Incidence of symptomatic gallstones after bariatric surgery: the impact of expectant management.

BACKGROUND: Bariatric surgery is the most effective treatment for sustained weight reduction and obesity-related comorbidities. The development of gallstones as a result of rapid weight loss is a well-known consequence of bariatric procedures. It remains unclear, if there is an increased risk of these gallstones becoming symptomatic. METHODS: A retrospective analysis of 505 consecutive patients submitted to either Roux-en-Y Gastric Bypass or Sleeve Gastrectomy between January and December 2019 was performed. The aim of our study was to determine the incidence of symptomatic cholelithiasis in asymptomatic patients with their gallbladder in situ after bariatric surgery and to identify potential risk factors for its development. RESULTS: Of the 505 patients included, 79 (15.6%) underwent either previous cholecystectomy. (n = 67, 84.8%) or concomitant cholecystectomy during bariatric surgery (n = 12, 15.2%). Among the remaining 426 (84.4%) patients, only 8 (1.9%) became symptomatic during the 12-month follow-up period. When compared with patients who remained asymptomatic, they had a higher median preoperative BMI (47.0 vs. 42.8, p = 0.046) and prevalence of cholelithiasis on preoperative ultrasound (62.5% vs. 10.7%, p = 0.001). Multivariate analysis revealed preoperative BMI and cholelithiasis on preoperative ultrasound as independent risk factors for symptomatic biliary disease (OR 1.187, 95%CI 1.025-1.376, p = 0.022 and OR 10.720, 95%CI 1.613-71.246, p = 0.014, respectively). CONCLUSION: Considering a low incidence of symptomatic gallstones after bariatric surgery, concomitant cholecystectomy should only be performed in symptomatic patients undergoing bariatric surgery. Preoperative factors, such as a higher BMI and positive ultrasound for cholelithiasis, may be related to the development of symptomatic gallstones.

Biliary colic in the emergency department: A state-wide analysis of one-year costs and clinical outcomes.

Importance: Approximately 335,000 cases of biliary colic present to US emergency departments (EDs) annually, and most patients without complications are discharged from the ED. It is unknown what are the subsequent surgery rates, subsequent complications of biliary disease, ED revisits, repeat hospitalizations and cost; and, how does the ED disposition decision (admission versus discharge) affect long-term outcomes. Objective: To determine whether there is a difference in one-year surgery rates, complications of biliary disease, ED revisits, repeat hospitalizations, and cost in ED patients with uncomplicated biliary colic who are admitted to the hospital versus those that are discharged from the ED. Design setting and participants: A retrospective observational study was conducted using records collected from the Maryland Healthcare Cost and Utilization Project (HCUP) in the Ambulatory Surgery, the Inpatient, and the ED setting between 2016 and 2018. After applying inclusion criteria, 7036 ED patients with uncomplicated biliary colic were followed for one year after their index ED visit for repeat healthcare utilization across multiple settings. A multivariable logistic regression study was performed to asses for risk factors for surgery allocation and hospital admission. Medicare Relative Value Units (RVUs) and HCUP Cost-Charge Ratio files were used to estimate direct costs. Exposures: Episodes of biliary colic were ascertained using ICD-10 codes at the index ED visit. Main outcomes and measures: The primary outcome was the one-year surgery rate, defined as a cholecystectomy. Secondary outcomes included the rate of new acute cholecystitis or other related complications, ED revisits, hospital admission and costs. Associations with hospital admission and surgeries were measured using adjusted odds ratios (ORs) with 95 % CIs. Results: Of the 7036 patients analyzed, 793 (11.3 %) were admitted and 6243 (88.7 %) were discharged on their initial ED visit. When comparing the groups who were initially admitted versus discharged, we observed similar one-year cholecystectomy rates (42 % versus 43 %, mean difference 0.5 %, 95 % CI -3.1 %-4.2 %; P < 0.001), lower rates of new cholecystitis occurrences (18 % versus 41 %, mean difference 23 %, 95 % CI, 20 %-26 %; P < 0.001), lower rates of ED revisits (96 vs 198 per 1000 patients, mean difference 102, 95 % CI, 74-130; P < 0.001) and higher costs ($9880 versus $1832, mean difference 8048, 95 % CI, 7478-8618; P < 0.001). Initial ED hospital admission was associated with increased age (adjusted odds ratio [aOR], 1.44; 95 % CI, 1.35-1.53; P < 0.001), obesity (aOR, 1.38; 95 % CI, 1.32-1.44; P < 0.001), ischemic heart disease (aOR, 1.39; 95 % CI, 1.30-1.48; P < 0.001), mood disorders (aOR, 1.18; 95 % CI, 1.13-1.24; P < 0.001), alcohol-related disorders (aOR, 1.20; 95 % CI, 1.12-1.27; P < 0.001), hyperlipidemia (aOR, 1.16; 95 % CI, 1.09-1.23; P < 0.001), hypertension (aOR, 1.15; 95 % CI, 1.08-1.21; P < 0.001), and nicotine dependence (aOR, 1.09; 95 % CI, 1.03-1.15; P = 0.003) but not associated with race (P > 0.9), ethnicity (P > 0.9), or income-stratified zip code (aOR, 1.04; 95 % CI, 0.98-1.09; P = 0.17). Conclusions and relevance: In our analysis of ED patients with uncomplicated biliary colic from a single state, the majority of patients do not receive a cholecystectomy within one year and hospital admission at the initial visit was not associated with an overall change in rates of cholecystectomy but was associated with increased costs. These findings inform our understanding of the long-term outcomes and are important considerations when communicating care options with ED patients with biliary colic.

