STUDY PROTOCOL published: 06 May 2022 doi: 10.3389/fsurg.2022.866041 Cost-Effectiveness of Robotic vs. Laparoscopic Surgery for Different Surgical Procedures: Protocol for a Prospective, Multicentric Study (ROBOCOSTES) Benedetto Ielpo 1*† , Mauro Podda 2† , Fernando Burdio 1 , Patricia Sanchez-Velazquez 1 , Maria-Alejandra Guerrero 1 , Javier Nuñez 3 , Miguel Toledano 4 , Salvador Morales-Conde 5 , Edited by: Julio Mayol 6 , Manuel Lopez-Cano 7 , Eloy Espín-Basany 8 , Gianluca Pellino 8,9 and Ka-Chun Siu, University of Nebraska Medical the ROBOCOSTES Study Collaborators Center, United States 1 Hepato-Biliary and Pancreatic Surgery Unit, Department of Surgery, Hospital del Mar, Barcelona, Spain, 2 Department of Reviewed by: Surgical Science, Emergency Surgery Unit, University of Cagliari, Cagliari, Italy, 3 IVEC (Instituto de Validación de la Eficiencia Christos Kontovounisios, Clínica), Fundación de Investigación HM Hospitales, Madrid, Spain, 4 General Surgery Department, University Hospital Rio Imperial College London, Hortega, Valladolid, Spain, 5 Unit of Innovation in Minimally Invasive Surgery, Department of Surgery, University Hospital United Kingdom Virgen del Rocio, University of Seville, Seville, Spain, 6 Department of Surgery, Hospital Clinico San Carlos, Universidad Argyrios Ioannidis, Complutense de Madrid, Madrid, Spain, 7 Abdominal Wall Surgery Unit, Vall d’Hebron University Hospital, Universitat Athens Medical Group, Greece Autónoma de Barcelona, UAB, Barcelona, Spain, 8 Colorectal Surgery, Vall d’Hebron University Hospital, Universitat Autónoma de Barcelona, UAB, Barcelona, Spain, 9 Department of Advanced Medical and Surgical Sciences, Università degli *Correspondence: Studi della Campania “Luigi Vanvitelli”, Naples, Italy Benedetto Ielpo ielpo.b@gmail.com † These authors have contributed Background: The studies which address the impact of costs of robotic vs. laparoscopic equally to this work and share first approach on quality of life (cost-effectiveness studies) are scares in general surgery. authorship Methods: The Spanish national study on cost-effectiveness differences among robotic Specialty section: and laparoscopic surgery (ROBOCOSTES) is designed as a prospective, multicentre, This article was submitted to national, observational study. The aim is to determine in which procedures robotic Visceral Surgery, a section of the journal surgery is more cost-effective than laparoscopic surgery. Several surgical operations Frontiers in Surgery and patient populations will be evaluated (distal pancreatectomy, gastrectomy, sleeve Received: 30 January 2022 gastrectomy, inguinal hernioplasty, rectal resection for cancer, Heller cardiomiotomy and Accepted: 31 March 2022 Nissen procedure). Published: 06 May 2022 Citation: Discussion: The results of this study will demonstrate which treatment (laparoscopic Ielpo B, Podda M, Burdio F, or robotic) and in which population is more cost-effective. This study will also assess the Sanchez-Velazquez P, Guerrero M-A, Nuñez J, Toledano M, impact of previous surgical experience on main outcomes. Morales-Conde S, Mayol J, Keywords: ROBOCOSTES study protocol robotic surgery, laparoscopic surgery, cost-effectiveness, QALY, Lopez-Cano M, Espín-Basany E, multicenter studies Pellino G and the ROBOCOSTES Study Collaborators (2022) Cost-Effectiveness of Robotic vs. Laparoscopic Surgery for Different BACKGROUND Surgical Procedures: Protocol for a Prospective, Multicentric Study The advantages of minimally invasive approach in general surgery procedures (ROBOCOSTES). have been reported in many studies (1). Robotic surgery provides three- Front. Surg. 9:866041. dimensional vision, seven motion degrees, stable vision, disabling hand’s doi: 10.3389/fsurg.2022.866041 tremor, and a well-established feasibility, safety, and effectiveness profile (1–3). Frontiers in Surgery | www.frontiersin.org 1 May 2022 | Volume 9 | Article 866041 Ielpo et al. ROBOCOSTES Study Protocol While randomized controlled trials and observational studies Indeed, overall costs should include not only operative costs have demonstrated the safety and effectiveness of robotic surgery, but also costs related to the rehabilitation facility, days out of they rarely assess