A New Procedure-Based Assessment of Operative Skills in Gastric Bypass Surgery, Evaluated by Video Fragment Rating.

PURPOSE: Feedback on technical and procedural skills is essential during the training of residents and fellows. The aim of this study was to assess the performance of a newly created instrument for the assessment of operative skills using laparoscopic Roux-en-Y gastric bypass (LRYGB) video fragments. MATERIALS AND METHODS: A new procedure-based assessment (PBA) was created by combining LRYGB key steps with a 5-point independence scale. LRYGB performed by residents and surgeons with different levels of expertise were video recorded. Fragments of the pouch creation, gastro-jejunostomy and jejunojejunostomy, were review by 12 expert bariatric surgeons and the operative skills assessed with the PBA, Objective Structured Assessment of Technical Skill (OSATS), and the Bariatric OSATS (BOSATS). The PBA was compared to the OSATS and BOSATS. Mean scores for all items of the different assessments were summarized and compared using a T-test. RESULTS: The scores of the procedural steps were combined and compared for all levels. The mean scores for beginner, intermediate, and expert level were 2.71, 3.70, and 3.90 for the PBA; for the OSATS 1.84, 2.86, and 3.44; and for the BOSATS 2.78, 3.56, and 4.19. Each of these assessments differentiated between the three skill levels (all p < 0.05). CONCLUSION: The PBA discriminates well between different levels of operative skills. Similar patterns were found for the OSATS and BOSATS, showing that the randomly selected video fragments are representative samples for assessing skill level. Future research will demonstrate whether these results can be extrapolated to clinical training, and which scores allow for procedure certification.

Procedure-based assessment for laparoscopic cholecystectomy can replace global rating scales.

INTRODUCTION: Global rating scales (GRSs) such as the Objective Structured Assessment of Technical Skills (OSATS) and Global Operative Assessment of Laparoscopic Surgery (GOALS) are assessment methods for surgical procedures. The aim of this study was to establish construct validity of Procedure-Based Assessment (PBA) and to compare PBA with GRSs for laparoscopic cholecystectomy. MATERIAL AND METHODS: OSATS and GOALS GRSs were compared with PBA in their ability to discriminate between levels of performance between trainees who can perform the procedure independently and those who cannot. Three groups were formed based on the number of procedures performed by the trainee: novice (1-10), intermediate (11-20) and experienced (>20). Differences between groups were assessed using the Kruskal-Wallis and Mann-Whitney U tests. RESULTS: Increasing experience correlated significantly with higher GRSs and PBA scores (all p < .001). Scores of novice and intermediate groups overlapped substantially on the OSATS (p = .1) and GOALS (p = .1), while the PBA discriminated between these groups (p = .03). The median score in the experienced group was higher with less dispersion for PBA (97.2[85.3-100]) compared to OSATS (82.1[60.7-100]) and GOALS (80[60-100]). CONCLUSION: For assessing skill level or the capability of performing a laparoscopic cholecystectomy independently, PBA has a higher discriminative ability compared to the GRSs.

Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer: a stepped-wedge cluster randomised trial.

