Patient-reported Outcome Measure (PROM) Rand-36-item Health Survey for Gallstone Disease Patients Five Years Following Surgery: A Prospective Randomized Study.

BACKGROUND/AIM: There are no studies assessing the long-term quality of life (QoL) following three-dimensional laparoscopy cholecystectomy (3D-LC) in patients with cholelithiasis (Chole). PATIENTS AND METHODS: A cohort of 200 patients with Chole were randomized into 3D-LC or minilaparotomy cholecystectomy (MC) groups. RAND-36 survey was performed before randomization, four weeks and five years postoperatively. RESULTS: Similar postoperative five years RAND-36 scores were reported in the 3D-LC and MC groups. The MC and 3D-LC groups combined analysis, social functioning (SF, p=0.007), mental health (MH, p=0.001), role physical (RP, p<0.001) and bodily pain (BP, p<0.001) domains increased significantly. In comparison to the Finnish reference RAND-36 (FRR) scores, the scores at five years increased significantly in the MH domain, while four RAND-36 domains; Physical functioning (PF), general health (GH), RP, BP remained significantly lower in comparison to the FRR scores. CONCLUSION: A relatively similar long-term outcome in the 3D-LC and MC patients is shown. Interestingly, five RAND-36 domains increased during five years follow-up, while four RAND-36 domains remained lower than FRR scores, which may indicate onset of possible new symptoms following cholecystectomy in long-term follow-up.

Preoperative difficulty assessment of interval laparoscopic cholecystectomy for gallstones.

BACKGROUND: Laparoscopic cholecystectomy is the gold standard treatment for benign gallbladder disease. However, few studies have reported the difficulty of interval cholecystectomy after cholecystitis because early cholecystectomy is recommended for acute cholecystitis. In this study, we evaluated the difficulties associated with interval cholecystectomy for cholecystitis with gallstones. METHODS: We retrospectively analyzed patients with gallstones who underwent interval laparoscopic cholecystectomy for cholecystitis at our institution between January 2012 and December 2021. Patients were classified into laparoscopic total cholecystectomy and bailout procedure groups depending on whether they were converted to a bailout procedure, and their characteristics and outcomes were subsequently compared. Additionally, a logistic regression analysis of the preoperative factors contributing to bailout procedure conversion was performed. RESULTS: Of the 269 participants, 39 converted to bailout procedure, and bile duct injury occurred in one case (0.4%). In patient characteristics comparison, patients in the bailout procedure group were significantly older, had more impacted stones, had higher post-treatment choledocholithiasis, had severe cholecystitis, and had a higher rate of percutaneous transhepatic gallbladder drainage. There were no differences in the bile duct injury or perioperative complications between the two groups. In logistic regression multivariate analysis of the factors contributing to the bailout procedure, post-treatment of choledocholithiasis (P < .001), impacted stone (P = .002), and age ≥71 (P = .007) were independent risk factors. CONCLUSION: Impacted stones and choledocholithiasis are risk factors for conversion to bailout procedure and high difficulty in interval cholecystectomy. For such patients, interval cholecystectomy should be performed cautiously.

ROBOtic Care Outcomes Project for acute gallbladder pathology.

BACKGROUND: Robotic cholecystectomy is being increasingly used for patients with acute gallbladder disease who present to the emergency department, but clinical evidence is limited. We aimed to compare the outcomes of emergent laparoscopic and robotic cholecystectomies in a large real-world database. METHODS: Patients who received emergent laparoscopic or robotic cholecystectomies from 2020 to 2022 were identified from the Intuitive Custom Hospital Analytics database, based on deidentified extraction of electronic health record data from US hospitals. Conversion to open or subtotal cholecystectomy and complications were defined using ICD10 and/or CPT codes. Multivariate logistic regression with inverse probability treatment weighting (IPTW) was performed to compare clinical outcomes of laparoscopic versus robotic approach after balancing covariates. Cost analysis was performed with activity-based costing and adjustment for inflation. RESULTS: Of 26,786 laparoscopic and 3,151 robotic emergent cholecystectomy patients being included, 64% were female, 60% were ≥45 years, and 24% were obese. Approximately 5.5% patients presented with pancreatitis, and 4% each presenting with sepsis and biliary obstruction. After IPTW, distributions of all baseline covariates were balanced. Robotic cholecystectomy decreased odds of conversion to open (odds ratio, 0.68; 95% confidence interval, 0.49-0.93; p = 0.035), but increased odds of subtotal cholecystectomy (odds ratio, 1.64; 95% confidence interval, 1.03-2.60; p = 0.037). Surgical site infection, readmission, length of stay, hospital acquired conditions, bile duct injury or leak, and hospital mortality were similar in both groups. There was no significant difference in hospital cost. CONCLUSION: Robotic cholecystectomy has reduced odds of conversion to open and comparable complications, but increased odds of subtotal cholecystectomy compared with laparoscopic cholecystectomy for acute gallbladder diseases. Further work is required to assess the long-term implications of these differences. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

Mild Thrombocytopenia, a Predictor of Outcomes After Laparoscopic Cholecystectomy: Assessment of Surgical Risk in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease.

