Laparoscopic cholecystectomy (LC) has become the gold standard surgical treatment for symptomatic gallstone disease, largely replacing open cholecystectomy since its introduction due to reduced postoperative pain, shorter hospital stay, faster recovery, and improved cosmetic outcomes [1]. With advances in laparoscopic techniques and equipment, LC is now routinely performed for a wide spectrum of gallbladder pathologies including chronic cholecystitis, acute cholecystitis, gallstone pancreatitis, and biliary dyskinesia [2]. In India, the burden of gallstone disease is steadily increasing, and laparoscopic cholecystectomy constitutes one of the most commonly performed abdominal surgical procedures [3]. Despite its widespread acceptance, laparoscopic cholecystectomy may be technically challenging in certain patients and can be associated with increased operative time, intraoperative complications, and conversion to open surgery. A difficult laparoscopic cholecystectomy (DLC) is commonly defined by prolonged operative duration, dense adhesions, excessive bleeding, bile duct injury, or the need for conversion to open cholecystectomy [4]. Conversion rates reported in the literature range from 2% to 15%, with inflammatory gallbladder disease, distorted anatomy, and dense adhesions being the most frequent causes [5]. Such conversions are associated with increased postoperative morbidity, longer hospital stay, and higher healthcare costs. Several patient-related, disease-related, and surgeon-related factors have been implicated in contributing to surgical difficulty during LC. Advanced age, male gender, obesity, previous upper abdominal surgery, acute cholecystitis, and comorbidities such as diabetes mellitus are known to increase operative complexity [6]. Additionally, ultrasonographic findings such as gallbladder wall thickening, pericholecystic fluid collection, impacted stones, and contracted gallbladder have been shown to correlate with difficult dissection. Biochemical markers including leukocytosis, elevated C-reactive protein (CRP), and raised alkaline phosphatase (ALP) further reflect the inflammatory severity and may influence intraoperative outcomes. To improve surgical planning and reduce intraoperative complications, several preoperative scoring systems have been proposed to predict the difficulty of laparoscopic cholecystectomy. Among these, the scoring system described by Randhawa and Pujahari, based on clinical and ultrasonographic parameters, has been widely studied and validated [7]. However, many existing models either rely solely on clinical or imaging parameters or lack incorporation of biochemical markers, limiting their predictive accuracy. There remains a need for validation of a comprehensive preoperative scoring system integrating clinical, biochemical, and ultrasonographic parameters to accurately predict difficult laparoscopic cholecystectomy and the likelihood of conversion to open surgery. The present study was therefore undertaken to validate such a scoring system in a prospective observational setting. Aim & Objectives Aim: To validate a preoperative clinical–biochemical–ultrasonographic scoring system for predicting difficult laparoscopic cholecystectomy. Objectives: 1. To assess the accuracy of the preoperative scoring system. 2. To correlate clinical, biochemical, and ultrasonographic factors with intraoperative difficulty. 3. To evaluate predictors of conversion to open cholecystectomy.

