Bimanual Fundamentals: Validation of a New Curriculum for Virtual Reality Training of Laparoscopic Skills

Background. To determine face and construct validity for the new Bimanual Fundamentals curriculum for the Simendo® Virtual Reality Laparoscopy Simulator and prove its efficiency as a training and objective assessment tool for surgical resident’s advanced psychomotor skills. Methods. 49 participants were recruited: 17 medical students (novices), 15 residents (intermediates), and 17 medical specialists (experts) in the field of gynecology, general surgery, and urology in 3 tertiary medical centers in the Netherlands. All participants performed the 5 exercises of the curriculum for 3 consecutive times on the simulator. Intermediates and experts filled in a questionnaire afterward, regarding the reality of the simulator and training goals of each exercise. Statistical analysis of performance was performed between novices, intermediates, and experts. Parameters such as task time, collisions/displacements, and path length right and left were compared between groups. Additionally, a total performance score was calculated for each participant. Results. Face validity scores regarding realism and training goals were overall positive (median scores of 4 on a 5-point Likert scale). Participants felt that the curriculum was a useful addition to the previous curricula and the used simulator would fit in their residency programs. Construct validity results showed significant differences on the great majority of measured parameters between groups. The simulator is able to differentiate between performers with different levels of laparoscopic experience. Conclusions. Face and construct validity for the new Bimanual Fundamental curriculum for the Simendo virtual reality simulator could be established. The curriculum is suitable to use in resident’s training programs to improve and maintain advanced psychomotor skills

Utility Scores and Preferences for Surgical and Organ-Sparing Approaches for Treatment of Intermediate and High-Risk Rectal Cancer

BACKGROUND: Organ-sparing approaches, including wait-and-see and local excision, are increasingly being offered to patients with rectal cancer following a good response to neoadjuvant therapy. Preferences regarding these treatment strategies are yet unknown. OBJECTIVE: This study aimed to determine the preferences and utility scores for rectal cancer treatment approaches. DESIGN: This is a cross-sectional study. SETTING: This study was conducted at the Radiation-Oncology Department of the University Medical Center Utrecht. PATIENTS: Fifty-seven patients with a history of rectal cancer and 38 volunteers were included. MAIN OUTCOME MEASURES: Participants assessed 6 hypothetical treatment-outcome scenarios, including short-course radiotherapy or chemoradiation followed by abdominoperineal resection, low anterior resection, local excision, or a wait-and-see approach. The hierarchy in preferences between scenarios was assessed by using ranking. Utilities were estimated with a visual analog scale and time trade-off. RESULTS: Organ-sparing approaches were ranked as the first preferred treatment option by 51% of the participants. Among all scenarios, wait-and-see was most often ranked highest by patients and volunteers (36% and 50%). Meanwhile, a substantial proportion ranked wait-and-see as their lowest preference (38% in patients and 35% in volunteers). Utility scores differed significantly between scenarios. Wait-and-see received a significantly higher score on the visual analog scale than the scenarios including abdominoperineal resection and the scenario including chemoradiation with low anterior resection, and a score similar to the scenarios including local excision and short-course radiotherapy with low anterior resection. LIMITATIONS: The study population consisted of patients with a history of rectal cancer treatment and volunteers related to patients. This may have influenced preferences. CONCLUSIONS: This study suggests that there is a wide disparity in preferences concerning organ-sparing approaches for rectal cancer in both patients with a history of rectal cancer and volunteers. Wait-and-see is often the highest preferred treatment, but it is also among the least preferred treatment options. These findings give insights into how patients may value the current rectal cancer treatment options. See Video Abstract at http://links.lww.com/DCR/A521

Utility Scores and Preferences for Surgical and Organ-Sparing Approaches for Treatment of Intermediate and High-Risk Rectal Cancer

