Cost-effectiveness of the RefluxStop device for management of refractory gastroesophageal reflux disease in Switzerland.

Introduction: One of the most prevalent conditions in Western societies is gastroesophageal reflux disease (GERD). In Switzerland, the standard treatment for GERD is proton pump inhibitor (PPI)-based medical management, but surgical options such as Nissen fundoplication and the MSA system are available. RefluxStop is a novel device that offers an alternative solution. The purpose of this report is to evaluate the cost-effectiveness of RefluxStop compared to PPIs and existing surgical treatments.Methods: A model (Markov) was developed using the Swiss healthcare payer perspective with a lifetime horizon, one-month cycle length, and a 3% annual discount rate for costs and benefits. Adverse events specific to treatment arms were incorporated, and benefits were measured in quality-adjusted life-years (QALYs). Clinical efficacy data for RefluxStop was obtained from its CE mark study, and comparator treatments were based on published literature. Deterministic and probabilistic sensitivity analyses were used to explore uncertainty. Since there are no head-to-head studies between RefluxStop and PPI therapy, Nissen fundoplication, or MSA, a limitation of this study is the use of naïve, indirect comparison of clinical effectiveness between the studied treatment options.Results: Higher QALYs and lower costs were provided by RefluxStop compared to Nissen fundoplication and the LINX system. The incremental cost-effectiveness ratio (ICER) for RefluxStop was CHF 2,116 in comparison to PPI-based medical management. At a cost-effectiveness threshold of CHF 100,000 per QALY gained, the probability of RefluxStop being cost-effective was high, with probabilities of 100%, 97%, and 100% against PPI-based medical management, Nissen fundoplication, and MSA, respectively. Robustness of the analysis was provided by deterministic and probabilistic sensitivity analyses.Conclusion: This cost-effectiveness analysis demonstrates that there is a high likelihood of RefluxStop being a cost-effective treatment modality in adults with GERD when compared with other treatment options available in Switzerland.

Gastroesophageal reflux disease (GERD) is one of the most prevalent conditions in Western societies. Standard treatment in Switzerland entails proton pump inhibitor (PPI)-based medical management or surgical options (i.e., Nissen fundoplication and magnetic sphincter augmentation [MSA]) in selected cases. RefluxStop is a new technology indicated for the surgical treatment of GERD that restores the normal anatomy of the anti-reflux barrier. The clinical benefits and monetary costs of RefluxStop must be weighed against available treatment options to determine the role of this new technology in Switzerland. Cost-effectiveness analyses compare the relative costs and clinical outcomes of disease management when pursuing different paths in the patient journey landscape, as measured by quality-adjusted life-years (QALYs). In the present study, RefluxStop in comparison to Nissen fundoplication, and MSA, provided higher QALYs and lower costs. Against PPI therapy, the costs were slightly higher but the QALYs were also higher, generating a favourable Incremental cost-effectiveness ratio. Furthermore, at the cost-effectiveness threshold of CHF 100,000 per QALY gained, RefluxStop was highly likely to be cost-effective in comparison to PPI therapy, Nissen fundoplication, and MSA with probabilities of 100%, 97%, and 100%, respectively. Ultimately, this cost-effectiveness analysis showed that RefluxStop has a high likelihood of cost-effectiveness as a GERD treatment in Switzerland against other treatment options, with results being robust even with uncertainties considered in additional sensitivity analyses.

Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial.