Study Design and Setting This was a prospective observational study conducted in the Department of General Surgery at Jagjivan Ram Western Railway Hospital, Mumbai, after obtaining approval from the Institutional Ethics Committee. The study was carried out over a period of two years. Study Population All consecutive patients diagnosed with symptomatic gallstone disease and scheduled for elective laparoscopic cholecystectomy during the study period were screened for eligibility. Written informed consent was obtained from all participants after explaining the nature and purpose of the study in their native language. Inclusion Criteria Patients aged 20–70 years Symptomatic cholelithiasis confirmed on ultrasonography Patients planned for elective laparoscopic cholecystectomy Patients willing to provide informed consent Exclusion Criteria Patients unfit for general anaesthesia Patients requiring conversion to open surgery due to instrument failure Patients with gallbladder malignancy Patients with contraindications to laparoscopic surgery (e.g., severe COPD, ischemic heart disease) Non-consenting patients Sample Size Sample size was calculated using the formula: n=(Z^2×P×Q)/L^2 Where: Z = 1.96 (95% confidence interval) P = expected proportion based on previous studies Q = 100 − P L = permissible error (5%) The calculated sample size was 59, and all eligible patients were included in the study. Preoperative Assessment All enrolled patients underwent a standardized preoperative evaluation, including: 1. Clinical Parameters Age (≤50 years or >50 years) Gender Body Mass Index (BMI ≤25 or >25 kg/m²) History of acute cholecystitis History of previous abdominal surgery (infra- or supra-umbilical) History of endoscopic retrograde cholangiopancreatography (ERCP) American Society of Anaesthesiologists (ASA) physical status classification 2. Biochemical Parameters Total leukocyte count (≤10,000 or >10,000 cells/mm³) C-reactive protein (CRP) Serum albumin CRP/Albumin ratio (<3.2 or ≥3.2) Serum alkaline phosphatase (ALP ≤100 or >100 IU/L) 3. Ultrasonographic Parameters Preoperative abdominal ultrasonography was performed for all patients and the following findings were documented: Gallbladder wall thickness (<3 mm or ≥3 mm) Presence of pericholecystic fluid Impacted stone at gallbladder neck Contracted gallbladder Preoperative Scoring System A modified preoperative scoring system was used, adapted from the Randhawa and Pujahari scoring method, incorporating clinical, biochemical, and ultrasonographic parameters. Each variable was assigned a predefined score, and the total preoperative score was calculated for every patient. Interpretation of Scores: Score 0–5: Easy laparoscopic cholecystectomy Score 6–10: Difficult laparoscopic cholecystectomy Score >10: Very difficult laparoscopic cholecystectomy Surgical Procedure All laparoscopic cholecystectomies were performed under general anaesthesia using a standard four-port technique (two 10-mm and two 5-mm ports). Pneumoperitoneum was established using carbon dioxide with an intra-abdominal pressure maintained between 10–14 mmHg. All procedures were performed by surgeons with a minimum of 10 years of laparoscopic experience, ensuring uniformity in surgical expertise. The operative time was recorded from insertion of the first port to closure of the last port. Intraoperative findings and complications were meticulously documented. Intraoperative Assessment of Difficulty Based on intraoperative findings, the operating surgeon categorized each procedure as: Easy LC: Operative time <60 minutes No bile or stone spillage No bile duct or vascular injury Difficult LC: Operative time 60–120 minutes and/or Bile or stone spillage and/or Minor ductal or vascular injury Very Difficult LC: Operative time >120 minutes or Conversion to open cholecystectomy The surgeon’s intraoperative grading was considered the gold standard for comparison. Statistical Analysis Categorical variables were expressed as frequency and percentages. Continuous variables were expressed as mean ± standard deviation. Association between preoperative scores and intraoperative outcomes was assessed using the Chi-square test or Fisher’s exact test. Multivariate analysis was performed to identify independent predictors. Diagnostic accuracy was assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy. A p-value <0.05 was considered statistically significant.

A total of 59 patients undergoing elective laparoscopic cholecystectomy were included in the study. The results describe baseline characteristics, preoperative scoring distribution, intraoperative outcomes, diagnostic accuracy of the scoring system, and predictors of difficult laparoscopic cholecystectomy. The mean age of the study population was 48.1 ± 12.1 years (range: 28–70 years). Females constituted the majority (71.2%). Most patients had a BMI ≤25 kg/m² (69.5%) and belonged to ASA grade III (47.5%). Table 1. Baseline demographic and clinical profile of patients (n = 59) Variable Category Frequency Percentage (%) Age (years) ≤50 31 52.5 >50 28 47.5 Gender Female 42 71.2 Male 17 28.8 BMI (kg/m²) ≤25 41 69.5 >25 18 30.5 ASA grade I 15 25.4 II 16 27.1 III 28 47.5 History of acute cholecystitis Yes 39 66.1 No 20 33.9 Previous abdominal surgery Yes 31 52.5 No 28 47.5 History of ERCP Yes 7 11.9 No 52 88.1 Leucocytosis was present in 28.8%, elevated CRP/albumin ratio in 13.6%, and raised ALP levels in 30.5% of patients. Gallbladder wall thickness ≥3 mm was noted in 30.5% cases, while pericholecystic fluid was present in 11.9%. Table 2. Preoperative laboratory and ultrasonographic parameters Parameter Category Frequency Percentage (%) Total leukocyte count ≤10,000 cells/mm³ 42 71.2 >10,000 cells/mm³ 17 28.8 CRP/Albumin ratio <3.2 51 86.4 ≥3.2 8 13.6 ALP (IU/L) ≤100 41 69.5 >100 18 30.5 GB wall thickness <3 mm 41 69.5 ≥3 mm 18 30.5 Pericholecystic fluid Present 7 11.9 Absent 52 88.1 Impacted stone Present 0 0 Contracted gallbladder Present 0 0 Based on the total preoperative score, 71.2% patients were predicted to have easy LC, 20.3% difficult LC, and 6.8% very difficult LC. Table 3. Distribution of cases according to preoperative scoring Preoperative score Interpretation Frequency Percentage (%) 0–5 Easy 42 71.2 6–10 Difficult 12 20.3 >10 Very difficult 4 6.8 According to surgeon’s intraoperative assessment, 40 cases (67.8%) were categorized as easy LC and 19 cases (32.2%) as difficult LC. No case was classified as very difficult intraoperatively. Table 4. Intraoperative grading of laparoscopic cholecystectomy Intraoperative outcome Frequency Percentage (%) Easy LC 40 67.8 Difficult LC 19 32.2 The most common causes of difficult LC were adhesions (55%), followed by bile duct injury (25%), conversion to open surgery (15%), and prolonged operative time (5%). When a score ≤5 was used to predict easy LC, the scoring system demonstrated high sensitivity (87.8%) but low specificity (44.4%). Table 5. Diagnostic accuracy of preoperative score for predicting easy LC Measure Value (%) Sensitivity 87.8 Specificity 44.4 Positive predictive value 78.3 Negative predictive value 61.5 Accuracy 74.6 For prediction of difficult LC (score ≥6), the system showed high specificity (87.8%) with moderate sensitivity. Table 6. Diagnostic accuracy of preoperative score for predicting difficult LC Measure Value (%) Sensitivity 44.4 Specificity 87.8 Positive predictive value 61.5 Negative predictive value 78.3 Accuracy 74.6 Multivariate analysis revealed that male gender, history of acute cholecystitis, prior ERCP, leucocytosis, elevated CRP/albumin ratio, raised ALP, increased gallbladder wall thickness, and pericholecystic fluid were statistically significant predictors of difficult LC. Table 7. Multivariate analysis of predictors for difficult laparoscopic cholecystectomy Predictor Odds Ratio (95% CI) p-value Male gender 0.2 (0.07–0.8) 0.02 Acute cholecystitis 20.4 (4.9–83.5) <0.001 Prior ERCP 20.0 (2.1–182.8) 0.008 Leukocytosis 9.2 (2.5–33.1) 0.0007 CRP/Albumin ≥3.2 25.4 (2.8–229.5) 0.003 ALP >100 IU/L 18.7 (4.6–75.3) <0.001 GB wall thickness ≥3 mm 32.4 (7.1–147.5) <0.001 Pericholecystic fluid 54.1 (2.8–1020.2) 0.0007

