Surgical quality assessment of critical view of safety in 283 laparoscopic cholecystectomy videos by surgical residents and surgeons.

INTRODUCTION: Surgical quality assessment has improved the efficacy and efficiency of surgical training and has the potential to optimize the surgical learning curve. In laparoscopic cholecystectomy (LC), the critical view of safety (CVS) can be assessed with a 6-point competency assessment tool (CAT), a task commonly performed by experienced surgeons. The aim of this study is to determine the capability of surgical residents to perform this assessment. METHODS: Both surgeons and surgical residents assessed unedited LC videos using a 6-point CVS, a CAT, using an online video assessment platform. The CAT consists of the following three criteria: 1. clearance of hepatocystic triangle, 2. cystic plate, and 3. two structures connect to the gallbladder, with a maximum of 2 points available for each criterion. A higher score indicates superior surgical performance. The intraclass correlation coefficient (ICC) was employed to assess the inter-rater reliability between surgeons and surgical residents. RESULTS: In total, 283 LC videos were assessed by 19 surgeons and 31 surgical residents. The overall ICC for all criteria was 0.628. Specifically, the ICC scores were 0.504 for criterion 1, 0.639 for criterion 2, and 0.719 for the criterion involving the two structures connected to the gallbladder. Consequently, only the criterion regarding clearance of the hepatocystic triangle exhibited fair agreement, whereas the other two criteria, as well as the overall scores, demonstrated good agreement. In 71% of cases, both surgeons and surgical residents scored a total score either ranging from 0 to 4 or from 5 to 6. CONCLUSION: Compared to the gold standard, i.e., the surgeons' assessments, surgical residents are equally skilled at assessing critical view of safety (CVS) in laparoscopic cholecystectomy (LC) videos. By incorporating video-based assessments of surgical procedures into their training, residents could potentially enhance their learning pace, which may result in better clinical outcomes.

Training in robotic-assisted surgery: a systematic review of training modalities and objective and subjective assessment methods.

INTRODUCTION: The variety of robotic surgery systems, training modalities, and assessment tools within robotic surgery training is extensive. This systematic review aimed to comprehensively overview different training modalities and assessment methods for teaching and assessing surgical skills in robotic surgery, with a specific focus on comparing objective and subjective assessment methods. METHODS: A systematic review was conducted following the PRISMA guidelines. The electronic databases Pubmed, EMBASE, and Cochrane were searched from inception until February 1, 2022. Included studies consisted of robotic-assisted surgery training (e.g., box training, virtual reality training, cadaver training and animal tissue training) with an assessment method (objective or subjective), such as assessment forms, virtual reality scores, peer-to-peer feedback or time recording. RESULTS: The search identified 1591 studies. After abstract screening and full-texts examination, 209 studies were identified that focused on robotic surgery training and included an assessment tool. The majority of the studies utilized the da Vinci Surgical System, with dry lab training being the most common approach, followed by the da Vinci Surgical Skills Simulator. The most frequently used assessment methods included simulator scoring system (e.g., dVSS score), and assessment forms (e.g., GEARS and OSATS). CONCLUSION: This systematic review provides an overview of training modalities and assessment methods in robotic-assisted surgery. Dry lab training on the da Vinci Surgical System and training on the da Vinci Skills Simulator are the predominant approaches. However, focused training on tissue handling, manipulation, and force interaction is lacking, despite the absence of haptic feedback. Future research should focus on developing universal objective assessment and feedback methods to address these limitations as the field continues to evolve.

Impact of 18FFDG-PET/CT and Laparoscopy in Staging of Locally Advanced Gastric Cancer: A Cost Analysis in the Prospective Multicenter PLASTIC-Study.

BACKGROUND: Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging. MATERIALS AND METHODS: In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18FFDG-PET/CT first, then SL, (2) SL only, (3) 18FFDG-PET/CT only, and (4) neither SL nor 18FFDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18FFDG-PET/CT and SL to staging advanced gastric cancer (cT3-4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18FFDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations). RESULTS: 18FFDG-PET/CT costs were €1104 including biopsy/cytology. Bottom-up calculations totaled €1537 per SL. D2-gastrectomy costs were €19,308. Total costs per patient were €18,137 for strategy 1, €17,079 for strategy 2, and €19,805 for strategy 3. If all patients undergo gastrectomy, total costs were €18,959 per patient (strategy 4). Performing SL only reduced costs by €1880 per patient. Adding 18FFDG-PET/CT to SL increased costs by €1058 per patient; IQR €870-1253 in the sensitivity analysis. CONCLUSIONS: For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18FFDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs. TRIAL REGISTRATION: NCT03208621. This trial was registered prospectively on 30-06-2017.

