Dataset Information

Robotic Versus Open Renal Transplantation in Obese Patients: Protocol for a Cost-Benefit Markov Model Analysis.

ABSTRACT: BACKGROUND:Recent studies have reported a significant decrease in wound problems and hospital stay in obese patients undergoing renal transplantation by robotic-assisted minimally invasive techniques with no difference in graft function. OBJECTIVE:Due to the lack of cost-benefit studies on the use of robotic-assisted renal transplantation versus open surgical procedure, the primary aim of our study is to develop a Markov model to analyze the cost-benefit of robotic surgery versus open traditional surgery in obese patients in need of a renal transplant. METHODS:Electronic searches will be conducted to identify studies comparing open renal transplantation versus robotic-assisted renal transplantation. Costs associated with the two surgical techniques will incorporate the expenses of the resources used for the operations. A decision analysis model will be developed to simulate a randomized controlled trial comparing three interventional arms: (1) continuation of renal replacement therapy for patients who are considered non-suitable candidates for renal transplantation due to obesity, (2) transplant recipients undergoing open transplant surgery, and (3) transplant patients undergoing robotic-assisted renal transplantation. TreeAge Pro 2017 R1 TreeAge Software, Williamstown, MA, USA) will be used to create a Markov model and microsimulation will be used to compare costs and benefits for the two competing surgical interventions. RESULTS:The model will simulate a randomized controlled trial of adult obese patients affected by end-stage renal disease undergoing renal transplantation. The absorbing state of the model will be patients' death from any cause. By choosing death as the absorbing state, we will be able simulate the population of renal transplant recipients from the day of their randomization to transplant surgery or continuation on renal replacement therapy to their death and perform sensitivity analysis around patients' age at the time of randomization to determine if age is a critical variable for cost-benefit analysis or cost-effectiveness analysis comparing renal replacement therapy, robotic-assisted surgery or open renal transplant surgery. After running the model, one of the three competing strategies will result as the most cost-beneficial or cost-effective under common circumstances. To assess the robustness of the results of the model, a multivariable probabilistic sensitivity analysis will be performed by modifying the mean values and confidence intervals of key parameters with the main intent of assessing if the winning strategy is sensitive to rigorous and plausible variations of those values. CONCLUSIONS:After running the model, one of the three competing strategies will result as the most cost-beneficial or cost-effective under common circumstances. To assess the robustness of the results of the model, a multivariable probabilistic sensitivity analysis will be performed by modifying the mean values and confidence intervals of key parameters with the main intent of assessing if the winning strategy is sensitive to rigorous and plausible variations of those values.

SUBMITTER: Molinari M

PROVIDER: S-EPMC5865002 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Robotic Versus Open Renal Transplantation in Obese Patients: Protocol for a Cost-Benefit Markov Model Analysis.

Molinari Michele M Puttarajappa Chethan C Wijkstrom Martin M Ganoza Armando A Lopez Roberto R Tevar Amit A

JMIR research protocols 20180308 3

<h4>Background</h4>Recent studies have reported a significant decrease in wound problems and hospital stay in obese patients undergoing renal transplantation by robotic-assisted minimally invasive techniques with no difference in graft function.<h4>Objective</h4>Due to the lack of cost-benefit studies on the use of robotic-assisted renal transplantation versus open surgical procedure, the primary aim of our study is to develop a Markov model to analyze the cost-benefit of robotic surgery versus ...[more]

PMID: 29519780

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Project description:INTRODUCTION:Minimally invasive surgery in urology has grown considerably in application since its initial description in the early 1990s. Herein, we present the protocol for a systematic review and meta-analysis comparing open versus robotic urological oncological surgery for various clinically relevant outcomes, as well as to assess their comparative penetrance over the past 20 years (2000-2020). METHODS AND ANALYSIS:We will document the penetrance of robotic versus open surgery in the urological oncological field using a national database.Second, we will perform a systematic review and meta-analysis of all published full-text English and non-English language articles from Pubmed, Scopus and Web of Science search engines on surgical treatment of localised prostate, bladder, kidney and testis cancer published between 1st January 2000 to 10th January 2020. We will focus on the highest-volume urological oncological surgeries, namely, radical prostatectomy, radical cystectomy, partial nephrectomy, radical nephrectomy and retroperitoneal lymph node dissection. Study inclusion criteria will comprise clinical trials and prospective and retrospective studies (cohort or case-control series) comparing robotic versus open surgery. Exclusion criteria will comprise meta-analyses, multiple papers with overalapping study-periods, studies analysing national databases and case series describing only one approach (robotic or open). Risk of bias for included studies will be assessed by the appropriate Cochrane risk of bias tool. Principal outcomes assessed will include perioperative, functional, oncological survival and financial outcomes of open versus robotic uro-oncological surgery. Sensitivity analyses will be performed to correlate outcomes of interest with key baseline characteristics and surrogates of surgical expertise. ETHICS AND DISSEMINATION:This comprehensive systematic review and meta-analysis will provide rigorous, consolidated information on contemporary outcomes and trends of open versus robotic urological oncological surgery based on all the available literature. These aggregate data will help physicians better advise patients seeking surgical care for urological cancers. PROSPERO REGISTRATION NUMBER:CRD42017064958.

Project description:BackgroundPartial pancreatoduodenectomy (PD) is the indicated surgical procedure for a wide range of benign and malignant diseases of the pancreatic head and distal bile duct and offers the only potential cure for pancreatic head cancer. The current gold standard, open PD (OPD) performed via laparotomy, is associated with morbidity in around 40% of cases, even at specialised centres. Robotic PD (RPD) might offer a viable alternative to OPD and has been shown to be feasible. Encouraging perioperative results have been reported for RPD in a number of small, non-randomised studies. However, since those studies showed a considerable risk of bias, a thorough comparison of RPD with OPD is warranted.MethodsThe EUROPA (EvalUation of RObotic partial PAncreatoduodenectomy) trial is designed as a randomised controlled unblinded exploratory surgical trial with two parallel study groups. A total of 80 patients scheduled for elective PD will be randomised after giving written informed consent. Patients with borderline or non-resectable carcinoma of the pancreatic head as defined by the National Comprehensive Cancer Network guidelines, distant metastases or an American Society of Anaesthesiologists (ASA) score > III will be excluded. The experimental intervention, RPD, will be compared with the control intervention, OPD. An intraoperative dropout of approximately eight patients per group is expected because they may receive another type of surgical procedure than planned. Overall, 64 patients need to be analysed. The primary endpoint of the trial is overall postoperative morbidity within 90 days after index operation, measured using the Comprehensive Complication Index (CCI). The secondary endpoints include the feasibility of recruitment and assessment of clinical, oncological and safety parameters and quality of life and cost-effectiveness.DiscussionThe EUROPA trial is the first randomised controlled trial comparing RPD with OPD. Differences in postoperative morbidity will be evaluated to design a future multicentre confirmatory efficacy trial.Trial registrationGerman Clinical Trial Register DRKS00020407 . Registered on 9 March 2020.

Dataset Information

Robotic Versus Open Renal Transplantation in Obese Patients: Protocol for a Cost-Benefit Markov Model Analysis.

Publications

Robotic Versus Open Renal Transplantation in Obese Patients: Protocol for a Cost-Benefit Markov Model Analysis.

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