Grober, E.D., Jewett, M.A.S.
|Objective:||To determine if intra-operative evaluations of technical skill by expert surgeons using Real-time Intra-operative Surgical Competence (RISC) assessments, predict clinical and operative outcomes in real patients.|
|Study Design:||A prospective analysis evaluating the predictive value of RISC assessments of technical skill in relation to clinically-relevant patient outcomes. Study Model: Cystoscopic transuretharal resection of bladder tumors (TURBT) – the direct visual inspection (via the urethra) of the inside of the bladder using a specialized telescope with simultaneous removal of bladder tumors using a heated knife/resection loop. Subjects include: 1) Surgeons performing TURBTs, and 2) Patients identified at diagnostic cystoscopy (internal bladder inspection) to have a bladder tumor requiring resection.|
|RISC Development:||Previously, study investigators had unedited intra-operative videos of 50 TURBT cases (25 with tumor recurrence and 25 free of recurrence following surgery) reviewed independently by three expert surgeons to identify fundamental technical skill domains thought to influence a tumor recurrence/recurrence-free state. Twenty-five fundamental technical domains were identified and were used to create the RISC assessment instrument. Study Intervention: Live TURBTs will be recorded on video and prospectively evaluated in a blinded fashion by three expert surgeons as to the overall technical quality of the tumor resection using the RISC assessment tool. Subjects will be followed for 18 months for signs of disease recurrence or progression according to current standards of care. Bladder tumor recurrence (primary outcome), disease progression, operative complications and need for further treatment will be correlated with RISC scores.|
|Significance:||Lessons learned from this research will contribute significantly towards the objective assessment of technical skill in real operative settings, on real patients, based on clinically-relevant patient outcomes. Similar methodology can be applied to develop RISC assessments for a variety of surgical procedures and disease states.|