The use of serum alkaline phosphatase as a choledocholithiasis marker to mitigate the cost of magnetic resonance cholangiography

ABSTRACT Objective To assess the predictive value of preoperative serum laboratory test results for identifying choledocholithiasis and reduce the use of cholangioresonance and its inherent costs. Methods Patients aged 21-69 years who underwent preoperative cholangioresonance examination at our institute were included. Patients with a history of fluctuating jaundice or biliary pancreatitis, bile duct dilatation on ultrasonography, and elevated levels of canalicular enzymes (alkaline phosphatase >100U/L and gamma-glutamyl transferase >50U/L) underwent cholangioresonance-guided surgery. Cases of choledocholithiasis confirmed by cholangioresonance were compared with those without choledocholithiasis. Serum laboratory data were evaluated and the diagnostic capabilities of these examinations were analyzed. Results A total of 104 patients were included. For detecting choledocholithiasis using alkaline phosphatase, the cut-off point was 78U/L, sensitivity was 97.6% (95%CI: 87.4-99.9), and specificity was 72.6% (95%CI: 59.8-83.1). In the binary logistic regression analysis, age (OR= 0.92; 95%CI: 0.86-0.98) and alkaline phosphatase level (OR= 1.02; 95%CI: 1.01-1.05) were selected for the final model. Conclusion Serum alkaline phosphatase levels may aid preoperative diagnosis of asymptomatic choledocholithiasis. After a global clinical assessment of the patient, serum laboratory findings may contribute to a reduction in cholangioresonance-related heathcare costs.

Patients with complicated gallstone disease in the emergency department: clinical impact and cost-effectiveness of emergency department disposition decision.

Objective: The objective of this study was to assess the 1-year outcomes of emergency department (ED) patients with complicated gallstone disease, including surgery rates, initial admission rates, ED revisits, repeat hospitalizations, and cost. Methods: Using 3 linked statewide databases from the Maryland Healthcare Cost and Utilization Project, we identified patients with a primary diagnosis of complicated gallstone disease treated in an ED between 2016 and 2018. We measured the healthcare use and direct costs in the ambulatory surgery, inpatient, and ED settings for 1 year after the initial ED visit. Finally, we performed a multivariate logistic regression analysis comparing initially admitted versus discharged patients. Results: Of the 8751 patients analyzed, 86.8% were admitted to the hospital and 13.2% were discharged on their initial ED visit. Of the admitted patients, 78.7% received a cholecystectomy during the initial hospitalization plus 6.1% at a later date; of the discharged patients, 41.5% received a cholecystectomy. Admitted patients demonstrated lower recurrent gallbladder complications compared with those discharged (7.5% vs 44.5%), fewer ED revisits (4% vs 20.3%), and fewer repeat hospitalizations (4.5% vs 16.7%). Despite this, the 1-year cost in the admitted patients was higher ($9448 vs $2933). Obesity, age, and mood disorders but not race, ethnicity, or zip code were associated with admission at initial ED visit. Conclusions: In our single-state analysis of ED patients with complications of gallstone disease, most patients are admitted on the initial visit and receive a cholecystectomy during that hospitalization. The discharged group had higher rates of 1-year complications, ED revisits, and repeat hospitalizations but lower cost.

Quality of recovery assessment of day case and multiday stay patients undergoing elective laparoscopic cholecystectomy.

Objectives: Many laparoscopic cholecystectomy operations are performed with at least overnight admission. Current research shows that laparoscopic cholecystectomy is safe and feasible to do as a day case. Patient centred outcomes are less well understood. Material and Methods: Elective laparoscopic cholecystectomy patients at a single metropolitan hospital in Melbourne, Australia were surveyed 24 hours after surgery using the 15-question Quality of Recovery (QoR-15) survey. A comparison was made between day case surgeries and multi-day surgeries. Results: One hundred and eight patients were recruited consisting of 34 day case and 74 multi-day patients. Patient groups did not differ in terms of age, sex or postoperative morbidity. The multi-day group had a higher proportion of comorbid patients (p-value = 0.03). There was no significant dif- ference in overall QoR-15 score between the two groups, although there was an observed trend towards a higher score in the day case group (132.0 vs 127.9, p= 0.147). QoR-15 individual question results showed that day cases rated significantly better for sleep quality and for less feelings of anxiety or worry. The differences narrowed when comparing patient groups as they were booked (intention-to-treat). There were no identified sub-groups that had a significantly higher score if admitted multi-day. Conclusion: Quality of recovery following day case laparoscopic cholecystectomy is just as good, if not better, than multi-day cases. Laparoscopic cholecystectomy as a day case is both safe and economically superior to multi-day management. This gives further weight to current recommendations suggesting that the majority of laparoscopic cholecystectomy operations could be performed as day cases.

