Background: The timing and degree of implementation of minimally invasive surgery (MIS) for colorectal cancer vary among countries. Insights in national differences regarding implementation of new... Show moreBackground: The timing and degree of implementation of minimally invasive surgery (MIS) for colorectal cancer vary among countries. Insights in national differences regarding implementation of new surgical techniques and the effect on postoperative outcomes are important for quality assurance, can show potential areas for country-specific improvement, and might be illustrative and supportive for similar implementation programs in other countries. Therefore, this study aimed to evaluate differences in patient selection, applied techniques, and results of minimal invasive surgery for colorectal cancer between the Netherlands and Sweden. Methods: Patients who underwent elective minimally invasive surgery for T1-3 colon or rectal cancer (2012-2018) registered in the Dutch ColoRectal Audit or Swedish ColoRectal Cancer Registry were included. Time trends in the application of MIS were determined. Outcomes were compared for time periods with a similar level of MIS implementation (Netherlands 2012-2013 versus Sweden 2017-2018). Multilevel analyses were performed to identify factors associated with adverse short-term outcomes.Results: A total of 46,095 Dutch and 8,819 Swedish patients undergoing MIS for colorectal cancer were included. In Sweden, MIS implementation was approximately 5 years later than in the Netherlands, with more robotic surgery and lower volumes per hospital. Although conversion rates were higher in Sweden, oncological and surgical outcomes were comparable. MIS in the Netherlands for the years 2012- 2013 resulted in a higher reoperation rate for colon cancer and a higher readmission rate but lower non- surgical complication rates for rectal cancer if compared with MIS in Sweden during 2017-2018.Conclusion: This study showed that the implementation of MIS for colorectal cancer occurred later in Sweden than the Netherlands, with comparable outcomes despite lower volumes. Our study demonstrates that new surgical techniques can be implemented at a national level in a controlled and safe way, with thorough quality assurance. Show less
Study objective: To assess whether different intensities of intra-abdominal pressure and deep neuromuscular blockade influence the risk of intra-operative surgical complications during laparoscopic... Show moreStudy objective: To assess whether different intensities of intra-abdominal pressure and deep neuromuscular blockade influence the risk of intra-operative surgical complications during laparoscopic donor nephrectomy.Design: A pooled analysis of ten previously performed prospective randomized controlled trials.Setting: Laparoscopic donor nephrectomy performed in four academic hospitals in the Netherlands: Radboudumc, Leiden UMC, Erasmus MC Rotterdam, and Amsterdam UMC.Patients: Five hundred fifty-six patients undergoing a transperitoneal, fully laparoscopic donor nephrectomy enrolled in ten prospective, randomized controlled trials conducted in the Netherlands from 2001 to 2017.Interventions: Moderate (tetanic count of four > 1) versus deep (post-tetanic count 1-5) neuromuscular blockade and standard (>= 10 mmHg) versus low (<10 mmHg) intra-abdominal pressure.Measurements: The primary endpoint is the number of intra-operative surgical complications defined as any deviation from the ideal intra-operative course occurring between skin incision and closure with five severity grades, according to ClassIntra. Multiple logistic regression analyses were used to identify predictors of intra- and postoperative complications.Main results: In 53/556 (9.5%) patients, an intra-operative complication with ClassIntra grade >= 2 occurred. Multiple logistic regression analyses showed standard intra-abdominal pressure (OR 0.318, 95% CI 0.118-0.862; p = 0.024) as a predictor of less intra-operative complications and moderate neuromuscular blockade (OR 3.518, 95% CI 1.244-9.948; p = 0.018) as a predictor of more intra-operative complications. Postoperative complications occurred in 31/556 (6.8%), without significant predictors in multiple logistic regression analyses.Conclusions: Our data indicate that the use of deep neuromuscular blockade could increase safety during laparoscopic donor nephrectomy. Future randomized clinical trials should be performed to confirm this and to pursue whether it also applies to other types of laparoscopic surgery. Show less
Background Robotic surgery may improve surgical performance during minimally invasive pancreatoduodenectomy as compared to 3D- and 2D-laparoscopy but comparative studies are lacking. This study... Show moreBackground Robotic surgery may improve surgical performance during minimally invasive pancreatoduodenectomy as compared to 3D- and 2D-laparoscopy but comparative studies are lacking. This study assessed the impact of robotic surgery versus 3D- and 2D-laparoscopy on surgical performance and operative time using a standardized biotissue model for pancreatico- and hepatico-jejunostomy using pooled data from two randomized controlled crossover trials (RCTs). Methods Pooled analysis of data from two RCTs with 60 participants (36 surgeons, 24 residents) from 11 countries (December 2017-July 2019) was conducted. Each