Background: Gallbladder-related diseases are among the most common reasons for elective and emergency surgeries. AIM: To Predict the intraoperative and postoperative complications in patients undergoing laparoscopic cholecystectomy using The Ten Point Scoring System
Methods: This study is a hospital-based cross-sectional observational study conducted in the Department of General Surgery at SMS Medical College and Hospital, Jaipur, from November 2022 to May 2024.
Results: Operative mortality for cholecystectomy is under 1%, but complications occur in 10–15% of cases, notably bile duct injuries and cystic duct leaks, which can be minimized by following the ten-point scoring system. In difficult cases, Laparoscopic cholecystectomy is more challenging and should be performed by experienced surgeons to reduce complications and conversion rates using ten-point scoring system.
Conclusion: Laparoscopic cholecystectomy is safe and effective, with negligible morbidity and no conversions to open cholecystectomy, by following ten-point scoring system
Gallstone disease is a common health issue worldwide, with prevalence rates of 20% in the USA, 9–21% in Europe, and 10% in Japan. In northern India, rates range from 6 to 13%.
Cholecystectomy, the most frequent abdominal surgery, sees about 300,000 procedures annually in the USA. While bile duct injury (BDI) is a rare complication, its overall impact is significant due to the high number of cholecystectomies performed globally1.
Cholelithiasis, the most prevalent disease of the gallbladder and biliary tree, affects 10% to 15% of the population worldwide. Chronic inflammation from this condition can lead to DNA damage due to abnormal bile acid exposure, increasing the risk of hepatobiliary cancers, including gallbladder cancer. Consequently, chronic cholecystitis and cholelithiasis represent significant medical challenges with substantial societal impact2.
Gallbladder-related diseases are among the most common reasons for elective and emergency surgeries. The management of cholecystitis has significantly advanced since the introduction of laparoscopic cholecystectomy in the mid-1990s, with an emphasis on performing this procedure during the initial hospital admission. Large studies and meta-analyses have provided detailed patient data and imaging findings, leading to international guidelines for care pathways and efforts to standardise definitions related to cholecystitis. Understanding surgical outcomes, including factors leading to conversion to open cholecystectomy and potential postoperative complications, is crucial for improving healthcare practices.Despite advancements in gallbladder disease management, there remains considerable variability in care approaches and outcomes. The lack of standardised operative classifications at laparoscopic surgery hinders outcome comparisons and future research.
Laparoscopic cholecystectomy is now the gold standard, though its outcomes are influenced by disease severity, surgical experience, and instrumentation. While asymptomatic gallstones can typically be monitored, prophylactic cholecystectomy may be warranted for certain high-risk groups, such as diabetic patients. Cholecystectomy is the preferred treatment for symptomatic gallstones, with an operative mortality rate under 1%. However, risks for postoperative mortality increase with age, comorbidities, and acute presentations, and complications occur in 10–15% of cases, with bile duct injuries being rare at about 0.5%3.
Bile duct injury (BDI) is a significant complication of laparoscopic cholecystectomy (LC), leading to prolonged morbidity, increased hospitalisation costs, and potential litigation. Most BDIs arise from "perception errors," particularly misidentifying the common bile duct and the right hepatic artery. Challenges in isolating the cystic duct can occur, especially in cases of severe cholecystitis, where dense adhesions obscure anatomy. In such cases, cholecystostomy may be a safer alternative. Rouviere's sulcus, an anatomical landmark found in over 80% of livers, can aid in safely dissecting Calot's triangle but is often overlooked. Despite advancements, injuries to the common bile duct and blood vessels during LC remain concerns.Patient- or surgeon-related multiple factors can lead to various complications and conversion to open cholecystectomy (OC). During laparoscopic procedure, complication rates can be reduced with proper care and caution. As a surgeon’s experience increases, complication and conversion rates decrease4.
