Development and clinical validation of an objective assessment tool for robotic-assisted and laparoscopic hysterectomy.

BACKGROUND

Hysterectomy is one of the most performed gynecological procedures worldwide. Recent decades have witnessed a marked uptake of laparoscopic approaches. While technical proficiency is increasingly recognized as being closely linked to patient outcomes in different surgical specialties, standardization of assessment in minimally invasive gynecological surgery remains challenging.

OBJECTIVE

This study aimed to develop and validate a comprehensive assessment tool for robotic-assisted and laparoscopic hysterectomy and investigate associations between surgical performance and perioperative outcomes.

STUDY

DESIGN

An international multicenter mixed-method study was conducted. Literature review was performed, and statements were proposed by a steering group of 7 expert gynecologists, followed by a Delphi consensus to identify essential procedural phases, potential technical errors or near misses. The resulting assessment tool was validated using 40 unedited minimally invasive hysterectomy videos assessed by multiple raters under a national prospective multicenter observational cohort study. Interrater and intrarater reliability was calculated using Cronbach's alpha and intraclass correlation. Concurrent validity was assessed through correlation with a validated error assessment tool (Objective Clinical Human Reliability Analysis), while predictive validity was established by correlating scores with clinical outcomes including operative time, blood loss, and postoperative complications according to the Clavien-Dindo classification.

RESULTS

Consensus was achieved amongst 17 international experts from 6 countries on the composition of an objective assessment tool, composed of 7 phases and 4 quality measures. Interrater and intrarater reliability and internal consistency were considered excellent: intraclass correlation =0.969 (confidence interval, 0.922-0.986; P<.001), intraclass correlation 0.810 (confidence interval, 0.800-0.842; P=.002), and Cronbach's α per phase was 0.743 to 0.834. When controlling potential confounders a higher Structured Tool for Evaluating technical skiLls during LAparoscopic and Robotic hysterectomy score was associated with shorter operating time, less blood loss and fewer postoperative complications. Increased tool score was associated with significant lower chance of post-operative complications: rs = -0.438, (confidence interval, -0.173 to -0.657; P=.004).

CONCLUSION

Operative performance during laparoscopic and robotic-assisted hysterectomy can be objectively measured and correlated with clinical outcomes. This newly developed objective assessment tool can be used for surgical quality assurance of surgical techniques during education and training sessions or surgical trials.