Radiomics for the prediction of a postoperative pancreatic fistula following a pancreatoduodenectomy: A systematic review and radiomic score quality assessment.

BACKGROUND: Postoperative pancreatic fistula (POPF) is a severe complication following a pancreatoduodenectomy. An accurate prediction of POPF could assist the surgeon in offering tailor-made treatment decisions. The use of radiomic features has been introduced to predict POPF. A systematic review was conducted to evaluate the performance of models predicting POPF using radiomic features and to systematically evaluate the methodological quality. METHODS: Studies with patients undergoing a pancreatoduodenectomy and radiomics analysis on computed tomography or magnetic resonance imaging were included. Methodological quality was assessed using the Radiomics Quality Score (RQS) and Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement. RESULTS: Seven studies were included in this systematic review, comprising 1300 patients, of whom 364 patients (28 %) developed POPF. The area under the curve (AUC) of the included studies ranged from 0.76 to 0.95. Only one study externally validated the model, showing an AUC of 0.89 on this dataset. Overall adherence to the RQS (31 %) and TRIPOD guidelines (54 %) was poor. CONCLUSION: This systematic review showed that high predictive power was reported of studies using radiomic features to predict POPF. However, the quality of most studies was poor. Future studies need to standardize the methodology. REGISTRATION: not registered.

Force-based assessment of tissue handling skills in simulation training for robot-assisted surgery.

INTRODUCTION: Although robotic-assisted surgery is increasingly performed, objective assessment of technical skills is lacking. The aim of this study is to provide validity evidence for objective assessment of technical skills for robotic-assisted surgery. METHODS: An international multicenter study was conducted with participants from the academic hospitals Heidelberg University Hospital (Germany, Heidelberg) and the Amsterdam University Medical Centers (The Netherlands, Amsterdam). Trainees with distinctly different levels of robotic surgery experience were divided into three groups (novice, intermediate, expert) and enrolled in a training curriculum. Each trainee performed six trials of a standardized suturing task using the da Vinci Surgical System. Using the ForceSense system, five force-based parameters were analyzed, for objective assessment of tissue handling skills. Mann-Whitney U test and linear regression were used to analyze performance differences and the Wilcoxon signed-rank test to analyze skills progression. RESULTS: A total of 360 trials, performed by 60 participants, were analyzed. Significant differences between the novices, intermediates and experts were observed regarding the total completion time (41 s vs 29 s vs 22 s p = 0.003), mean non zero force (29 N vs 33 N vs 19 N p = 0.032), maximum impulse (40 Ns vs 31 Ns vs 20 Ns p = 0.001) and force volume (38 N3 vs 32 N3 vs 22 N3 p = 0.018). Furthermore, the experts showed better results in mean non-zero force (22 N vs 13 N p = 0.015), maximum impulse (24 Ns vs 17 Ns p = 0.043) and force volume (25 N3 vs 16 N3 p = 0.025) compared to the intermediates (p ≤ 0.05). Lastly, learning curve improvement was observed for the total task completion time, mean non-zero force, maximum impulse and force volume (p ≤ 0.05). CONCLUSION: Construct validity for force-based assessment of tissue handling skills in robot-assisted surgery is established. It is advised to incorporate objective assessment and feedback in robot-assisted surgery training programs to determine technical proficiency and, potentially, to prevent tissue trauma.

Assessment of technical skills based on learning curve analyses in laparoscopic surgery training.