included participant completed two pancreatico- and two hepatico-jejunostomies in biotissue using 3D-robotic surgery, 3D-laparoscopy, or 2D-laparoscopy. Primary outcomes were the objective structured assessment of technical skills (OSATS: 12-60) rating, scored by observers blinded for 3D/2D and the operative time required to complete both anastomoses. Sensitivity analysis excluded participants with excess experience compared to others. Results A total of 220 anastomoses were completed (robotic 80, 3D-laparoscopy 70, 2D-laparoscopy 70). Participants in the robotic group had less surgical experience [median 1 (0-2) versus 6 years (4-12), p < 0.001], as compared to the laparoscopic group. Robotic surgery resulted in higher OSATS ratings (50, 43, 39 points, p = .021 and p < .001) and shorter operative time (56.5, 65.0, 81.5 min, p = .055 and p < .001), as compared to 3D- and 2D-laparoscopy, respectively, which remained in the sensitivity analysis. Conclusion In a pooled analysis of two RCTs in a biotissue model, robotic surgery resulted in better surgical performance scores and shorter operative time for biotissue pancreatic and biliary anastomoses, as compared to 3D- and 2D-laparoscopy. Show less
Wenzel, H.H.B.; Smolders, R.G.V.; Beltman, J.J.; Lambrechts, S.; Trum, H.W.; Yigit, R.; ... ; Aa, M.A. van der 2020
Aim: Recently, the safety of laparoscopic radical hysterectomy (LRH) has been called into question in early-stage cervical cancer. This study aimed to evaluate overall survival (OS) and disease... Show moreAim: Recently, the safety of laparoscopic radical hysterectomy (LRH) has been called into question in early-stage cervical cancer. This study aimed to evaluate overall survival (OS) and disease-free survival (DFS) in patients treated with abdominal radical hysterectomy (ARH) and LRH for early-stage cervical cancer and to provide a literature review.Methods: Patients diagnosed between 2010 and 2017 with International Federation of Gynaecology and Obstetrics (2009) stage IA2 with lymphovascular space invasion, IB1 and IIA1, were identified from the Netherlands Cancer Registry. Cox regression with propensity score, based on inverse probability treatment weighting, was applied to examine the effect of surgical approach on 5-year survival and calculate hazard ratios (HR) and 95% confidence intervals (CIs). Literature review included observational studies with (i) analysis on tumours <4 cm (ii) median follow-up >= 30 months (iii) >= 5 events per predictor parameter in multivariable analysis or a propensity score.Results: Of the 1109 patients, LRH was performed in 33%. Higher mortality (9.4% vs. 4.6%) and recurrence (13.1% vs. 7.3%) were observed in ARH than LRH. However, adjusted analyses showed similar DFS (89.4% vs. 90.2%), HR 0.92 [95% CI: 0.52-1.60]) and OS (95.2% vs. 95.5%), HR 0.94 [95% CI: 0.43-2.04]). Analyses on tumour size (<2/>2 cm) also gave similar survival rates. Review of nine studies showed no distinct advantage of ARH, especially in tumours <2 cm.Conclusion: After adjustment, our retrospective study showed equal oncological outcomes between ARH and LRH for early-stage cervical cancer - also in tumours <2 cm. This is in correspondence with results from our literature review. (C) 2020 The Authors. Published by Elsevier Ltd. Show less
The main objectives of this thesis are to obtain clinically relevant tools to evaluate quality during the introduction of new interventions in laparoscopic hysterectomy (LH) (the most frequently... Show moreThe main objectives of this thesis are to obtain clinically relevant tools to evaluate quality during the introduction of new interventions in laparoscopic hysterectomy (LH) (the most frequently performed advanced gynecological minimally invasive procedure) and to support clinicians to ensure surgical safety by means of process analysis. We performed a Delphi study to achieve consensus on a uniform and multidisciplinary applicable definition. Based on this definition, we described the relevance, evidence and controllability of conversion rate as a means of evaluation in LH. We performed a systematic review with cumulative analysis to evaluate the outcomes of abdominal, laparoscopic and vaginal hysterectomy (VH) in patients with a BMI ≥35kg/m2 and concluded that the feasibility of LH and VH should be considered prior to the abdominal approach to hysterectomy in these patients. Furthermore, we performed a prospective study using video observation, to assess the incidence and effect of equipment-/instrument-related surgical flow disturbances during LH and validated a questionnaire to detect potential safety hazards during the introduction of new interventions in an early stage. Finally, the Digital Operating Room Assistance (DORA) model was introduced which is a novel system for automated procedural progress monitoring that enables prediction of the remaining procedure duration. Show less