Importance: Venous thromboembolism (VTE) is a leading cause of morbidity and mortality after bariatric surgery. Clinical end point studies on thromboprophylaxis with direct oral anticoagulants in patients undergoing bariatric surgery are lacking. Objective: To assess the efficacy and safety of a prophylactic dose of 10 mg/d of rivaroxaban for both 7 and 28 days after bariatric surgery. Design, Setting, and Participants: This assessor-blinded, phase 2, multicenter randomized clinical trial was conducted from July 1, 2018, through June 30, 2021, with participants from 3 academic and nonacademic hospitals in Switzerland. Intervention: Patients were randomized 1 day after bariatric surgery to 10 mg of oral rivaroxaban for either 7 days (short prophylaxis) or 28 days (long prophylaxis). Main Outcomes and Measures: The primary efficacy outcome was the composite of deep vein thrombosis (symptomatic or asymptomatic) and pulmonary embolism within 28 days after bariatric surgery. Main safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and mortality. Results: Of 300 patients, 272 (mean [SD] age, 40.0 [12.1] years; 216 women [80.3%]; mean body mass index, 42.2) were randomized; 134 received a 7-day and 135 a 28-day VTE prophylaxis course with rivaroxaban. Only 1 thromboembolic event (0.4%) occurred (asymptomatic thrombosis in a patient undergoing sleeve gastrectomy with extended prophylaxis). Major or clinically relevant nonmajor bleeding events were observed in 5 patients (1.9%): 2 in the short prophylaxis group and 3 in the long prophylaxis group. Clinically nonsignificant bleeding events were observed in 10 patients (3.7%): 3 in the short prophylaxis arm and 7 in the long prophylaxis arm. Conclusions and Relevance: In this randomized clinical trial, once-daily VTE prophylaxis with 10 mg of rivaroxaban was effective and safe in the early postoperative phase after bariatric surgery in both the short and long prophylaxis groups. Trial Registration: ClinicalTrials.gov Identifier: NCT03522259.

Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Once Daily Empagliflozin 25 mg for the Treatment of Postprandial Hypoglycemia After Roux-en-Y Gastric Bypass.

Aims: To investigate the effect of empagliflozin on glucose dynamics in individuals suffering from postbariatric hypoglycemia (PBH) after Roux-en-Y gastric bypass (RYGB). Methods: Twenty-two adults with PBH after RYGB were randomized to empagliflozin 25 mg or placebo once daily over 20 days in a randomized, double-blind, placebo-controlled, crossover trial. The primary efficacy outcome was the amplitude of plasma glucose excursion (peak to nadir) during a mixed-meal tolerance test (MMTT). Outcomes of the outpatient period were assessed using continuous glucose monitoring (CGM) and an event-tracking app. Results: The amplitude of glucose excursion during the MMTT was 8.1 ± 2.4 mmol/L with empagliflozin versus 8.1 ± 2.6 mmol/L with placebo (mean ± standard deviation, P = 0.807). CGM-based mean amplitude of glucose excursion during the 20-day period was lower with empagliflozin than placebo (4.8 ± 1.3 vs. 5.2 ± 1.6. P = 0.028). Empagliflozin reduced the time spent with CGM values >10.0 mmol/L (3.8 ± 3.5% vs. 4.7 ± 3.8%, P = 0.009), but not the time spent with CGM values <3.0 mmol/L (1.7 ± 1.6% vs. 1.5 ± 1.5%, P = 0.457). No significant difference was observed in the quantity and quality of recorded symptoms. Eleven adverse events occurred with empagliflozin (three drug-related) and six with placebo. Conclusions: Empagliflozin 25 mg reduces glucose excursions but not hypoglycemia in individuals with PBH. Clinical Trial Registration: Clinicaltrials.gov: NCT05057819.

Fostering physical activity-related health competence after bariatric surgery with a multimodal exercise programme: A randomised controlled trial.

Regular physical activity (PA) supports the long-term success of bariatric surgery. However, integrating health-enhancing physical activity in daily life requires specific competences. In this study, we evaluated a multimodal exercise programme to build these competences.Forty adults who underwent bariatric surgery were randomised to a multimodal exercise programme or control group. Primary outcomes were the facets of PA-related health competences, namely the control competence for physical training, PA-specific affect regulation, motivational competence and PA-specific self-control. Secondary outcomes were PA behaviour and subjective vitality. Outcomes were assessed before, directly after the intervention and at 3 months follow-up.Significant treatment effects were found for control competence for physical training and PA-specific self-control but not for PA-specific affect regulation and motivational competence. Significant treatment effects were further observed for self-reported exercise and subjective vitality, all in favour of the intervention group. In contrast, no treatment effect was found for device-based PA. Overall, this study provides a foundation for future research to optimise long-term post bariatric surgery outcomes.

Insufficient weight loss after banded vs. non-banded primary gastric bypass surgery: insights from an observational 5 year follow-up study.

