Adopting “Culture of Safety for Laparoscopic Cholecystectomy” in a Rural Hospital: A Prospective Observational Study

DISCUSSION

Gallstone disease is a common disease affecting general adult population.^8,9 LC has evolved as the standard of care treatment for management of this disease due to its various advantages.^10–12 Although it is invariably accepted as a safe procedure, complications still happen in approximately 5% of patient.¹³ Of these, BDI remains the most feared and dreadful complication of LC that at times can be life-threatening. The etiology is multifactorial, but misidentification of anatomy is perhaps the most important factor responsible for BDI mishap.¹⁴ Way et al. concluded that primary cause of BDI was a visual perceptual illusion in which the surgeon misidentifies common bile duct (CBD) as cystic duct. Erroneous technical skills were identified as the primary mechanism of injury in only 3% of cases.⁶ To minimize the risk of BDI, SAGES, in 2014, formed the Safe Cholecystectomy Task Force, with the aim of propagating a culture of safety around LC.⁷ Following six steps were described to create a culture of safe cholecystectomy and minimize the risk of BDI: (a) identification of the cystic duct and artery by using CVS, (b) awareness of the potential for aberrant anatomy, (c) identification of anatomy using IOC or any other relevant method, (d) intraoperative time-out or pause during surgery before clipping and dividing the structures in Calot’s triangle for verification of anatomy, (e) early adaptation of the bailout options, (f) call for help from another surgeon whenever required.

The CVS has been adapted for clear identification of structures in Calot’s triangle to reduce the risk of BDI.¹⁵ The requirements are as follows: The hepatocystic triangle must be cleared of all the fatty and fibrous tissue. Second, the lowest one-third of the gallbladder must be separated from the liver bed. The third requirement is to ensure that only two structures are seen to be entering the gallbladder. Once these three criteria have been fulfilled, CVS is said to be attained. Most surgeons around the world acknowledge the importance of CVS during LC for prevention of biliary injury.^16,17 There has been indirect evidence from literature to suggest that the use of the CVS is helpful in preventing BDI. None of the patients in the study conducted by Yegiyants and Collins had an injury to biliary ducts because of visual misidentification when CVS was achieved.¹⁶ CVS was achieved in 998 of the 1,046 patients in the study conducted by Avgerinas et al. who reported a conversion rate of 2.7%. Five patients had minor bile leak that resolved spontaneously. They didn’t report any major BDI.¹⁸ Heistermann et al. evaluated 100 patients who had LC in whom CVS was achieved. Only one patient in their study had postoperative cystic duct stump leak.¹⁹

Variations in biliary anatomy are common.¹⁴ Variable biliary anatomy can predispose to BDI. Awareness to variation in biliary anatomy can be enhanced by starting from a fixed point a concept borrowed by Huge from maritime and aviation industries.²⁰ Rouviere’s sulcus is one such extra biliary fixed point.²⁰ The right portal pedicle runs in this fissure and thus demarcates the plane of the porta hepatis. The dissection during the procedure should always stay anterior to this sulcus. Minimal incidence of BDI has been reported in a large series of LC by Huge et al.²¹ and Singh and Ohri²² when dissection is done ventral to this sulcus.

As per SAGES recommendations, it is advised to keep IOC available as an integral tool while performing LC. Selective use, however, has been practiced more commonly.²³ Utility of IOC is, however, controversial as many authors report it to be time-consuming and complex procedure. It is also considered to be inefficient with few authors suggest that many surgeons may not be able to read it correctly.^24,25 As per the current literature, there is no level evidence to suggest the use of IOC.²⁶ An alternative is laparoscopic ultrasonography, but it is subject to significant interoperator variability.^27,28 Another method to identify and continuously map the biliary anatomy is near-infrared fluorescent cholangiography, which is technically easy but the data as of now are insufficient to suggest its role in minimizing biliary injury.¹⁴ Due to the lack of expertise or for logistic reasons, these methods of mapping biliary anatomy are not available in most rural hospitals in India.

Intraoperative time-out should be considered by operating surgeon always in the process of dissection of Calot’s triangle. This step helps to confirm that the CVS has been achieved. The proposed disadvantage of this step is that this step is adopted by the operating surgeon who may still suffer from the heuristic error.²⁹ As already discussed, injuries stem principally from misidentification secondary to visual misperception rather than error of skill, knowledge, or judgement.⁶ This visual misperception is a result of misplaced cognitive map,³⁰ and sometimes this illusion is so compelling as to end into an error. A detached observer can be helpful in this situation.³¹ The detached observer present should agree with the surgeon that CVS has been achieved. Hori et al. have also advised to take the opinion of an independent detached surgeon while demonstrating CVS as he is unbiased and free from the any heuristic impression of the primary surgeon.³² Surgical colleague can act as an unbiased observer free from heuristic impression of operating surgeon. He or she can ascertain whether the CVS is achieved or not, whether it is safe to continue dissection in the assumed plane, and when to apply stopping rules. Kapoor also suggests that the primary surgeon should always call another surgical colleague for opinion and assessment of the biliary ductal anatomy, if in doubt, before the structures of Calot’s triangle are divided.²⁹ The new and unbiased input of the detached observer can avoid the visual perception error of the primary surgeon. He calls this “in vicinity colleaguography.”

Bystander surgeon for the reason that he is detached is more likely to seek information from surgical field and more likely to recognize misplacement of cognitive map by the operating surgeon that can result in spatial disorientation.³¹ He is more alert for cues from surgical environment if demanded by the situation. He can refute the working hypothesis which the operator has entertained. Significance of unexpected observation may go unrecognized by the operating surgeon due to conformation bias.⁶ Since detached observer is not committed to a judgment and is free from confirmation bias, he may be able to attach significance to some unexpected observation.³¹ As mentioned by Way et al. in their seminal paper, “human performance cannot be pushed to perfection and that most fruitful correction strategy often lies outside the individual.”⁶ Bystander surgeon can be considered as one such outside correction strategy.³¹

Alternative or bailout options should be considered in those cases where achievement of CVS remains elusive due to dense adhesions, uncertain anatomy, or severe inflammation.¹⁴ Conversion to open cholecystectomy is the most practical option in this situation. The decision to convert to open should take into consideration the experience of surgeon since difficult LC usually suggests a difficult open cholecystectomy with chances of biliary injuries remaining higher.¹⁴ Subtotal cholecystectomy may also be considered in select situations. It can be done by laparoscopic or open method. Surgical cholecystostomy tube drainage is a safe alternative in difficult situations. In case of inexperience, the best possible method to prevent BDI may be to abort the procedure and referral to the higher center.