Laparoscopic cholecystectomy remains the preferred surgical approach for gallstone disease; however, intraoperative difficulty continues to pose significant challenges despite advances in technique and experience. The ability to predict difficult laparoscopic cholecystectomy (DLC) preoperatively allows for better operative planning, patient counselling, and reduction in perioperative complications. The present prospective observational study validates a preoperative clinical–biochemical–ultrasonographic scoring system for predicting difficult laparoscopic cholecystectomy and conversion risk. In the present study, 32.2% of cases were classified as difficult laparoscopic cholecystectomy intraoperatively. This incidence is comparable to previous reports, where difficulty rates ranging from 25% to 40% have been documented depending on patient selection and definition of difficulty [8,9]. Variability across studies can be attributed to differences in scoring criteria, surgeon experience, and inclusion of acute inflammatory cases. Male gender was found to be a significant predictor of difficult LC in this study. Similar observations have been reported in earlier studies, where males demonstrated higher conversion rates and operative difficulty due to delayed presentation, dense adhesions, and severe inflammation [10]. A prior history of acute cholecystitis also showed a strong association with difficult LC, consistent with existing literature identifying inflammation-related fibrosis and distorted Calot’s anatomy as major contributors to operative complexity [11]. Biochemical parameters emerged as important predictors in the present study. Elevated leukocyte count, raised alkaline phosphatase, and increased CRP/albumin ratio were significantly associated with difficult laparoscopic cholecystectomy. These findings support previous evidence suggesting that inflammatory markers reflect disease severity and correlate with operative difficulty [12,13]. The inclusion of biochemical variables enhances the predictive strength of the scoring system compared to models relying solely on clinical and ultrasonographic factors. Ultrasonographic findings such as increased gallbladder wall thickness and presence of pericholecystic fluid were strongly associated with difficult LC in this study. Gallbladder wall thickness ≥3 mm has consistently been shown to predict difficult dissection and higher conversion rates [14]. Pericholecystic fluid, indicative of active inflammation, further complicates anatomical delineation during surgery and has been identified as a reliable marker of operative difficulty [15]. The preoperative scoring system demonstrated high sensitivity for predicting easy LC and high specificity for predicting difficult LC, indicating its usefulness in both ruling out and identifying challenging cases. These findings are comparable to validation studies of the Randhawa scoring system and its modifications, which emphasize the importance of preoperative risk stratification [16]. The present study further strengthens existing evidence by incorporating biochemical markers, thereby improving predictive accuracy. The practical implication of this validated scoring system lies in its simplicity, reproducibility, and applicability in routine surgical practice. Surgeons can anticipate operative difficulty, arrange experienced surgical teams, counsel patients regarding possible conversion, and ensure availability of resources. However, the study is limited by a relatively small sample size and single-centre design, which may restrict generalizability. Larger multicentric studies are recommended to further validate and refine the scoring system.

The preoperative clinical–biochemical–ultrasonographic scoring system is a useful and reliable tool for predicting difficult laparoscopic cholecystectomy. It helps identify patients at higher risk of operative difficulty and possible conversion to open surgery. Use of this scoring system can aid in better preoperative planning, patient counselling, and safer surgical outcomes.

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