its economic impact on the healthcare system work after surgery and its impact on the quality of life (QoL), compared with the laparoscopic technique (4–7). This needs to which make an exact estimate challenging. Studies which address be addressed but planning such analyses before starting the study the impact of costs of a new technique on QoL are named is essential and most of the times was not properly measured. cost-effectiveness studies. THE RATIONALE FOR THE STUDY CURRENT EVIDENCE The current debate about introducing a new technology mainly Several studies have shown that robotic-assisted surgery concerns its cost-effectiveness (15). Only a cost-effectiveness is associated with higher costs than laparoscopy (6–8). analysis can shed light on uncertainties concerning the economic Contributing factors include purchasing the robot by the impact of robotic vs. laparoscopic surgery. However, reliable, healthcare institution, maintenance costs, disposable materials, prospective, adequately designed cost-effectiveness studies are and longer operative times. These apply to most general still lacking (16–21). surgery procedures; but some organ- and procedure-specific QoL after a surgical procedure can be measured through considerations are needed. different scores (22). In order to conduct cost-effectiveness Regarding distal pancreatectomy, two recent meta-analyses studies, QoL needs to be objectively and consistently measured, aiming to compare the costs of robotic and laparoscopic distal using validated tools. The most used scores to grade QoL are pancreatectomy, demonstrated that the latter seems to contain the generic SF-36 and the EuroQol EQ-5D-5L tests, that can costs, despite some potential technical advantages of the robotic be transformed into QALYs, giving a more objective view of technique (e.g., decreased conversion rate) (8, 9). However, the the patient’s improvement after the planned treatment (health surplus cost of robotic distal pancreatectomy resection might be perspective) (23). reduced given the decrease in hospitalization costs. Apart from prospective series, some studies only used a Regarding rectal surgery, six studies in the literature reported decision-analytic model derived from available literature for on the costs of robotic vs. laparoscopic rectal resection (7, 10– costs, QoL and outcomes (24). However, these results must be 14). According to Morelli et al., hospital costs were slightly higher interpreted with great caution since the insufficient data available in the laparoscopic group, whereas higher operative costs were in the literature imply a high risk of bias. reported in the robotic rectal resection group (11). Baek et al. According to the pyramid of evidence, randomized clinical reported overall costs to be higher in the robotic group, and data trials represent the highest level of study types. However, on hospitalization costs were found to be generally lacking (13). in a surgical setting of robotic vs. laparoscopic approach, Some published result must be interpreted with caution as these trials are difficult to be performed (e.g., expensive, the analysis is based on heterogeneous data with outcomes ethical issue, blinding) and generalized (strict inclusion criteria) conditioned by the lack of an economical standardization of (25). Hence, prospective, adequately designed and conducted reported costs. A study from 2014 reported that robotic-assisted non-randomized clinical trials can provide very clinically colorectal resections had higher total ($5,272 increase, p < relevant information. 0.001) and direct costs ($4,432 increase, p < 0.001), longer A well-designed cost-effectiveness study would answer operating time (39 min, p < 0.001), and were more frequently whether its superiority justifies the higher costs of robotics associated to postoperative bleeding (OR 1.6, p = 0.014) than in terms of gained QoL after surgery. This protocol describes laparoscopic resections. The data source for this study was the study of nationwide assessment of the cost-effectiveness of a United States national inpatient database evaluating a total the laparoscopic vs. robotic approach, which will define which of 17,265 laparoscopic and 744 robotic colorectal