Sages 6-step Protocol for Minimizing Bile Duct Injuries: A Single Center Experience

Tushar C Barot, MD, MPH, Alexander Canales, MD, Jorge Irving, MD, Stephen W Unger, MD. Mount Sinai Medical Center

Introduction: Over 750,000 Laparoscopic Cholecystectomies (LC) are performed yearly in US. Benefits are reduced pain, wound infection and length of stay (LOS) with LC compared to open operation. One of the devastating complication of LC is bile duct injury, occurring in about 0.3% procedures leading to significant morbidity. In 2014 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) launched 6-step protocol to minimize these injuries. Our surgery department has adapted and implemented this protocol as a part of our quality improvement initiative beginning of February 2015. We performed a retrospective analysis to evaluate the feasibility and efficacy of this protocol.

Methods: After IRB approval, study period from November 2014 to July 2015 was reviewed retrospectively for patients undergoing LC, including cases three months before and six months following implementation of 6-step protocol. The parameters were age, sex, BMI, Inpatient status, LoS, and peri-operative complications. In addition to that we also collected data on adherence to SAGES 6-steps protocol namely critical view of safety (CVS) , Intra-op timeout, recognizing aberrant anatomy, use of intra-op cholangiogram(IOC), conversion to open and getting assistance if needed. A statistical analysis was performed using SPSS 22. A chi-square test, student’s t-test and descriptive frequency analysis performed on the data comparing parameters before and after initiation of SAGES protocol.

Results: Total 173 cases matched study criteria, including 70 males (40.5%) and 103 females (59.5%) with mean age 56 years (22-92). Mean BMI was 28.45 (17.34-56.09), LoS was 3.52 days (0-31). No statistically significant difference was found between two groups in age, sex, BMI or LoS. Statistically significant difference was found in following three SAGES parameters after implementation of protocol. The visualization of CVS increased from 57.10% to 95.10% (p =0.0001), Intra-op timeout increased from 0% to 12.6% (p=0.001), and recognition of aberrant anatomy increased from 1.4% to 8.7% (p=0.039). No difference was observed in use of IOC (71.4% to 68.9%, p=0.429), conversion to open (0% to 2.9%, p=0.209), or getting assistance (1.4% to 0%, p=0.405). Statistically significant reduction was observed in Intra-op complications (5.7% to 0%, p=0.025).

Conclusion: After implementation of 6 step protocol we have seen statistically significant improvement in surgeons’ adherence to protocol and resulting reduction in complication rate. With continued efforts to increase the awareness and use of the SAGES six-step protocol amongst surgeons; we hope to see reproducible reduction in morbidity and mortality related to CBD injuries from LC.