AIM
To Predict the intraoperative and postoperative complications in patients undergoing laparoscopic cholecystectomy using The Ten Point Scoring System
This study is a hospital-based cross-sectional observational study conducted in the Department of General Surgery at SMS Medical College and Hospital, Jaipur, from November 2022 to May 2024. The study population will consist of patients admitted to the surgical wards of SMS Hospital Jaipur for laparoscopic cholecystectomy, all of whom will provide written informed consent. A sample size of 150 subjects is required to predict complications in patients with anatomical variations, calculated based on a 95% confidence level, a 10% absolute error, and a 15% attrition rate, following guidelines from the seed article.(4)
The sample size (n) will be calculated using the formula
n =z2pq/d2
where z represents the standard deviation at a 95% confidence interval,
P is the prevalence,
and d is the absolute error.
Patients will be included based on specific criteria: those undergoing laparoscopic cholecystectomy, those who provide informed consent, and those aged 18 years and above. Exclusion criteria include patients who are unfit for general anesthesia or laparoscopic surgery, those with concomitant acute cholangitis or acute hepatitis, those with acute cholecystitis and choledocholithiasis, patients lost to follow-up, and immunocompromised patients.
Most of the patients were admitted for elective procedure. Patients with symptoms of acute cholecystitis were either operated within 2–3 days of presentation or 6 weeks after the resolution of symptoms. Detailed history of the onset of symptoms, duration, and progression was obtained. Patients were subjected to routine blood tests, including complete blood count, liver function test, kidney function test, serum electrolytes, HIV, HBSAg, HCV, bleeding time, clotting time, prothrombin time, and the international normalized ratio. Serum amylase and lipase were evaluated to rule out pancreatitis, and serum alkaline phosphatase was evaluated to rule our biliary obstruction. Imaging studies, such as ultrasonography (USG), were performed. In some doubtful cases, magnetic resonance cholangiopancreatography (MRCP) and computed tomography scans were performed to look for other pathology. Those detected with CBD stones in USG were subjected to MRCP and endoscopic retrograde cholangiopancreaticography (ERCP) for stone clearance and operated after 6 weeks.
A ten-point strategy was used to perform LC based on visible anatomy on entering the abdomen; points were assigned as shown in Table
Table 1- Intra-operative scoring system for safe laparoscopic cholecystectomy i.e. TEN POINT SCORING SYSTEM is followed throughout the procedure.
OPERATIVEFINDINGS |
SCORE |
CBD VISUALISED |
3 |
DISSECTIONABOVEROUVIERESULCUS |
1 |
ONLYTWOSTRUCTUREENTERINGGB |
1 |
CALOT ‘STRINGLECLEAR |
2 |
LOWER1/3CHOLECYSTICPLATEFREE |
2 |
ELEPHANTHEADAPPEARANCE |
1 |
TOTAL SCORE |
LEVELOF SAFETY |
1 –4 |
LOWSAFETY |
5 –7 |
EQUIVOCALSAFETY |
8–10 |
SAFECHOLECYSTECTOMY |
STUDY PLAN
Table1 : Distribution of study subjects according to Classified groups
Groups |
N |
Percentage |
Group 1 (point1 – 4) |
12 |
8 |
Group 2 (point 5 – 7) |
27 |
18 |
Group 3 (point 8 – 10) |
111 |
74 |
Total |
150 |
100 |
This table details about the distribution of study subjects according to classified groups, which is based on points given on intraoperative findings. The majority of patients (74%) had included in group 3, some patients in group 2(18%) and few patients in group1(8%).
Table 2: Age distribution of study subjects
Age group (years) |
Group 1 |
Group 2 |
Group 3 |
|||
N |
% |
N |
% |
N |
% |
|
<30 years |
1 |
8.3 |
9 |
33.4 |
19 |
17.2 |
30-44 years |
3 |
25.1 |
7 |
25.9 |
35 |
31.5 |
45-59 years |
4 |
33.3 |
4 |
14.8 |
27 |
24.3 |
≥60 years |
4 |
33.3 |
7 |
25.9 |
30 |
27 |
Total |
12 |
100 |
27 |
100 |
111 |
100 |
Mean ± SD |
51.33 ± 16.96 |
42.59 ± 17.09 |
47.44 ± 16.80 |
|||
Chi-square = 5.689 with 6 degrees of freedom; P = 0.459 |
The study groups showed a statistically insignificant age distribution, with the highest number of patients aged 30-44 in group 3, under 30 in group 2, and over 45 in group 1 (p > 0.05).