BACKGROUND: Objective force- and motion-based assessment is currently lacking in laparoscopic skills curricula. This study aimed to evaluate the added value of parameter-based assessment and feedback during training. METHODS: Laparoscopy-naïve surgical residents that took part in a 3-week skills training curriculum were included. A box trainer equipped with the ForceSense system was used for assessment of tissue manipulation- (MaxForce) and instrument-handling skills (Path length and Time). Learning curves were established using linear regression tests. Pre- and post-course comparisons indicated the overall progression and were compared to predefined proficiency levels. A post-course survey was carried out to assess face validity. RESULTS: In total, 4,268 trials, executed by 24 residents, were successfully assessed. Median (interquartile range) MaxForce outcomes improved from 2.7 Newton (interquartile range 1.9-3.8) to 1.8 Newton (interquartile range 1.2-2.4) between pre- and post-course assessment (P ≤ .009). Instrument Path length improved from 7,102.2 mm (interquartile range 5,255.2-9,025.9) to 3,545.3 mm (interquartile range 2,842.9-4,563.2) (P ≤.001). Time to execute the task improved from 159.8 seconds (interquartile range 119.8-219.0) to 60.7 seconds (interquartile range 46.0-79.5) (P ≤ .001). The learning curves revealed during what training phase the proficiency benchmarks were reached for each trainee. In the survey outcomes, trainees indicated that this curriculum should be part of a surgical residency program (mean visual analog scale score of 9.2 ± 0.9 standard deviation). CONCLUSION: Force-, motion-, and time-parameters can be objectively measured during basic laparoscopic skills curricula and do indicate progression of skills over time. The ForceSense parameters enable curricula to be designed for specific proficiency-based training goals and offer the possibility for objective classification of the levels of expertise.

Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial.

BACKGROUND: Observational cohort studies have suggested that minimally invasive distal pancreatectomy (MIDP) is associated with better short-term outcomes compared with open distal pancreatectomy (ODP), such as less intraoperative blood loss, lower morbidity, shorter length of hospital stay, and reduced total costs. Confounding by indication has probably influenced these findings, given that case-matched studies failed to confirm the superiority of MIDP. This accentuates the need for multicenter randomized controlled trials, which are currently lacking. We hypothesize that time to functional recovery is shorter after MIDP compared with ODP even in an enhanced recovery setting. METHODS: LEOPARD is a randomized controlled, parallel-group, patient-blinded, multicenter, superiority trial in all 17 centers of the Dutch Pancreatic Cancer Group. A total of 102 patients with symptomatic benign, premalignant or malignant disease will be randomly allocated to undergo MIDP or ODP in an enhanced recovery setting. The primary outcome is time (days) to functional recovery, defined as all of the following: independently mobile at the preoperative level, sufficient pain control with oral medication alone, ability to maintain sufficient (i.e. >50%) daily required caloric intake, no intravenous fluid administration and no signs of infection. Secondary outcomes are operative and postoperative outcomes, including clinically relevant complications, mortality, quality of life and costs. DISCUSSION: The LEOPARD trial is designed to investigate whether MIDP reduces the time to functional recovery compared with ODP in an enhanced recovery setting. TRIAL REGISTRATION: Dutch Trial Register, NTR5188 . Registered on 9 April 2015.

Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial.

BACKGROUND: Currently, a cervical esophagogastric anastomosis (CEA) is often performed after minimally invasive esophagectomy (MIE). However, the CEA is associated with a considerable incidence of anastomotic leakage requiring reintervention or reoperation and moderate functional results. An intrathoracic esophagogastric anastomosis (IEA) might reduce the incidence of anastomotic leakage, improve functional results and reduce costs. The objective of the ICAN trial is to compare anastomotic leakage and postoperative morbidity, mortality, quality of life and cost-effectiveness between CEA and IEA after MIE. METHODS/DESIGN: The ICAN trial is an open randomized controlled multicentre superiority trial, comparing CEA (control group) with IEA (intervention group) after MIE. All patients with esophageal cancer planning to undergo curative MIE are considered for inclusion. A total of 200 patients will be included in the study and randomized between the groups in a 1:1 ratio. The primary outcome is anastomotic leakage requiring reintervention or reoperation, and secondary outcomes are (amongst others) other postoperative complications, new onset of organ failure, length of stay, mortality, benign strictures requiring dilatation, quality of life and cost-effectiveness. DISCUSSION: We hypothesize that an IEA after MIE is associated with a lower incidence of anastomotic leakage requiring reintervention or reoperation than a CEA. The trial is also designed to give answers to additional research questions regarding a possible difference in functional outcome, quality of life and cost-effectiveness. TRIAL REGISTRATION: Netherlands Trial Register: NTR4333 . Registered on 23 December 2013.

Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

BACKGROUND: For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. METHODS: The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. DISCUSSION: In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient. TRIAL REGISTRATION: NCT02248519.