BACKGROUND: While Roux-en-Y gastric bypass (RYGB) is effective in achieving weight loss and improving obesity-related co-morbidities, insufficient weight loss in the long-term can occur. The goal was to assess whether banded vs. non-banded RYGB reduces the risk of insufficient weight loss at 5-year follow-up. METHODS: This is a retrospective single-center cohort study from Switzerland. We assessed the 5-year metabolic trajectories in terms of body weight, body mass index, glucose control, lipid profile and blood pressure of two surgical cohorts undergoing identical RYGB procedures with or without banding using a uniform 6.5 cm silastic Fobi band. Insufficient weight loss was defined as < 50% excess weight loss (EWL) at 5 years. RESULTS: A total of 55 patients receiving banded (Fobi) and 55 patients receiving non-banded (non-Fobi) RYGB were included in the analysis. 5-year follow-up was 91% for both groups. Percentage of EWL at 5 years was 78.11 ± 26.1% and 73.5 ± 27%.3 for the Fobi vs. non-Fobi group (p = 0.368), respectively. Insufficient weight loss (defined as < 50%EWL) at 5 years or last follow-up was significantly higher in the non-Fobi group compared to the Fobi group (19/55 vs. 9/55, respectively, OR = 2.639 (95% CI 1.066, 6.531), p = 0.036). Surrogate markers for cardiometabolic outcomes consistently improved over time, without differences between the groups. During the follow-up period, Fobi-removal was necessary in nine patients (16.3%). CONCLUSION: Banded-RYGB lowered the odds of insufficient weight loss at 5 years follow-up by approximately 62%. Further research is needed to explore the effect of restriction on eating behaviour and neuroendocrine responses after RYGB.

The impact of postbariatric hypoglycaemia on driving performance: A randomized, single-blind, two-period, crossover study in a driving simulator.

Postbariatric hypoglycaemia (PBH) is an increasingly recognized complication of bariatric surgery, but its effect on daily functioning remains unclear. In this randomized, single-blind, crossover trial we assessed driving performance in patients with PBH. Ten active drivers with PBH (eight females, age 38.2 ± 14.7 years, body mass index 27.2 ± 4.6 kg/m2 ) received 75 g glucose to induce PBH in the late postprandial period and aspartame to leave glycaemia unchanged, on two different occasions. A simulator was driven during 10 minutes before (D0) and 20 (D1), 80 (D2), 125 (D3) and 140 minutes (D4) after the glucose/aspartame ingestion, reflecting the expected blood glucose (BG) increase (D1), decrease (D2) and hypoglycaemia (D3, D4). Seven driving features indicating impaired driving were integrated in a Bayesian hierarchical regression model to assess the difference in driving performance after glucose/aspartame ingestion. Mean ± standard deviation peak and nadir BG after glucose were 182 ± 24 and 47 ± 14 mg/dL, while BG was stable after aspartame (85 ± 4 mg/dL). Despite the lack of a difference in symptom perception, driving performance was significantly impaired after glucose versus aspartame during D4 (posterior probability 98.2%). Our findings suggest that PBH negatively affects driving performance.

Clinical outcome after laparoscopic Nissen fundoplication in patients with GERD and PPI refractory heartburn.

Typical reflux symptoms that respond well to proton pump inhibitor (PPI) therapy are key factors predictive of an excellent outcome with antireflux surgery for gastroesophageal reflux disease (GERD). Our aim was to evaluate whether poor preoperative heartburn (HB) relief with PPIs was associated with a worse outcome after Nissen fundoplication. Patients with a main symptom of HB and a positive pH-test who had a laparoscopic Nissen fundoplication between January 2008 and December 2014 were included. Prior to surgery, patients graded how effectively their HB symptoms were relieved by PPIs. Three groups were defined: good response (76-100% relief), partial response (26-75% relief) and poor response (0-25% relief). Outcomes and satisfaction were assessed at a minimum of 1 year after fundoplication. There were 129 patients who met inclusion criteria and 75 agreed to participate. The median follow-up was 48 months. Prior to Nissen fundoplication 13 patients had a good HB response to PPI-therapy, 36 had a partial response and 26 had a poor response. All patients were satisfied with their HB relief after fundoplication (mean satisfaction score: 9.5/10) and there was no difference in satisfaction score or heartburn relief between groups. Heartburn symptoms that respond poorly to PPI therapy are reliably relieved with a Nissen fundoplication in patients with objectively confirmed GERD. Patient satisfaction after Nissen fundoplication was excellent and was similar in patients with poor versus excellent HB relief with preoperative PPI therapy. Therefore, antireflux surgery is an option for patients with HB and confirmed GERD regardless of the degree of relief of HB symptoms provided by PPI medications.