BACKGROUND: A common cause of mild thrombocytopenia is chronic liver disease, the most common etiology being metabolic dysfunction-associated steatotic liver disease (MASLD). Mild thrombocytopenia is a well-defined, independent marker of hepatic fibrosis in patients with chronic liver disease. Currently, there is a paucity of information available to characterize perioperative risk in patients with MASLD; therefore, the characterization of perioperative morbidity is paramount. We used a platelet threshold of 150×10 9 as a surrogate for fibrosis in patients undergoing laparoscopic cholecystectomy to study its effect on perioperative complications and mortality. PATIENTS AND METHODS: We queried the American College of Surgeons National Surgical Quality Improvement Program database for laparoscopic cholecystectomies occurring from 2005 through 2018. Demographic differences between patients with and without thrombocytopenia were evaluated using the t test or the χ 2 test, whereas adjusted and unadjusted differences in outcome risk were evaluated using log-binomial regression models. RESULTS: We identified 437,630 laparoscopic cholecystectomies of which 6.9% included patients with thrombocytopenia. Patients with thrombocytopenia were more often males, older, and with chronic disease. Patients with thrombocytopenia and higher Aspartate Aminotransferase to Platelet Ratio Index scores had 30-day mortality rates risk ratio of 5.3 (95% CI: 4.8-5.9), with higher complication rates risk ratio of 2.4 (95% CI: 2.3-2.5). The most frequent complications included the need for transfusion, renal, respiratory, and cardiac. CONCLUSIONS: Perioperatively, patients with mild thrombocytopenia undergoing laparoscopic cholecystectomy had higher mortality rates and complications compared with patients with normal platelet counts. Thrombocytopenia may be a promising, cost-effective tool to identify patients with MASLD and estimate perioperative risk, especially if used in high-risk populations.

[Clinical and economic aspects of laparoscopic surgery for acute cholecystitis in delayed presentation]. / Kliniko-ekonomicheskie aspekty laparoskopicheskikh operatsii pri ostrom kholetsistite v usloviyakh pozdnei gospitalizatsii.

OBJECTIVE: To study the clinical and economic features of laparoscopic surgery for acute cholecystitis in delayed presentation. MATERIAL AND METHODS: A prospective non-randomized study (2020-2021) included 101 patients (73.2% (n=74) men and 26.8% (n=27) women, mean age 58±14.9 years) with acute cholecystitis who underwent laparoscopic cholecystectomy. Cost-effectiveness analysis of laparoscopic cholecystectomy at various periods after clinical manifestation was performed. RESULTS: Surgical treatment within 72 hours was performed in 15% (n=16) of cases (group 1), within 4-10 days - in 57.5% (n=58) (group 2), after 10 days - in 26.7% (n=27) of patients (group 3). Overall incidence of postoperative complications was 2.9%, postoperative mortality - 1.9% (two patients died from widespread peritonitis). Surgery time was 70 [65-83], 85 [69-110] and 115 [80-125] min (H=15.55, p<0.001), hospital-stay - 6 [5-7], 9 [7-10] and 11 [7-14] days, respectively (H=21.86, p<0.001). Cost of direct (medical and non-medical) treatment amounted to 29484 [27 509-33 885], 41265 [34 306-48 301] and 50591 [37 069-62 483] rubles, respectively (H=29.71, p<0.001)). CONCLUSION: Delayed hospitalization and surgical treatment of acute cholecystitis after 72 hours are accompanied by higher treatment costs by 29% in the period up to 10 days and by 58% after 10 days. These results require further validation and adjustment in large samples.

Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial): pragmatic, multicentre randomised controlled trial.