BACKGROUND: Organ-sparing approaches, including wait-and-see and local excision, are increasingly being offered to patients with rectal cancer following a good response to neoadjuvant therapy. Preferences regarding these treatment strategies are yet unknown. OBJECTIVE: This study aimed to determine the preferences and utility scores for rectal cancer treatment approaches. DESIGN: This is a cross-sectional study. SETTING: This study was conducted at the Radiation-Oncology Department of the University Medical Center Utrecht. PATIENTS: Fifty-seven patients with a history of rectal cancer and 38 volunteers were included. MAIN OUTCOME MEASURES: Participants assessed 6 hypothetical treatment-outcome scenarios, including short-course radiotherapy or chemoradiation followed by abdominoperineal resection, low anterior resection, local excision, or a wait-and-see approach. The hierarchy in preferences between scenarios was assessed by using ranking. Utilities were estimated with a visual analog scale and time trade-off. RESULTS: Organ-sparing approaches were ranked as the first preferred treatment option by 51% of the participants. Among all scenarios, wait-and-see was most often ranked highest by patients and volunteers (36% and 50%). Meanwhile, a substantial proportion ranked wait-and-see as their lowest preference (38% in patients and 35% in volunteers). Utility scores differed significantly between scenarios. Wait-and-see received a significantly higher score on the visual analog scale than the scenarios including abdominoperineal resection and the scenario including chemoradiation with low anterior resection, and a score similar to the scenarios including local excision and short-course radiotherapy with low anterior resection. LIMITATIONS: The study population consisted of patients with a history of rectal cancer treatment and volunteers related to patients. This may have influenced preferences. CONCLUSIONS: This study suggests that there is a wide disparity in preferences concerning organ-sparing approaches for rectal cancer in both patients with a history of rectal cancer and volunteers. Wait-and-see is often the highest preferred treatment, but it is also among the least preferred treatment options. These findings give insights into how patients may value the current rectal cancer treatment options. See Video Abstract at http://links.lww.com/DCR/A521

Robotic Single-Port Laparoscopic Cholecystectomy Is Safe but Faces Technical Challenges

Background: For cholecystectomy, multiport laparoscopy is the recommended surgical approach. Single-port laparoscopy (SPL) was introduced to reduce postoperative pain and provide better cosmetic results, but has technical disadvantages. Robotic SPL (RSPL) was developed to overcome these disadvantages. In this prospective study, we aim to describe intraoperative results and postoperative outcomes of RSPL cholecystectomies and evaluate technical aspects of the technique. Methods: A prospective database of all patients who underwent a RSPL cholecystectomy between January 2012 and December 2014 was analyzed. Intraoperative results and postoperative complications were evaluated. Results: A total of 27 patients underwent RSPL cholecystectomy. Median age was 59 (20-78) years and median body mass index was 25 (19-35) kg/m2. The majority of patients had American Society of Anesthesiologists (ASA) II classification (67%) and 89% underwent surgery for cholecystolithiasis or cholecystitis. The median operating time was 81 (41-115) minutes. Conversion to a multiport procedure occurred in 2; one due to insufficient length of the robotic instruments. In the second and third patients, conversion to an open procedure was necessary due to inadequate exposure caused by liver cirrhosis and purulent ascites, respectively. In seven procedures, spill occurred due to rupture of the gallbladder. Postoperative complications occurred in 4 patients, including 1 bleeding (no reintervention), 1 peritonitis, and 2 wound infections. After a median follow-up of 33 (10-44) months, 5 (19%) trocar-site hernias were seen. Conclusion: RSPL cholecystectomy is feasible, however, encountered by technical challenges due to inadequate length of the nonwristed robotic instruments. A high incidence of gallbladder rupture and trocar-site hernias may limit its application

A Novel Diagnostic Tool for Selecting Patients With Mesenchymal-Type Colon Cancer Reveals Intratumor Subtype Heterogeneity

