of proton-pump inhibitor (PPI), persistent dysphagia requiring intervention, and GERD health-related quality-of-life (HRQL) scores 1 year from surgery. RESULTS: During the study period, 47 of 53 (89%) patients underwent concomitant MSA with HHR and complied with surveillance. Hiatal hernias ranged from 3 to 7 cm (mean 4 ± 1). Mean clinical follow-up time was 19 months (range 1-39). GERD-HRQL score decreased from 20.3 to 3.1 (p < .001), 89% of patients remained off PPIs, and 97% of patients reported improvement or resolution of symptoms. Two recurrent hiatal hernias were identified on surveillance imaging for a recurrence rate of 4.3% at a mean 18 (± 10) months after initial operation. Persistent dysphagia occurred in 13% (6/47) over the first year, which resolved after a single balloon dilation in 67% (4/6). Two patients elected for device removal due to dilation-refractory dysphagia and persistent reflux symptoms. CONCLUSION: Concomitant magnetic sphincter augmentation and hiatal hernia repair in patients with gastroesophageal reflux disease and a moderate-sized hiatal hernia demonstrates durable subjective reflux control and an acceptable hiatal hernia recurrence rate at 1- to 2-year follow-up.

Esophageal adenocarcinoma stage III: Survival based on pathological response to neoadjuvant treatment.

BACKGROUND: Neoadjuvant chemoradiotherapy is the standard treatment for locally advanced esophageal adenocarcinomas (EAC). Pathological response is thought to be a major prognostic factor. Aims of this study were to determine the frequency of complete response and to compare the survival of complete and incomplete responders in stage III EAC. METHODS: A retrospective review was performed of all stage III patients that underwent neoadjuvant therapy followed by esophagectomy between 1999 and 2015. Patients were classified into complete (pCR) versus incomplete responders (pIR). RESULTS: 110 patients were included. Neoadjuvant chemotherapy was applied in 25 (23%) and chemoradiotherapy in 85 (77%) patients. Pathologic response was complete in 25% (n = 27) and was more common after chemoradiotherapy. Mean F/U interval was 36 months (0.3-173). There was a significant difference in the overall survival between complete and incomplete responders (p = 0.036). Median survival in the pIR group was 24.4 months and the median survival was not reached during the observation time in pCR. The 3-year-survival-rate was 70% in pCR and 40% in pIR (p = 0.01). Positive lymph nodes (ypN+) were present in 56 patients (51%). The 3-year-survival-rate was 59% in pIR with ypN0 and 29% in pIR with ypN+ (p = 0.005). CONCLUSIONS: Complete response to neoadjuvant therapy has a significantly better overall and 3-year-survival after esophagectomy than incomplete response. In incomplete responders, residual lymph node disease was associated with a significantly worse survival. These findings suggest that the degree of pathologic response and lymph node status are major prognostic factors for survival in EAC patients with stage III disease.

Efficacy of magnetic sphincter augmentation in patients with large hiatal hernias.

BACKGROUND: Magnetic sphincter augmentation (MSA) has demonstrated long-term safety and efficacy in the treatment of patients with gastroesophageal reflux (GERD), but its efficacy in patients with large hiatal hernias has yet to be proven. The aim of our study was to assess outcomes of MSA in patients with hiatal hernias ≥3 cm. METHODS: We retrospectively reviewed all patients who underwent MSA at our institutions over a 6-year period. Information obtained consisted of patient demographics, symptoms of GERD, preoperative GERD Health-Related Quality-of-Life (HRQL) scores, perioperative details, and implantation of the MSA device. Primary endpoints included postoperative GERD-HRQL scores, proton-pump inhibitor (PPI) use, symptom change, and procedure-related complications. A large hiatal hernia was defined as a hernia measuring ≥3 cm by intraoperative measurement. RESULTS: A total of 192 patients were reviewed. Median follow-up was 20 months (3-75 months). Mean GERD-HRQL scores in the overall population before and after MSA were 18.9 and 5.0, respectively (p < 0.001). In the majority of patients symptoms improved or resolved (N = 177, p < 0.001). Fifty-two patients (27.0 %) had a hiatal hernia ≥3 cm (range 3-7 cm). Their mean GERD-HRQL score decreased from 20.5 to 3.6 (p < 0.001) following MSA. When compared to patients with smaller hernias, patients with large hiatal hernias had decreased postoperative PPI requirement (9.6 vs. 26.6 %, p = 0.011) and lower mean postoperative GERD-HRQL scores (3.6 vs. 5.6, p = 0.027). The percent of patients requiring postoperative intervention for dysphagia was similar (13.5 vs. 17.9 %, p = 0.522), as was the incidence of symptom resolution or improvement (98.1 vs. 91.3 %, p = 0.118). CONCLUSION: MSA in patients with large hiatal hernias demonstrates decreased postoperative PPI requirement and mean GERD-HRQL scores compared to patients with smaller hernias. The incidence of symptom resolution or improvement and the percentage of patients requiring intervention for dysphagia are similar. Short-term outcomes of MSA are encouraging in patients with gastroesophageal reflux disease and large hiatal hernias.