OBJECTIVE: To assess the clinical and cost effectiveness of conservative management compared with laparoscopic cholecystectomy for the prevention of symptoms and complications in adults with uncomplicated symptomatic gallstone disease. DESIGN: Parallel group, pragmatic randomised, superiority trial. SETTING: 20 secondary care centres in the UK. PARTICIPANTS: 434 adults (>18 years) with uncomplicated symptomatic gallstone disease referred to secondary care, assessed for eligibility between August 2016 and November 2019, and randomly assigned (1:1) to receive conservative management or laparoscopic cholecystectomy. INTERVENTIONS: Conservative management or surgical removal of the gallbladder. MAIN OUTCOME MEASURES: The primary patient outcome was quality of life, measured by area under the curve, over 18 months using the short form 36 (SF-36) bodily pain domain, with higher scores (range 0-100) indicating better quality of life. Other outcomes included costs to the NHS, quality adjusted life years (QALYs), and incremental cost effectiveness ratio. RESULTS: Of 2667 patients assessed for eligibility, 434 were randomised: 217 to the conservative management group and 217 to the laparoscopic cholecystectomy group. By 18 months, 54 (25%) participants in the conservative management arm and 146 (67%) in the cholecystectomy arm had received surgery. The mean SF-36 norm based bodily pain score was 49.4 (standard deviation 11.7) in the conservative management arm and 50.4 (11.6) in the cholecystectomy arm. The SF-36 bodily pain area under the curve up to 18 months did not differ (mean difference 0.0, 95% confidence interval -1.7 to 1.7; P=1.00). Conservative management was less costly (mean difference -£1033, (-$1334; -€1205), 95% credible interval -£1413 to -£632) and QALYs did not differ (mean difference -0.019, 95% credible interval -0.06 to 0.02). CONCLUSIONS: In the short term (≤18 months), laparoscopic surgery is no more effective than conservative management for adults with uncomplicated symptomatic gallstone disease, and as such conservative management should be considered as an alternative to surgery. From an NHS perspective, conservative management may be cost effective for uncomplicated symptomatic gallstone disease. As costs, complications, and benefits will continue to be incurred in both groups beyond 18 months, future research should focus on longer term follow-up to establish effectiveness and lifetime cost effectiveness and to identify the cohort of patients who should be routinely offered surgery. TRIAL REGISTRATION: ISRCTN registry ISRCTN55215960.

Factors influencing delayed discharge after day-surgery laparoscopic cholecystectomy: the DeDiLaCo study protocol.

OBJECTIVE: Laparoscopic cholecystectomy (LC) is the gold standard for most benign gallbladder diseases. Early discharge (<24 hours) has the same outcomes as longer (>24 hours) hospital stay. Nevertheless, the rate of delayed discharge >24 hours range from 4.6% to 37%. The primary endpoint of this Italian nationwide study is to analyze the prevalence of patients undergoing elective LC who experienced a delayed discharge >24 hours and identify potential limiting factors of early discharge. Results from these analyses will be used to select patients who can be safely discharged on the same day after surgery. Secondary endpoints will be to evaluate the patient's quality of life (QoL), assess the direct health costs associated with late discharge, and quantify the patient's involvement in the treatment process. PATIENTS AND METHODS: This prospective, observational study was conducted following a resident-led model and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. All patients were treated according to the local hospital protocol and received routine care as standard therapy. RESULTS: We expected to obtain the enrollment of at least 500 patients based on an assumed difference in discharge delay between the reference and the recruitable population of 6% and the identification of factors related to discharge failure within 24 h. Early discharge after LC leads to advantages both in terms of clinical outcomes and quality of life of the patient, and it is highly effective in terms of health costs and shortening the waiting list. However, clinical reality differs from the results of randomized studies by a complex series of non-objectionable real-world data influencing treatment plans. Therefore, we expected to identify independent predictors and factors of failure of early discharge. CONCLUSIONS: Clinical reality often differs from randomized trial results. In Italy, the vast majority of delayed discharges after LC may not be related to surgery and can be prevented both with logistical reorganization and with a readjustment of the trust reimbursement policies.

Comparative Safety of Robotic-Assisted vs Laparoscopic Cholecystectomy.

