Background: Quality of gastric cancer surgery is crucial for favorable prognosis. Generally, prospective trials lack quality control measures. This study assessed surgical quality and a novel D2... Show moreBackground: Quality of gastric cancer surgery is crucial for favorable prognosis. Generally, prospective trials lack quality control measures. This study assessed surgical quality and a novel D2-lymphadenectomy photo-scoring in the LOGICA-trial.Methods: The multicenter LOGICA-trial randomized laparoscopic versus open total/distal D2-gastrectomy for resectable gastric cancer (cT1-4aN0-3M0) in 10 Dutch hospitals. During the trial, two reviewers prospectively analyzed intraoperative photographs of dissected nodal stations for quality control, and provided centers weekly feedback on their D2-lymphadenectomy, as continuous quality-enhancing incentive. After the trial, these photographs were reanalyzed to develop a photo-scoring for future trials, rating the D2-lymphadenectomy dissection quality (optimal-good-suboptimal-unevaluable). Interobserver variability was calculated (weighted kappa). Regression analyses related the photo-scoring to nodal yield, recurrence and 5-years survival.Results: Between 2015 and 2018, 212 patients underwent total/distal D2-gastrectomy (n = 122/n = 90), and 158 (75%) received neoadjuvant chemotherapy. R0-resection rate was 95%. Rate of =15 retrieved lymph nodes was 95%. Moderate agreement was obtained in stations 8 + 9 (? = 0.522), 11p/11d (? = 0.446) and 12a (? = 0.441). Consensus was reached for discordant cases (30%). Stations 8 + 9, 11p/11d and 12a were rated 'optimal' in 76%, 63% and 68%. Laparoscopic photographs could be rated better than open (2% versus 12% 'unevaluable'; 73% versus 50% 'optimal'; p = 0.042). The photo-scoring did not show associations with nodal yield (p = 0.214), recurrence (p = 0.406) and survival (p = 0.988).Conclusions: High radicality and nodal yield demonstrated good quality of D2-gastrectomy. The prospective quality control probably contributed to this. The photo-scoring did not show good performance, but can be refined. Laparoscopic D2-gastrectomy was better suited for standardized surgical photo-evaluation than open surgery. Show less
Meershoek, P.; Kleinjan, G.H.; Willigen, D.M. van; Bauwens, K.P.; Spa, S.J.; Beurden, F. van; ... ; Oosterom, M.N. van 2020
The field of fluorescence-guided surgery builds on colored fluorescent tracers that have become available for different clinical applications. Combined use of complementary fluorescent emissions... Show moreThe field of fluorescence-guided surgery builds on colored fluorescent tracers that have become available for different clinical applications. Combined use of complementary fluorescent emissions can allow visualization of different anatomical structures (e.g. tumor, lymphatics and nerves) in the same patient. With the aim to assess the requirements for multi-color fluorescence guidance under in vivo conditions, we thoroughly characterized two FDA-approved laparoscopic Firefly camera systems available on the da Vinci Si or da Vinci Xi surgical robot. In this process, we studied the cameras' performance with respect to the photophysical properties of the FDA-approved dyes Fluorescein and ICG. Our findings indicate that multi-wavelength fluorescence imaging of Fluorescein and ICG is possible using clinical-grade fluorescence laparoscopes, but critical factors for success include the photophysical dye properties, imaging system performance and the amount of accumulated dye. When comparing the camera performance, the Xi system provided more effective excitation (adaptions in the light source) and higher detection sensitivity (chip-on-a-tip and/or enhanced image processing) for both Fluorescein and ICG. Both systems can readily be used for multi-wavelength fluorescence imaging of Fluorescein and ICG under clinically relevant conditions. With that, another step has been made towards the routine implementation of multi-wavelength image-guided surgery concepts. Show less
Boon, M.; Martini, C.H.; Aarts, L.P.H.J.; Dahan, A. 2019
This thesis assessed methods to identify possible hazards to patient safety of new surgical instruments in minimally invasive surgery, before their introduction in daily clinical practice. Using a... Show moreThis thesis assessed methods to identify possible hazards to patient safety of new surgical instruments in minimally invasive surgery, before their introduction in daily clinical practice. Using a newly developed uterine manipulator and uterine power morcellators as a template, the concepts of a clinically driven approach and a prospective risk inventory were explored. Show less
Intraoperative imaging using near-infrared (NIR) fluorescence is a relatively new technique that can be used to visualize tumor tissue, sentinel nodes and vital anatomical structures. This thesis... Show moreIntraoperative imaging using near-infrared (NIR) fluorescence is a relatively new technique that can be used to visualize tumor tissue, sentinel nodes and vital anatomical structures. This thesis is divided in three parts. In part one the ability to visualize surgical margins using NIR fluorescence imaging is demonstrated. Tumor visualization is established using the clinically approved contrast agent indocyanine green, as well as newly developed tumor targeted probes. The proportion of laparoscopic procedures has steadily increased over the last two decades. A challenging aspect of this conversion to minimal invasive surgery is the lack of tactile information, making it of particular interest for the development and improvement of laparoscopic NIR fluorescence imaging systems. Part two focusses on the clinical implementation of NIR fluorescence guided sentinel lymph node mapping for several indications (e.g. breast, skin and vulvar cancer). Besides visualization of structures that need to be resected (e.g. tumor tissue or sentinel nodes), NIR fluorescence has also the potential to be of value for the identification of structures that should be spared. In part three, we demonstrate the first-in-human application of NIR fluorescence guided ureteral visualization, and also the optimization of bile duct imaging for routine laparoscopic cholecystectomies. Show less
