A multicenter study of initial experience with single-incision robotic cholecystectomies (SIRC) demonstrating a high success rate in 465 cases.

BACKGROUND: Recently, the robotic single-site platform has been used to ameliorate the difficulties seen in single-incision laparoscopic surgery (SILC) while preserving the benefits of standard laparoscopic cholecystectomy. The purpose of this study is to describe the clinical outcomes of a large series of single-incision robotic cholecystectomy (SIRC). METHODS: Medical records of consecutive patients who underwent SIRC were retrospectively reviewed. All procedures were performed by six surgeons at five different North American centers involved in the study. All patients included in the study underwent a cholecystectomy attempted through single site at the umbilicus, using the da Vinci(®) Surgical System (Intuitive Surgical Inc. Sunnyvale, CA). RESULTS: A total of 465 patients met study criteria. Median age was 48 years (range 18-89); 351 (75.5 %) were female and 304 (66.4 %) were overweight or obese. Except for gender, case characteristics differed significantly by surgeon/site. Previous abdominal surgery was reported for 226 (48.6 %) cases. SIRC was successfully completed in 455 (97.8 %) cases, and there were no conversions to open surgery. Median surgical time was 52 min with a decreasing trend after 55-85 cases. Male gender, obesity and diagnoses other than biliary dyskinesia were independent predictors of longer surgical times. The complication rate was 2.6 %. CONCLUSIONS: Our large, multicenter study demonstrates that robotic single-site cholecystectomy is safe and feasible in a wide range of patients.

Clinical outcomes of the Realize Adjustable Gastric Band-C at 2 years in a United States population.

BACKGROUND: In 2008, the Realize Band (RB) adopted a precurved design (RB-C). We present 2-year outcomes data from the first multiinstitutional study of RB-C. The objective of this study was to analyze weight loss and safety data from bariatric practices in the United States, including academic, nonacademic, public, and private. METHODS: The study included adult RB-C patients with a preoperative body mass index (BMI)≥40 kg/m(2) or >35 kg/m(2) with co-morbidity. Exclusions included RB-C's label contraindications for use. Outcomes parameters were percent excess weight loss (%EWL), BMI change, number and volume of band adjustments, and adverse events. RESULTS: A total of 231 patients met inclusion/exclusion criteria. Of these, 161 had 24-month data available. Mean %EWL was 44.4%±26.9% (P<.0001). BMI decreased from 44.1±5.7 kg/m(2) to 35.3±6.9 kg/m(2) (P<.0001). Percent EWL varied by preoperative BMI (P = .0002), bariatric practice (P<.0001), aftercare frequency (P = .0004), and band fill frequency (P = .0271), but %EWL was not influenced by gender, race, or age (P>.20 each). Adverse events were dysphagia (21.2%), gastroesophageal reflux (21.6%), and vomiting (30.7%). Incidence of pouch dilation, esophageal dilation, and slippage was ≤1%. Revisions (2.2%) were for unbuckled band, tube kinking, slippage, and suspected band leak (1 each). No erosions, explants, or mortality were reported. CONCLUSION: RB-C appears to be as well tolerated and effective as the first generation RB for weight loss. The near 45% EWL at 2 years is consistent with other high-quality publications on the RB. Preoperative BMI and frequency of postoperative care, including frequency of band fills, influence %EWL. Significant weight loss is achievable with RB-C despite variable postoperative management practices. The low morbidity and the absence of mortality at 24 months reflect positively on the RB-C characteristics.

Robotics in advanced gastrointestinal surgery: the bariatric experience.

Robotic surgery for laparoscopic procedures such as advanced gastrointestinal surgery and abdominal malignancies is currently on the rise. The first robotic systems have been used since the 1990s with increasing number of clinical cases and broader clinical applications each year. Although high-evidence-level data are scarce, studies suggest that the technical advantages of robotic surgery result in a clinical value for procedures of advanced complexity such as Roux-en-Y gastric bypass and revisional bariatric surgery. Ultimately, the digital interface of the robotic system with the option to integrate augmented reality and real-time imaging will allow advanced applications particularly in the field of gastrointestinal surgery for malignancies.

Early outcomes of the first Brazilian experience in totally robotic bariatric surgery.

