The efficacy of virtual reality simulation training in laparoscopy: a systematic review of randomized trials.

BACKGROUND: Virtual reality (VR) simulators for surgical training might possess the properties needed for basic training in laparoscopy. Evidence for training efficacy of VR has been investigated by research of varying quality over the past decade. OBJECTIVE: To review randomized controlled trials regarding VR training efficacy compared with traditional or no training, with outcome measured as surgical performance in humans or animals. DATA SOURCES: In June 2011 Medline, Embase, the Cochrane Central Register of Controlled Trials, Web of Science and Google Scholar were searched using the following medical subject headings (MeSh) terms: Laparoscopy/standards, Computing methodologies, Programmed instruction, Surgical procedures, Operative, and the following free text terms: Virtual real* OR simulat* AND Laparoscop* OR train* LIMITS: Controlled trials. STUDY ELIGIBILITY CRITERIA: All randomized controlled trials investigating the effect of VR training in laparoscopy, with outcome measured as surgical performance. METHODS: A total of 98 studies were screened, 26 selected and 12 included, with a total of 241 participants. RESULTS: Operation time was reduced by 17-50% by VR training, depending on simulator type and training principles. Proficiency-based training appeared superior to training based on fixed time or fixed numbers of repetition. Simulators offering training for complete operative procedures came out as more efficient than simulators offering only basic skills training. CONCLUSIONS: Skills in laparoscopic surgery can be increased by proficiency-based procedural VR simulator training. There is substantial evidence (grade IA - IIB) to support the use of VR simulators in laparoscopic training.

Retention of laparoscopic procedural skills acquired on a virtual-reality surgical trainer.

BACKGROUND: Virtual-reality (VR) simulator training has been shown to improve surgical performance in laparoscopic procedures in the operating room. We have, in a randomised controlled trial, demonstrated transferability to real operations. The validity of the LapSim virtual-reality simulator as an assessment tool has been demonstrated in several reports. However, an unanswered question regarding simulator training is the durability, or retention, of skills acquired during simulator training. The aim of the present study is to assess the retention of skills acquired using the LapSim VR simulator, 6 and 18 months after an initial training course. METHODS AND MATERIALS: The investigation was designed as a 6- and 18-month follow-up on a cohort of participants who earlier participated in a skills training programme on the LapSim VR. The follow-up cohort consisted of trainees and senior consultants allocated to two groups: (1) novices (experience < 5 procedures, n = 9) and (2) experts (experience > 200 procedures during the past 3 years, n = 10). Each participant performed ten sessions. Assessment of skills was based on time, economy of movement and the error parameter "bleeding". The novice group were re-tested after 6 and 18 months, whereas the expert group were only retested once, after 6 months. None of the novices performed laparoscopic surgery in the follow-up period. The experts continued their daily work with laparoscopic surgery. RESULTS AND CONCLUSIONS: Novices showed retention of skills after 6 months. After 18 months, novices' laparoscopic skills had returned to the pre-training level. This indicates that laparoscopic skills seemed to deteriorate in the period between 6 and 18 months without training. Experts showed consistent performance over time. This information can be included when planning training curricula in minimal invasive surgery.

Effect of virtual reality training on laparoscopic surgery: randomised controlled trial.

OBJECTIVE: To assess the effect of virtual reality training on an actual laparoscopic operation. DESIGN: Prospective randomised controlled and blinded trial. SETTING: Seven gynaecological departments in the Zeeland region of Denmark. PARTICIPANTS: 24 first and second year registrars specialising in gynaecology and obstetrics. INTERVENTIONS: Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls). MAIN OUTCOME MEASURE: The main outcome measure was technical performance assessed by two independent observers blinded to trainee and training status using a previously validated general and task specific rating scale. The secondary outcome measure was operation time in minutes. RESULTS: The simulator trained group (n=11) reached a median total score of 33 points (interquartile range 32-36 points), equivalent to the experience gained after 20-50 laparoscopic procedures, whereas the control group (n=10) reached a median total score of 23 (22-27) points, equivalent to the experience gained from fewer than five procedures (P<0.001). The median total operation time in the simulator trained group was 12 minutes (interquartile range 10-14 minutes) and in the control group was 24 (20-29) minutes (P<0.001). The observers' inter-rater agreement was 0.79. CONCLUSION: Skills in laparoscopic surgery can be increased in a clinically relevant manner using proficiency based virtual reality simulator training. The performance level of novices was increased to that of intermediately experienced laparoscopists and operation time was halved. Simulator training should be considered before trainees carry out laparoscopic procedures. TRIAL REGISTRATION: ClinicalTrials.gov NCT00311792.