Workload, Recurrence, Quality of Life and Long-term Efficacy of Endoscopic Therapy for High-grade Dysplasia and Intramucosal Esophageal Adenocarcinoma.

OBJECTIVE: To review the workload, type and frequency of recurrence, long-term quality of life (QOL), and late oncologic outcomes with endoscopic therapy. BACKGROUND: The short-term oncologic efficacy of endoscopic resection (ER) and ablation for patients with high-grade dysplasia (HGD) or intramucosal adenocarcinoma (IMC) is well-established in the literature. METHODS: A retrospective chart review was performed of the initial 40 patients who had endoscopic therapy from 2001 to 2010 at 1 center by 1 physician. RESULTS: Initial pathology was HGD in 22 and IMC in 18 patients, but 9 patients (41%) with HGD progressed to invasive cancer during endotherapy. The median follow-up was 82 months. Four patients had an esophagectomy, and in the remaining 36 patients, 70 ERs and 111 ablations were performed. The median number of endoscopic sessions was 4 in patients with short segment compared with 7 in patients with long-segment Barrett's. Complete resolution of intestinal metaplasia (CRIM) was achieved in 30 patients (83%) at a median of 21 months. In 18 patients (60%), CRIM was maintained, whereas 12 patients developed recurrence at a median of 14 months. Additional endotherapy (n = 11) led to CRIM again in 10 patients (83%). There were no cancer deaths when CRIM was achieved. Overall survival with endotherapy was 73% at 5 years and 67% at 10 years. Quality of life (QOL) was below population means in 4 of 8 areas, but alimentary satisfaction was good after endotherapy. CONCLUSIONS: Endotherapy is successful in most patients, but multiple sessions are usually required and disease progression can occur. Once CRIM is achieved, recurrence is common and mandates continued endoscopic follow-up. QOL is impaired with endotherapy, but alimentary satisfaction and oncologic outcomes support esophageal preservation with endotherapy for patients with HGD or IMC.

Long-term outcomes and frequency of reoperative bariatric surgery beyond 15 years after gastric banding: a high band failure rate with safe revisions.

BACKGROUND: Laparoscopic adjustable gastric band (LAGB) has had encouraging early results. However, intermediate and late results were discouraging, and LAGB is presently being replaced by stapled procedures. There is still ongoing debate whether LAGB should be abandoned altogether. OBJECTIVE: To present our outcomes beyond 15-year follow-up after LAGB. SETTING: Private hospital, Bern, Switzerland. METHODS: This is a retrospective review of patients receiving LAGB between 1997 and 2002 with minimum 15-year follow-up. Patient characteristics, co-morbidities, reoperative bariatric surgery (RBS), and weight trends were analyzed. RESULTS: A total of 387 LAGB patients were identified. Of them, 342 (88.4%) had a minimum of 15 years of follow-up (range, 15-21 yr). There were 270 (78.9%) women with a mean age of 40.3 years (range, 15-62 yr) and body mass index (BMI) of 43.1 kg/m2 (range, 30.0-60.1 kg/m2) and 72 (21.1%) men with a mean age of 41.2 years (range, 16-61 yr) and BMI of 43.6 kg/m2 (range, 33.0-72.5 kg/m2). During follow-up, 283 (82.7%) patients underwent a mean of 3.3 reoperative bariatric operations (range, 1-5), with 224 (65.5%) converted to Roux-en-Y gastric bypass (RYGB). At the end of the study period, 96 (28%) patients still had a band in place. No deaths were recorded. At most recent follow-up after LAGB, mean excess BMI loss was 65.4% (range, -9.4% to 134.5%) with significant decrease in co-morbidities. CONCLUSIONS: Only 28% of patients had sufficient weight loss outcomes after LAGB alone and predictive selection criteria are lacking. The majority of LAGB operations fail even with close structured follow-up. RBS can be performed safely.