BACKGROUND: Currently, bariatric surgery is the most effective therapy for morbid obesity, and the laparoscopic approach is considered gold-standard for Roux-en-Y gastric bypass. Totally robotic Roux-en-Y gastric bypass has been proposed as a major evolution in minimally invasive bariatric surgery and its use is becoming more widespread. AIM: To provide an early report of the first Brazilian case-series of totally robotic gastric bypass and perioperative short-term outcomes. METHODS: All consecutive patients who underwent totally robotic gastric bypass at two recognized centers of bariatric surgery were included. Patient demographic data, body mass index, operative times, hospital stay, complications and mortality in the 30 postoperative days were recorded. The surgeons received the same training program before the clinical procedures and all the surgeries were performed under the supervision of an experienced robotic surgeon. RESULTS: The surgeries were performed by five surgeons and included 68 patients (52 women - 76.5%), with a mean age of 40.5 years (range 18 to 59) and mean BMI of 41.3 (35.2 - 59.2). Total mean operative time was 158 minutes (range 90 to 230) and mean overall hospital stay was 48 h. Postoperative surgical complication rate (30 day) was 5.9%, with three minor and one major complication. There was no mortality, leak or stricture. CONCLUSION: Even with surgeons in early learning curves, the robotic approach within a well-structured training model was safe and reproducible for the surgical treatment of the morbid obesity.

Resultados iniciais da primeira série de casos brasileira de cirurgia bariátrica totalmente robótica / Early outcomes of the first Brazilian experience in totally robotic bariatric surgery

RACIONAL: Atualmente a cirurgia bariátrica é o tratamento mais eficaz para a obesidade mórbida. Embora ainda tenha algumas dificuldades, a abordagem laparoscópica tem-se tornando o padrão-ouro para o by-pass gástrico em Y-de-Roux. O uso da robótica representa grande evolução no campo da cirurgia bariátrica minimamente invasiva e seu uso tem sido cada vez mais difundido. OBJETIVO: Relatar a primeira experiência brasileira em cirurgia bariátrica totalmente robótica. MÉTODOS: Foram avaliados todos os pacientes submetidos à cirurgia bariátrica totalmente robótica em dois centros de excelência em cirurgia bariátrica. Foram registrados a incidência demográfica, índice de massa corporal, tempos operatórios, duração da internação hospitalar, mortalidade e todas as complicações em até 30 dias. As equipes cirúrgicas receberam treinamento específico para aprendizagem da técnica robótica e todos os procedimentos foram feitos com supervisão. RESULTADOS: O procedimento foi realizado por cinco equipes cirúrgicas em 68 pacientes (52 mulheres - 76,5%), com idade média de 40,5 anos e IMC médio de 41,3. O tempo médio operatório total foi de 158 minutos e a média de permanência hospitalar foi de 48 h. O percentual de complicações perioperatórias foi de 5,9%. Não houve mortalidade, fístulas ou estenoses. CONCLUSÃO: Mesmo com cirurgiões em período inicial da curva de aprendizagem, o by-pass gástrico por abordagem totalmente robótica é opção técnica segura e reproduzível no tratamento cirúrgico da obesidade mórbida, desde que respeitado modelo de treinamento bem estruturado.

BACKGROUND: Currently, bariatric surgery is the most effective therapy for morbid obesity, and the laparoscopic approach is considered gold-standard for Roux-en-Y gastric bypass. Totally robotic Roux-en-Y gastric bypass has been proposed as a major evolution in minimally invasive bariatric surgery and its use is becoming more widespread. AIM: To provide an early report of the first Brazilian case-series of totally robotic gastric bypass and perioperative short-term outcomes. METHODS: All consecutive patients who underwent totally robotic gastric bypass at two recognized centers of bariatric surgery were included. Patient demographic data, body mass index, operative times, hospital stay, complications and mortality in the 30 postoperative days were recorded. The surgeons received the same training program before the clinical procedures and all the surgeries were performed under the supervision of an experienced robotic surgeon. RESULTS: The surgeries were performed by five surgeons and included 68 patients (52 women - 76.5%), with a mean age of 40.5 years (range 18 to 59) and mean BMI of 41.3 (35.2 - 59.2). Total mean operative time was 158 minutes (range 90 to 230) and mean overall hospital stay was 48 h. Postoperative surgical complication rate (30 day) was 5.9%, with three minor and one major complication. There was no mortality, leak or stricture. CONCLUSION: Even with surgeons in early learning curves, the robotic approach within a well-structured training model was safe and reproducible for the surgical treatment of the morbid obesity.