Table 3: Comparison of mean GB wall thickness (mm) of study groups
Group |
N |
Mean GB wall thickness in mm (Mean ± SD) |
P value |
Group 1 |
12 |
4.67 ± 1.37 |
<0.001 (S) |
Group 2 |
27 |
3.89 ± 1.05 |
|
Group 3 |
111 |
3.22 ± 0.91 |
The comparison of gallbladder wall thickness revealed maximum thickness in group 1 and minimum in group 3, with a statistically significant difference (p < 0.001), indicating that greater thickness may complicate the procedure.
Graph 1: Distribution of study subjects according to post ERCP status
The distribution of post-ERCP patients was statistically significant across groups, with 25% in group 1, 7.4% in group 2, and 3.6% in group 3 (p < 0.05), suggesting increased difficulty in operative procedures following ERCP.
Table 4: Distribution of study subjects according to ten points – CBD visualised
CBD visualised |
Group 1 |
Group 2 |
Group 3 |
|||
N |
% |
N |
% |
N |
% |
|
No |
6 |
50 |
5 |
18.5 |
1 |
0.9 |
Yes |
6 |
50 |
22 |
81.5 |
110 |
99.1 |
Total |
12 |
100 |
27 |
100 |
111 |
100 |
Chi-square = 40.420 with 2 degrees of freedom; P <0.001 (S) |
The intraoperative visualization of the CBD was highest in group 3 (99.1%) and group 2 (81.5%), with a statistically significant difference compared to group 1 (50%) (p < 0.001).
Table 5: Distribution of study subjects according to dissection above ROUVIERE SULCUS
|
Group 1 |
Group 2 |
Group 3 |
|||
N |
% |
N |
% |
N |
% |
|
No |
9 |
75 |
8 |
29.6 |
3 |
2.7 |
Yes |
3 |
25 |
19 |
70.4 |
108 |
97.3 |
Total |
12 |
100 |
27 |
100 |
111 |
100 |
Chi-square = 56.551 with 2 degrees of freedom; P <0.001 (S) |
Intraoperative visualization of the Rouviere sulcus was highest in group 3 (97.3%) and group 2 (70.4%), with a statistically significant difference compared to group 1 (25%) (p < 0.001).
Graph 2: present distributions of study subjects based on the structures entering the gallbladder (CA and CD), clarity of Calot's triangle, clearance of the cholecystic plate, elephant head appearance, and intraoperative adhesions, respectively.
Intraoperative visualization of the cystic artery and duct was highest in group 3 (99.1%), 1/3 of the cholecystic plate was fully cleared in all patients of group 3 (100%), elephant head appearance was observed in 93.7% of group 3, and intraoperative adhesions were present in all group 1 patients (100%), all showing statistically significant differences (p < 0.001).
Table 6: Distribution of study subjects according to ten points
Ten points |
Group 1 |
Group 2 |
Group 3 |
P value |
|||
N |
% |
N |
% |
N |
% |
||
CBD visualised |
6 |
50 |
22 |
81.5 |
110 |
99.1 |
<0.001 (S) |
Dissection above ROUVIERE sulcus |
3 |
25 |
19 |
70.4 |
108 |
97.3 |
<0.001 (S) |
two structure entering into GB, CA & CD |
3 |
25 |
8 |
29.6 |
110 |
99.1 |
<0.001 (S) |
CALOT’S TRIANGLE clear |
1 |
8.3 |
8 |
29.6 |
110 |
99.1 |
<0.001 (S) |
1/3 of cholecystic plate cleared |
1 |
8.3 |
7 |
25.9 |
111 |
100 |
<0.001 (S) |
Elephant head appearance |
0 |
0 |
4 |
14.8 |
104 |
93.7 |
<0.001 (S) |
The distribution of ten parameters indicated that group 3 had the highest intraoperative visualisation and clearance rates, with significant differences among groups (p < 0.001), suggesting that laparoscopic cholecystectomy is safest in group 1, equivocal in group 2, and most difficult in group 3.