Although hospitals increasingly opt for the laparoscopic over the conventional approach and the decline in diagnostic procedures is well compensated by an increase in numbers of all types of... Show moreAlthough hospitals increasingly opt for the laparoscopic over the conventional approach and the decline in diagnostic procedures is well compensated by an increase in numbers of all types of therapeutic procedures, the implementation of laparoscopic hysterectomy in the Netherlands seems to be hampered and scattered (chapter 2). The majority of hospitals that apply laparoscopic hysterectomy perform only a minority of the total volume of procedures, whereas the minority of hospitals performs a high annual caseload of procedures. From our studies, preference and referral tendencies seem to be suboptimal, despite knowledge indication and advantages of this minimally invasive technique (chapter 4). Gynecologists employed in a hospital that did not perform laparoscopic hysterectomies were much less likely to refer candidates for this procedure, despite basic knowledge about the indication and limitations of the approach. Furthermore, patient related factors, such as body mass index and uterus weight, might play a role in this tendency. The level of experience (expressed in number of laparoscopic hysterectomies performed) did not significantly influence the laparoscopist__s opinion on body mass index, uterus weight and previous abdominal surgery as restrictive characteristics for the laparoscopic approach. Both, performers as well as referring colleagues regarded a high body mass index, big uterus weight and previous abdominal surgery as restricting parameters for the laparoscopic approach. This is worrisome, as we know that the majority of these __challenging__ patients have an uneventful procedure (85%) and especially since there is evidence that the obese patient is better served by a laparoscopic approach than by conventional abdominal surgery. Furthermore, it was shown that with growing popularity of this procedure (half of laparoscopic hysterectomy performing gynecologists had less than five years experience), a steady state of implementation of this advanced laparoscopic surgical procedure has yet not been reached. The Laparoscopic Assisted Vaginal Hysterectomy (LAVH), a variant of laparoscopic hysterectomy, showed to be generally performed by inexperienced surgeons in low volume hospitals, while adverse events and blood loss were increased compared to Total Laparoscopic Hysterectomy (chapter 3 and chapter 5). In our prospective study in 79 surgeons (the LapTop! study), we observed that the success of surgical outcomes was significantly influenced by uterus weight, body mass index, ASA classification and previous abdominal surgeries, next to the type of laparoscopic hysterectomy (chapter 5). Surgical experience also predicted the successful outcome of laparoscopic hysterectomy with respect to blood loss and adverse events. However, also an experience independent surgical skills factor was identified, representing a crucial determinant in measuring quality of surgery. This skills factor was also present in the probability of conversion to laparotomy in the same cohort (chapter 6). The majority of conversions were performed because of strategic considerations, while uncontrollable bleeding was the main adverse event leading to a reactive conversion. A high body mass index and increased uterus weight predicted conversion probability, while experience did not.vaginal and abdominal hysterectomy (chapter 7). Therefore, minimally invasive surgery is not necessarily minimally painful. However, patients in the minimally invasive group reported a steeper decline in pain scores postoperatively. Acquiring and maintaining skills in laparoscopic hysterectomy by mentorship showed to be effective, safe and durable, as indication, operative time and adverse event rates were comparable to those of the mentor in his own hospital during and after completing the mentorship program (chapter 8). Assessment of skills in advanced laparoscopic surgery is increasingly demanded. Prediction of surgical skills based on __in vitro__ box trainers outcomes was not conclusive as surgeons with suboptimal average clinical outcomes could not be indicated by means of a box trainer task (chapter 9). However, __real time__ risk-adjusted clinical monitoring of performance by means of cumulative sum (CUSUM) analysis appeared to be a valuable tool in order to signal derailing performance in a timely fashion (chapter 10). This is paramount, as in laparoscopic hysterectomy no definitive accomplishment of the proficiency curve is foreseen and applying relevant predictors of quality of surgery should guard patient safety. Show less