Post-Nissen Dysphagia and Bloating Syndrome: Outcomes After Conversion to Toupet Fundoplication.

INTRODUCTION: Protracted dysphagia and bloating are potential troublesome side effects following Nissen fundoplication. The aim of this study was to evaluate the effects of conversion from Nissen to Toupet on dysphagia and bloating. METHODS: The study used a retrospective chart review of all patients who had undergone conversion from Nissen to Toupet between 2001 and 2014. Endpoints were to determine the effect of conversion on dysphagia, bloating, and reflux control. RESULTS: Twenty-five patients underwent conversion at a median of 3.7 years (1.4-10.5) after initial fundoplication. Indications were dysphagia in 19 (76%) and bloating syndrome in 6 (24%) patients. The median operative time was 104 min (86-146). There were no serious complications or mortality. Median follow-up was 27 months (0.8-130). Dysphagia was relieved in 16 (84%) and bloating in all 6 patients. Two patients developed reflux requiring a redo-Nissen. Two patients had persistent dysphagia and required endoscopic dilation. The GERD-HRQL post-conversion showed a median score of 5 (3-13). CONCLUSIONS: Conversion relieved dysphagia in 84% and bloating in 100%. Significant recurrence of GERD was rare. Given the absence of serious complications, conversion should be considered in patients with severe bloating or dysphagia.

Intraoperative Assessment of Perfusion of the Gastric Graft and Correlation With Anastomotic Leaks After Esophagectomy.

OBJECTIVE: The aim of the study was to evaluate laser-assisted fluorescent-dye angiography (LAA) to assess perfusion in the gastric graft and to correlate perfusion with subsequent anastomotic leak. BACKGROUND: Anastomotic leaks are a major source of morbidity after esophagectomy with gastric pull-up (GPU). In large part, they occur as a consequence of poor perfusion in the gastric graft. METHODS: Real-time intraoperative perfusion was assessed using LAA before bringing the graft up through the mediastinum. When there was a transition from rapid and bright to slow and less robust perfusion, this site was marked with a suture. The location of the anastomosis relative to the suture was noted and the outcome of the anastomosis ascertained by retrospective record review. RESULTS: Intraoperative LAA was used to assess graft perfusion in 150 consecutive patients undergoing esophagectomy with planned GPU reconstruction. An esophagogastric anastomosis was performed in 144 patients. A leak was found in 24 patients (16.7%) and were significantly less likely when the anastomosis was placed in an area of good perfusion compared with when the anastomosis was placed in an area of less robust perfusion by LAA (2% vs 45%, P < 0.0001). By multivariate analysis perfusion at the site of the anastomosis was the only significant factor associated with a leak. CONCLUSIONS: Intraoperative real-time assessment of perfusion with LAA correlated with the likelihood of an anastomotic leak and confirmed the critical relationship between good perfusion and anastomotic healing. The use of LAA may contribute to reduced anastomotic morbidity.

Laparoscopic wedge fundectomy for collis gastroplasty creation in patients with a foreshortened esophagus.

OBJECTIVE: To assess the outcome of a laparoscopic wedge-fundectomy Collis gastroplasty for a short esophagus during fundoplication and hiatal hernia repair. BACKGROUND: The Collis gastroplasty provides a surgical solution for a foreshortened esophagus but has been associated with postoperative dysphagia and esophagitis. METHODS: We identified 150 patients who underwent a Collis gastroplasty from 1998 to 2012, and of these, 85 patients underwent laparoscopic procedures using the wedge-fundectomy technique. RESULTS: The median age of the 85 patients (42 men/43 women) was 66 years (range, 37-84 years). A Nissen fundoplication was added to the Collis gastroplasty in 56 patients (66%) and a Toupet fundoplication in 29 patients. No patient had a staple line leak or abscess, and the median hospital stay was 3.5 days (interquartile range, 3-4.5 days). At a median follow-up of 12 months, 93% of patients were free of heartburn. Dysphagia was significantly less common after surgery (preoperative: 58% vs postoperative: 16%; P < 0.0001). New-onset dysphagia developed in only 2 patients. An upper endoscopy was performed in 54 patients at a median of 6 months after surgery, and erosions above the fundoplication were seen in 6 patients (11%). A small (1-2 cm) recurrent hernia was seen in 2 patients (2.4%). CONCLUSIONS: The laparoscopic wedge-fundectomy Collis gastroplasty can be performed safely and is associated with a low prevalence of new-onset dysphagia and esophagitis. The addition of a Collis gastroplasty to an antireflux operation is an effective strategy in patients with short esophagus, and its more liberal use is encouraged.