Importance: Robotic-assisted cholecystectomy is rapidly being adopted into practice, partly based on the belief that it offers specific technical and safety advantages over traditional laparoscopic surgery. Whether robotic-assisted cholecystectomy is safer than laparoscopic cholecystectomy remains unclear. Objective: To determine the uptake of robotic-assisted cholecystectomy and to analyze its comparative safety vs laparoscopic cholecystectomy. Design, Setting, and Participants: This retrospective cohort study used Medicare administrative claims data for nonfederal acute care hospitals from January 1, 2010, to December 31, 2019. Participants included 1 026 088 fee-for-service Medicare beneficiaries 66 to 99 years of age who underwent cholecystectomy with continuous Medicare coverage for 3 months before and 12 months after surgery. Data were analyzed August 17, 2022, to June 1, 2023. Exposure: Surgical technique used to perform cholecystectomy: robotic-assisted vs laparoscopic approaches. Main Outcomes and Measures: The primary outcome was rate of bile duct injury requiring definitive surgical reconstruction within 1 year after cholecystectomy. Secondary outcomes were composite outcome of bile duct injury requiring less-invasive postoperative surgical or endoscopic biliary interventions, and overall incidence of 30-day complications. Multivariable logistic analysis was performed adjusting for patient factors and clustered within hospital referral regions. An instrumental variable analysis was performed, leveraging regional variation in the adoption of robotic-assisted cholecystectomy within hospital referral regions over time, to account for potential confounding from unmeasured differences between treatment groups. Results: A total of 1 026 088 patients (mean [SD] age, 72 [12.0] years; 53.3% women) were included in the study. The use of robotic-assisted cholecystectomy increased 37-fold from 211 of 147 341 patients (0.1%) in 2010 to 6507 of 125 211 patients (5.2%) in 2019. Compared with laparoscopic cholecystectomy, robotic-assisted cholecystectomy was associated with a higher rate of bile duct injury necessitating a definitive operative repair within 1 year (0.7% vs 0.2%; relative risk [RR], 3.16 [95% CI, 2.57-3.75]). Robotic-assisted cholecystectomy was also associated with a higher rate of postoperative biliary interventions, such as endoscopic stenting (7.4% vs 6.0%; RR, 1.25 [95% CI, 1.16-1.33]). There was no significant difference in overall 30-day complication rates between the 2 procedures. The instrumental variable analysis, which was designed to account for potential unmeasured differences in treatment groups, also showed that robotic-assisted cholecystectomy was associated with a higher rate of bile duct injury (0.4% vs 0.2%; RR, 1.88 [95% CI, 1.14-2.63]). Conclusions and Relevance: This cohort study's finding of significantly higher rates of bile duct injury with robotic-assisted cholecystectomy compared with laparoscopic cholecystectomy suggests that the utility of robotic-assisted cholecystectomy should be reconsidered, given the existence of an already minimally invasive, predictably safe laparoscopic approach.

Incidence and management of choledocholithiasis on routine intraoperative cholangiogram: a 5-year tertiary centre experience.

BACKGROUND: The incidence of choledocholithiasis on routine intraoperative cholangiogram (IOC) during cholecystectomy is approximately 12%. Cholecystectomy without IOC may lead to undiagnosed choledocholithiasis placing patients at risk of complications such as pancreatitis or cholangitis. This study aims to determine the incidence of choledocholithiasis intraoperatively as well as the associated risk factors and the methods of management. METHODS: A retrospective observational analysis of all laparoscopic cholecystectomies with IOC at the Gold Coast Hospital and Health Service from 1 January 2016 to 2 December 2021 was carried out. Patient demographics, operative data and cholangiogram findings were collected from electronic medical systems. RESULTS: A total of 3904 cholecystectomies were carried out over the study period. 3520 (90.1%) had an IOC, and 474 (13.4%) had positive IOC findings. 158 (33.3%) of the cases were managed intraoperatively with hyoscine butylbromide with or without intravenous glucagon followed by biliary tree flushing alone, 183 (38.6%) received transcystic bile duct exploration (TCBDE) with a success rate of 83% and 167 (35.2%) received endoscopic retrograde cholangiopancreatography (ERCP). Choledocholithiasis was incidental in 44 (9.28%) patients. CONCLUSION: Incidental choledocholithiasis during routine IOC is not uncommon. Management predominantly includes intraoperative TCBDE or postoperatively via an ERCP. This study has not found reliable preoperative factors to predict choledocholithiasis based on preoperative clinical, radiological and biochemical factors. A small proportion of patients received preoperative endoscopic intervention, and the decision-making process requires further investigation.

Outcome assessment of biliary stricture repair following cholecystectomy in a tertiary care centre.

PURPOSE: Bile duct injuries (BDIs) are the potential grievous complications of cholecystectomy that result in substantial morbidity and mortality. Outcomes of BDI management depend on multiple factors such as the type and extent of injury, timing of repair, and surgical expertise. The present retrospective study was conducted to analyse the risk factors associated with the BDI repair outcomes. METHODS: The data of patients having primary or recurrent bile duct stricture following BDI from 1985 to 2018 were retrospectively evaluated. RESULTS: A total of 268 patients underwent hepaticojejunostomy (HJ). Of the total, 218 patients had primary bile duct stricture, and 50 patients had HJ stricture. The most commonly performed procedure for primary BDI was Roux-en-Y HJ (RYHJ), followed by right hepatectomy, right posterior sectionectomy, and left hepatectomy. All patients with strictured HJ underwent RYHJ, except one who underwent a right hepatectomy. Outcome assessment using the McDonald grading system showed that 62%, 27%, 5%, and 6% of patients with primary bile duct stricture had grade A, grade B, grade C, and grade D complications, respectively, with a mortality rate of 3.21%, whereas 46%, 34%, and 18% patients with strictured HJ had grade A, grade B, and grade C complications, respectively, with a mortality rate of 2%. High-up biliary strictures, early repair, and blood loss > 350 mL are the surrogate markers for failure of repair. CONCLUSION: Management of BDI needs a multidisciplinary approach. The outcomes of both primary biliary stricture and strictured HJ can be improved with management of patients in a tertiary care centre. However, attempts to repair within 2 weeks of injury, Strasberg E4 and E5, and blood loss of > 350 mL may have an adverse effect on the outcome of HJ.