Gastric cancer in the young: An advanced disease with poor prognostic features.

BACKGROUND AND OBJECTIVES: Gastric cancer in young patients is rare. We analyzed the clinicopathological features and prognosis of early-onset gastric carcinoma. METHODS: We retrospectively reviewed patients with gastric adenocarcinoma aged ≤45 years and >45 years at our institution over a 17-year period. Clinicopathological features were compared and survival analysis was performed using Kaplan-Meier curves. RESULTS: A total of 121 patients with gastric carcinoma aged ≤45 years were identified. The young group (YG) had a higher incidence of stage III/IV disease (86.8% vs. 57.9%, P < 0.001), poorly-differentiated carcinoma (95.9% vs. 74.4%, P < 0.001), and signet-cell type tumor (88.4% vs. 32.2%, P < 0.001) relative to the older group (OG). The majority of tumors were in the middle third of the stomach in both groups (P = 0.108). Three-year survival in the YG was 87.1%, 32.2%, and 6.9% in stage I/II, III, and IV disease, respectively. Surgical intervention in young patients with advanced carcinoma was not associated with improved survival. Although median survival was shorter in the YG compared to the OG (11.7 vs. 41.0 months, P < 0.001), stage-specific survival was similar. CONCLUSION: Early-onset gastric cancer demonstrates advanced stage of disease, and a high incidence of poorly-differentiated and signet-cell type carcinoma. Overall survival is poor with no added benefit to surgical intervention in advanced disease.

A Durable Laparoscopic Technique for the Repair of Large Paraesophageal Hernias.

Laparoscopic repair of large paraesophageal hernias has been challenging due to high recurrence rates with primary repair and complications associated with the use of nonabsorbable mesh to reinforce the hiatus. The aim of our study was to evaluate the recurrence rate over time and mesh-related complications using an absorbable polyglactin mesh secured with Bioglue to reinforce the hiatus after laparoscopic repair of large paraesophageal hernias. There were 190 patients who met inclusion criteria from June 2006 to June 2014. Follow-up was routinely performed at 1-year intervals, including endoscopy and/or video esophagram, and the gastroesophageal reflux disease health-related quality of life questionnaire. Mean follow-up was 21 months (3-88). There were no incidences of mesh erosion. Recurrence was detected in 17 patients (15.3%), with a median time to recurrence of 23 months (8-67). Recurrence rate was estimated with the Kaplan-Meier method to be 2.9 ± 1.6 per cent, 11.6 ± 3.7 per cent, 22.4 ± 5.6 per cent, 25.1 ± 6.0 per cent, and 29.5 ± 7.9 per cent at 12, 24, 36, 48, and 60 months, respectively. The mean gastroesophageal reflux disease health-related quality of life was 2 in patients both with and without recurrence. Laparoscopic intrathoracic stomach repair using absorbable polyglactin mesh and Bioglue for crural reinforcement is effective, safe, and durable. The rate of recurrence plateaus over time with the majority of recurrences being small to moderate asymptomatic hernias.

Intraoperative assessment of the effects of laparoscopic sleeve gastrectomy on the distensibility of the lower esophageal sphincter using impedance planimetry.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has emerged as an effective weight-loss procedure for morbid obesity that is also effective for treating comorbidities such as diabetes. However, it has been associated with the development of GERD postoperatively. The pathophysiology of post-LSG GERD is unknown, and current studies have shown conflicting results. The aim of our study is to shed light on this issue by investigating the effect of LSG on the lower esophageal sphincter (LES) function and the relationship of LES function to GERD symptoms. METHODS: A prospective study of patients undergoing LSG from 10/2013 to 8/2014 at a single academic tertiary referral center was carried out. Patients undergoing a concomitant procedure such as hiatal hernia repair or laparoscopic gastric band removal were excluded. Distensibility of the LES was measured after pneumoperitoneum and after LSG. Baseline GERD-HRQL was obtained with follow-up GERD-HRQL and weight at 3 and 6 months. The primary outcomes measured were LES distensibility and GERD-HRQL scores after LSG. Our secondary outcome was a correlation between LES distensibility and GERD-HRQL scores after LSG. RESULTS: Fifteen subjects were enrolled (5M/10F). Mean age was 51 years (30-71 years), and mean BMI 45 kg/m2 (30-58). We were able to obtain follow-up data for all patients at 3 months. Mean LES distensibility increased from 1.2 before LSG to 2.2 after LSG (p = 0.017). Median GERD-HRQL was 0 before LSG and remained essentially negative at 1 and 0 (3 and 6 months postoperatively, respectively). Three (27 %) of the patients had de novo GERD at 3 months following LSG. One (25 %) patient had remission of GERD. There was no correlation between LES distensibility and GERD symptoms. CONCLUSION: While LSG weakens the LES immediately, it does not predictably affect postoperative GERD symptoms; therefore, distensibility is not the only factor affecting development of postoperative GERD, confirming the multifactorial nature of post-LSG GERD.

Charges, outcomes, and complications: a comparison of magnetic sphincter augmentation versus laparoscopic Nissen fundoplication for the treatment of GERD.