Sleep quality and duration before and after bariatric surgery.

BACKGROUND: Shortened sleep duration causes hormonal and metabolic changes that favor fat accumulation and weight gain. Obesity, in turn, may reduce sleep quality and contribute to sleep loss. The purpose of this study was to evaluate the sleep durations of individuals with morbid obesity, compared to their nonobese counterparts, and to determine the effects of surgical weight reduction on sleep duration and sleep quality. METHODS: The study population included 45 bariatric (BA) surgical patients (mean body mass index [BMI] = 49) and 45 gender-matched nonobese controls (NC; BMI = 24). Self-reported sleep durations were obtained and overall sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). RESULTS: The data show that average sleep durations of the preoperative BA patients were significantly (p < 0.0001) less than those of the NC, i.e., 6.0 and 7.2 h, respectively. Sleep loss for the BA patients was associated with poor sleep quality, along with an increased frequency of conditions that interfere with sleep, including coughing and snoring, difficulty breathing, feeling too hot, and experiencing pain. Overall, 78% of the BA patients, compared to 36% of the NC, had PSQI scores indicative of poor sleep quality. Surgery after 3 to 12 months resulted in significant (p < 0.0001) weight loss (percentage total change in BMI = 34) and improved sleep quality, i.e., PSQI = 8.8 preoperatively vs. 4.6 postoperatively. Sleep durations increased significantly (p < 0.0001) post-surgery from 6.0 to 6.8 h. CONCLUSIONS: Individuals with extreme obesity, compared to the nonobese, obtain less sleep and experience poorer sleep quality. Bariatric surgery improves sleep duration and quality.

Clinical outcomes of the REALIZE adjustable gastric band-C at one year in a U.S. population.

BACKGROUND: In 2008, the REALIZE Band (RB) adopted a precurved design (RB-C). The present study is the first multi-institutional report of RB-C outcomes. Our objective was to analyze the 1-year weight loss and safety data from adult RB-C patients treated at multiple U.S. centers (7 typical U.S. bariatric practices, including academic, nonacademic, public, and private practice). METHODS: Patients implanted with the RB-C (preoperative body mass index ≥ 40 kg/m(2) or >35 kg/m(2) with co-morbidity) were recruited. The exclusion criteria included the RB-C label contraindications for use. The outcomes parameters were the percentage of excess weight loss (%EWL), change in body mass index, number and volume of band adjustments, and incidence of complications. RESULTS: Of the 239 patients enrolled in the 2-year study, 158 had 1-year data available for analysis in November 2010. The mean %EWL was 39.2% ± 20.5% (range -7.7 to -116.8, P < .0001). The body mass index decreased from 44.4 ± 5.5 kg/m(2) to 36.4 ± 5.8 kg/m(2) (P < .0001). The variability in the %EWL was significant among the study centers (P < .0001). The average band fill volume at 1 year was 8.0 ± 2.0 mL (range .0-11.1). The total fill volume was >11 mL in 1 patient. No band erosions/migrations, explants, or deaths occurred. CONCLUSION: RB-C appears to be as safe and effective as the first-generation RB. The near 40% EWL at 1 year was consistent with other high-quality publications of the RB. Good weight loss results are achievable, despite the varying postoperative management practices. The low morbidity and the absence of mortality at 12 months reflect positively on the RB-C characteristics. Our findings suggest that the learning curve, related to the postoperative management of the RB-C, might vary by practice and that a greater frequency and smaller band fills might result in better weight loss at 12 months.

Tooth regeneration: a revolution in stomatology and evolution in regenerative medicine.