Complications After Inpatient Laparoscopic Cholecystectomy: Effect of Surgeon Experience, Procedure Volume, and Other Surgeon-Based Characteristics.

BACKGROUND: Previous studies have examined how factors such as gender, education, type of training (MD or DO), and experience of the treating surgeon affect patient outcomes. We investigated patient complications after elective laparoscopic cholecystectomy based on surgeon characteristics. METHODS: A Medicare database was used to identify surgeon-specific data. The main outcome measure was the adjusted complication rates (ACR) for individual surgeons as reported by the ProPublica Surgeon Scorecard. Surgeon gender, type of training, medical school rank, years since graduation, procedure volume, and teaching status of the primary hospital affiliation were assessed for any association with increased ACR using logistic regression analysis. We explored the associations among procedure volume, years of experience, and ACR using Spearman correlation. RESULTS: 1107 predominantly male (94.6%) surgeons were included. 94.4% were MDs and 34.5% were affiliated with teaching hospitals. Mean length of practice was 24 ± 9 years, and median surgeon procedure volume was 28 (IQR = 23, 37). Overall median ACR was 4.3%. Multivariate analysis demonstrated that surgeon gender (P = .71), medical school rank, type of training (P = .68), or hospital affiliation (P = .77) did not have a significant impact on ACR. Increased surgeons' years in practice (r = -.028, P = .35) and increased surgeon procedure volume (r = -.021, P = .49) were negatively associated with increased ACR. CONCLUSION: Surgeon gender, type of training, medical school rank, or hospital affiliation had no impact on complications after laparoscopic cholecystectomy. Surgeon experience and procedure volume may have clinical implications for patient outcomes. Further studies to elucidate factors associated with surgeon quality and patient outcomes are necessary.

The effect of surgical strategy in difficult cholecystectomy cases on postoperative complications outcome: a value-based healthcare comparative study.

BACKGROUND: In patients undergoing laparoscopic cholecystectomy (LC) for complicated biliary disease, complication rates increase up to 30%. The aim of this study is to assess the effect of differences in surgical strategy comparing outcome data of two large volume hospitals. METHODS: A prospective database was created for all the patients who underwent a LC in two large volume hospitals between January 2017 and December 2018. In cases of difficult cholecystectomy in clinic A, regular LC or conversion were surgical strategies. In clinic B, laparoscopic subtotal cholecystectomy was performed as an alternative in difficult cases. The difficulty of the cholecystectomy (score 1-4) and surgical strategy (regular LC, subtotal cholecystectomy, conversion) were scored. Postoperative complications, reinterventions, and ICU admission were assessed. For predicting adverse postoperative complication outcomes, uni- and multivariable analyses were used. RESULTS: A total of 2104 patients underwent a LC in the study period of which 974 were from clinic A and 1130 were from clinic B. In total, 368 procedures (17%) were scored as a difficult cholecystectomy. In clinic A, more conversions were performed (4.4%) compared to clinic B (1.0%; p < 0.001). In clinic B, more subtotal laparoscopic cholecystectomies were performed (1.8%) compared to clinic A (0%; p = < 0.001). Overall complication rate was 8.2% for clinic A and 10.2% for clinic B (p = 0.121). Postoperative complication rates per group for regular LC, conversion, and subtotal cholecystectomy in difficult cholecystectomies were 45 (15%), 12 (24%), and 7 (35%; p = 0.035), respectively. The strongest predictor for Clavien-Dindo grade 3-5 complication was subtotal cholecystectomy. CONCLUSION: Surgical strategy in case of a difficult cholecystectomy seems to have an important impact on postoperative complication outcome. The effect of a subtotal cholecystectomy on complications is of great concern.

National trends in cholecystectomies in the US: a 15-year comparison of two surgical approaches.