BACKGROUND: Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard treatment for locally advanced oesophageal cancer. With this treatment, 29% of patients have a pathologically complete response in the resection specimen. This provides the rationale for investigating an active surveillance approach. The aim of this study is to assess the (cost-)effectiveness of active surveillance vs. standard oesophagectomy after nCRT for oesophageal cancer. METHODS: This is a phase-III multi-centre, stepped-wedge cluster randomised controlled trial. A total of 300 patients with clinically complete response (cCR, i.e. no local or disseminated disease proven by histology) after nCRT will be randomised to show non-inferiority of active surveillance to standard oesophagectomy (non-inferiority margin 15%, intra-correlation coefficient 0.02, power 80%, 2-sided α 0.05, 12% drop-out). Patients will undergo a first clinical response evaluation (CRE-I) 4-6 weeks after nCRT, consisting of endoscopy with bite-on-bite biopsies of the primary tumour site and other suspected lesions. Clinically complete responders will undergo a second CRE (CRE-II), 6-8 weeks after CRE-I. CRE-II will include 18F-FDG-PET-CT, followed by endoscopy with bite-on-bite biopsies and ultra-endosonography plus fine needle aspiration of suspected lymph nodes and/or PET- positive lesions. Patients with cCR at CRE-II will be assigned to oesophagectomy (first phase) or active surveillance (second phase of the study). The duration of the first phase is determined randomly over the 12 centres, i.e., stepped-wedge cluster design. Patients in the active surveillance arm will undergo diagnostic evaluations similar to CRE-II at 6/9/12/16/20/24/30/36/48 and 60 months after nCRT. In this arm, oesophagectomy will be offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant dissemination. The main study parameter is overall survival; secondary endpoints include percentage of patients who do not undergo surgery, quality of life, clinical irresectability (cT4b) rate, radical resection rate, postoperative complications, progression-free survival, distant dissemination rate, and cost-effectiveness. We hypothesise that active surveillance leads to non-inferior survival, improved quality of life and a reduction in costs, compared to standard oesophagectomy. DISCUSSION: If active surveillance and surgery as needed after nCRT leads to non-inferior survival compared to standard oesophagectomy, this organ-sparing approach can be implemented as a standard of care.

The predictive value of aptitude assessment in laparoscopic surgery: a meta-analysis.

CONTEXT: Current methods of assessing candidates for medical specialties that involve laparoscopic skills suffer from a lack of instruments to assess the ability to work in a minimally invasive surgery environment. OBJECTIVES: A meta-analysis was conducted to investigate whether aptitude assessment can be used to predict variability in the acquisition and performance of laparoscopic skills. METHODS: PubMed, PsycINFO and Google Scholar were searched to November 2014 for published and unpublished studies reporting the measurement of a form of aptitude for laparoscopic skills. The quality of studies was assessed with QUADAS-2. Summary correlations were calculated using a random-effects model. RESULTS: Thirty-four studies were found to be eligible for inclusion; six of these studies used an operating room performance measurement. Laparoscopic skills correlated significantly with visual-spatial ability (r = 0.32, 95% confidence interval [CI] 0.25-0.39; p < 0.001), perceptual ability (r = 0.31, 95% CI 0.22-0.39; p < 0.001), psychomotor ability (r = 0.26, 95% CI 0.10-0.40; p = 0.003) and simulator-based assessment of aptitude (r = 0.64, 95% CI 0.52-0.73; p < 0.001). Three-dimensional dynamic visual-spatial ability showed a significantly higher correlation than intrinsic static visual-spatial ability (p = 0.024). CONCLUSIONS: In general, aptitude assessments are associated with laparoscopic skill level. Simulator-based assessment of aptitude appears to have the potential to represent a job sample and to enable the assessment of all forms of aptitude for laparoscopic surgery at once. A laparoscopy aptitude test can be a valuable additional tool in the assessment of candidates for medical specialties that require laparoscopic skills.

Validity, reliability and support for implementation of independence-scaled procedural assessment in laparoscopic surgery.

BACKGROUND: There is no widely used method to evaluate procedure-specific laparoscopic skills. The first aim of this study was to develop a procedure-based assessment method. The second aim was to compare its validity, reliability and feasibility with currently available global rating scales (GRSs). METHODS: An independence-scaled procedural assessment was created by linking the procedural key steps of the laparoscopic cholecystectomy to an independence scale. Subtitled and blinded videos of a novice, an intermediate and an almost competent trainee, were evaluated with GRSs (OSATS and GOALS) and the independence-scaled procedural assessment by seven surgeons, three senior trainees and six scrub nurses. Participants received a short introduction to the GRSs and independence-scaled procedural assessment before assessment. The validity was estimated with the Friedman and Wilcoxon test and the reliability with the intra-class correlation coefficient (ICC). A questionnaire was used to evaluate user opinion. RESULTS: Independence-scaled procedural assessment and GRS scores improved significantly with surgical experience (OSATS p = 0.001, GOALS p < 0.001, independence-scaled procedural assessment p < 0.001). The ICCs of the OSATS, GOALS and independence-scaled procedural assessment were 0.78, 0.74 and 0.84, respectively, among surgeons. The ICCs increased when the ratings of scrub nurses were added to those of the surgeons. The independence-scaled procedural assessment was not considered more of an administrative burden than the GRSs (p = 0.692). DISCUSSION/CONCLUSION: A procedural assessment created by combining procedural key steps to an independence scale is a valid, reliable and acceptable assessment instrument in surgery. In contrast to the GRSs, the reliability of the independence-scaled procedural assessment exceeded the threshold of 0.8, indicating that it can also be used for summative assessment. It furthermore seems that scrub nurses can assess the operative competence of surgical trainees.