[Urinary incontinence surgery in Denmark 2001-2003]. / Urininkontinenskirurgi i Danmark 2001-2003.

INTRODUCTION: The centralisation of surgical activity is an important aspect of the ongoing planning of the Danish Healthcare System. Knowledge of the actual status is crucial in the process of decision. In this article incontinence surgery in Denmark, including the frequency of complications, during a three year period is outlined. MATERIAL AND METHODS: This was a retrospective study, where data were extracted from the Danish National Patient Register (LPR) from 2001 to 2003. Data were supported by discharge letters and chart operation descriptions for women readmitted within 30 days after primary operation or if the hospital stays were prolonged. RESULTS: In total 2678 incontinence operations were performed in the period by 51 different departments. Seven departments carried out 51% of all the procedures, while 33 departments carried out 14% of all the procedures. The frequency of postoperative complications was 33.9% after an abdominal procedure, 10.8% after a Tension free Vaginal Tape (TVT) like procedure and 2.3% after urethral injection therapy. For abdominal procedures, "high volume" departments (> 45 operations/3 years) had significantly fewer complications compared to "low volume" departments (<15 operations/3 years), while no difference was found in the TVT-like group. Registration of complications and reoperations was incomplete and incorrect, especially in the TVT-like group. Mortality within 30 days was 0. CONCLUSION: This study shows a decentralised organisation of surgical incontinence activity in Denmark. Many departments carried out very few operations. There is a need for better registration, especially of TVT slings, and there is a need to reliably monitor the quality of incontinence surgery in Denmark. Surgical incontinence activity should be more centralised.

[Quadrivalent HPV 6/11/16/18 vaccine]. / Quadrivalent vaccine mod humant papillomvirus til forebyggelse af svaere celleforandringer på livmoderhalsen.

This randomized, double-blind study included 12,167 women who received three doses of quadrivalent HPV 6/11/16/18 vaccine or placebo (day 1, month 2, and month 6). The participants were followed for an average of 3 years. The vaccine prevented 98% of CIN2, CIN3 and adenocarcinoma in situ related to HPV 16 or HPV 18 among women not previously exposed to these types, and 44% among all women (i.e. both those with and without previous infection). The vaccine efficacy against all high-grade cervical lesions, independent of causal HPV type, was estimated to 17%.

[The first HPV vaccine is now available]. / Nu kommer den første vaccine mod humant papillomvirus.

More than two thirds of carcinomas of the uterine cervix are caused by human papilloma virus (HPV) types 16 and 18, and 90% of all genital warts are caused by HPV 6 and 11. In June 2006, the US Food and Drug Administration accepted the first prophylactic HPV vaccine against HPV 6, 11, 16 and 18 to be offered to girls and young women. This new vaccine is also now available in Denmark. Questions concerning economics, ethics, organization, and vaccine monitoring need to be discussed in connection with the establishment of a vaccine program. In addition, information to the general population as well as to health care providers and decision-makers should have been given a high priority.

[Simulation training of laparoscopic skills in gynaecology]. / Simulationstraening af laparoskopiske faerdigheder i gynaekologien.

Laparoscopic techniques are increasingly being applied in gynaecology in Denmark. Despite this, the training and assessment of basic skills are still not managed with a valid, reliable and systematic approach. Laparoscopic simulators might be the innovative answer to this challenge, but implementation needs to be evidence-based This paper discusses the latest metaanalysis of the evidence of simulator systems for evaluation and transfer of technical surgical skills, and the paper also points out areas that need further investigation before implementation of simulators in the gynaecological surgical curriculum.

[Accelerated course after operation for ovarian cancer]. / Accelereret forløb efter operation for ovariecancer.

INTRODUCTION: Introduction of principles for postoperative multimodal rehabilitation (fast track surgery) has decreased hospital stay from about 8-10 days to 2-4 days after colonic resection. The aim of this study was to investigate the effect of a similar fast track regimen in patients operated for ovarian cancer. METHOD: 72 consecutive patients operated with a conventional perioperative treatment regimen (group 1) were compared with the initial 69 consecutive patients (group 2) with a multimodal rehabilitation regimen and the next 50 consecutive patients (group 3) where the fast track regimen was implemented as a routine. RESULTS: Patients demographics and surgical characteristics were comparable between groups. Median postoperative hospital stay was reduced from six days in group 1, to five days in group 2, and four days in group 3 (p < 0,05). Surgical complications were similar while medical complications were reduced from 12% to 1% (p < 0,05) and readmissions from 10% to 2% (p < 0,05) with the fast track regimen. CONCLUSION: Principles for postoperative multimodal rehabilitation from colonic surgery lead to faster rehabilitation, decreased risk of medical complications and hospital stay in patients operated for ovarian cancer.