BACKGROUND: The two approaches for performing cholecystectomy are open and laparoscopic ones. This study aims to characterize national trends of cholecystectomies in the United States (US) and determine differences by approach, age group, primary payer, teaching status and location of healthcare center. METHODS: Retrospective analysis of patients undergoing cholecystectomy was done using the US National Inpatient Sample from 1997 to 2011. Trends in open and laparoscopic cholecystectomy were analyzed, as well as comparison between age groups, primary payer, location and teaching status of hospitals operations were performed at. RESULTS: Around 6 million cholecystectomies performed from 1997 to 2011. The laparoscopic approach was significantly more common than the open (P<0.001). A significant decrease in open cholecystectomies is seen since 1997. Age group of 65-84 had significantly the most cases in the open approach (P<0.001), while in laparoscopic the 18-44 age group had the significantly highest amount (P<0.001). Medicare covered the most cases for open, while private insurance covered the most in the laparoscopic approach. Most cases were performed in urban, private non-profit, non-teaching hospitals in both groups. In the laparoscopic group the South had a significantly higher (P<0.001) number of cases compared to all other US regions. CONCLUSIONS: Cholecystectomies remained constant from 1997 to 2011. The number of open cholecystectomies decreased over time in favor of laparoscopic ones. More funding should be given to private non-teaching hospitals as they perform the majority of cholecystectomies nationwide. Better management of cholecystectomy risk factors is needed in the South.

View from the Patient Perspective: Mixed-Methods Analysis of Post-Discharge Virtual Visits in a Randomized Controlled Trial.

BACKGROUND: Virtual visits (VVs) are being used increasingly to provide patient-centered care and have undergone rapid uptake during the COVID-19 pandemic. Our aim was to compare satisfaction and convenience of virtual post-discharge follow-up for surgical patients and qualitatively analyze free-text survey responses in a randomized controlled noninferiority trial. Patient satisfaction with VVs has not been evaluated previously in a randomized controlled trial and few mixed-methods analyses have been done to understand barriers and facilitators to post-discharge visits. STUDY DESIGN: Patients undergoing laparoscopic appendectomy or cholecystectomy were randomized to VV or in-person visit (2:1). Surveys with 11 multiple-choice and 2 open-ended questions evaluated patient satisfaction and convenience. Univariate analysis compared responses to the multiple-choice questions and qualitative content analysis evaluated open-ended responses. RESULTS: Of 442 enrolled patients, 289 completed their postoperative visit and were sent surveys (55% response rate). Patients were categorized as VV (n = 135), crossover (randomized to virtual but completed in-person; n = 53), and in-person visits (n = 101). Patient-reported satisfaction was similar, but convenience was higher for VV patients. Open-ended responses (72 VVs, 14 crossovers, and 41 in-person visits) were qualitatively analyzed. In all groups, patient experience was influenced by quality of care, efficiency, and convenience. Barriers were different for virtual and in-person appointments. CONCLUSIONS: We found that quality of, and access to, care-whether in person or virtual-remained critical components of patient satisfaction. VVs address many barriers associated with in-person visits and were more convenient, but can present additional technological barriers.

When Should We Perform Intraoperative Cholangiography? A Prospective Assessment of 1000 Consecutive Laparoscopic Cholecystectomies.

BACKGROUND: Intraoperative cholangiography (IOC) has been historically used to detect common bile duct (CBD) stones, delineate biliary anatomy, and avoid or promptly diagnose bile duct injuries (BDIs) during laparoscopic cholecystectomy (LC). We aimed to determine the usefulness of routine IOC during LC in an urban teaching hospital. METHODS: A consecutive series of patients undergoing LC with routine IOC from 2016 to 2018 was prospectively analyzed. Primary outcomes of interest were: CBD stones, BDI, and anatomical variations of the biliary tract. Secondary outcomes of interest were: IOC success rate, IOC time, and readmission for residual lithiasis. A comparative analysis was performed between patients with and without preoperative suspicion of CBD stones. RESULTS: A total of 1003 LC were analyzed; IOC was successful in 918 (91.5%) patients. Mean IOC time was 10 (4 to 30) minutes. Mean radiation received by the surgeon per procedure was 0.06 millisieverts (mSv). Normal IOC was found in 856 (93.2%) patients. CBD stones and aberrant biliary anatomy were present in 58 (6.3%) and 4 (0.4%) cases, respectively. Two patients (0.2%) underwent unnecessary CBD exploration because of false-positive IOC. Four patients (0.4%) with normal IOC were readmitted for residual CBD stones. Five (0.5%) minor BDI undetected by the IOC were diagnosed. Patients with preoperative suspicion of CBD stones had significantly higher rates of CBD stones detected on IOC as compared with those without suspicion (23.2% vs. 2.1%, P<0.0001). CONCLUSION: Routine use of IOC resulted in low rates of BDI diagnosis, aberrant biliary anatomy identification and/or CBD stones detection. Selection of patients for IOC, rather than routine use of IOC appears a more reasonable approach.

Intraoperative Time-Out to Promote the Implementation of the Critical View of Safety in Laparoscopic Cholecystectomy: A Video-Based Assessment of 343 Procedures.