Decision analysis of minimally invasive management options for cholecysto-choledocholithiasis.

BACKGROUND: The management of cholecysto-choledocholithiasis is controversial with the risks and benefits of one versus two-stage approaches debated. This study aims to perform decision analysis of minimally invasive laparo-endoscopic approaches. METHODS: An advanced decision tree was constructed to compare pre, intra and post-operative ERCP and laparoscopic common bile duct exploration in terms of primary ductal clearance and significant complications for patients intended to undergo laparoscopic cholecystectomy. Transition probabilities were calculated from randomised controlled trials following a comprehensive literature search. Model uncertainties were extensively tested through deterministic and probabilistic Monte Carlo sensitivity analysis. Utility outcomes were 1 and 0.5 for successful primary clearance without and with complications, respectively, and 0 for failure of primary clearance of the duct. RESULTS: Twenty-one studies (n = 2697) were included in the analysis. At base case analysis, a laparo-endoscopic rendezvous approach had the highest utility output (0.90; no complication probability: 0.87/complication probability 0.06). Laparoscopic common bile duct exploration was ranked second with a utility output 0.87 (no complication probability: 0.82/complication probability 0.10). Pre-operative ERCP utility score was 0.84 (no complication probability: 0.78/ complication probability 0.11) and post-operative ERCP utility score was 0.78 (no complication probability: 0.71/complication probability 0.13). Monte Carlo analysis showed that laparo-endoscopic rendezvous and laparoscopic common bile duct exploration had an equal mean utility output of 0.57 (standard deviation 0.36; variance 0.13; 95% confidence interval 0.00-0.99 versus standard deviation 0.34; variance 0.12; 95% confidence interval 0.01-0.98). Laparo-endoscopic rendezvous had a superior treatment selection frequency of 39.93% followed by laparoscopic bile duct exploration (36.11%), pre-operative ERCP (20.67%) and post-operative ERCP (2.99%). CONCLUSION: One-stage approach to the management of cholecysto-choledocholithiasis is superior to two-stage, in terms of primary clearance of the duct and risk of operative morbidity. Laparo-endoscopic rendezvous approach could offer marginal additional benefit but more high-quality randomised controlled trials are needed.

Cost effectiveness of intraoperative laparoscopic ultrasound for suspected choledocholithiasis; outcomes from a specialist benign upper gastrointestinal unit.

INTRODUCTION: Common bile duct stones are present in 10% of patients with symptomatic gallstones. One-third of UK patients undergoing cholecystectomy will have preoperative ductal imaging, commonly with magnetic resonance cholangiopancreatography. Intraoperative laparoscopic ultrasound is a valid alternative but is not widely used. The primary aim of this study was to assess cost effectiveness of laparoscopic ultrasound compared with magnetic resonance cholangiopancreatography. MATERIALS AND METHODS: A prospective database of all patients undergoing laparoscopic cholecystectomy between 2015 and 2018 at a district general hospital was assessed. Inclusion criteria were all patients, emergency and elective, with symptomatic gallstones and suspicion of common bile duct stones (derangement of liver function tests with or without dilated common bile duct on preoperative ultrasound, or history of pancreatitis). Patients with known common bile duct stones (magnetic resonance cholangiopancreatography or failed endoscopic retrograde cholangiogram) were excluded. Ninety-day morbidity data were also collected. RESULTS: A total of 420 (334 elective and 86 emergency) patients were suspected to have common bile duct stones and were included in the study. The cost of a laparoscopic ultrasound was £183 per use. The cost of using the magnetic resonance cholangiopancreatography unit was £365 per use. Ten postoperative magnetic resonance cholangiopancreatographies were performed for inconclusive intraoperative imaging. The estimated cost saving was £74,650. Some 128 patients had common bile duct stones detected intraoperatively and treated. There was a false positive rate of 4.7%, and the false negative rate at 90 days was 0.7%. laparoscopic ultrasound use saved 129 bed days for emergency patients and 240 magnetic resonance cholangiopancreatography hours of magnetic resonance imaging. CONCLUSION: The use of laparoscopic ultrasound during laparoscopic cholecystectomy for the detection of common bile duct stone is safe, accurate and cost effective. Equipment and maintenance costs are quickly offset and hospital bed days can be saved with its use.

Normalization of Serum Lipase Levels Versus Resolution of Abdominal Pain: A Comparison of Preoperative Management in Children With Biliary Pancreatitis.

