European Journal of Cardiovascular Medicine

There are various risk factors that can lead to cholesterol gallstones in a subject including genetic susceptibility, family history, gender, age, and/or ethnicity. On the contrary, factors modifiable factors associated with cholesterol gallstones include sedentary lifestyle, sudden weight loss, and obesity. Laparoscopic cholecystectomy has been considered as the conventional and gold standard management strategy for managing the pathologies of the gall bladder which carries a slightly higher risk for damage to the bile duct compared to tradition open surgery of the gallbladder. With an increase in incidence of metabolic syndrome and obesity, the incidence of cholesterol stones is becoming more common.¹

A significant increase on the burden of gallstone disease in healthcare sector has resulted in increased rates of mortality despite of comparatively low mortality rates as 0.6% reported. In industrialized societies, there is reported incidence of 10-15% adults having gallstones. More commonly, these laparoscopic cholecystectomies are done using assessment of ultrasonographic findings which is dependent on operator and usually these ultrasonographic investigations miss the anatomical anomalies of bile duct and disease severity making laparoscopic cholecystectomy a difficult procedure.² 

In contrast to this, not all the subjects having gallstone diseases need further advanced investigations as MRCP which pose high financial burden on the affected subjects and undue burden on Department of Radiodiagnosis. Hence, it is warranted and pivotal to formulate and apply objective methods for prediction of the preoperative difficulty during the plan for laparoscopic cholecystectomy to allow the advice for predicted subjects to undergo higher investigations.³

These preoperative assessments in radiodiagnosis can also allow the identification of the risk factors linked with the physical examination and history. Also, such assessment can help the surgeons to formulate a decision concerning proper preoperative investigations and can also help to guide between MRCP and ultrasound.⁴ The present study was aimed to use grading system to anticipate potential complications during laparoscopic cholecystectomy before surgery, to support the reliability of our scoring method for evaluating the difficulties of laparoscopic cholecystectomy, and to prevent intraoperative complications while laparoscopic cholecystectomy for those predicted patient.

The present observational study was aimed to use grading system to anticipate potential complications during laparoscopic cholecystectomy before surgery, to support the reliability of our scoring method for evaluating the difficulties of laparoscopic cholecystectomy, and to prevent intraoperative complications while laparoscopic cholecystectomy for those predicted patient.

The study assessed subjects with cholelithiasis who meet the inclusion and exclusion criteria and are seen in the outpatient or inpatient departments of the General Surgery Department at ESIC Medical College and Hospital in Chennai from 5/08/2022 – 04/08/2023. Institutional Ethical Committee permission was acquired before the start of the investigation. Informed written consent was collected from each participant.

Using inclusion and exclusion criteria, convenient sampling was used to recruit study participants. The inclusion criteria for the study were subjects within the age group of 20-70 years with the history of acute calculous cholecystitis and/or incidental cholelithiasis who required cholecystectomy were included in this study, both male and female gender, and subjects having both single and multiple gall stones. The exclusion criteria for the study were subjects with cholangitis, raised alkaline phosphatase, Common bile duct stones, Dilated common bile duct, Empyema of the gallbladder, perforated gall bladder, cholecystitis with pregnancy, and unwillingness for informed consent.

The required sample size for the study was taken as 125 subjects with cholelithiasis. Sample size was calculated using sensitivity of scoring system used in reference article. n-Master soft (2.0) was used to calculate the sample size. The sampling method used in the study patients was recruited based on visiting the general surgery OPD and on a consecutive manner after checking the eligibility criteria and consent.

From all 125 patients, below data are obtained and preoperative score was calculated, which was compared against intraoperative findings. Preoperative score was compared against intraoperative findings, preoperative scores of all parameters summated, if score <5 it was predicted as easy and score >or =5 it was predicted as difficult and the same was compared against intraoperative findings (Table 1, 2, and 3).

The data gathered were subjected to statistical evaluation using the chi-square test, Fisher’s exact test, Mann Whitney U test, and SPSS (Statistical Package for the Social Sciences) software version 24.0 (IBM Corp., Armonk. NY, USA) using ANOVA, chi-square test, and student's t-test. The significance level was considered at a p-value of <0.05.

The present observational study was aimed to use grading system to anticipate potential complications during laparoscopic cholecystectomy before surgery, to support the reliability of our scoring method for evaluating the difficulties of laparoscopic cholecystectomy, and to prevent intraoperative complications while laparoscopic cholecystectomy for those predicted patient. There were 41.6% (n=52) subjects in the age range of 21-40 years followed by 40% (n=50) subjects in 41-60 years, and 18.4% (n=23) subjects in >60 years of age. There were 35.2% (n=44) males and 64.8% (n=81) females in the study. Alcohol history was positive in 10.4% (n=13) study subjects. Hepatomegaly was positive in 4% (n=5) study subjects. Palpable gallbladder was seen in 1.6% (n=2) subjects, abdominal scar was present in 40% (n=50) study subjects, and pericholecystic fluid collection was seen in 6.4% (n=8) study subjects. Impacted stones were noted in 10.4% (n=13) study subjects (Table 4).

