Surgical Quality Assurance in COLOR III : Standardization and Competency Assessment in a Randomized Controlled Trial

OBJECTIVE: The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer. BACKGROUND OF SUMMARY DATA: SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable. METHOD: Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory. RESULTS: Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT. CONCLUSION: We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial

Effects of High Temperature on the Residual Performance of Portland Cement Concretes

In this work we analyzed the "residual" performance of Portland cement concretes heat-treated at 600 °C after cooling down to room temperature. Concretes with characteristic compressive strength at 28 days of 45 MPa and of 60 MPa were studied. The heat-treatment was carried out without any imposed load. We measured the residual compressive strength and modulus of elasticity. The geometry of the structure was described by mercury intrusion porosimetry and nitrogen sorption tests. We observed a decrease of residual compressive strength and modulus of elasticity, with the raise of heat-treatment temperature, as a result of heat-induced material degradation. The results also indicated that the microstructural damage increased steadily with increasing temperature. Based on the results of this experimental work we concluded that residual mechanical properties of concrete are dependent of their original non heat-treated values

Structural Evaluation and Performance of Portland Cement Concretes After Exposure to High Temperatures

We evaluated the "residual" thermal conductivity of Portland cement concretes (with characteristic compressive strength at 28 days, f ck, of 20 MPa and 50 MPa) at room temperature after heat-treating at 180 °C, 300 °C and 600 °C. The description of the geometry of the structure was carried out using mercury intrusion porosimetry and nitrogen sorption. The results showed a decreasing tendency of residual thermal conductivity, which we attributed to heat-induced concrete degradation. Furthermore, the results from mercury intrusion porosimetry and nitrogen sorption tests showed that a coarser pore structure is produced with the raise of heat-treatment temperatures

Surgical site infection after gastrointestinal surgery in children: An international, multicentre, prospective cohort study

Introduction Surgical site infection (SSI) is one of the most common healthcare-associated infections (HAIs). However, there is a lack of data available about SSI in children worldwide, especially from low-income and middle-income countries. This study aimed to estimate the incidence of SSI in children and associations between SSI and morbidity across human development settings. Methods A multicentre, international, prospective, validated cohort study of children aged under 16 years undergoing clean-contaminated, contaminated or dirty gastrointestinal surgery. Any hospital in the world providing paediatric surgery was eligible to contribute data between January and July 2016. The primary outcome was the incidence of SSI by 30 days. Relationships between explanatory variables and SSI were examined using multilevel logistic regression. Countries were stratified into high development, middle development and low development groups using the United Nations Human Development Index (HDI). Results Of 1159 children across 181 hospitals in 51 countries, 523 (45·1%) children were from high HDI, 397 (34·2%) from middle HDI and 239 (20·6%) from low HDI countries. The 30-day SSI rate was 6.3% (33/523) in high HDI, 12·8% (51/397) in middle HDI and 24·7% (59/239) in low HDI countries. SSI was associated with higher incidence of 30-day mortality, intervention, organ-space infection and other HAIs, with the highest rates seen in low HDI countries. Median length of stay in patients who had an SSI was longer (7.0 days), compared with 3.0 days in patients who did not have an SSI. Use of laparoscopy was associated with significantly lower SSI rates, even after accounting for HDI. Conclusion The odds of SSI in children is nearly four times greater in low HDI compared with high HDI countries. Policies to reduce SSI should be prioritised as part of the wider global agenda