[Paper Review] Intraoperative time out to promote the implementation of the critical view of safety in laparoscopic cholecystectomy: a video-based assessment of 343 procedures

Pietro Mascagni, María Rita Rodríguez‐Luna+8 more|arXiv (Cornell University)|Apr 6, 2021

Gallbladder and Bile Duct Disorders49 references34 citations

TL;DR

This study evaluates a 5-second intraoperative time out to improve the critical view of safety (CVS) during laparoscopic cholecystectomy. Using video-based assessment of 343 procedures, the intervention increased CVS achievement from 15.9% to 44.1%, significantly enhancing safety awareness and procedural consistency without increasing morbidity.

ABSTRACT

Background: The critical view of safety (CVS) is poorly adopted in surgical practices although it is ubiquitously recommended to prevent major bile duct injuries during laparoscopic cholecystectomy (LC). This study aims to determine whether performing a short intraoperative time out can improve CVS implementation. Methods: Surgeons performing LCs at an academic centre were invited to perform a 5-second long time out to verify CVS before dividing the cystic duct (5-second rule). The primary endpoint was to compare the rate of CVS achievement between LCs performed in the year before and the year after the 5-second rule. The CVS achievement rate was computed using the mediated video-based assessment of two independent reviewers. Clinical outcomes, LC workflows, and postoperative reports were also compared. Results: Three hundred and forty-three (171 before and 172 after the 5-second rule) of the 381 LCs performed over the 2-year study were analysed. After the implementation of the 5-second rule, the rate of CVS achievement increased significantly (15.9 vs 44.1 %; P<0.001) as well as the rate of bailout procedures (8.2 vs 15.7 %; P=0.045), the median time to clip the cystic duct or artery (17:26 [interquartile range: 16:46] vs 23:12 [17:16] minutes; P=0.007), and the rate of postoperative CVS reporting (1.3 vs 28.8 %; P<0.001). Morbidity was comparable (1.75 vs 2.33 % before and after the 5-second rule respectively; P=0.685). Conclusion: Performing a short intraoperative time out improves CVS implementation during LC. Systematic intraoperative cognitive aids should be studied to sustain the uptake of guidelines.

Motivation & Objective

• To evaluate whether a brief intraoperative time out improves adherence to the critical view of safety (CVS) during laparoscopic cholecystectomy.
• To assess the impact of the 5-second rule on CVS achievement, surgical workflow, and postoperative reporting.
• To determine if the intervention enhances safety culture and reduces the risk of bile duct injuries.
• To explore the role of cognitive aids in improving guideline uptake in surgical practice.

Proposed method

• A before-and-after quality improvement study design was used, comparing 171 laparoscopic cholecystectomies performed before and 172 after the 5-second rule intervention.
• Surgeons were instructed to perform a 5-second pause before dividing the cystic duct to verify CVS criteria: two structures (cystic duct and artery), a well-dissected hepatocystic triangle, and separation of the gallbladder from the cystic plate.
• Video-based assessment (VBA) was conducted by two independent reviewers using a validated binary method to evaluate CVS achievement, with mediation by a third expert in case of disagreement.
• Primary outcome was CVS achievement rate; secondary outcomes included operative time, bailout procedures, intraoperative cholangiogram use, and postoperative CVS reporting.
• Inter-rater reliability was assessed using Cohen’s kappa, and statistical comparisons were made using Fisher’s exact test for categorical variables.
• All data were collected from electronic medical records and video annotations, with no in-person observation of the operating room.

Experimental results

Research questions

• RQ1 Does implementing a 5-second intraoperative time out increase the rate of critical view of safety (CVS) achievement in laparoscopic cholecystectomy?
• RQ2 How does the 5-second rule affect surgical workflow, including time to clip and frequency of bailout procedures?
• RQ3 To what extent does the intervention improve postoperative reporting of CVS status?
• RQ4 Does the 5-second rule influence the rate of major bile duct injuries or overall morbidity?
• RQ5 What is the impact of the time out on surgeons’ awareness and application of safety principles in cholecystectomy?

Key findings

• The rate of critical view of safety (CVS) achievement increased significantly from 15.9% before the 5-second rule to 44.1% after its implementation (p < 0.001).
• The median time to clip the cystic duct or artery increased from 17:26 minutes (IQR: 16:46) to 23:12 minutes (IQR: 17:16), indicating more deliberate dissection.
• The rate of bailout procedures rose from 8.2% to 15.7%, with more frequent use of fundus-first cholecystectomy over subtotal cholecystectomy.
• Postoperative CVS reporting increased dramatically from 1.3% to 28.8% after the intervention, suggesting improved documentation and awareness.
• Morbidity remained comparable between groups (1.75% vs. 2.33%, p = 0.685), indicating no adverse impact on patient outcomes.
• Inter-rater agreement for CVS assessment was almost perfect (Cohen’s kappa > 0.90), confirming the reliability of the video-based assessment method.