Henk W.R. Schreuder

Training and learning robotic surgery, time for a more structured approach: a systematic review

Please cite this paper as: Schreuder H, Wolswijk R, Zweemer R, Schijven M, Verheijen R. Training and learning robotic surgery, time for a more structured approach: a systematic review. BJOG 2012;119:137–149.

Clinical outcome and dosimetric parameters of chemo-radiation including MRI guided adaptive brachytherapy with tandem-ovoid applicators for cervical cancer patients: A single institution experience

PURPOSE To evaluate dosimetric parameters and clinical outcome for cervical cancer patients treated with chemo-radiation and MR-image guided adaptive brachytherapy (MR-IGABT) using tandem-ovoid applicators for intracavitary or combined intracavitary/interstitial approaches. METHOD This retrospective analysis includes 46 patients treated between 2006 and 2008. Dose-volume parameters D90 HR-CTV (high-risk clinical target volume) and D(2cc) OARs (organs at risk) were determined and converted into biologically equivalent doses in 2 Gy fractions (EQD2). Clinical outcome parameters (local control (LC), progression free survival (PFS) and overall survival (OS)) were analysed actuarially and late morbidity crude rates were scored using CTCAEv3.0. RESULTS Mean D90 HR-CTV was 84 (SD9) Gy EQD2 for HR-CTV volumes of mean 57 (SD37) cm(3) at time of first brachytherapy (BT). Median follow-up was 41 (range, 4-67) months. Three year LC, PFS, and OS rates were 93, 71, and 65%, respectively. Node negative patients had significantly higher 3-year survival rates compared to node positive ones (PFS 85 versus 53% (p=0.013), OS 77 versus 50% (p=0.032), respectively) with an even larger difference for patients with FIGO stages IB-IIB (PFS 87 versus 42% (p=0.002), OS 83 versus 46% (p=0.007), respectively). Late grade 3-4 mainly gastrointestinal or vaginal morbidity was observed in 4 patients (9.5%). No correlations were seen between morbidity and D(2cc) OAR values. CONCLUSION (Chemo-) radiation and MR-IGABT with tandem-ovoid applicators result in high LC and promising survival rates with reasonable morbidity.

Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer

BACKGROUND Treatment of newly diagnosed advanced‐stage ovarian cancer typically involves cytoreductive surgery and systemic chemotherapy. We conducted a trial to investigate whether the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery would improve outcomes among patients who were receiving neoadjuvant chemotherapy for stage III epithelial ovarian cancer. METHODS In a multicenter, open‐label, phase 3 trial, we randomly assigned 245 patients who had at least stable disease after three cycles of carboplatin (area under the curve of 5 to 6 mg per milliliter per minute) and paclitaxel (175 mg per square meter of body‐surface area) to undergo interval cytoreductive surgery either with or without administration of HIPEC with cisplatin (100 mg per square meter). Randomization was performed at the time of surgery in cases in which surgery that would result in no visible disease (complete cytoreduction) or surgery after which one or more residual tumors measuring 10 mm or less in diameter remain (optimal cytoreduction) was deemed to be feasible. Three additional cycles of carboplatin and paclitaxel were administered postoperatively. The primary end point was recurrence‐free survival. Overall survival and the side‐effect profile were key secondary end points. RESULTS In the intention‐to‐treat analysis, events of disease recurrence or death occurred in 110 of the 123 patients (89%) who underwent cytoreductive surgery without HIPEC (surgery group) and in 99 of the 122 patients (81%) who underwent cytoreductive surgery with HIPEC (surgery‐plus‐HIPEC group) (hazard ratio for disease recurrence or death, 0.66; 95% confidence interval [CI], 0.50 to 0.87; P=0.003). The median recurrence‐free survival was 10.7 months in the surgery group and 14.2 months in the surgery‐plus‐HIPEC group. At a median follow‐up of 4.7 years, 76 patients (62%) in the surgery group and 61 patients (50%) in the surgery‐plus‐HIPEC group had died (hazard ratio, 0.67; 95% CI, 0.48 to 0.94; P=0.02). The median overall survival was 33.9 months in the surgery group and 45.7 months in the surgery‐plus‐HIPEC group. The percentage of patients who had adverse events of grade 3 or 4 was similar in the two groups (25% in the surgery group and 27% in the surgery‐plus‐HIPEC group, P=0.76). CONCLUSIONS Among patients with stage III epithelial ovarian cancer, the addition of HIPEC to interval cytoreductive surgery resulted in longer recurrence‐free survival and overall survival than surgery alone and did not result in higher rates of side effects. (Funded by the Dutch Cancer Society; ClinicalTrials.gov number, NCT00426257; EudraCT number, 2006‐003466‐34.)