BACKGROUND: Controversy exists over the timing of cholecystectomy for biliary pancreatitis in children. Some surgeons await normalization of serum lipase levels while others are guided by resolution of abdominal pain; however, there are minimal data to support either practice. We hypothesized that resolution of abdominal pain is equivalent in outcome to awaiting normalization of lipase levels in patients undergoing cholecystectomy for biliary pancreatitis. METHODS: After institutional review board (IRB) approval, the medical record was retrospectively queried for all cases of cholecystectomy for biliary pancreatitis at our institution from 2007 to 2017. Patients undergoing chemotherapy, admitted for another cause, or who had severe underlying comorbidities like ventilator dependence were excluded. Patients were stratified into two cohorts: those managed preoperatively by normalization of serum lipase levels versus resolution of abdominal pain. Demographics, serum lipase levels, postoperative complications, cost of stay, readmissions, and return to the emergency department were collected and analyzed using multivariate regression. RESULTS: Seventy-four patients met inclusion: 29 patients had lipase levels trended until normalization compared with 45 patients who had resolution of abdominal pain prior to cholecystectomy. Among the two cohorts there was no statistical difference in age, gender, race, ethnicity, or type of preoperative imaging used. Trended patients were found to have more serum lipase levels tested (8.5 ± 6.2 versus 3.4 ± 2.5, P < 0.0001). The trended lipase cohort was significantly more likely to require preoperative total parenteral nutrition (48% versus 11%, P = 0.007) and consequently a longer time before resuming a diet (10 ± 7.3 versus 4.6 ± 2.4 d, P < 0.0001). When comparing the two groups, we found no significant difference in the duration of surgery, postoperative complications, or readmissions. Lipase trended patients had a significantly longer length of stay compared with nontrended patients (11.5 ± 8.1 versus 4.2 ± 2.3 d, P < 0.0001) and had a higher total cost of stay ($38,094 ± 25,910 versus $20,205 ± 5918, P = 0.0007). CONCLUSIONS: Our data suggest that in children with biliary pancreatitis, proceeding with cholecystectomy after resolution of abdominal pain is equivalent in outcomes to trending serum lipase levels but is more cost-effective with a decreased length of stay and decreased need for preoperative total parenteral nutrition.

A Cost-Utility Study of Laparoscopic Cholecystectomy for the Treatment of Symptomatic Gallstones.

BACKGROUND: Laparoscopic cholecystectomy is a high-volume surgery that is an end-stage treatment for gallstones. There is little understanding of the surgery's effect on the gain in patients' health relative to its cost. The objective of this study is to measure health gain, cost and cost utility of elective laparoscopic cholecystectomy. METHODS: Participants completed the EQ-5D(3L) pre-operatively and post-operatively. Quality adjusted life years attributable to cholecystectomy were calculated by comparing health state utility values between the pre- and post-operative time points. Laparoscopic cholecystectomy cost was calculated from a health system perspective and included hospital and specialists' fees (in 2016 Canadian dollars). Cost per QALY was calculated for the entire sample and demographic sub-groups. RESULTS: The cohort consisted of 135 participants who completed surveys between February 2013 and June 2017. The response rate among eligible patients was 50%. Assuming that health gain accrued to the participant for 25 years after cholecystectomy, the mean gain in QALYs was 1.7430, corresponding to an average cost per QALY of $2102. Older patients, on average, had less gain in QALYs than younger patients. CONCLUSION: Laparoscopic cholecystectomies are inexpensive relative to the gains in health they provide patients. The gains in health were not uniform across age categories. These results should provide health system planners confidence that incremental increases in surgical capacity for elective cholecystectomies is beneficial.

Análise do perfil clínico epidemiológico dos pacientes submetidos a Colecistectomia Videolaparoscópica em um hospital de ensino de Curitiba / Epidemiological and clinical assessment of patients undergoing Videolaparoscopic Cholecystectomy at a Curitiba teaching hospital

RESUMO Objetivo: Analisar o perfil clínico e epidemiológico de pacientes submetidos a colecistectomia por vídeo no Hospital da Cruz Vermelha do Paraná, unidade de Curitiba, operados no período de setembro de 2016 a setembro de 2018, assim como a influência de comorbidades, sexo e idade avançada no prognóstico pós-operatório, durante o mesmo internamento. Métodos: Estudo retrospectivo analítico, com dados coletados por revisão de prontuários. Análises estatísticas realizadas, considerando nível de significância p < 0,05. Resultados: 389 casos foram incluídos, sendo 265 mulheres e 124 homens. A média de idade foi de 51,5 anos, 58,8% dos pacientes eram portadores de pelo menos uma comorbidade e 74,6% dos doentes tinham sobrepeso ou eram obesos. A incidência de complicações intraoperatórias foi de 1,3%, pós-operatórias de 3,8% e, a mortalidade, de 0,3%. Foram identificados fatores clínicos relacionados a pior prognóstico pós-operatório, como DM, HAS, presença de uma ou mais comorbidades e, destacadamente, idade avançada, que relacionou-se com maior tempo de internamento (p < 0,001), necessidade de UTI (p < 0,001), conversão para operação aberta (p = 0,003) e risco de complicações pós-operatórias (p < 0,001). Além disso, o sexo masculino foi preditivo para maior tempo de internamento (p = 0,003) e maior necessidade de UTI (p = 0,01). Conclusão: o perfil clínico-epidemiológico corresponde àquele exposto na literatura e a presença de comorbidades, o sexo masculino e a idade avançada são fatores preditivos de mau prognóstico na evolução pós-operatória de pacientes submetidos a colecistectomia videolaparoscópica.