resections approach is more convenient for each condition or patient. between 2009 and 2011 (10). However, there were some limitations in this study that may have influenced the results. First, the authors used an administrative database which had the AIMS OF THE STUDY possibility of coding errors. Second, many centers were involved, Primary Aim of the Study which also suggests a high heterogeneity of the techniques in To determine if robotic surgery is more cost-effective than both the laparoscopic and robotic groups, including the type laparoscopic surgery in several surgical conditions and patient of devices, the implementation of hybrid vs. totally robotic populations. The present prospective study will evaluate the techniques, the phase of the learning curve, and patient volume incremental cost per quality-adjusted life year (QALY) gained at the center. Furthermore, some data were missing, such as the from healthcare perspectives. conversion rate. The main reasons why the costs of robotic approach are poorly Secondary Aims of the Study reported in the literature are mainly due to the challenge in their The secondary aim is to explore the difference between groups calculation. If, from one hand, costs associated with the hardware concerning assessment of efficacy (hospital stay, pain, proportion are easy to obtain, the impact of the surgical procedure on overall and time to uptake of chemotherapy), and measures of safety costs is difficult to be quantified. (adverse health events). Frontiers in Surgery | www.frontiersin.org 2 May 2022 | Volume 9 | Article 866041 Ielpo et al. ROBOCOSTES Study Protocol STUDY DESIGN time, blood loss, surgical equipment, number of surgeons), hospital stay (intensive care unit, high dependency unit, ward), The Spanish national study on cost-effectiveness differences complications and associated management (interventions, among robotic and laparoscopic surgery (ROBOCOSTES) is additional imaging, additional hospitalization). This data will designed as a prospective, multicentre, national, observational be entered into an electronic Case Report Form (eCRF) online study conducted in Spain between the 15th of January and the database (CASTOR). 15th of December 2022. Complications will be classified according to the Clavien- Dindo classification of surgical complications (26) and Study Population registered as adverse or serious adverse events. Participants’ Patients are considered eligible to enter the study if they meet the overall morbidity will be assessed using the Comprehensive following inclusion criteria: Complication Index (CCI) (27). The 95% confidence intervals 1. Adults aged ≥18 years of age. (CI) for the difference in the means between the two groups will 2. Consecutive patients undergoing: distal pancreatectomy, be reported as a primary result. Since the CCI is approximately gastrectomy (total and subtotal), sleeve gastrectomy, inguinal normally distributed, the 95% CI can be computed using the hernioplasty with mesh, rectal resection for cancer, Heller normal distribution. Further descriptive measures will be cardiomiotomy and Nissen procedure. reported in terms of mean and standard deviation. 3. Type of disease approachable by both laparoscopic and Missing data will thus be managed depending on the cause of robotic minimal access surgery. missingness. If missingness may directly or indirectly be related to the treatment, it may cause a bias even in the intention-to-treat Exclusion Criteria analysis. In such a situation, the missing data will be reported The following exclusion criteria will apply: in the final report, and missing data in the intention to treat 1. Patients with peritoneal metastases. analysis will be analyzed according to the worst-case scenario 2. Patients with ASA physical status IV-V. method (failure). 3. Emergency surgery: that is required to deal with an acute threat to life. 4. Inability to give written informed consent. DATA COMPLETENESS 5. Surgery for recurrent disease of the included procedure. 