BACKGROUND: Magnetic sphincter augmentation (MSA) is approved for uncomplicated GERD. Multiple studies have shown MSA to compare favorably to laparoscopic Nissen fundoplication (LNF) in terms of symptom control with results out to 5 years. The MSA device itself, however, is an added cost to an anti-reflux surgery, and direct cost comparison studies have not been done between MSA and LNF. The aim of the study was to compare charges, complications, and outcome of MSA versus LNF at 1 year. METHODS: This is a retrospective analysis of all patients who underwent MSA or LNF for the treatment of GERD between January 2010 and June 2013. Patient charges were collected for the surgical admission. We also collected data on 30-day complications and symptom control at 1 year assessed by GERD-HRQL score and PPI use. RESULTS: There were 119 patients included in the study, 52 MSA and 67 LNF. There was no significant difference between the mean charges for MSA and LNF ($48,491 vs. $50,111, p = 0.506). There were significant differences in OR time (66 min MSA vs. 82 min LNF, p < 0.01) and LOS (17 h MSA vs. 38 h LNF, p < 0.01). At 1-year follow-up, mean GERD-HRQL was 4.3 for MSA versus 5.1 for LNF (p = 0.47) and 85 % of MSA patients versus 92 % of LNF patients were free from PPIs (p = 0.37). MSA patients reported less gas bloat symptoms (23 vs. 53 %, p ≤ 0.01) and inability to belch (10 vs. 36 %, p ≤ 0.01) and vomit (4 vs. 19 %, p ≤ 0.01). CONCLUSION: The side effect profile of MSA is better than LNF as evidenced by less gas bloat and increase ability to belch and vomit. LNF and MSA are comparable in symptom control, safety, and overall hospital charges. The charge for the MSA device is offset by less charges in other categories as a result of the shorter operative time and LOS.

Multi-institutional outcomes using magnetic sphincter augmentation versus Nissen fundoplication for chronic gastroesophageal reflux disease.

BACKGROUND: Magnetic sphincter augmentation (MSA) has emerged as an alternative surgical treatment of gastroesophageal reflux disease (GERD). The safety and efficacy of MSA has been previously demonstrated, although adequate comparison to Nissen fundoplication (NF) is lacking, and required to validate the role of MSA in GERD management. METHODS: A multi-institutional retrospective cohort study of patients with GERD undergoing either MSA or NF. Comparisons were made at 1 year for the overall group and for a propensity-matched group. RESULTS: A total of 415 patients (201 MSA and 214 NF) underwent surgery. The groups were similar in age, gender, and GERD-HRQL scores but significantly different in preoperative obesity (32 vs. 40 %), dysphagia (27 vs. 39 %), DeMeester scores (34 vs. 39), presence of microscopic Barrett's (18 vs. 31 %) and hiatal hernia (55 vs. 69 %). At a minimum of 1-year follow-up, 354 patients (169 MSA and 185 NF) had significant improvement in GERD-HRQL scores (pre to post: 21-3 and 19-4). MSA patients had greater ability to belch (96 vs. 69 %) and vomit (95 vs. 43 %) with less gas bloat (47 vs. 59 %). Propensity-matched cases showed similar GERD-HRQL scores and the differences in ability to belch or vomit, and gas bloat persisted in favor of MSA. Mild dysphagia was higher for MSA (44 vs. 32 %). Resumption of daily PPIs was higher for MSA (24 vs. 12, p = 0.02) with similar patient-reported satisfaction rates. CONCLUSIONS: MSA for uncomplicated GERD achieves similar improvements in quality of life and symptomatic relief, with fewer side effects, but lower PPI elimination rates when compared to propensity-matched NF cases. In appropriate candidates, MSA is a valid alternative surgical treatment for GERD management.

Three-dimensional Laparoscopy: Does Improved Visualization Decrease the Learning Curve Among Trainees in Advanced Procedures?

PURPOSE: Complex laparoscopy is difficult to master because it involves 3-dimensional (3D) interpretation on a 2-dimensional (2D) viewing screen. The use of 3D technology has an uncertain effect on training surgeons. We aim to evaluate the effectiveness of 3D on learning and performing laparoscopic tasks. METHODS: Medical students without laparoscopic experience (novices) were evaluated doing inanimate object transfer and laparoscopic suturing. Tasks were repeated using 2D and 3D cameras with standard instruments. Time and error rates (missed attempts, dropped objects, and failure to complete the task) were recorded. RESULTS: Twenty-nine novice medical students experienced a 45.5% decrease in the time to complete PEG transfer using 3D (mean 207 s with 2D vs. 113 s with 3D). Error rate was reduced to 50% (2D, 4 errors vs. 3D, 2 errors) and mean drop rate was reduced to 0. Similar decreases in suture time (46.5%) were seen (mean 403 s with 2D vs. 220 s with 3D). CONCLUSIONS: Our results indicate that 3D significantly improved visualization and ability to perform complex tasks in the skills laboratory setting. This technology may be very effective in teaching advanced laparoscopic skills in the era of work-hour restrictions.