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.

Colorectal Surgery Fellowship Improves In-hospital Mortality After Colectomy and Proctectomy Irrespective of Hospital and Surgeon Volume.

BACKGROUND: General surgery residents are increasingly pursuing sub-specialty training in colorectal (CR) surgery. However, the majority of operations performed by CR surgeons are also performed by general surgeons. This study aimed to assess in-hospital mortality stratified by CR training status after adjusting for surgeon and hospital volume. METHODS: The Statewide Planning and Research Cooperative system database was used to identify all patients who underwent colectomy/proctectomy from January 1, 2000, to December 31, 2014, in the state of New York. Operations performed by board-certified CR surgeons were identified. The relationships between CR board certification and in-hospital mortality, in-hospital complications, length of stay, and ostomy were assessed using multivariate regression models. RESULTS: Two hundred seventy thousand six hundred eighty-four patients underwent colectomy/proctectomy over the study period. Seventy-two thousand two hundred seventy-nine (26.7%) of operations were performed by CR surgeons. Without adjusting for hospital and surgeon volume, in-hospital mortality was lower for those undergoing colectomy/proctectomy by a CR surgeon (OR 0.49, CI 0.44-0.54, p = 0.001). After controlling for hospital and surgeon volume, the odds of inpatient mortality after colectomy/proctectomy for those operated on by CR surgeons weakened to 0.76 (CI 0.68-0.86, p = 0.001). Hospital and surgeon volume accounted for 53% of the reduction in in-hospital mortality when CR surgeons performed colectomy/proctectomy. Patients who underwent surgery by a CR surgeon had a shorter inpatient stay (0.8 days, p = 0.001) and a decreased chance of colostomy (OR 0.86, CI 0.78-0.95, p < 0.001). CONCLUSIONS: For patients undergoing colectomy/proctectomy, in-hospital mortality decreased when the operation was performed by a CR surgeon even after accounting for hospital and surgeon volume.