6. Palliative surgery: performed only for symptom relief even Questionnaires despite negligible impact on the patient’s survival. All participants will be asked to provide an additional informed consent to receive the validated QoL questionnaires EuroQol EQ- 5D-5LTM (official Spanish version) and will be asked to score QUALITY CONTROL five aspects of health status using the EQ-5DTM questionnaire: Center Registration mobility, self-care, usual activities, pain/complaints, and mood Centers will be allowed to upload data after the registration (anxiety/depression). This questionnaire is considered the most procedure. Local ethics committee approval is needed, and each representative QoL tool for cost-effectiveness studies (28). study local lead will be responsible for local study approval before Patients will receive questionnaires at inclusion, one, and 3 the study start. Each center will register a principal investigator months after surgery, by mail, digitally, or in person, according and a co-investigator for each type of procedure eligible for to their preference. the study. Surgeon Registration Cost Data Invitation emails will be sent to every associated member Data on costs will be collected from the Spanish Hospital by the AEC. Data about hospital characteristics (academic, Costs Network (Red Española de Costes Hospitalarios, RECH teaching, referral, or country hospital, number of beds) https://www.rechosp.org/rech/faces/en/jsf/index.jsp). RECH is and surgical volumes both for robotic and laparoscopic an official Spanish project initiated to obtain an extensive surgery will be registered using a Google Form survey database to provide reliable information on the per-patient cost (Google, Mountain View, California, USA): https://forms.gle/ of hospital care. The RECH database is a healthcare database eHCELgr5nZCRwUgP9. Each surgeon introducing data and that brings together the results of different management efforts participating in the study will be asked about his previous in many Spanish Healthcare System institutions. Overall direct experience in both laparoscopic and robotics concerning the hospital costs will be collected, except for the costs associated selected procedure. with the acquisition or maintenance of the robotic device. Pre- admission charges for screening will not be considered, as these DATA COLLECTION are equal for both surgical techniques. All readmission-related costs will be added to the total hospital expenses. A discount rate Clinical Data of 3% per year will be used to estimate the costs and QALYs, as Clinicians will be requested to register medical data related recommended by health economic guidelines (28). All costs will to surgery (operation equipment, skin-to-skin operating be presented in Euros (exchange rate 2022). Frontiers in Surgery | www.frontiersin.org 3 May 2022 | Volume 9 | Article 866041 Ielpo et al. ROBOCOSTES Study Protocol AUDITING will be performed. For categorical variables, a Chi-square test will be implemented. Results with a P-value lower than 0.05 will be Independent qualified monitors will monitor the study. Data will considered statistically significant. be entered into an electronic eCRF, and after the monitoring, visits will be marked as “complete data.” Monitoring visits will be scheduled according to the number of visits ready for Cost-Effectiveness Analysis The economic evaluation will be performed as cost effectiveness verification. The date of the visit will be agreed upon with centers and cost–utility analyses from a healthcare perspective, with a in advance. Before initiation of the trial, interactive training will time horizon of 3 months. be conducted, and an electronic test database will be created The cost–utility endpoint will be the cost per QALY. The for familiarization with the system and test data entry. Data’s results will be reported in accordance with CHEERS guidelines completeness, validity, and plausibility will be checked at the time (23). Data will be collected in the early post-operative period of of data entry (edit checks) and by using validating programs time (3 months from the surgery) in order to capture as much that generate queries. The completed eCRF must be reviewed as possible only the QoL mainly related to the surgical approach and signed by the investigator named in the trial protocol or a instead of the issues related to all treatment process (adjuvant designated sub-investigator. The investigator