BACKGROUND: The critical view of safety (CVS) is poorly adopted in surgical practices, although it is recommended ubiquitously to prevent major bile duct injuries during laparoscopic cholecystectomy (LC). This study aimed to investigate whether performing a short intraoperative time-out can improve CVS implementation. STUDY DESIGN: In this before vs after study, surgeons performing LCs at an academic center were invited to use a 5-second long time-out to verify CVS before dividing the cystic duct (5-second rule). The primary aim was to compare the rate of CVS achievement for LC performed in the year before vs the year after implementation of the 5-second rule. The CVS achievement rate was computed after exclusion of bailout procedures using a mediated video-based assessment made by 2 independent reviewers. Clinical outcomes, LC workflows, and postoperative reports were also compared. RESULTS: Three hundred and forty-three of 381 LC performed between December 2017 and November 2019 (171 before and 172 after implementation of the 5-second rule) were analyzed. The 5-second rule was associated with a significantly increased rate of CVS achievement (15.9% vs 44.1% before vs after the 5-second rule, respectively; p < 0.001). Significant differences were also observed with respect to the rate of bailout procedures (8.2% vs 15.7%; p = 0.04), median time (hours:minutes:seconds) to clip the cystic duct or artery (00:17:26; interquartile range 00:11:48 to 00:28:35 vs 00:23:12; interquartile range 00:14:29 to 00:31:45 duration; p = 0.007), and the rate of postoperative CVS reporting (1.3% vs 28.8%; p < 0.001). Postoperative morbidity was comparable (1.8% vs 2.3%; p = 0.68). CONCLUSIONS: Performing a short intraoperative time-out was associated with an improved CVS achievement rate. Systematic intraoperative cognitive aids should be studied to sustain the uptake of guidelines.

Randomised controlled trial to establish the clinical and cost-effectiveness of expectant management versus preoperative imaging with magnetic resonance cholangiopancreatography in patients with symptomatic gallbladder disease undergoing laparoscopic cholecystectomy at low or moderate risk of common bile duct stones (The Sunflower Study): a study protocol.

INTRODUCTION: Surgery to remove the gallbladder (laparoscopic cholecystectomy (LC)) is the standard treatment for symptomatic gallbladder disease. One potential complication of gallbladder disease is that gallstones can pass into the common bile duct (CBD) where they may remain dormant, pass spontaneously into the bowel or cause problems such as obstructive jaundice or pancreatitis. Patients requiring LC are assessed preoperatively for their risk of CBD stones using liver function tests and imaging. If the risk is high, guidelines recommend further investigation and treatment. Further investigation of patients at low or moderate risk of CBD stones is not standardised, and the practice of imaging the CBD using magnetic resonance cholangiopancreatography (MRCP) in these patients varies across the UK. The consequences of these decisions may lead to overtreatment or undertreatment of patients. METHODS AND ANALYSIS: We are conducting a UK multicentre, pragmatic, open, randomised controlled trial with internal pilot phase to compare the effectiveness and cost-effectiveness of preoperative imaging with MRCP versus expectant management (ie, no preoperative imaging) in adult patients with symptomatic gallbladder disease undergoing urgent or elective LC who are at low or moderate risk of CBD stones. We aim to recruit 13 680 patients over 48 months. The primary outcome is any hospital admission within 18 months of randomisation for a complication of gallstones. This includes complications of endoscopic retrograde cholangiopancreatography for the treatment of gallstones and complications of LC. This will be determined using routine data sources, for example, National Health Service Digital Hospital Episode Statistics for participants in England. Secondary outcomes include cost-effectiveness and patient-reported quality of life, with participants followed up for a median of 18 months. ETHICS AND DISSEMINATION: This study received approval from Yorkshire & The Humber - South Yorkshire Research Ethics Committee. Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN10378861.

Protocol for a randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones (C-Gall trial).