A tooth is a complex biological organ and consists of multiple tissues including the enamel, dentin, cementum and pulp. Tooth loss is the most common organ failure. Can a tooth be regenerated? Can adult stem cells be orchestrated to regenerate tooth structures such as the enamel, dentin, cementum and dental pulp, or even an entire tooth? If not, what are the therapeutically viable sources of stem cells for tooth regeneration? Do stem cells necessarily need to be taken out of the body, and manipulated ex vivo before they are transplanted for tooth regeneration? How can regenerated teeth be economically competitive with dental implants? Would it be possible to make regenerated teeth affordable by a large segment of the population worldwide? This review article explores existing and visionary approaches that address some of the above-mentioned questions. Tooth regeneration represents a revolution in stomatology as a shift in the paradigm from repair to regeneration: repair is by metal or artificial materials whereas regeneration is by biological restoration. Tooth regeneration is an extension of the concepts in the broad field of regenerative medicine to restore a tissue defect to its original form and function by biological substitutes.

Totally robotic gastric bypass: approach and technique.

Despite the advantages of the da Vinci robotic system in the performance of abdominal surgery (Maeso et al. Ann Surg 252:254-262, 2010), there has been limited application of this technology to bariatric surgery. The robotic platform may be ideal for performance of Roux-en-Y gastric bypass (RYGB), providing significant ergonomic advantage and greater ability to maneuver more precisely in limited spaces. However, there has been slow adoption of robotic technology for the performance of the RYGB procedure due, in part, to the perceived difficulty of conversion from laparoscopic to totally robotic procedures and the associated initial increase in operative time. In this report, we describe our approach to developing a standardized totally robotic technique with focus on patient safety and attention to operative times, the technique itself, and surgery outcomes of nearly 300 RYGB cases. Our findings show that totally robotic RYGB can be safely approached through systematic stepwise progression with minimal complications and comparable operative times.

Utilization rate of bariatric surgery in an employee-based healthcare system following surgery coverage.

Incidence rates for obesity co-morbidities are high for individuals with class III morbid obesity. Bariatric surgery resolves/improves these co-morbidities, along with reduction in healthcare costs. Despite surgery benefits, payors are reluctant to provide coverage for fear of increased demand and costs. This study examines surgery utilization rates following coverage by an employee-based healthcare system. Bariatric surgery utilization rates were measured 1 year before and after healthcare coverage. The data show before coverage that 18 persons had bariatric surgery for a utilization rate of 1.71%. In the year after surgery, 16 persons elected to have bariatric surgery for a utilization rate of 1.42%. These findings should help to dispel the notion by employee-based insurers that coverage of bariatric surgery will lead to high utilization and associated costs in the early-coverage period.

Clinical implication of the difference between transcutaneous bilirubinometry and total serum bilirubin for the classification of newborns at risk of hyperbilirubinemia.

OBJECTIVES: 1) To determine the relationship between transcutaneous bilirubin measurements (TcB), performed using BiliCheck or Minolta Air-Shields JM-103, and total serum bilirubin levels (TSB) and 2) to evaluate the predictive accuracy of TcB measurements for risk using the nomogram recommended by the Canadian Pediatric Society (CPS). METHODS: A total of 154 healthy term neonates from the newborn nursery at McMaster Children's Hospital meeting the inclusion criteria were enrolled. TcB measurements were performed within 30 min of obtaining the TSB measurement. RESULTS: Both devices showed a good correlation with the laboratory method (BiliCheck-Vitros, R2=0.86; Minolta Air-Shields JM-103-Vitros, R2=0.85), but underestimated the serum bilirubin. Applying the risk classification using the 40th, 75th, and 95th percentile of the Bhutani nomogram a 6%, 0%, and 1% false negative rate was found for BiliCheck and 62%, 74% and 81% for the Minolta Air-Shields JM-103 device. After correcting for the differences using either the bias or the 95% CI the false negative rate was reduced to zero in all cases. CONCLUSION: TcB measurements cannot be directly applied to a TSB nomogram but must be adjusted for any observed biases in order to avoid misclassifying newborns at risk for hyperbilirubinemia.

Cost-return prediction in morbidly obese employees following weight loss interventions: a study framework.

Obesity and its many complications potentially can collapse most medical plans, unless attempts at prevention and therapy become more effective and widespread. An important incentive for providing effective treatment is proper reimbursement. We present here an evaluation of the feasibility, constrains and requirements for comparative cost-effectiveness evaluation of weight loss intervention from the payer's and employer's points of view, and propose a general framework for this type of studies toward decision making.