or the designated treatment, stoma issues, etc.) which patients are dealing with in a representative will be obliged to complete the eCRF as soon as later period of time. possible after information is collected and to clarify or explain An independent company (Institute for Validation of Clinical the queries. Efficacy - IVEC) will perform the financial analysis, eliminating the risk of an observer bias. SAMPLE SIZE CALCULATION AND A model-based cost-utility analysis estimating mean costs and STATISTICAL METHODS QALYs per patient will be performed. A stochastic cost-utility analysis will be undertaken. The incremental cost-effectiveness Sample Size ratio (ICER) will be estimated using the overall costs of the There are concerns about calculating power and sample size robotic and laparoscopic procedures and QALYs derived from in cost-effectiveness studies (28). Although there is some patient interviews to find the incremental cost per QALYs gained. uncertainty, the Incremental Net Benefit (INB) is a measure that The INB will be calculated to estimate decision-makers is easier to interpret and work with, since a positive INB means maximum willingness to pay (WTP) for a QALY gained. The that the new proposed treatment is cost-effective (29). Medicare INB will be calculated as the mean QALYs per patient multiplied calculations of power and sample size are calculated against by WTP threshold minus the mean cost per patient for the some value of Maximum Willingness to Pay (WTP) for a unit of treatment. The decision rule is to adopt the treatment if the INB treatment effect. The WTP is defined from a societal perspective, > 0, and the alternative with the highest INB represents best value and, although in Spain there is no specific WTP threshold for money. in healthcare, according to the National Institute for Health Care Excellence (NICE) (30) and Spanish Recommendations on Economic Evaluation of Health Technologies (31) we use a WTP Sensitivity Analysis of 20,000 e and 30,000 e per QALY as a threshold, to recognize A sensitivity analysis will be implemented to propagate the which treatment is most cost-effective, as follow: uncertainty of the estimations to the model’s results. We will use a multivariate and stochastic sensitivity analysis performed by INB = [(EffectNew-EffectComparatore) ∗ WTP] 5,000 Monte Carlo simulations. The cost-effectiveness plane will represent all pairs of solutions of the model. −(CostNew-CostComparator) The results of the one-way sensitivity analysis will be reported in the tornado diagram, which depicts graphically how variations This sample size calculation was realized with consultation of in each input affect the outcome. In addition, the 95% CI intervals two statisticians. around the base case values will be derived using the 2.5 and 97.5 Considering previous retrospective reports on cost- percentiles calculated from the sensitivity analysis. effectiveness studies (16–21) in which a minimum of 3,000 The tornado diagram will be stacked in order of decreasing e for QALY gained was considered cost-effective, assuming a 5% width, indicating that variations in inputs near the top lost-to-follow-up-rate and the two-sided significance level (α) set (Total Costs of Robotics procedures) have the most significant at 5% and power (1-β) at 80%, a minimum total of 60 patients effect on the outcome, while variations in inputs near the need to be allocated in each procedure group comparison (30 bottom (QALYs discount rate) have relatively small effects on laparoscopic vs. 30 robotic). the outcome. Statistical Method Data will be analyzed using the SPSS statistical program (SPSS Acceptability Curve Inc. Chicago, IL, USA). In order to compare the means of the The analysis will also include a cost-effectiveness acceptability quantitative variables when these followed a normal distribution, curve that plots the probability that the robotic technique is cost- a variance analysis and Student’s t-test will be used. For the rest of effective relative to laparoscopy over a reasonable range of levels the variables, both the Mann-Whitney and Kruskal-Wallis tests of WTP. Frontiers in Surgery | www.frontiersin.org 4 May 2022 | Volume 9 | Article 866041 Ielpo et al. ROBOCOSTES