ABSTRACT Objective: to assess clinical and epidemiological factors of patients undergoing video cholecystectomy at the Hospital da Cruz Vermelha do Paraná, Curitiba unit, operated from September 2016 to September 2018, as well as the influence of comorbidities, sex and advanced age on the postoperative prognosis, while in the hospital. Methods: Analytic retrospective study. The analyzed variables were obtained by the review of medical records. Statistical analyses were performed considering the significance level p < 0.05. Results: 389 patients, of whom 265 were women and 124 men, were included. The mean age was 51.5 years, 58.8% of the patients were diagnosed with at least one comorbidity, and 74.6% were overweight or obese. The incidence of intraoperative complications was 1.3%, postoperative 3.8% and, mortality, 0.3%. Some risk factors were identified as worse postoperative prognosis, such as Diabetes Mellitus, hypertension, presence of one or more comorbidities and mainly, advanced age, which was related to longer hospitalization times (p < 0,001), need of intensive therapy (p < 0,001), conversion to open surgery (p = 0,003) and postoperative complications (p < 0,001). Furthermore, the male sex was predictive of longer hospitalization times (p = 0,003) and need of intensive therapy (p = 0,01). Conclusion: the presence of comorbidities, male sex, and advanced age are predictive factors of bad prognosis for patients undergoing video laparoscopic cholecystectomy.

Colangiopancreatografia retrógrada endoscópica para cálculos no ducto biliar comum: overview de revisões sistemáticas e estudos econômicos / Endoscopic retrograde cholangiopancreatography for common bile duct calculi: overview of systematic reviews and economic assessments

Objetivo: Avaliar a eficácia, segurança e custo-efetividade da colangiopancreatografia retrógrada endoscópica (CPRE) comparada à exploração laparoscópica do ducto biliar comum (ELDBC) para coledocolitíase. Métodos: Foi realizada uma busca eletrônica nas bases de dados Medline, The Cochrane Library, Lilacs e Center for Reviews and Dissemination por revisões sistemáticas e estudos econômicos que reportassem dados sobre a comparação entre a CPRE e a ELDBC em pacientes com coledocolitíase. Uma busca complementar foi realizada nas referências dos estudos incluídos, periódicos, resumos de congresso e Google Acadêmico. A seleção foi realizada por dois pesquisadores independentes. Além da síntese qualitativa, uma ressíntese quantitativa para os desfechos primários foi conduzida em Review Manager® 5.3 utilizando um modelo de efeitos randômicos. Resultados: Foram incluídos 15 estudos (9 revisões sistemáticas e 6 estudos econômicos). Não foi demonstrada diferença estatisticamente significativa entre a colecistectomia laparoscópica (CL)+CPRE e a CL+ELDBC em termos de remoção dos cálculos do colédoco (88,5% vs. 92,8%; RR = 0,97, valor-p = 0,08; N = 1.881), morbidade pós-operatória (14,1% vs. 13,8%; RR = 0,98, valor-p = 0,88; N = 1.469), mortalidade (0,8% vs. 0,2%; RR = 2,13, valor-p = 0,33; N = 1.471), cálculos retidos (7,3% vs. 5,8%; RR = 1,17, valor-p = 0,40; N = 1.731), conversão para outros procedimentos (8,7% vs. 6,7%; RR = 1,20, valor-p = 0,55; N = 1.287), duração do procedimento (MD = 10,91, valor-p = 0,61; N = 717) ou tempo de hospitalização (MD = 1,31, valor-p = 0,10; N = 757). A literatura de custo-efetividade é dividida, com alguns estudos favorecendo a CL+CPRE e outros, a CL+ELDBC. Conclusão: Não é possível concluir sobre a superioridade da ELDBC sobre a CPRE ou vice-versa para a remoção de cálculos no colédoco.