Laparoscopic versus open repair of paraesophageal hernia: the second decade.

BACKGROUND: A decade ago we reported that laparoscopic repair of paraesophageal hernia (PEH) had an objective recurrence rate of 42% compared with 15% after open repair. Since that report we have modified our laparoscopic technique. The aim of this study was to determine if these modifications have reduced the rate of objective hernia recurrence. STUDY DESIGN: We retrospectively identified all patients that had primary repair of a PEH with ≥ 50% of the stomach in the chest from May 1998 to January 2010 with objective follow-up by videoesophagram. The finding of any size of hernia was considered to be recurrence. RESULTS: There were 73 laparoscopic and 73 open PEH repairs that met the study criteria. There were no significant differences in gender, body mass index, or prevalence of a comorbid condition between groups. The median follow-up was similar (12 months laparoscopic versus 16 months open; p = 0.11). In the laparoscopic group, 84% of patients had absorbable mesh reinforcement of the crural closure and 40% had a Collis gastroplasty, compared with 32% and 26%, respectively, in the open group. A recurrent hernia was identified in 27 patients (18%), 9 after laparoscopic repair and 18 after open repair (p = 0.09). The median size of a recurrent hernia was 3 cm, and the incidence of recurrence increased yearly in those with serial follow-up with no early peak or late plateau. CONCLUSIONS: In our first decade of laparoscopic PEH repair, no mesh crural reinforcement was used, and no patient had a Collis gastroplasty. Evolution in the technique of laparoscopic PEH repair during the subsequent decade has reduced the hernia recurrence rate to that seen with an open approach. Reduced morbidity and shorter hospital stay make laparoscopy the preferred approach, but continued efforts to reduce hernia recurrence are warranted.

Endoscopic resection and ablation versus esophagectomy for high-grade dysplasia and intramucosal adenocarcinoma.

BACKGROUND: Esophagectomy has been the traditional therapy for high-grade dysplasia and intramucosal adenocarcinoma. New endoscopic approaches allow treatment of these lesions with esophageal preservation. The aim of this study was to compare the outcome of endoscopic therapy with esophagectomy for high-grade dysplasia and intramucosal cancer. METHODS: A retrospective review was performed of all patients treated for high-grade dysplasia or intramucosal adenocarcinoma from 2001 to April 2010. RESULTS: Endoscopic therapy was performed in 40 patients (high-grade dysplasia = 22, intramucosal cancer = 18) and esophagectomy in 61 patients (high-grade dysplasia = 13, intramucosal cancer = 48). Endotherapy consisted of 102 endoscopic resections and 79 mucosal ablations (median 3 interventions per patient). In the endotherapy group, intramucosal cancer was completely resected in all patients. At last assessment, 10 patients have been converted to intestinal metaplasia without dysplasia and 21 to no residual intestinal metaplasia. Five patients have follow-up biopsy procedures pending after recent ablation, and esophagectomy was performed in 3 patients for failed endotherapy. A laparoscopic Nissen fundoplication has been performed in 8 patients after eradication of intestinal metaplasia. Esophagectomy resected the mucosal disease with negative margins in all patients. Compared with esophagectomy, endotherapy was associated with significantly lower morbidity (39% vs 0; P < .0001) and similar survival (94% at 3 years in both groups; median follow-up 34 months after esophagectomy vs 17 months after endotherapy; P = .0026). CONCLUSIONS: Endoscopic therapy for high-grade dysplasia or intramucosal cancer has lower morbidity than an esophagectomy and similar survival during short-term follow-up, but required multiple procedures in most patients. Both therapies are appropriate options, but preservation of the esophagus allows the option of a fundoplication for reflux control, perhaps further improving long-term quality of life.

The prevalence of lymph node metastases in patients with T1 esophageal adenocarcinoma a retrospective review of esophagectomy specimens.