Study Protocol Although there is no specific willingness to pay threshold ETHICS STATEMENT in healthcare in Spain, as described above, according to the National Institute for Health Care Excellence (NICE) (30) and the The studies involving human participants were reviewed and Spanish Recommendations on Economic Evaluation of Health approved by IMIM. The patients/participants provided their Technologies (31) a WTP of 20,000 e and 30,000 e per QALY written informed consent to participate in this study. will be used as a threshold to recognize which treatment is most cost-effective. AUTHOR CONTRIBUTIONS METHODS FOR MINIMIZING BIAS BI contributed to conception and design of the study. GP, MP, FB, and PS-V organized the database. BI, JN, and MT wrote the The number of patients screened, the number included, and those first draft of the manuscript. SM-C, JM, ML-C, and EE-B wrote analyzed will be reported, and differences will be explained. In sections of the manuscript. All authors contributed to manuscript addition, the patient flow and the Consolidated Standards of revision, read, and approved the submitted version. Reporting Trials (CONSORT) flowchart will be reported in the final analysis (32). FUNDING In addition, analysis will be stratified according to each surgeon’s previous experience before starting the study, type of Project PI20/00008, funded by Instituto de Salud Carlos III hospital (public, university) and total number of beds. (ISCIII) and co-funded by the European Union. INTERIM ANALYSIS ACKNOWLEDGMENTS An interim analysis of the primary outcome will be performed The authors thank the Spanish Association of Surgeons (AEC), after inclusion of 50% of the sample. which funded this study with its budget. ROBOCOSTES STUDY COLLABORATORS ETHICS Research Ethics Approval Dulce Momblan, Sandra Castro Boix, Esteban Cugat, pardo, The study has been registered in ClinicalTrials.gov (ID Marcel Pujadas, Rosa Jorba, Juan Bellido Luque, Carmen Cagigas, NCT04861974). The Local Ethical Committee of the Jacobo Trebol, Juan Carlos Martín del Olmo, Helena Álvarez Coordinating Center (Parc Salut Mar Hospital, Barcelona) García, José Herreros Rodríguez, Silva Fernández, Luis Sanchez has approved this study with the code: 2020/9514/I and Guillen, José Francisco Noguera Aguilar, Raquel Sánchez Santos, institutional review boards of the participating centers will be Juan José Segura Sampedro, Ma Asuncion Acosta Mérdia, requested to provide their approval. Furthermore, the study is Iván Jesús Arteaga González, Irene Ortega Vázquez, Mario approved by the Spanish Surgical Association committee which Álvarez Gallego, Emilio Vicente, Sagrario Martinez Cortijo, funded this study with its budget. Sergio Pedro Olivares Pizarro, David Fernandez Luengas, David Alías Jiménez, Carolina González-Abós, Amaia Gantxegi, Clara Consent and Assent Codony Bassols, Isaias Alarcon del Agua, Carlos Rafael Díaz Informed consent will be obtained by the treating surgeons in Maag, Aroa Abascal Amo, Carlos Jezieniecki Fernández, David each participating center. In addition, patients will be allowed Pacheco Sánchez, Julián García Orozco, Beatriz Guil Ortiz, to provide separate permission for collecting blood and/or Manuel Alberto Lasaia, Raquel Ríos, Jorge Zárate Gómez, tissue samples for translational research and for receiving the Gustavo Díaz García, Víctor Rodrígues, Guillermo Ais Conde, QoL questionnaires. Esther Ferrero Celemín, Santiago Linacero, Miguel Josa, Marta Pascual, Miquel Kraft Carré, Pere Planellas Giné, Javier Sánchez Confidentiality González, Alberto Rojo López, Rita Medina Quintana, Ana Individual patient information obtained from this study Pilar Morante, Fabio Ausania, Elisabeth Pando, Santiago López- will be considered confidential, and their handling will Ben, Ángel Cuadrado García, José Antonio Pereira, Alex Bravo, conform with the Spanish policy on data protection. In Juan Beltrán de Heredia Rentería, Daniel Sánchez López, Anna addition, patients’ confidentiality will be ensured by using Casajoana, Ramón Vilallonga Puy, Luis García Sancho, María study numbers. Hernández O‘Reilly, and José María Gil López. REFERENCES 2. Flynn J, Larach JT, Kong JCH, Waters PS, Warrier SK, Heriot A. The learning curve in robotic colorectal surgery compared with laparoscopic 1. Roh HF, Nam SH, Kim JM. Robot-assisted laparoscopic colorectal surgery: a systematic review. Colorectal Dis. (2021) 23:2806−2820. surgery vs. conventional laparoscopic surgery in randomized doi: 10.1111/codi.15843 controlled trials: a systematic review and meta-analysis. 