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Feasibility and safety of robotic-assisted total pancreatectomy: a pilot western series.

ABSTRACT: This study was designed to demonstrate non-inferiority of robot-assisted total pancreatectomy (RATP) to open total pancreatectomy (OPT) based on an intention-to-treat analysis, having occurrence of severe post-operative complications (SPC) as primary study endpoint. The two groups were matched (2:1) by propensity scores. Assuming a rate of SPC of 22.5% (non-inferiority margin: 15%; α: 0.05; β: 0.20; power: 80%), a total of 25 patients were required per group. During the study period (October 2008-December 2019), 209 patients received a total pancreatectomy. After application of exclusion and inclusion criteria, matched groups were extracted from an overall cohort of 132 patients (OPT: 107; RATP: 25). Before matching, the two groups were different with respect to prevalence of cardiac disease (24.3% versus 4.0%; p = 0.03), presence of jaundice (45.8% versus 12.0%; p = 0.002), presence of a biliary drainage (23.4% versus 0; p = 0.004), history of weight loss (28.0% versus 8.0%; p = 0.04), and vein involvement (55.1% versus 28.0%) (p = 0.03). After matching, the two groups (OTP: 50; RATP: 25) were well balanced. Regarding primary study endpoint, SPC developed in 13 patients (26.0%) after OTP and in 6 patients (24.0%) after RATP (p = 0.85). Regarding secondary study endpoints, RATP was associated with longer median operating times [475 (408.8-582.5) versus 585 min (525-637.5) p = 0.003]. After a median follow-up time of 23.7 months (10.4-71), overall survival time [22.6 (11.2-81.2) versus NA (27.3-NA) p = 0.006] and cancer-specific survival [22.6 (11.2-NA) versus NA (27.3-NA) p = 0.02] were improved in patients undergoing RATP. In carefully selected patients, robot-assisted total pancreatectomy is non-inferior to open total pancreatectomy regarding occurrence of severe post-operative complications.

SUBMITTER: Kauffmann EF

PROVIDER: S-EPMC8184722 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceRobotic-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.ObjectiveTo determine the uptake of robotic-assisted cholecystectomy and to analyze its comparative safety vs laparoscopic cholecystectomy.Design, setting, and participantsThis 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.ExposureSurgical technique used to perform cholecystectomy: robotic-assisted vs laparoscopic approaches.Main outcomes and measuresThe 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.ResultsA 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 relevanceThis 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.

Project description:BackgroundTotal knee arthroplasty (TKA) with mechanical alignment (MA) aims to achieve neutral limb alignment in all patients, whereas TKA with functional alignment (FA) aims to restore native, patient-specific anatomy and knee kinematics by manipulating bone resections and fine-tuning implant positioning. The objective of this study is to determine the optimal alignment technique in TKA by comparing patient satisfaction, functional outcomes, implant survivorship, complications, and cost-effectiveness in MA TKA versus FA TKA. Robotic technology will be used to execute the planned implant positioning and limb alignment with high-levels of accuracy in all study patients.Methods and analysisThis prospective double-blinded randomised control trial will include 100 patients with symptomatic knee osteoarthritis undergoing primary robotic arm-assisted TKA. Following informed consent, patients will be randomised to MA TKA (the control group) or FA TKA (the investigation group) at a ratio of 1:1 using an online random number generator. Blinded observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to postoperative rehabilitation, clinical progress, functional outcomes, accuracy of implant positioning and limb alignment, gait, implant stability, cost-effectiveness, and complications. A superiority study design will be used to evaluate whether FA TKA provides superior outcomes compared to MA TKA. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Surrey Research Ethics Committee, UK. The study is sponsored by University College London, UK.DiscussionThis is the first study to describe the use of robotic technology to achieve FA TKA, and the only existing clinical trial comparing robotic MA TKA versus robotic FA TKA. The findings of this study will enable an improved understanding of the optimal alignment technique in TKA for achieving high-levels of patient satisfaction, improving functional outcomes, increasing implant survivorship, improving cost-effectiveness, and reducing complications.RegistrationClinical Trials.gov, NCT04092153. Registered on 17 September 2019.

Project description:Purpose Total knee arthroplasty (TKA) is widely recognized as an effective treatment for end-stage knee osteoarthritis (OA). Compared with conventional TKA, robotic-arm assisted TKA may improve patients’ functionality and resulting quality of life by more accurate and precise component placement. Currently, the literature on cost-effectiveness of robotic-arm assisted TKA in the US is limited. The objective of this study was to assess the cost-effectiveness of robotic-arm assisted TKA relative to TKA in the Medicare-aged population including exploring the impact of hospital volume on cost-effectiveness outcomes. Methods We developed a decision-analytic model to evaluate the costs, health outcomes, and incremental cost-effectiveness ratio (ICER) of robotic-arm assisted TKA vs TKA in Medicare population with OA. We evaluated cost-effectiveness at a willingness-to-pay (WTP) threshold of $50,000 per quality-adjusted life-year (QALY). We sourced costs from the literature including episode-of-care (EOC) costs from a Medicare study. We assessed cost-effectiveness of robotic-arm assisted TKA by hospital procedure volume and conducted deterministic (DSA) and probabilistic sensitivity analysis (PSA). Results For the average patient treated in a hospital with an annual volume of 50 procedures, robotic-arm assisted TKA resulted in a total QALY of 6.18 relative to 6.17 under conventional TKA. Total discounted costs per patient were $32,535 and $31,917 for robotic-arm assisted TKA and conventional TKA, respectively. Robotic-arm assisted TKA was cost-effective in the base case with an ICER of $41,331/QALY. In univariate DSA, cost-effectiveness outcomes were most sensitive to the annual hospital procedure volume. Robotic-arm assisted TKA was cost-effective at a WTP of $50,000/QALY only when hospital volume exceeded 49 procedures per year. In PSA, robotic-arm assisted TKA was cost-effective at a $50,000/QALY WTP threshold in 50.4% of 10,000 simulations. Conclusions Despite high robotic purchase costs, robotic-arm assisted TKA is likely to be cost-effective relative to TKA in the Medicare population with knee OA in high-volume hospitals through lowering revision rates and decreasing post-acute care costs. Higher-volume hospitals may deliver higher value in performing in robotic-arm assisted TKA.

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Feasibility and safety of robotic-assisted total pancreatectomy: a pilot western series.

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