Competency assessment for the Versius surgical robot: a validity investigation study of a virtual reality simulator-based test.

BACKGROUND: When introducing new equipment like robotic surgical systems, it is essential to ensure that surgeons have the basic skills before operating on patients. The objective was to investigate the validity evidence for a competency-based test for basic robotic surgical skills using the Versius® trainer. METHODS: We recruited medical students, residents, and surgeons which were classified based on data on clinical experience with the Versius system as either novices (0 min), intermediates (1-1000 min), or experienced (> 1000 min). All participants completed three rounds of eight basic exercises on the Versius trainer, where the first was used for familiarization and the final two for data analysis. The simulator automatically recorded data. Validity evidence was summarized using Messick's framework, and the contrasting groups' standard-setting method was used to define pass/fail levels. RESULTS: 40 participants completed the three rounds of exercises. The discriminatory abilities of all parameters were tested, and five exercises including relevant parameters were selected to be part of the final test. 26 of 30 parameters could differentiate between novices and experienced surgeons but none of the parameters could discriminate between the intermediate and experienced surgeons. Test-retest reliability analysis using Pearson's r or Spearman's rho showed only 13 of 30 parameters had moderate or higher reliability. Non-compensatory pass/fail levels were defined for each exercise and showed that all novices failed all the exercises and that most experienced surgeons either passed or nearly passed all five exercises. CONCLUSION: We identified relevant parameters for five exercises that could be used to assess basic robotic skills for the Versius robotic system and defined a credible pass/fail level. This is the first step in developing a proficiency-based training program for the Versius system.

Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial.

BACKGROUND: Miscarriage in the second trimester and preterm birth are significant global problems. Vaginal cervical cerclage is performed to prevent pregnancy loss and preterm birth. We aimed to determine the effectiveness of a monofilament suture thread compared with braided suture thread on pregnancy loss rates in women undergoing a cervical cerclage. METHODS: C-STICH was a pragmatic, randomised, controlled, superiority trial done at 75 obstetric units in the UK. Women with a singleton pregnancy who received a vaginal cervical cerclage due to a history of pregnancy loss or premature birth, or if indicated by ultrasound, were centrally randomised (1:1) using minimisation to receive a monofilament suture or braided suture thread for their cervical cerclage. Women and outcome assessors were masked to allocation as far as possible. The primary outcome was pregnancy loss, defined as miscarriage, stillbirth, or neonatal death in the first week of life, analysed in the intention-to-treat population (ie, all women who were randomly assigned). Safety was also assessed in the intention-to-treat population. The trial was registered with ISRCTN, ISRCTN15373349. FINDINGS: Between Aug 21, 2015, and Jan 28, 2021, 2049 women were randomly assigned to receive a monofilament suture (n=1025) or braided suture (n=1024). The primary outcome was ascertained in 1003 women in the monofilament suture group and 993 women in the braided suture group. Pregnancy loss occurred in 80 (8·0%) of 1003 women in the monofilament suture group and 75 (7·6%) of 993 women in the braided suture group (adjusted risk ratio 1·05 [95% CI 0·79 to 1·40]; adjusted risk difference 0·002 [95% CI -0·02 to 0·03]). INTERPRETATION: Monofilament suture did not reduce rate of pregnancy loss when compared with a braided suture. Clinicians should use the results of this trial to facilitate discussions around the choice of suture thread to optimise outcomes. FUNDING: National Institute of Health Research Health Technology Assessment Programme.

Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery.

OBJECTIVES: Versius is a teleoperated surgical robotic system intended for use in minimal access surgery. This study aimed to validate the safety and effectiveness of the Versius user interface in the hands of trained users and identify and address the causes of any user errors. DESIGN: Surgical teams completed a commercially representative training program over 3.5 days. After training was completed, the usability-related aspects of the system were assessed. SETTING: A simulated operating room using a cadaveric model. PARTICIPANTS: Surgical teams consisting of a lead surgeon, assistant surgeon, scrub nurse and circulating nurse. MAIN OUTCOME MEASURES: Usability-related aspects of the system were assessed through the completion of critical and non-critical tasks. A critical task was defined according to the Food and Drug Administration's definition, as a user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care. RESULTS: In total, 17 surgical teams participated in the study and all were experienced in laparoscopic surgery. The number of robotic surgeries performed by the participants per month ranged from 0 to 100. Surgical specialties were similarly represented from obstetrics and gynecology, colorectal, urology and upper gastrointestinal. No critical task failures were observed. Of all the tasks completed, 98% were recorded as a pass or a pass with difficulty. CONCLUSIONS: These results demonstrate that in a simulated clinical setting, Versius can be safely used by both laparoscopically and robotically trained healthcare professionals. These results support the progression to assessment of Versius in preclinical studies.

Rate, type, and cost of pelvic organ prolapse surgery in Germany, France, and England.

OBJECTIVE: To estimate the rate, type and costs of surgical interventions for pelvic organ prolapse (POP) in Germany, France, and England. STUDY DESIGN: We identified the number, rate, and type of hospital admissions for pelvic floor surgery in 2005 from national hospital activity databases in each country: the German Hospital Episode, the French Medical Care Program Information System, and the National Health Service England Hospital Episode Statistics. Costs to the payer were estimated using the Diagnosis-Related Group reimbursement rates for each country. RESULTS: In 2005, the number (rate) of admissions for POP surgery was 36,854 (0.87 per 1000 women) in Germany, 36,679 (1.14 per 1000 women) in France, and 28,959 (1.13 per 1000 women) in England. Admissions for POP surgery constituted 10.4%, 16.7% and 16.9% of all admissions for female genital tract therapeutic interventions in Germany, France and England, respectively. At least 20% of hysterectomies were performed for the primary indication of POP. 57.4%, 45.0%, and 40.1% of all admissions for POP surgery included a hysterectomy. The costs to payers were 144,236,557 euro, 83,067,825 euro, and 81,030,907 euro in Germany, France, and England, respectively. CONCLUSION: Burden and costs associated with POP surgery are substantial in the three countries studied. Thus, programs aimed at reducing the burden of this disease are desirable.