Background: Consensus molecular subtype 4 (CMS4) is a recently identified aggressive colon cancer subtype for which platelet-derived growth factor receptors (PDGFRs) and KIT are potential therapeutic targets. We aimed to develop a clinically applicable CMS4 reverse transcription polymerase chain reaction (RT-qPCR) test to select patients for PDGFR/KIT-targeted therapy. Methods: We used logistic regression to develop a CMS4 prediction rule based on microarray expression values of PDGFRA , PDGFRB , PDGFC , and KIT (566 training and 1259 test samples, using the 273-gene random forest classifier as CMS4 reference standard). We next translated the prediction rule into a single-sample RT-qPCR test, which we independently validated in 29 fresh tumor samples. To study intratumor CMS4 heterogeneity, we used the RT-qPCR test to analyze five random regions of 20 colon tumors. Results: The microarray-based prediction rule diagnosed CMS4-type tumors extremely well in both training and independent test samples (training: area under the curve [AUC] = 0.95, 95% confidence interval [CI] = 0.94 to 0.97; test: AUC = 0.95, 95% CI = 0.94 to 0.96), with excellent calibration and approximately 80% overall net benefit over a large threshold range. Translation into an RT-qPCR test did not affect discrimination (AUC = 0.97, 95% CI = 0.93 to 1.00, independent validation). RT-qPCR analysis of five random tumor regions revealed extensive intratumor CMS4 heterogeneity in nine out of 20 tumors. At least two regions likely have to be analyzed to identify patients that are predominantly CMS4 positive (>50% average CMS4 chance). Conclusion: The CMS4 RT-qPCR test is a promising clinical tool for selecting individual patients for CMS4-subtype-targeted therapy

Comparison of Systematic Video Documentation with Narrative Operative Report in Colorectal Cancer Surgery

Importance: Despite ongoing advances in the field of colorectal surgery, the quality of surgical treatment is still variable. As an intrinsic part of surgical quality, the technical information regarding the surgical procedure is reflected only by the narrative operative report (NR), which has been found to be subjective and regularly omits important information. Objective: To investigate systematic video recording (SVR) as a potential improvement in quality and safety with regard to important information in colorectal cancer surgery. Design, Setting, and Participants: The Imaging for Quality Control Trial was a prospective, observational cohort study conducted between January 12, 2016, and October 30, 2017, at 3 centers in the Netherlands. The study group consisted of 113 patients 18 years or older undergoing elective laparoscopic surgery for colorectal cancer. These patients were case matched and compared with cases from a historical cohort that received only an NR. Interventions: Among study cases, participating surgeons were requested to systematically capture predefined key steps of the surgical procedure intraoperatively on video in short clips. Main Outcomes and Measures: The SVRs and NRs were analyzed for adequacy with respect to the availability of important information regarding the predefined key steps. Adequacy of the reported information was defined as the proportion of key steps with available and sufficient information in the report. Adequacy of the SVR and NR was compared between the study and control groups, with the SVR alone and as an adjunct to the NR in the study group vs NR alone in the control group. Results: Of the 113 study patients, 69 women (61.1%) were included; mean (SD) age was 66.3 (9.8) years. In the control group, a mean (SD) of 52.5% (18.3%) of 631 steps were adequately described in the NR. In the study group, the adequacy of both the SVR (78.5% [16.5%], P <.001) and a combination of the SVR with NR (85.1% [14.6%], P <.001) was significantly superior to NR alone. The only significant difference between the study and historical control groups regarding postoperative and pathologic outcomes was a shorter postoperative mean (SD) length of stay in favor of the study group (8.0 [7.7] vs 8.6 [6.8] days; P =.03). Conclusions and Relevance: Use of SVR in laparoscopic colorectal cancer surgery as an adjunct to the NR might be superior in documenting important steps of the operation compared with NR alone, adding to the overall availability of necessary intraoperative information and contributing to quality control and objectivity.

Postoperative Outcomes of Screen-Detected vs Non-Screen-Detected Colorectal Cancer in the Netherlands