Objective: To evaluate the efficacy, safety and cost-effectiveness of endoscopic retrograde cholangiopancreatography (ERCP) compared to laparoscopic common bile duct exploration (LCBDE) for choledocholithiasis. Methods: An electronic search was conducted in the Medline, The Cochrane Library, Lilacs and Center for Reviews and Dissemination databases for systematic reviews and economic studies that reported data on the comparison between ERCP and LCBDE in patients with choledocholithiasis. A complementary search was conducted on references of included studies, journals, conference abstracts and Google Scholar. The selection was performed by two independent reviewers. In addition to the qualitative synthesis, a quantitative re-synthesis for primary outcomes was conducted in Review Manager® 5.3 using a random effects model. Results: Fifteen studies (9 systematic reviews and 6 economic studies) were included. There was no statistically significant difference between laparoscopic cholecystectomy (LC)+ERCP and LC+LCBDE in terms of removal of choledochal stones (88.5% vs. 92.8%, RR = 0.97, p-value = 0.08; N = 1,881), morbidity (14.1% vs. 13.8%, RR = 0.98, p-value = 0.88; N = 1,469), mortality (0.8% vs. 0,2%; RR = 2.13, p-value = 0.33, N = 1,471), retained stones (7.3% vs. 5.8%, RR = 1.17, p-value = 0.40; N = 1,731), conversion to other procedures (8.7% vs. 6.7%, RR = 1.20, p-value = 0.55, N = 1,287), duration of the procedure (MD = 10.91, p = 0.61, N = 717) or hospital stay (MD = 1.31, p-value = 0.10, N = 757). The cost-effectiveness literature is divided. Some studies favor LC+ERCP and others LC+LCBDE. Conclusion: It is not possible to conclude on the superiority of the LCBDE on ERCP or vice-versa for choledocholithiasis

Complicaciones biliares en pacientes con diagnóstico previo de litiasis vesicular sintomática: Comparación entre un hospital público y otro privado del Gran Buenos Aires / Biliary complications in patients with previous diagnosis of symptomatic gallstones: Comparison between a public and a private hospital in Greater Buenos Aires

Antecedentes: la demora en el tratamiento de la litiasis vesicular sintomática (LVS) aumenta el riesgo de complicaciones biliares. Se plantea la hipótesis de que existen diferencias en el tratamiento de la LVS entre el sector público y el de obras sociales del Gran Buenos Aires (GBA). Objetivo: comparar la proporción de pacientes con litiasis biliar complicada (LBC) que presentaban diagnóstico previo de LVS, y evaluar la historia previa de la LBC según la presencia de síntomas y la relación con el sistema de salud. Material y métodos: estudio de corte transversal comparativo entre un hospital público (HPu) y otro privado (HPr) del GBA. Se analizó la historia clínica y se realizó una encuesta a pacientes colecistectomizados por LBC (colecistitis aguda, pancreatitis aguda y coledocolitiasis). Resultados: se incluyeron 105 pacientes del HPu y 136 del HPr. Las características basales difirieron en la edad, nivel educativo, distancia domicilio-hospital y ASA. El diagnóstico previo de LVS fue más frecuente en el HPu (60% vs. 39,7%; p = 0,02), diferencia que se mantuvo luego del ajuste multivariable (OR 2,14; IC 95%: 1,1 a 4,1; p = 0,02). Los pacientes del HPu mostraron una mayor frecuencia de dolores abdominales, tiempo desde el diagnóstico, número de consultas de urgencia luego del diagnóstico y mayor tiempo en lista de espera. Conclusiones: ell HPu mostró mayor pérdida de oportunidad quirúrgica de la litiasis vesicular en un estadio previo no complicado. Las causas podrían ser multifactoriales, pero se necesitan más estudios para corroborar esta hipótesis.

Background: Delays in the treatment of symptomatic cholelithiasis (SCL) increases the risk of biliary complications. There may be differences in the treatment of SCL between the public sector and the social security in the Greater Buenos Aires (GBA). Objectives: The aim of this study was to compare the proportion of patients with complicated gallstone disease (CGD) with previous diagnosis of SCL and to evaluate the history of CGD according to the presence of symptoms and its relation with the health care system. Material and methods: We conducted a cross-sectional study comparing a public hospital (PH) versus a private center (PrH) in the GBA. The clinical records were analyzed and patients with a history of cholecystectomy due to CGD (acute cholecystitis, acute pancreatitis and acute choledocholithiasis) were surveyed. Results: A total of 105 PH patients and 136 PrH patients were included. The baseline characteristics differed in terms of age, educational level, distance from home to hospital and ASA physical status classification. The previous diagnosis of SCL was more common in the PH (60% vs. 39.7%; p = 0.02) and this difference persisted after multivariate adjustment (OR 2.14; 95% CI, 1.1-4.1; p = 0.02). The PH presented more patients with abdominal pain and more visits to the emergency department (ED) after the diagnosis; time after the diagnosis was greater and these patients spent more time on the waiting list. Conclusions: The PH showed greater loss of surgical opportunity of uncomplicated cholelithiasis. This may be due to multiple factors, but further studies are necessary to confirm this hypothesis.

Assessment of clinical outcome of cholecystectomy according to age in preparation for the "Silver Tsunami".

BACKGROUND: Recent rapid increases in the aging population have created an impending "Silver Tsunami" in advanced countries. The overall prevalence of gallstone disease and its related complications will soon increase, and there will be a larger demand for gallbladder surgery. METHODS: We examined the outcomes of cholecystectomy according to age among patients with cholelithiasis to determine how a patient's age influences the outcome of cholecystectomy. All patients with gallstone disease who presented for cholecystectomy at our institute from January 2006 to December 2018 were analyzed. RESULTS: All perioperative outcomes (operation length, length of hospital stay, rate of open surgery, urgent surgery, postoperative complications, incidental gallbladder cancer, postoperative hospital death, concomitant bile duct stones, and total medical costs per patient) increased as patients aged. CONCLUSIONS: To prevent the progression of biliary disease, elective laparoscopic cholecystectomy is recommended before patients with cholelithiasis advance in age.