UNLABELLED: Knowledge of the risk of lymph node metastases is critical to planning therapy for T1 esophageal adenocarcinoma. This study retrospectively reviews 75 T1a and 51 T1b tumors and correlates lymph node metastases with depth of tumor invasion, tumor size, presence of lymphovascular invasion, and tumor grade. OBJECTIVES: Increasingly, patients with superficial esophageal adenocarcinoma are being treated endoscopically or with limited surgical resection techniques. Since no lymph nodes are removed with these therapies, it is critical to have a clear understanding of the risk of lymph node metastases in these patients. The aim of this study was to define the risk of lymph node metastases for intramucosal and submucosal (T1) esophageal adenocarcinoma and to analyze factors potentially associated with an increased risk of lymph node involvement. METHODS: We reanalyzed the pathology specimens of all patients that had primary esophagectomy for T1 adenocarcinoma of the distal esophagus or gastroesophageal junction from January 1985 to December 2008. The prevalence of lymph node metastases was correlated with tumor size, depth of invasion, presence of lymphovascular invasion, and degree of tumor differentiation. RESULTS: There were 126 patients, 102 men (81%) and 24 women (19%), with a mean age of 64 (± 10) years. Tumor invasion was limited to the mucosa (T1a) in 75 patients (60%), whereas submucosal invasion (T1b) was present in 51 patients (40%). Tumors that had poor differentiation, lymphovascular invasion, and size ≥2 cm were significantly more likely to be invasive into the submucosa. Lymph node metastases were rare (1.3%) with intramucosal tumors but increased significantly with submucosal tumor invasion (22%)[P = 0.0003]. Lymph node metastases were also significantly associated with poor differentiation (P = 0.0015), lymphovascular invasion (P < 0.0001), and tumor size ≥2 cm (P = 0.01). Division of the submucosa into thirds did not show a layer with a significantly decreased prevalence of node metastases. CONCLUSIONS: Adenocarcinoma invasive deeper than the muscularis mucosa is associated with a significant increase in the prevalence of lymph node metastases,and there is no "safe" level of invasion into the submucosa. Lymphovascular invasion, tumor size ≥2 cm, and poor differentiation are associated with an increased risk of submucosal invasion and lymph node metastases and should be factored into the decision for endoscopic therapy or esophagectomy

Conversion in laparoscopic cholecystectomy in low versus high-volume hospitals: is there a difference?

BACKGROUND: Contraindications to laparoscopic cholecystectomy (LC) have diminished over the last decade but still conversion rate is about 5% to 6% in elective cases and higher in acute cholecystitis. AIM: The aim of this study was to analyze whether the conversion rate is related to low (100 LC/y) versus high-volume hospitals (HVHs; >300 LC/y). METHODS: From 1999 to 2004, operations were performed in a low-volume hospital (LVH) and a HVH, divided into 3 groups: primary open cholecystectomy (OC), LC, and conversion (CC). These groups were analyzed with regard to indications, intraoperative findings, reason for conversion, and postoperative complications, and compared between the 2 hospitals. RESULTS: In LVHs of the 550 patients who underwent cholecystectomy, 19 were OC (3.5%). Of the 531 patients who were started with laparoscopy, 5.3% (28 patients) were CC. In HVHs of the 1634 patients who underwent cholecystectomy, 82 were OC (5%). Of the 1552 patients who were started with laparoscopy, 5.8% (85 patients) were CC; P=0.7496. Dense adhesions (LVH 35.8% and HVH 37.6%, P=0.8544), severe cholecystitis (LVH 39.8% and HVH 34%, P=0.6199), and difficulties with the anatomy in Calot's triangle (LVH 7.2% and HVH 8.2%, P=0.8531) were the main reasons for conversion. There was no difference in the postoperative complication rate and reoperation rate between a LVH and a HVH. CONCLUSIONS: There is no difference in conversion rate in LC in LVHs versus HVHs. The quality of LC and even CC is similar in LVH and HVH.

A simplified technique for intrathoracic stomach repair: laparoscopic fundoplication with Vicryl mesh and BioGlue crural reinforcement.