Importance: The nationwide fecal immunochemical test-based screening program has influenced surgical care for patients with colorectal cancer (CRC) in the Netherlands, although these implications have not been studied in much detail so far. Objective: To compare surgical outcomes of patients diagnosed as having CRC through the fecal immunochemical test-based screening program (screen detected) and patients with non-screen-detected CRC. Design, Setting, and Participants: This was a population-based comparative cohort study using the Dutch ColoRectal Audit and analyzed all Dutch hospitals performing CRC resections. Patients who underwent elective resection for CRC between January 2011 to December 2016 were included. Interventions: Colorectal cancer surgery. Main Outcomes and Measures: Postoperative nonsurgical complications, postoperative surgical complications, postoperative 30-day or in-hospital mortality, and complicated course (postoperative complication resulting in a hospital stay >14 days and/or a reintervention and/or mortality). A risk-stratified comparison was made for different postoperative outcomes based on screening status (screen detected vs not screen detected), cancer stage (I-IV), and for cancer stage I to III also on age (aged ≤70 years and >70 years) and American Society of Anesthesiologists score (I-II and III-IV). To determine any residual case-mix-corrected differences in outcomes between patients with screen-detected and non-screen-detected cancer, univariable and multivariable logistic regression analyses were performed. Results: In total, 36242 patients with colon cancer and 17416 patients with rectal cancer were included for analysis. Compared with patients with non-screen-detected CRC, screen-detected patients were younger (mean [SD] age, 68 [5] vs 70 [11] years), more often men (3777 [60%] vs 13506 [57%]), and had lower American Society of Anesthesiologists score (American Society of Anesthesiologists score III+: 838 [13%] vs 5529 [23%]). Patients with stage I to III colon cancer who were screen detected had a significantly lower mortality and complicated course rate compared with non-screen-detected patients. For patients with rectal cancer, only a significant difference was found in mortality rate in patients with a cancer stage IV disease, which was higher in the screen-detected group. Compared with non-screen-detected colon cancer, an independent association was found for screen-detected colon cancer on nonsurgical complications (adjusted odds ratio, 0.81; 95% CI, 0.73-0.91), surgical complications (adjusted odds ratio, 0.80; 95% CI, 0.72-0.89), and complicated course (adjusted odds ratio, 0.80; 95% CI, 0.71-0.90). Screen-detected rectal cancer had significantly higher odds on mortality. Conclusions and Relevance: Postoperative outcomes were significantly better for patients with colon cancer referred through the fecal immunochemical test-based screening program compared with non-screen-detected patients. These differences were not found in patients with rectal cancer. The outcomes of patients with screen-detected colon cancer were still better after an extensive case-mix correction, implying additional underlying factors favoring patients referred for surgery through the screening program

External validation of the MSKCC nomogram to estimate five-year overall survival after surgery for stage I–III colon cancer in a Dutch population

Introduction: The Memorial Sloan Kettering Cancer Centre (MSKCC) nomogram has been developed to estimate five-year overall survival (OS) after curative-intent surgery of colon cancer based on age, sex, T stage, differentiation grade, number of positive and examined regional lymph nodes. This is the first evaluation of the performance of the MSKCC model in a European population regarding prediction of OS. Material and methods: Population-based data from patients with stage I–III colon cancer diagnosed between 2010 and 2016 were obtained from the Netherlands Cancer Registry (NCR) for external validation of the MSKCC prediction model. Five-year survival probabilities were estimated for all patients in our dataset by using the MSKCC prediction equation. Histogram density plots were created to depict the distribution of the estimated probability and prognostic index. The performance of the model was evaluated in terms of its overall performance, discrimination, and calibration. Results: A total of 39,805 patients were included. Five-year OS was 71.9% (95% CI 71.5; 72.3) (11,051 events) with a median follow up of 5.6 years (IQR 4.1; 7.7). The Brier score was 0.10 (95% CI 0.10; 0.10). The C-index was 0.75 (95% CI 0.75; 0.76). The calibration measures and plot indicated that the model slightly overestimated observed mortality (observed/expected ratio = 0.86 [95% CI 0.86; 0.87], calibration intercept = −0.14 [95% CI −0.16; −0.11], and slope 1.07 [95% CI 1.05; 1.09], ICI = 0.04, E50 = 0.04, and E90 = 0.05). Conclusions: The external validation of the MSKCC prediction nomogram in a large Dutch cohort supports the use of this practical tool in the European patient population. These personalised estimated survival probabilities may support clinicians when informing patients about prognosis. Adding potential relevant prognostic factors to the model, such as primary tumour location, might further improve the model