BACKGROUND: Gallstone disease (cholelithiasis) is common. In most people it is asymptomatic and does not require treatment, but in about 20% it can become symptomatic, causing pain and other complications requiring medical attention and/or surgery. A proportion of symptomatic people with uncomplicated gallstone disease do not experience further episodes of pain and, therefore, could be treated conservatively. Moreover, surgery carries risks of perioperative and postoperative complications. METHODS AND ANALYSIS: C-Gall is a pragmatic, multicentre, randomised controlled trial and economic evaluation to assess whether cholecystectomy is cost-effective compared with observation/ conservative management (here after referred to as medical management) at 18 months post-randomisation (with internal pilot). PRIMARY OUTCOME MEASURE: Patient-reported quality of life (QoL) (36-Item Short Form Survey (SF-36) bodily pain domain) up to 18 months after randomisation.The primary economic outcome is incremental cost per quality-adjusted life year gained at 18 months. SECONDARY OUTCOME MEASURES: Secondary outcome measures include condition-specific QoL, SF-36 domains, complications, further treatment, persistent symptoms, healthcare resource use, and costs assessed at 18 and 24 months after randomisation. The bodily pain domain of the SF-36 will also be assessed at 24 months after randomisation.A sample size of 430 participants was calculated. Computer-generated 1:1 randomisation was used.The C-Gall Study is currently in follow-up in 20 UK research centres. The first patient was randomised on 1 August 2016, with follow-up to be completed by 30 November 2021. STATISTICAL ANALYSIS: Statistical analysis of the primary outcome will be intention-to-treat and a per-protocol analysis. The primary outcome, area under the curve (AUC) for the SF-36 bodily pain up to 18 months, will be generated using the Trapezium rule and analysed using linear regression with adjustment for the minimisation variables (recruitment site, sex and age). For the secondary outcome, SF-36 bodily pain, AUC up to 24 months will be analysed in a similar way. Other secondary outcomes will be analysed using generalised linear models with adjustment for minimisation and baseline variables, as appropriate. Statistical significance will be at the two-sided 5% level with corresponding CIs. ETHICS AND DISSEMINATION: The North of Scotland Research Ethics Committee approved this study (16/NS/0053). The dissemination plans include Health Technology Assessment monograph, international scientific meetings and publications in high-impact, open-access journals. TRIAL REGISTRATION NUMBER: ISRCTN55215960; pre-results.

The assessment of the effect of different intraabdominal pressures used for laparoscopic cholecystectomy surgery on optic nerve sheath diameter: a prospective observational cohort study

Background/aim: During laparoscopic cholecystectomy operations, increases in intraabdominal, intrathoracic, and intracranial pressures (ICP) can be seen after pneumoperitoneum created for surgical imaging. Orbital ultrasonography (USG), which has been developed in recent years, is a method that can evaluate the ICP by measuring the optic nerve sheath diameter (ONSD) from the eyeball. In our study, we aimed to evaluate whether different intraabdominal pressure values created during laparoscopic cholecystectomy operations correlate with ICP by measuring ONSD. Materials and methods: The study included a total of 90 patients with American Society of Anesthesiologists (ASA) physical status classification I (ASA I) and II (ASA II) and ages from 18 to 65 years with laparoscopic cholecystectomy planned. After the patients were intubated, at the 5th min, bilateral ONSD measurements were performed. The same measurements were performed at the 15th and 30th min after CO2 insufflation and additionally 10 min after CO2 was released at the end of the operation. During intrabdominal CO2 insufflation, patients with 10 mmHg pressure applied comprised Group 1, patients with 12 mmHg pressure applied comprised Group 2, and patients with 14 mmHg pressure applied comprised Group 3. Results: The study was completed with 89 patients, 51 female and 38 males. One patient was excluded from the study due to erroneous values. The variations in ONSD measured in the right-left eye before pneumoperitoneum and at the 15th and 30th min after abdominal CO2 insufflation were observed to be statistically significant (p < 0.01). In all three groups, the right and left eye ONSD values were not identified to be statistically significantly different (p > 0.01). A significant increase was observed in ONSD values in direct proportion to the increase in intraabdominal pressure in patients undergoing laparoscopic cholecystectomy surgery. Conclusion: USG-guided ONSD measurements appear be a guide to ensure optimization of intraabdominal pressures and safe anesthesia administration for patients, especially those at risk of ICP increase, during laparoscopic surgery.

Attending Surgeons Demonstrate Greater Correlations of Skill Assessment and Anticipation of Adverse Events Than Residents During Laparoscopic Cholecystectomy.

BACKGROUND: Surgical training includes the development of technical and nontechnical skills. While technical skills are more easily quantified, nontechnical skills such as situation awareness (SA) are more difficult to measure and quantify. This study investigated the relationships between different SA elements and expertise. METHODS: Twenty attending and resident surgeons rated their anticipation of an impending adverse event while watching 20 videos of laparoscopic cholecystectomies with and without adverse events. After watching each video, they assessed surgeon skills and self-assessed their anticipation ratings. All participants answered a general confidence questionnaire before and after the study. RESULTS: Videos with adverse events led to significantly higher anticipation of adverse events (P < 0.001), lower surgeon skill rating (P < 0.001), and higher self-assessment in their anticipation ratings (P < 0.001) across both participant groups. General confidence was significantly lower for residents than that for attending surgeons (P < 0.001). Compared with the residents, attendings exhibited stronger and more stable correlations between measurements of SA. When viewing videos with adverse events, attendings showed significantly higher correlation between anticipation of an impending adverse event and skill assessment of the surgeon (P = 0.005). CONCLUSIONS: This study investigated how different elements of SA and their relationships were influenced by experience. The results indicated that attendings had stronger and more stable correlations between SA elements than residents, demonstrating how measurement correlations could be meaningful and sensitive indicators of expertise and autonomy readiness.