Implementation of simulation in surgical practice: Minimally invasive surgery has taken the lead: The Dutch experience

Minimal invasive techniques are rapidly becoming standard surgical techniques for many surgical procedures. To develop the skills necessary to apply these techniques, box trainers and/or inanimate models may be used, but these trainers lack the possibility of inherent objective classification of results. In the past decade, virtual reality (VR) trainers were introduced for training minimal invasive techniques. Minimally invasive surgery (MIS) is, by nature, very suitable for this type of training. The specific psychomotor skills and eye–hand coordination needed for MIS can be mastered largely using VR simulation techniques. It is also possible to transfer skills learned on a simulator to real operations, resulting in error reduction and shortening of procedural operating time. The authors aim to enlighten the process of gaining acceptance in the Netherlands for novel training techniques. The Dutch Societies of Surgery, Obstetrics and Gynecology, and Urology each developed individual training curricula for MIS using simulation techniques, to be implemented in daily practice. The ultimate goal is to improve patient safety. The authors outline the opinions of actors involved, such as different simulators, surgical trainees, surgeons, surgical societies, hospital boards, government, and the public. The actual implementation of nationwide training curricula for MIS is, however, a challenging step.

Face and construct validity of virtual reality simulation of laparoscopic gynecologic surgery

OBJECTIVE The objective of the study was to validate virtual reality simulation in assessing laparoscopic skills in gynecology by establishing the extent of realism of the simulation to the actual task (face validity) and the degree to which the results of the test one uses reflects the subject tested (construct validity). STUDY DESIGN Subjects (n = 56) were divided into 3 groups: novices (n = 15), intermediates (n = 20), and experts (n = 21). Participants completed 3 repetitions of a training program consisting of 4 basic skills and 3 gynecologic procedural simulations. The performance was compared between groups using a post hoc Student t test with the Bonferroni technique. Face validity was determined by using a questionnaire of 27 statements. RESULTS Resulting from the questionnaire, the opinion about the realism and training capacities of the tasks was favorable among all groups. The degree of prior laparoscopic experience was reflected in the outcome performance parameters of the tasks. Experts achieved significant better scores on specific parameters. CONCLUSION The results of this study indicate acceptance and thus face validity of the system among both reference (novice, intermediate) and expert group. There is a significant difference between subjects with different laparoscopic experience and thereby construct validity for the laparoscopic simulator could be established.

Vaccination against Oncoproteins of HPV16 for Noninvasive Vulvar/Vaginal Lesions: Lesion Clearance Is Related to the Strength of the T-Cell Response

Purpose: Therapeutic vaccination with human papillomavirus type 16 (HPV16) E6 and E7 synthetic long peptides (SLP) is effective against HPV16-induced high-grade vulvar and vaginal intraepithelial neoplasia (VIN/VaIN). However, clinical nonresponders displayed weak CD8+ T-cell reactivity. Here, we studied if imiquimod applied at the vaccine site could improve CD8+ T-cell reactivity, clinical efficacy, and safety of HPV16-SLP (ISA101). Experimental Design: A multicenter open-label, randomized controlled trial was conducted in patients with HPV16+ high-grade VIN/VaIN. Patients received ISA101 vaccination with or without application of 5% imiquimod at the vaccine site. The primary objective was the induction of a directly ex vivo detectable HPV16-specific CD8+ T-cell response. The secondary objectives were clinical responses (lesion size, histology, and virology) and their relation with the strength of vaccination-induced immune responses. Results: Forty-three patients were assigned to either ISA101 with imiquimod (n = 21) or ISA101 only (n = 22). Imiquimod did not improve the outcomes of vaccination. However, vaccine-induced clinical responses were observed in 18 of 34 (53%; 95% CI, 35.1–70.2) patients at 3 months and in 15 of 29 (52%; 95% CI, 32.5–70.6) patients, 8 of whom displayed a complete histologic response, at 12 months after the last vaccination. All patients displayed vaccine-induced T-cell responses, which were significantly stronger in patients with complete responses. Importantly, viral clearance occurred in all but one of the patients with complete histologic clearance. Conclusions: This new study confirms that clinical efficacy of ISA101 vaccination is related to the strength of vaccine-induced HPV16-specific T-cell immunity and is an effective therapy for HPV16-induced high-grade VIN/VaIN. Clin Cancer Res; 22(10); 2342–50. ©2016 AACR. See related commentary by Karaki et al., p. 2317

Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study.