Statistical analysis plan of a randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy (SECURE trial).

BACKGROUND: Cholecystectomy is the preferred treatment for symptomatic cholecystolithiasis. However, persistent pain after cholecystectomy for symptomatic cholecystolithiasis is reported in up to 40% of patients. The aim of the SECURE trial is to compare the effectiveness of usual care with a restrictive strategy using a standardized work-up with stepwise selection for cholecystectomy in patients with gallstones and abdominal complaints. The SECURE trial is designed as a multicenter, randomized, parallel-arm, non-inferiority trial in patients with abdominal symptoms and ultrasound-proven gallstones or sludge. Randomization was performed to either usual care (standard practice, according to the physician's knowledge and experience, and physician's and patient's preference) or a restrictive standardized strategy: treated with interval evaluation and stepwise selection for laparoscopic cholecystectomy based on fulfilment of pre-specified criteria. This article presents in detail the statistical analysis plan (SAP) of this trial and was submitted before outcomes were available to the investigators. RESULTS: The primary end point of this trial is defined as the proportion of patients being pain-free at 12 months' follow-up. Pain will be assessed with the Izbicki Pain Score. Secondary endpoints will be the proportion of patients with complications due to gallstones or cholecystectomy, quality of life, the association between the patients' symptoms and treatment, work performance, and cost-effectiveness. DISCUSSION: The data from the SECURE trial will provide evidence whether or not a restrictive strategy in patients with symptomatic cholecystolithiasis is associated with similar patient reported outcomes and a reduction in the number of cholecystectomies compared to usual care. The data from this trial will be analyzed according to this pre-specified SAP. TRIAL REGISTRATION: The Netherlands National Trial Register NTR4022 . Registered on 5 June 2013.

Recent advances in understanding and managing cholesterol gallstones.

The high prevalence of cholesterol gallstones, the availability of new information about pathogenesis, and the relevant health costs due to the management of cholelithiasis in both children and adults contribute to a growing interest in this disease. From an epidemiologic point of view, the risk of gallstones has been associated with higher risk of incident ischemic heart disease, total mortality, and disease-specific mortality (including cancer) independently from the presence of traditional risk factors such as body weight, lifestyle, diabetes, and dyslipidemia. This evidence points to the existence of complex pathogenic pathways linking the occurrence of gallstones to altered systemic homeostasis involving multiple organs and dynamics. In fact, the formation of gallstones is secondary to local factors strictly dependent on the gallbladder (that is, impaired smooth muscle function, wall inflammation, and intraluminal mucin accumulation) and bile (that is, supersaturation in cholesterol and precipitation of solid crystals) but also to "extra-gallbladder" features such as gene polymorphism, epigenetic factors, expression and activity of nuclear receptors, hormonal factors (in particular, insulin resistance), multi-level alterations in cholesterol metabolism, altered intestinal motility, and variations in gut microbiota. Of note, the majority of these factors are potentially manageable. Thus, cholelithiasis appears as the expression of systemic unbalances that, besides the classic therapeutic approaches to patients with clinical evidence of symptomatic disease or complications (surgery and, in a small subgroup of subjects, oral litholysis with bile acids), could be managed with tools oriented to primary prevention (changes in diet and lifestyle and pharmacologic prevention in subgroups at high risk), and there could be relevant implications in reducing both prevalence and health costs.

Cost analysis of robot-assisted choledochotomy and common bile duct exploration as an option for complex choledocholithiasis.

AIM: The aim of this study is to evaluate the clinical outcomes and cost-effectiveness of elective, robot-assisted choledochotomy and common bile duct exploration (RCD/CBDE) compared to open surgery for ERCP refractory choledocholithiasis. METHOD: A prospective database of all RCD/CBDE has been maintained since our first procedure in April 2007 though April 2016. With ethics approval, this database was compared with all contemporaneous elective open procedures (OCD/CBDE) performed since March 2005. Emergency procedures were excluded from analysis. Cost analysis was calculated using a micro-costing approach. Outcomes were analyzed on the basis of intent-to-treat. A p value of 0.05 denoted statistical significance. RESULTS: A total of 80 cases were performed since 2005 compromising 50 consecutive, unselected RCD/CBDE and 30 OCD/CBDE. Comparing RCD/CBDE to OCD/CBDE there were no significant differences between groups with respect to age (65 ± 20 vs. 67 ± 18 years, p = 0.09), gender (14/30 vs. 16/25 male/female, p = 0.52), ASA class or co-morbidities. The mean duration of surgery for RCD/CBDE trended longer compared to OCD/CBDE (205 ± 70 min vs. 174 ± 73 min, p = 0.08). However, there was significant reduction in postoperative complications with RCD/CBDE versus OCD/CBDE (22% vs. 56%, p = 0.002). Median hospital stay was also significantly reduced (6 vs 12 days, p = 0.01). The net overall hospital cost for RCD/CBDE was lower ($8449.88 CAD vs. $11671.2 CAD). CONCLUSION: In this single-centre, cohort study, robotic-assisted CD/CBDE for ERCP refractory common bile duct stones provides the dominating strategy of improved patient outcomes with a reduction of overall cost.

Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: study protocol for a randomized controlled trial (UPGRADE trial).

BACKGROUND: The number of bariatric interventions for morbid obesity is increasing worldwide. Rapid weight loss is a major risk factor for gallstone development. Approximately 11 % of patients who underwent Roux-en-Y gastric bypass develop symptomatic gallstone disease. Gallstone disease can lead to severe complications and often requires hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation of gallstones after bariatric surgery. However, randomized controlled trials with symptomatic gallstone disease as primary endpoint have not been conducted. Currently, major guidelines make no definite statement about postoperative UDCA prophylaxis and most bariatric centers do not prescribe UDCA. METHODS: A randomized, placebo-controlled, double-blind multicenter trial will be performed for which 980 patients will be included. The study population consists of consecutive patients scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy in three bariatric centers in the Netherlands. Patients will undergo a preoperative ultrasound and randomization will be stratified for pre-existing gallstones and for type of surgery. The intervention group will receive UDCA 900 mg once daily for six months. The placebo group will receive similar-looking placebo tablets. The primary endpoint is symptomatic gallstone disease after 24 months, defined as admission or hospital visit for symptomatic gallstone disease. Secondary endpoints consist of the development of gallstones on ultrasound at 24 months, number of cholecystectomies, side-effects of UDCA and quality of life. Furthermore, cost-effectiveness, cost-utility and budget impact analyses will be performed. DISCUSSION: The UPGRADE trial will answer the question whether UDCA reduces the incidence of symptomatic gallstone disease after Roux-en-Y gastric bypass or sleeve gastrectomy. Furthermore it will determine if treatment with UDCA is cost-effective. TRIAL REGISTRATION: Netherlands Trial Register (trialregister.nl) 6135 . Date registered: 21-Nov-2016.

Less is more: an outcome assessment of patients operated for gallstone ileus without fistula treatment.

BACKGROUND: The treatment of gallstone ileus (GI) consists of surgical removal of the impacted bilestone with or without cholecystectomy and repair of the biliodigestive fistula. The objective of this study was to assess whether sparing patients a definitive biliary procedure adversely influenced the outcome. MATERIALS AND METHODS: Patients with a diagnosis of GI were reviewed. Two groups were identified: patients who underwent a definitive biliary procedure with relieving the intestinal obstruction (group 1/G1) and those who did not have a definitive biliary procedure (group 2/G2). In G2, patients were evaluated on long-term follow-up for the risk of recurrent GI disease, cholecystitis, cholangitis and gallbladder cancer. RESULTS: Among 1075 patients admitted for small bowel obstruction, 20 (1.9%) were diagnosed with gallstone ileus. 3 (15%) of these belong to G1, 17 (85%) to G2. The overall postoperative morbidity rate was 35% (7/20) with one complication exceeding grade II in each group. No deaths were reported. Mean follow-up was 50 months. During follow-up, one of G2 patients had recurrent disease. No biliary tract infections or gallbladder cancer were identified. CONCLUSION: Enterolithotomy without fistula closure is confirmed to be safe and effective for the management of gallstone ileus both on a short- and long-term basis.

Financial Burden Secondary to Delay in Cholecystectomy Following Mild Biliary Pancreatitis.

AIM OF THE STUDY: The guidelines recommend that patients with mild gallstones pancreatitis should undergo a definitive management for gallstones during the same admission or within the next two weeks. The aim of this study was to estimate the financial cost resulting from a delay in surgical management following mild gallstones pancreatitis. This includes the costs of readmissions with biliary events and the subsequent investigations required during these admissions. MATERIALS AND METHODS: A retrospective analysis included patients with gallstone pancreatitis who were admitted to a district general hospital in the United Kingdom over one year. Patients with severe pancreatitis and those unfit for surgery were excluded. RESULTS: Forty patients were included in the study, 27 females (67%) and 13 males (33%). Mean age was 50.2 years. Twenty-two patients of the total presented with a single admission with gallstone pancreatitis prior to an elective surgery; however, 18 patients (45%) required recurrent admissions. The duration between the first admission and surgery ranged from 14 to 389 days (median of 99 days). Only one patient (2.5%) had cholecystectomy within two weeks of admission as per guidelines. Twenty-two ultrasound scans, four computed tomography scans, 15 magnetic resonance cholangiopancreatography, and two endoscopic retrograde cholangiopancreatography were the total of the extra-investigations required during readmissions. Estimated costs of extra admissions and extra investigations exceeded £33,000. CONCLUSIONS: The delay in cholecystectomy for patients admitted with mild gallstone pancreatitis and fit for surgery has resulted in high readmission rate with biliary events, and subsequently high extrax costs.