Introduction: The role of laparoscopy in the surgical management of rectal cancer is debated. Randomised trials have reported contrasting results with inadequate specimens obtained in a minority of patients. The reasons behind these findings are unclear. Complex surgical interventions and human performance are prone to variation, which may account for outcome differences, but neither are robustly measured. Application of quality assurance (QA) to the intraoperative period could explore surgical performance and any relationship with subsequent outcomes. The overarching aim of this thesis is the promotion of oncological and patient safety through application of QA to laparoscopic TME surgery.
Methods: Evidence synthesis of QA tools was obtained through a systematic review to identify reported objective laparoscopic total mesorectal excision (TME) assessment tools. Development of novel QA tools for laparoscopic TME was performed and applied and validated using case video from two multicentre randomised trials with reliability and validity of the laparoscopic TME performance tool (L-TMEpt) assessed. A multicentre randomised trial comparing 3D vs. 2D laparoscopic TME was performed incorporating objective performance analyses. Scores divided surgeons into quartiles and compared with histopathological and clinical endpoints. A novel intraoperative adverse event classification was developed and piloted.
Results: 176 cases from 48 credentialed surgeons were analysed. L-TMEpt inter-rater, test-retest and internal consistency reliabilities were established. Substantial variation in surgical performance were seen. Scores were strongly associated with the number of intraoperative errors, plane of mesorectal dissection and short-term patient morbidity. Upper quartile surgeons obtained excellent results compared with the lower quartile (mesorectal fascia 93% vs. 59%, NNT 2.9, p=0.002; 30-day morbidity 23% vs. 48%, NNT 4, p=0.043).
Conclusions: Intraoperative QA using assessment tools can objectively and reliably measure complex cancer interventions. Laparoscopic TME surgical performance assessment showed substantial variation which is strongly associated with clinical outcomes holding implications for surgical trial design and interpretation.