BACKGROUND: Laparoscopic repair of an intrathoracic stomach has been associated with a high recurrence rate. The use of biologic or synthetic mesh to reinforce the crural repair has been shown to reduce recurrence. This study aimed to assess a simplified technique for reinforcing the crural repair using absorbable Vicryl mesh secured with BioGlue during laparoscopic repair of an intrathoracic stomach. METHODS: The charts of all patients who underwent laparoscopic repair of an intrathoracic stomach from June 2006 to March 2009 using the described technique were retrospectively reviewed. Intrathoracic stomach was defined as more than 50% of the stomach herniated into the chest. Follow-up assessment was routinely performed 1 year or more after surgery and included endoscopy, video esophagram, Bravo 48-h pH monitoring, and a gastroesophageal reflux disease (GERD)-health-related quality-of-life (HRQL) questionnaire. RESULTS: A total of 35 patients (male:female = 10:25) with a mean age of 70 years (48-89 years) and a mean body mass index (BMI) of 30.4 kg/m(2) (20.4-44.8 kg/m(2)) underwent repair using this technique. The median operating time was 144 min (101-311 min), and the median hospital stay was 2 days (1-21 days). There were three conversions (8.6%) and one intraoperative complication (2.9%). Three patients (8.6%) experienced postoperative complications. No mesh-related complications occurred. Follow-up assessment 1 year or more after surgery was available for 21 of the 25 eligible patients [median follow-up period, 14 months (11-34 months)]. There were two recurrences (9.5%), one of them asymptomatic. The median GERD-HRQL score was 5 (2-28). Nearly all the patients (91.3%) were satisfied with the operation, and 96% would have it again. CONCLUSION: Vicryl mesh secured with BioGlue is a simple and easy method for reinforcing the crural closure during laparoscopic repair of an intrathoracic stomach. The recurrence rate at 1 year is low and comparable with that of other series using biologic mesh secured with sutures or tacks.

Treatment of Barrett's esophagus with high-grade dysplasia and intramucosal adenocarcinoma.

High-grade dysplasia and intramucosal adenocarcinoma are premalignant and malignant lesions of the esophagus. The incidence of lymphatic or systemic metastases is low and esophagectomy is curative in most patients. Until recently, complete removal of the neoplastic tissue was reliably accomplished with only esophagectomy. New technologies have been developed that allow endoscopic mucosal resection and ablation with preservation of the esophagus for these lesions. Optimal treatment of the patient requires consideration of not only the stage of the lesion but also the pathophysiology of the esophagus and the severity of the underlying reflux disease. Only with this approach can outcomes be optimized for both the dysplasia or cancer and the patient's reflux disease and long-term quality of life. In this article, we summarize the experience from a surgical center's perspective.

Lessons learned from the analysis of 200 laparoscopic sigmoid resections for diverticulitis.

INTRODUCTION: Since the beginning of laparoscopic surgery indications for laparoscopic colon resections are still discussed controversively. In the latest studies benefit for laparoscopic approach is reported. The aim of this study was to evaluate the feasibility of laparoscopic sigmoid resections for diverticulitis regarding conversion rate, operation time and intraoperative and postoperative complications, and defining strategies to prevent complications. METHODS: Out of a prospective database with all laparoscopic colon resection between May 1999 and January 2008 the patients with laparoscopic sigmoid resection for diverticulitis were analyzed. Preoperative diagnosis was made by abdominal computed tomography with irrigoscopy and/or endoscopy. Indications for laparoscopic sigmoid resections were diverticulitis as an early elective or elective operation and selected cases with perforated diverticulitis. RESULTS: Between May 1999 and January 2008, 200 patients (97 women, 103 men) were operated by laparoscopy for diverticulitis. Mean age at surgery was 59 years (range: 27 to 86); mean preoperative body mass index was 27.2 kg/m2 (range: 20 to 38). Mean operating time was 121 minutes (range: 60 to 239). Operating time was reduced due to experience and dropped from a mean of 150 minutes for the first 50 patients, 115 minutes for the second, 110 minutes for the third, and 107 minutes for the last 50 patients (P<0.05). Conversion rate was 1.5%, total morbidity rate was 19%, and reoperation rate was 6%. CONCLUSIONS: Laparoscopic sigmoid resections for diverticulitis can be performed with great safety and low conversion rate. Several adjustments in operation technique and perioperative management had to be done to achieve a complication rate and conversion rate at an acceptable low level.