BackgroundStandard treatment of advanced ovarian cancer is surgery and chemotherapy. The goal of surgery is to remove all macroscopic tumour, as the amount of residual tumour is the most important prognostic factor for survival. When removal off all tumour is considered not feasible, neoadjuvant chemotherapy (NACT) in combination with interval debulking surgery (IDS) is performed. Current methods of staging are not always accurate in predicting surgical outcome, since approximately 40% of patients will have more than 1 cm residual tumour after primary debulking surgery (PDS). In this study we aim to assess whether adding laparoscopy to the diagnostic work-up of patients suspected of advanced ovarian carcinoma may prevent unsuccessful primary debulking surgery for ovarian cancer.MethodsMulticentre randomized controlled trial, including all gynaecologic oncologic centres in the Netherlands and their affiliated hospitals. Patients are eligible when they are planned for PDS after conventional staging. Participants are randomized between direct PDS or additional diagnostic laparoscopy. Depending on the result of laparoscopy patients are treated by PDS within three weeks, followed by six courses of platinum based chemotherapy or with NACT and IDS 3-4 weeks after three courses of chemotherapy, followed by another three courses of chemotherapy. Primary outcome measure is the proportion of PDSs leaving more than one centimetre tumour residual in each arm. In total 200 patients will be randomized. Data will be analysed according to intention to treat.DiscussionPatients who have disease considered to be resectable to less than one centimetre should undergo PDS to improve prognosis. However, there is a need for better diagnostic procedures because the current number of debulking surgeries leaving more than one centimetre residual tumour is still high. Laparoscopy before starting treatment for ovarian cancer can be an additional diagnostic tool to predict the outcome of PDS. Despite the absence of strong evidence and despite the possible complications, laparoscopy is already implemented in many countries. We propose a randomized multicentre trial to provide evidence on the effectiveness of laparoscopy before primary surgery for advanced stage ovarian cancer patients.Trial registrationNetherlands Trial Register number NTR2644

Laparoscopic skills training using inexpensive box trainers: which exercises to choose when constructing a validated training course

Please cite this paper as: Schreuder H, van den Berg C, Hazebroek E, Verheijen R, Schijven M. Laparoscopic skills training using inexpensive box trainers: which exercises to choose when constructing a validated training course. BJOG 2011;118:1576–1584.

The value of 3.0 Tesla diffusion-weighted MRI for pelvic nodal staging in patients with early stage cervical cancer

OBJECTIVE The purpose of this study is to investigate the diagnostic accuracy of 3.0Tesla (3T) diffusion-weighted magnetic resonance imaging (MRI) in addition to conventional MRI for the detection of lymphadenopathy in patients with early stage cervical cancer compared to histopathological evaluation of the systematically removed pelvic lymph nodes as reference standard. METHODS 68 fédération internationale de gynécologie obstétrique (FIGO) stage Ia2 to IIb cervical cancer patients were included. Sensitivity and specificity rates for two experienced observers were computed for the detection of lymphatic metastasis. Reproducibility of conventional MRI was tested by kappa statistics. The variables included in the analysis were: size of the long axis, short axis, ratio short to long axis and apparent diffusion coefficient (ADC). RESULTS Nine patients had 15 positive pelvic nodes at histopathological examination. The sensitivity and specificity of lymphatic metastasis detection by predefined conventional MRI characteristics was 33% (95% Confidence Interval (CI) 3-64) and 83% (95% CI 74-93) on patient level, and 33% (95% CI 7-60) and 97% (95% CI 95-99) on regional level respectively for observer 1. For observer 2 the sensitivity was 33% (95% CI 3-64) and the specificity 93% (95% CI 87-100) on patient level, and 25% (95% CI 1-50) and 98% (95% CI 97-100) on regional level, respectively. The kappa-value for reproducibility of metastasis detection on regional level was 0.50. The short axis diameter showed the highest diagnostic accuracy (area under the curve (AUC)=0.81 95% CI 0.70-0.91); ADC did not improve diagnostic accuracy (AUC=0.83 95% CI 0.73-0.93). CONCLUSIONS Diffusion-weighted MRI did not result in additional diagnostic value compared to conventional MRI.

Validation of a Novel Virtual Reality Simulator for Robotic Surgery

Objective. With the increase in robotic-assisted laparoscopic surgery there is a concomitant rising demand for training methods. The objective was to establish face and construct validity of a novel virtual reality simulator (dV-Trainer, Mimic Technologies, Seattle, WA) for the use in training of robot-assisted surgery. Methods. A comparative cohort study was performed. Participants (n = 42) were divided into three groups according to their robotic experience. To determine construct validity, participants performed three different exercises twice. Performance parameters were measured. To determine face validity, participants filled in a questionnaire after completion of the exercises. Results. Experts outperformed novices in most of the measured parameters. The most discriminative parameters were “time to complete” and “economy of motion” (P < 0.001). The training capacity of the simulator was rated 4.6 ± 0.5 SD on a 5-point Likert scale. The realism of the simulator in general, visual graphics, movements of instruments, interaction with objects, and the depth perception were all rated as being realistic. The simulator is considered to be a very useful training tool for residents and medical specialist starting with robotic surgery. Conclusions. Face and construct validity for the dV-Trainer could be established. The virtual reality simulator is a useful tool for training robotic surgery.