3. Chan KS, Wang ZK, Syn N, Goh BKP. Learning curve of laparoscopic and PLoS ONE. (2018) 13:e0191628. doi: 10.1371/journal.pone.01 robotic pancreas resections: a systematic review. Surgery. (2021) 170:194−206. 91628 doi: 10.1016/j.surg.2020.11.046 Frontiers in Surgery | www.frontiersin.org 5 May 2022 | Volume 9 | Article 866041 Ielpo et al. ROBOCOSTES Study Protocol 4. Ziogas IA, Evangeliou AP, Mylonas KS, Athanasiadis DI, Cherouveim P, Geller 21. Ferri V, Quijano Y, Nu, N J, Caruso R, Duran H, et al. Robotic- DA, et al. Economic analysis of open vs. laparoscopic vs. robotic hepatectomy: assisted right colectomy vs. laparoscopic approach: case-matched a systematic review and meta-analysis. Eur J Health Econ. (2021) 22:585−604. study and cost-effectiveness analysis. J Robot Surg. (2021) doi: 10.1007/s10198-021-01277-1 15:115−123 Surgdoi: 10.1007/s11701-020-01084-5 5. Gavriilidis P, Roberts KJ, Aldrighetti L, Sutcliffe RP, A. comparison 22. Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing between robotic, laparoscopic and open hepatectomy: a systematic review of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. (2011) and network meta-analysis. Eur J Surg Oncol. (2020) 461214−1224. 20:1727–727. doi: 10.1007/s11136-011-9903-x doi: 10.1016/j.ejso.2020.03.227 23. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et 6. Ielpo B, Nulpo B, NuID: J, Diago MV, Hidalgo algQuijano Y, Vicente E. The al. Consolidated health economic evaluation reporting standards (CHEERS) issue of the cost of robotic distal pancreatectomies. Hepatobiliary Surg Nutr. statement. BMJ. (2013) 346:f1049. doi: 10.1136/bmj.f1049 (2019) 8:655−658. doi: 10.21037/hbsn.2019.09.23 24. Simianu VV, Gaertner WB, Kuntz K, Kwaan MR, Lowry AC, Madoff RD, et al. 7. Ielpo B, Duran H, Diaz E, Fabra I, Caruso R, Malava L, et al. Cost-effectiveness evaluation of laparoscopic vs. robotic minimally invasive Robotic vs. laparoscopic surgery for rectal cancer: a comparative study of colectomy. Ann Surg. (2020) 272:334. doi: 10.1097/SLA.0000000000003196 clinical outcomes and costs. Int J Colorectal Dis. (2017) 32:1423−1429. 25. Pellino G, Harrison EM, Biondo S, Espin-Basany E. El doi: 10.1007/s00384-017-2876-7 estudio observacional en investigaciones quirúrgicas. Cir Esp. 8. Di Martino M, Caruso R, D’Ovidio A, NA, Ndio A, N J, et al. Robotic (2021). doi: 10.1016/j.ciresp.2021.11.008. [Epub ahead of print]. vs. laparoscopic distal pancreatectomies: a systematic review and meta- 26. Dindo D, Demartines N, Clavien PA. Classification of surgical com- analysis on costs and perioperative outcome. Int J Med Robot. (2021) plications: a new proposal with evaluation in a cohort of 6,336 17:e2295. doi: 10.1002/rcs.2295 patients and results of a survey. Ann Surg. (2004) 240:205–13. 9. Partelli S, Ricci C, Cinelli L, Montorsi RM, Ingaldi C, Andreasi V, et al. doi: 10.1097/01.sla.0000133083.54934.ae Evaluation of cost-effectiveness among open, laparoscopic and robotic distal 27. Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive pancreatectomy: a systematic review and meta-analysis. Am J Surg. (2021) complication index: a novel continuous scale to measure surgical morbidity. 222:513−520. doi: 10.1016/j.amjsurg.2021.03.066 Ann Surg. (2013) 258:1–7. doi: 10.1097/SLA.0b013e318296c732 10. Keller DS, Senagore AJ, Lawrence JK, et al. Comparative effectiveness 28. Gomes M, Ng ES, Grieve R, Nixon R, Carpenter J, Thompson of laparoscopic vs. robot-assisted colorectal resection. Surg Endosc. SG. l. Developing appropriate methods for cost- effectiveness (2014) 28:212. doi: 10.1007/s00464-013-3163-5 analysis of cluster randomised trials. Med Decis Making. (2012) 11. Morelli L, Guadagni S, Lorenzoni V, et al. Robot-assisted versus laparoscopic 32:350–61. doi: 10.1177/0272989X11418372 rectal resection for cancer in a single surgeon’s experience: a cost analysis 29. Willan AR. Sample size determination