[Ovarian cancer in Denmark. Status of the surgical intervention]. / Ovariekraeft i Danmark. Status for den kirurgiske indsats.

INTRODUCTION: In Denmark women have not only one of the highest risks of ovarian cancer but also the highest mortality rate. The primary surgery is a key factor in the outcome. MATERIALS AND METHODS: Surgery for the treatment of ovarian cancer in Denmark was evaluated for the period from 1 July 2002 to 31 December 2003 using data from the Danish National Patient Registry (Landspatientregisteret, LPR) as well as the letter with the discharge note. The analysis included all primary surgical procedures during this period where information about number of surgical procedures per department, post-operative hospital stay, complications and mortality were obtained. RESULTS: 765 women, mean age 61 years (range 5-96 years), were operated on for ovarian cancer. The operations were distributed among 52 different hospital departments, and the surgery for advanced stage III patients took place in 32 different departments. The mean postoperative hospital stay was 9.0 days; 28% experienced one or more complications, and 8.1% were reoperated. The mortality rate was 4.2%. CONCLUSION: This first nationwide evaluation of surgery for ovarian cancer in Denmark showed that the surgery took place in far more hospital departments than the five recommended by the Danish National Board of Health. There seems to be room for improvement of quality, and a plan for the next five years is presented.

Lower urinary tract symptoms after total and subtotal hysterectomy: results of a randomized controlled trial.

The aim of this Danish multicenter trial was to compare the proportion of women with lower urinary tract symptoms after total abdominal hysterectomy (TAH) and subtotal abdominal hysterectomy (SAH) for benign uterine disorders. A total of 319 women were randomized to TAH (n = 158) or SAH (n = 161). Women were followed up for 1 year by strict data collection procedures, including postal questionnaires. Results were analyzed by intention-to-treat analyses. Urinary incontinence was found less often among TAH women than among SAH women. This was due to a larger reduction of the number of women with stress and urinary incontinence in the TAH group. No other differences were found between the two operation methods. The number of women with urinary incontinence and frequency was reduced from study entry for follow-up, while double/triple voiding was increased. Incontinent women had significantly lower quality of life scores than continent women

[The Danish Hysterectomy Database seen from a public health-economic perspective]. / Dansk Hysterektomi Database set i et sundhedsøkonomisk perspektiv.

INTRODUCTION: National clinical databases are a tool for quality improvement in clinical divisions. Furthermore, they can be used to make the quality of health care contributions visible to the population, as part of the free choice of hospital. Using data from one of the Danish nationwide databases, this article is the first to illustrate the potential economic resource gains from the use of these databases. MATERIALS AND METHODS: The calculations performed are based on the Danish Hysterectomy Database. This database has selected quality indicators and measures for quality improvements for a three years period and include reduction of complications to one in three (from 18% to 6%), reduction of admission to one in two (from 4 to 2 days) and reduction of rehospitalisation and reoperation to one in two (from 6% to 3%). RESULTS: Provided the proposed improvements are achieved, the expected resource gain will be approximately Dkr. 22 million (depending on the method of calculation). In-bed per day charges and "hotel charges" may vary considerably among hospitals. DISCUSSION: Every year, Dkr. 15 million are allocated to the national clinical databases, and in 2003, 34 different databases received financial support. The maximum amount that each database can receive is Dkr. 500,000. The amount currently allocated to quality monitoring is small compared to the potential resource gains from these databases and the annual expenditures by the Danish health care sector, which amount to a total of Dkr. 48 billion.

Total versus subtotal hysterectomy: an observational study with one-year follow-up.

The aim of this study was to compare total and subtotal abdominal hysterectomy for benign indications, with regard to urinary incontinence, postoperative complications, quality of life (SF-36), constipation, prolapse, satisfaction with sexual life, and pelvic pain at 1-year postoperative. Eighty women chose total and 105 women chose subtotal abdominal hysterectomy. No significant differences were found between the 2 operation methods in any of the outcome measures at 12 months. Fourteen women (15%) from the subtotal abdominal hysterectomy group experienced vaginal bleeding and three women had their cervix removed.