Table 7: Comparison of mean operative time (min) of study groups
Group |
N |
Mean operative time in min (Mean ± SD) |
P value |
Group 1 |
12 |
88.50 ± 18.5 |
<0.001 (S) |
Group 2 |
27 |
55.37 ± 13.22 |
|
Group 3 |
111 |
36.34 ± 9.3 |
The comparison of mean operative times showed that group 1 had the longest duration while group 3 had the shortest, with a statistically significant difference (p < 0.001).
Table 8: Distribution of study subjects according to partial cholecystectomy
Partial cholecystectomy |
Group 1 |
Group 2 |
Group 3 |
||
N |
% |
N |
% |
N |
|
No |
10 |
83.3 |
27 |
100 |
111 |
Yes |
2 |
16.7 |
0 |
0 |
0 |
Total |
12 |
100 |
27 |
100 |
111 |
Chi-square = 23.311 with 2 degrees of freedom; P<0.001 (S) |
The distribution of study subjects showed that only 16.7% of patients in group 1 underwent conversion to partial cholecystectomy, with no conversions in groups 2 and 3, indicating a statistically significant difference (p < 0.001).
While operative mortality for cholecystectomy is below 1%, complications occur in 10–15% of cases, with bile duct injuries being particularly serious and primarily resulting from perception errors, emphasising the importance of correctly identifying the common bile duct and right hepatic artery during surgery.
To minimise complications during laparoscopic cholecystectomy, it's essential to adhere to the critical view of safety as outlined by Professor Steven Strasberg, which involves clearing Calot’s triangle, freeing the lower third of the gallbladder, and ensuring that only two structures enter the gallbladder before any duct is clipped or divided.
Cystic duct leaks5-7, accounting for about 60% of post-cholecystectomy biliary leakage cases, often arise from slipped clips or ligatures, thermal injuries, or blowouts due to residual CBD stones, making suturing advisable for wide, edematous cystic ducts to ensure secure ligation8,9,10,11. Cystic duct stump leak occurred in 3.6% of patients12.Biliary leakage was suspected in the case of bile appearance from either ultrasound-guided tubal drainage of abdominal collection or abdominal drain placed at the time of cholecystectomy.
Sahoo et al. 13 reported that the late LC after ERCP had a long operative time that was possibly caused by the scarring and fibrosis in Calot’s triangle and the biliary system. Mistakes in dissection at the junction of the cystic duct, common hepatic duct, and CBD could occur.
ERCP has been the primary definitive intervention in cases of CBD stones14. LC is the standard management for gallstones after CBD clearance by ERCP, but it was believed to be more difficult than ordinary cases of LC8,15. ERCP itself includes interventions that could produce edema and inflammation, forming adhesions, and may cause pancreatitis such as sphincteroplasty, cannulation of the CBD, and clearance by the Dormia basket16. Normal anatomy could be affected after ERCP. So, it was recommended that LC after ERCP and endoscopic sphincterotomy (ES) should be performed by experienced laparoscopic surgeons to decrease conversion and morbidity rates8,17.
To minimize complications and avoid conversion to open cholecystectomy, surgeons should follow a ten-point strategy and perform gentle, careful dissection, which allows for the successful removal of gallbladders with complex anatomy through laparoscopy.
This study also shows that if LC is performed with patience, complication rates can be reduced to minimal and conversion rates can be reduced to zero.
Complication rates were highest in group I with complicated anatomy, which also required more time for safe surgery, while group III, with simpler anatomy, had the least complications and most procedures completed within the target time of 45 minutes.
Laparoscopic cholecystectomy is safe and effective, particularly in patients with clear anatomical landmarks (Group III), while those with complex anatomy (Group I) require cautious dissection and may benefit from intraoperative cholangiography or conversion to partial cholecystectomy to minimize complications. Surgeons should remain prepared to convert to open cholecystectomy when faced with significant challenges.Not a single case of conversion to OC was found.Complication was divided into intraoperative and postoperative. No mortality occurred, and morbidity was negligible.No any cases were complicated by bile duct injury, any bowel injury and major vascular injury