for cost- covering the initial 50 robotic cases with the da Vinci Si. Int J Colorectal Dis. effectiveness trials. Pharmacoeconomics. (2011) 29933−9949. (2016) 31:1639−1648. doi: 10.1007/s00384-016-2631-5 doi: 10.2165/11587130-000000000-00000 12. Bertani E, Chiappa A, Biffi R, et al. Assessing appropriateness and quality- 30. National Institute for Health and Care Excellence (NICE). Developing NICE of-life short-term outcomes employing different treatment approaches. Int J Guidelines: The Manual. (2014). Available online at: https://www.nice.org.uk/ Colorectal Dis. (2011) 26:1317–317. doi: 10.1007/s00384-011-1270-0 process/pmg20/chapter/introduction-and-overview 13. Baek SJ, Kim SH, Cho JS, Shin JW, Kim J. Robotic vs. conventional 31. López-Bastida J, Oliva J, AntoOliva F, GarcGarca J, A, Gisbert R, et al. Spanish laparoscopic surgery for rectal cancer: a cost analysis from a single institute recommendations on economic evaluation of health technologies. Euro J in Korea. World J Surg. (2012) 36:2722–9. doi: 10.1007/s00268-012-1728-4 Health Eco. (2010) 11:513–20. doi: 10.1007/s10198-010-0244-4 14. Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, et al. 32. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman Effect of robotic-assisted vs conventional laparoscopic surgery on risk of DG, et al. for reporting randomized controlled trials in journal and conversion to open laparotomy among patients undergoing resection for conference abstracts: explanation and elaboration. PLoS Med. (2008) rectal cancer: the ROLARR randomized clinical trial. JAMA. (2017) 318:1569– 5:e20. doi: 10.1371/journal.pmed.0050020 80. doi: 10.1001/jama.2017.7219 15. Knocke K, Wagner TW. The evolving economics of implementation. BMJ Conflict of Interest: The authors declare that the research was conducted in the Qual Saf. (2021). doi: 10.1136/bmjqs-2021-014411 absence of any commercial or financial relationships that could be construed as a 16. Ielpo B, Nulpo B, Nus-o J, Duran H, Diaz E, Fabra I, et al. Cost-effectiveness potential conflict of interest. of randomized study of laparoscopic vs. open bilateral inguinal hernia repair. Ann Surg. (2018) 268:725–730. doi: 10.1097/SLA.0000000000002894 Publisher’s Note: All claims expressed in this article are solely those of the authors 17. Vicente E, Nicente E, N00 J, Ielpo B, Ferri V, et al. cost-effectiveness analysis and do not necessarily represent those of their affiliated organizations, or those of of robotic vs. laparoscopic distal pancreatectomy. Int J Med Robot. (2020) the publisher, the editors and the reviewers. Any product that may be evaluated in 16:e2080. doi: 10.1002/rcs.2080 this article, or claim that may be made by its manufacturer, is not guaranteed or 18. Quijano Y, Nu, Nuo Y, Nu. J, Ielpo B, Ferri V, Caruso R, Dur C H, et al. Robotic vs. laparoscopic surgery for rectal cancer: a comparative cost-effectiveness endorsed by the publisher. study. Tech Coloproctol. (2020) 24:247–254. doi: 10.1007/s10151-020-02151-7 19. Caruso R, Vicente E, Naruso R, Vice J, Ferri V, et al. Robotic-assisted Copyright © 2022 Ielpo, Podda, Burdio, Sanchez-Velazquez, Guerrero, Nuñez, gastrectomy compared with open resection: a comparative study of clinical Toledano, Morales-Conde, Mayol, Lopez-Cano, Espín-Basany, Pellino and the outcomes and cost-effectiveness analysis. J Robot Surg. (2020) 14:627-632. ROBOCOSTES Study Collaborators. This is an open-access article distributed doi: 10.1007/s11701-019-01033-x under the terms of the Creative Commons Attribution License (CC BY). The use, 20. De Pastena M, Esposito A, Paiella S, Surci N, Montagnini G, Marchegiani G, distribution or reproduction in other forums is permitted, provided the original et al. Cost-effectiveness and quality of life analysis of laparoscopic and robotic author(s) and the copyright owner(s) are credited and that the original publication distal pancreatectomy: a propensity score-matched study. Surg Endosc. (2021) in this journal is cited, in accordance with accepted academic practice. No use, 35:1420–42. doi: 10.1007/s00464-020-07528-1 distribution or reproduction is permitted which does not comply with these terms. Frontiers in Surgery | www.frontiersin.org 6 May 2022 | Volume 9 | Article 866041