Table 1: Estimation of sensitivity of a new test

Table 2: Preoperative findings and scores in study subjects

Table 3: Intraoperative findings in study subjects

Table 4: Demographic and disease data in study subjects

Table 5: Comparison of preoperative scores to intraoperative findings in study subjects

Table 6: Levene’s test and t-test for equality of variance and means in study subjects

Table 7: Mann Whitney U test

Table 8: Test statistics for operative time <60 minutes and no spillage of bile or stones

It was seen that for comparison of preoperative scores to intraoperative findings in study subjects, preoperative score of ≥5 was seen in 50% (n=5) subjects each with difficult and easy scoring and scores of <5 was seen in 4.3% (n=5) subjects with difficult scoring and 95.7% (n=110) subjects with easy scoring respectively. The difference in preoperative scores in difficult and easy scoring was statistically significant with p=0.000. Concerning group statistics, in 10 subjects with difficult scoring, mean preoperative scores for difficult and easy scores were 2.43±1.944 and 2.43±0.956 respectively and standard error was .615 and .089 respectively (Table 5).

The study results showed that for preoperative parameters, for equal variance (assumed), Levene’s test for equality of variance showed f as 17.257 and significance level was .000 and for t-test for equality of means, t, df, 2-tailed significance, mean difference, standard error of difference, 95% CI lower, and 95% CI upper was 7.367, 123, .000, 2.574, 0.349. 1.882, and 3.265 respectively. For non-assumed equal variance, concerning t-test for equality of means, , t, df, 2-tailed significance, mean difference, standard error of difference, 95% CI lower, and 95% CI upper was4.144, 9.38, .002, 2.574, .621, 1.178, and 3.970 respectively depicting statistical significance (Table 6).

On applying the Mann Whitney U test and test statistics for operative time <60 minutes and no spillage of bile or stones, preoperatively, in 10 subjects with difficult scoring, mean rank and sum of ranks was 107.60 and 1076.00 respectively and for easy scores in 115 subjects, mean rank and sum of ranks was 59.12 and 6799.00 respectively (Table 7). Concerning preoperative scores, Mann-Whitney U test, Wilcoxon W test, and Z was 129.000, 6799.000, and -4.299 respectively. These values showed statistical significance with p=0.000 (Table 8).

In the present study it is evident that, increase in preoperative score is directly proportional to difficulty in lap cholecystectomy. Initially, laparoscopic cholecystectomy had a high complication rate; however, with advanced increased expertise, this rate has significantly decreased to a range of 2.0% to 6.0%. Conversion rates, as reported in the literature, range from 7% to 35%. In our study we used predictive factors such as Age, Gender, Alcoholic history, Hospitalisation for acute cholecystitis, BMI, Palpable gall bladder, Hepatomegaly, Abdominalscar, Pericholecystic fluid collection, Intrahepatic gall bladder, Thickened gall bladder, impacted stone, Enlarged left lobe of liver. These results were consistent with the previous studies of Lee NW et al⁵ in 2012 and Majeski J et al⁶ in 2007 where authors assessed subjects on demographic and disease data comparable to the present study in their respective studies.

The study results showed that a preoperative score increase of more than 5 is significant when compared with intraoperative findings. The scoring is based on these predictive factors. In a multivariate analysis of intraoperative outcome with risk factors, we look for predictive associations between risk factors and intraoperative outcome. These findings were in agreement with the results of Bourgouin S et al⁷ in 2016 and Agarwal N et al⁸ in 2015 where results reported by authors in their studies were comparable to the results of the present study.

In the above multivariate analysis, p-value of thick gall bladder wall, BMI and intrahepatic gall bladder found to be ≥5 and out of these <5 patients have difficulty in laparoscopic cholecystectomy and p value found to be 5, then higher investigations like MRCP can be recommended to rule out any anatomical variation and to rule out common bile duct pathology which will increase the difficulty of lap cholecystectomy independent of other risk factors. These results correlated with the findings of Hussain A⁹ in 2011 and Bouarfa L¹⁰ in 2011 where scoring results comparable to the present study were also reported by the authors in their respective studies.

Other factors like age, sex, alcoholic history, abdominal scar, history of hospitalization, palpable gallbladder, pericholecystic collection, impacted stones are not independently associated with increased difficulty in lap cholecystectomy, overall preoperative score is associated with difficulty in lap cholecystectomy. In our difficult cases, 2 cases are of bile leak, which is settled with conservative management, 2 cases are of open conversion patient follow up done which is uneventful, 1 case abandoned because of frozen calots and referred to higher centre, all difficult cases managed conservatively. These findings were in line with the results of Nachnani J et al¹¹ in 2005 and Randhawa JS et al¹² in 2009 where authors also reported that factors like age, sex, alcoholic history, abdominal scar, history of hospitalization, palpable gallbladder, pericholecystic collection, impacted stones are not independently associated with increased difficulty in lap cholecystectomy as seen in results of the present study.

The present study, within its limitations, the present study conclude that the reported scoring system is found to be significant by P value based on data. This preoperative scoring system is useful in future for preoperative assessment for patients planned for cholecystectomy to avoid intraoperative complication and to prevent morbidity and mortality rates. The study also concluded that none of the 125 subjects were considered difficult preoperatively using the present scoring system and there is a statistically significant connection in increase in preoperative score and difficulty in laparoscopic cholecystectomy.

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