Validity and reliability of global operative assessment of laparoscopic skills (GOALS) in novice trainees performing a laparoscopic cholecystectomy.

PURPOSE: Global Operative Assessment of Laparoscopic Skills (GOALS) assessment has been designed to evaluate skills in laparoscopic surgery. A longitudinal blinded study of randomized video fragments was conducted to estimate the validity and reliability of GOALS in novice trainees. METHODS: In total, 10 trainees each performed 6 consecutive laparoscopic cholecystectomies. Sixty procedures were recorded on video. Video fragments of (1) opening of the peritoneum; (2) dissection of Calot's triangle and achievement of critical view of safety; and (3) dissection of the gallbladder from the liver bed were blinded, randomized, and rated by 2 consultant surgeons using GOALS. Also, a grade was given for overall competence. The correlation of GOALS with live observation Objective Structured Assessment of Technical Skills (OSATS) scores was calculated. Construct validity was estimated using the Friedman 2-way analysis of variance by ranks and the Wilcoxon signed-rank test. The interrater reliability was calculated using the absolute and consistency agreement 2-way random-effects model intraclass correlation coefficient. RESULTS: A high correlation was found between mean GOALS score (r = 0.879, p = 0.021) and mean OSATS score. The GOALS score increased significantly across the 6 procedures (p = 0.002). The trainees performed significantly better on their sixth when compared with their first cholecystectomy (p = 0.004). The consistency agreement interrater reliability was 0.37 for the mean GOALS score (p = 0.002) and 0.55 for overall competence (p < 0.001) of the 3 video fragments. CONCLUSION: The validity observed in this randomized blinded longitudinal study supports the existing evidence that GOALS is a valid tool for assessment of novice trainees. A relatively low reliability was found in this study.

Ergonomic assessment of the French and American position for laparoscopic cholecystectomy in the MIS Suite.

BACKGROUND: Cholecystectomy was one of the first surgical procedures to be performed with laparoscopy in the 1980s. Currently, two operation setups generally are used to perform a laparoscopic cholecystectomy: the French and the American position. In the French position, the patient lies in the lithotomy position, whereas in the American position, the patient lies supine with the left arm in abduction. To find an ergonomic difference between the two operation setups the movements of the surgeon's vertebral column were analyzed in a crossover study. METHODS: The posture of the surgeon's vertebral column was recorded intraoperatively using an electromagnetic motion-tracking system with three sensors attached to the head and to the trunk at the levels of Th1 and S1. A three-dimensional posture analysis of the cervical and thoracolumbar spine was performed to evaluate four surgeons removing a gallbladder in the French and American position. The body angles assessed were flexion/extension of the cervical and thoracolumbar spine, axial rotation of the cervical and thoracolumbar spine, lateroflexion of the cervical and thoracolumbar spine, and the orientation of the head in the sagittal plane. For each body angle, the mean, the percentage of operation time within an ergonomic acceptable range, and the relative frequencies were calculated and compared. RESULTS: No statistical difference was observed in the mean body angles or in the percentages of operation time within an acceptable range between the French and the American position. The relative frequencies of the body angles might indicate a trend toward slight thoracolumbar flexion in the French position. CONCLUSION: In a modern dedicated minimally invasive surgery suite, the body posture of the neck and trunk and the orientation of the head did not differ significantly between the French and American position.