Nationwide standardization of minimally invasive right hemicolectomy for colon cancer and development and validation of a video-based competency assessment tool (the Right study).

BACKGROUND: Substantial variation exists when performing a minimally invasive right hemicolectomy (MIRH) due to disparities in training, expertise and differences in implementation of innovations. This study aimed to achieve national consensus on an optimal and standardized MIRH technique for colon cancer and to develop and validate a video-based competency assessment tool (CAT) for MIRH. METHOD: Statements covering all elements of MIRH were formulated. Subsequently, the Delphi technique was used to reach consensus on a standardized MIRH among 76 colorectal surgeons from 43 different centres. A CAT was developed based on the Delphi results. Nine surgeons assessed the same 12 unedited full-length videos using the CAT, allowing evaluation of the intraclass correlation coefficient (ICC). RESULTS: After three Delphi rounds, consensus (≥80% agreement) was achieved on 23 of the 24 statements. Consensus statements included the use of low intra-abdominal pressure, detailed anatomical outline how to perform complete mesocolic excision with central vascular ligation, the creation of an intracorporeal anastomosis, and specimen extraction through a Pfannenstiel incision using a wound protector. The CAT included seven consecutive steps to measure competency of the MIRH and showed high consistency among surgeons with an overall ICC of 0.923. CONCLUSION: Nationwide consensus on a standardized and optimized technique of MIRH was reached. The CAT developed showed excellent interrater reliability. These achievements are crucial steps to an ongoing nationwide quality improvement project (the Right study).

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 METHODS: PubMed, PsycINFO and Google Scholar were searched to November 2014 for published and unpublished studies reporting the measurement of a form of aptitude for laparoscopic skills.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.

Assessment of Clinical Complete Response After Chemoradiation for Rectal Cancer with Digital Rectal Examination, Endoscopy, and MRI: Selection for Organ-Saving Treatment.

BACKGROUND: The response to chemoradiotherapy (CRT) for rectal cancer can be assessed by clinical examination, consisting of digital rectal examination (DRE) and endoscopy, and by MRI. A high accuracy is required to select complete response (CR) for organ-preserving treatment. The aim of this study was to evaluate the value of clinical examination (endoscopy with or without biopsy and DRE), T2W-MRI, and diffusion-weighted MRI (DWI) for the detection of CR after CRT. METHODS: This prospective cohort study in a university hospital recruited 50 patients who underwent clinical assessment (DRE, endoscopy with or without biopsy), T2W-MRI, and DWI at 6-8 weeks after CRT. Confidence levels were used to score the likelihood of CR. The reference standard was histopathology or recurrence-free interval of >12 months in cases of wait-and-see approaches. Diagnostic performance was calculated by area under the receiver operator characteristics curve, with corresponding sensitivities and specificities. Strategies were assessed and compared by use of likelihood ratios. RESULTS: Seventeen (34 %) of 50 patients had a CR. Areas under the curve were 0.88 (0.78-1.00) for clinical assessment and 0.79 (0.66-0.92) for T2W-MRI and DWI. Combining the modalities led to a posttest probability for predicting a CR of 98 %. Conversely, when all modalities indicated residual tumor, 15 % of patients still experienced CR. CONCLUSIONS: Clinical assessment after CRT is the single most accurate modality for identification of CR after CRT. Addition of MRI with DWI further improves the diagnostic performance, and the combination can be recommended as the optimal strategy for a safe and accurate selection of CR after CRT.

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.

Transanal endoscopic microsurgery versus endoscopic mucosal resection for large rectal adenomas (TREND-study).

BACKGROUND: Recent non-randomized studies suggest that extended endoscopic mucosal resection (EMR) is equally effective in removing large rectal adenomas as transanal endoscopic microsurgery (TEM). If equally effective, EMR might be a more cost-effective approach as this strategy does not require expensive equipment, general anesthesia and hospital admission. Furthermore, EMR appears to be associated with fewer complications.The aim of this study is to compare the cost-effectiveness and cost-utility of TEM and EMR for the resection of large rectal adenomas. METHODS/DESIGN: Multicenter randomized trial among 15 hospitals in the Netherlands. Patients with a rectal adenoma > or = 3 cm, located between 1-15 cm ab ano, will be randomized to a TEM- or EMR-treatment strategy. For TEM, patients will be treated under general anesthesia, adenomas will be dissected en-bloc by a full-thickness excision, and patients will be admitted to the hospital. For EMR, no or conscious sedation is used, lesions will be resected through the submucosal plane in a piecemeal fashion, and patients will be discharged from the hospital. Residual adenoma that is visible during the first surveillance endoscopy at 3 months will be removed endoscopically in both treatment strategies and is considered as part of the primary treatment. Primary outcome measure is the proportion of patients with recurrence after 3 months. Secondary outcome measures are: 2) number of days not spent in hospital from initial treatment until 2 years afterwards; 3) major and minor morbidity; 4) disease specific and general quality of life; 5) anorectal function; 6) health care utilization and costs. A cost-effectiveness and cost-utility analysis of EMR against TEM for large rectal adenomas will be performed from a societal perspective with respectively the costs per recurrence free patient and the cost per quality adjusted life year as outcome measures. Based on comparable recurrence rates for TEM and EMR of 3.3% and considering an upper-limit of 10% for EMR to be non-inferior (beta-error 0.2 and one-sided alpha-error 0.05), 89 patients are needed per group. DISCUSSION: The TREND study is the first randomized trial evaluating whether TEM or EMR is more cost-effective for the treatment of large rectal adenomas. TRIAL REGISTRATION NUMBER: (trialregister.nl) NTR1422.