Background: Initial staging of gastric cancer consists of computed tomography (CT) and gastroscopy. In locally advanced (cT3-4) gastric cancer, fluorodeoxyglucose positron emission tomography with... Show moreBackground: Initial staging of gastric cancer consists of computed tomography (CT) and gastroscopy. In locally advanced (cT3-4) gastric cancer, fluorodeoxyglucose positron emission tomography with CT (FDG-PET/CT or PET) and staging laparoscopy (SL) may have a role in staging, but evidence is scarce. The aim of this study is to evaluate the impact and cost-effectiveness of PET and SL in addition to initial staging in patients with locally advanced gastric cancer.Methods: This prospective observational cohort study will include all patients with a surgically resectable, advanced gastric adenocarcinoma (cT3-4b, N0-3, M0), that are scheduled for treatment with curative intent after initial staging with gastroscopy and CT. The modalities to be investigated in this study is the addition of PET and SL. The primary outcome of this study is the proportion of patients in whom the PET or SL lead to a change in treatment strategy. Secondary outcome parameters are: diagnostic performance, morbidity and mortality, quality of life, and cost-effectiveness of these additional diagnostic modalities. The study recently started in August 2017 with a duration of 36 months. At least 239 patients need to be included in this study to demonstrate that the diagnostic modalities are break-even. Based on the annual number of gastrectomies in the participating centers, it is estimated that approximately 543 patients are included in this study.Discussion: In this study, it is hypothesized that performing PET and SL for locally advanced gastric adenocarcinomas results in a change of treatment strategy in 27% of patients and an annual cost-reduction in the Netherlands of (sic)916.438 in this patient group by reducing futile treatment. The results of this study may be applicable to all countries with comparable treatment algorithms and health care systems. Show less
In the current project, our main focus was to test the effectiveness of different training interventions and their impact on skill acquisition and long-term retention of laparoscopic motor skills.... Show moreIn the current project, our main focus was to test the effectiveness of different training interventions and their impact on skill acquisition and long-term retention of laparoscopic motor skills. Based on the research in this dissertation and the existing literature, I recommend instructors to design training with predetermined proficiency targets, patient-oriented (adaptive) feedback on a spaced schedule with intervals of a week instead of smaller time frames. Instructors may experiment with larger spacing intervals, but more research is needed to determine the effectiveness of more time in between training sessions. I urge instructors to be cautious in increasing training variability in training novices, since laparoscopy is an inherently complex task and can be overwhelming at the start of training. Fractionation of training of the different facets of laparoscopic surgery may be fine initially, but training focused on skill integration is desirable at a later stage. In examination, a dual-task setup can be used to assess the degree of automatization of the acquired skills. Trainers can implement the use of force measures as an additional metric, to ensure that trainees also learn how to handle different tissues safely. Show less
Haak, L. van den; Alleblas, C.; Rhemrev, J.P.; Scheltes, J.; Nieboer, T.E.; Jansen, F.W. 2017
The current thesis explores the evidence base of new techniques in minimally invasive surgery. For this purpose the main objectives of this thesis are: • To present a multidisciplinary... Show moreThe current thesis explores the evidence base of new techniques in minimally invasive surgery. For this purpose the main objectives of this thesis are: • To present a multidisciplinary evidence based guideline for MIS including the main topics in laparoscopic surgery; • To identify the evidence of three new minimally invasive techniques: trocar types for laparoscopy, LESS-hysterectomy and hysteroscopic sterilization; • To evaluate the course of introduction of a new minimally invasive technique (robot-assisted surgery) and the status of the evidence; • To assess whether recent RCTs serve the clinical needs of the MIS approach. Providing the answers to these questions, this thesis provides insight in the evidence of MIS and its limitations. Therewith, it provides guidance to optimize research and evidence based implementation of MIS towards better minimally invasive surgical care. Show less
Berg, N.S. van den; Buckle, T.; KleinJan, G.H.; Poel, H.G. van der; Leeuwen, F.W.B. van 2017
This thesis shows that quality of colorectal cancer care is irrevocably associated with hospital costs. Although surgical auditing is a cost and time-consuming exercise, it has a strong potential... Show moreThis thesis shows that quality of colorectal cancer care is irrevocably associated with hospital costs. Although surgical auditing is a cost and time-consuming exercise, it has a strong potential to improve outcomes in healthcare and simultaneously reduce hospital costs. Comparing hospital performances on both quality and costs makes identification of ‘best practice’ hospitals possible. Moreover, providing combined quality-cost outcomes of frail patients or operation techniques provides valuable insights where to start quality improvement initiatives. Finally, rewarding healthcare providers based on operative risk could be a first step in developing powerful reimbursement systems. This all might catalyze the continuous improvement of value leading to a more sustainable healthcare system in the future. Show less
