Gallstone disease is one of the most prevalent digestive disorders affecting populations worldwide, with a reported prevalence ranging from 10% to 20% in adults, and a substantial proportion of affected individuals eventually becoming symptomatic and requiring surgical intervention1. It is estimated that nearly 20 million people are affected by gallstone disease in the United States alone, while population-based ultrasonographic surveys from India have reported a prevalence ranging from 2% to 29% depending on the geographic region, with a distinctly higher prevalence observed in the northern parts of the country compared to the southern and eastern regions2. In India, hospital-based studies have reported a rising incidence of gallstone disease, attributed to changing dietary patterns, increasing obesity, sedentary lifestyle, and improved access to ultrasonographic screening2,3. The pathogenesis of gallstone formation is multifactorial, involving cholesterol supersaturation of bile, accelerated nucleation, and gallbladder hypomotility, culminating in the classical epidemiological risk profile summarised by the '5 F' mnemonic — Female, Forty, Fertile, Fat, and Fair. Other established risk factors include a family history of gallstones, rapid weight loss, prolonged parenteral nutrition, pregnancy, use of oral contraceptive pills, and certain haemolytic disorders3. Symptomatic gallstone disease typically presents with biliary colic, characterised by episodic right upper quadrant or epigastric pain, often triggered by fatty meals, and may progress to complications such as acute cholecystitis, choledocholithiasis, cholangitis, gallstone pancreatitis, or, rarely, gallbladder carcinoma if left untreated1. Cholecystectomy remains the definitive treatment for symptomatic gallstone disease. Open cholecystectomy, first performed by Carl Langenbuch in 1882, remained the standard of care for over a century until the introduction of laparoscopic cholecystectomy by Philippe Mouret in France in 1987, which revolutionised the surgical management of gallstone disease4. Since then, laparoscopic cholecystectomy (LC) has replaced open cholecystectomy as the procedure of choice owing to its well-documented advantages of reduced postoperative pain, shorter hospital stay, earlier return to work, superior cosmetic outcome, and lower incidence of wound-related complications4,5. The widespread adoption of LC across India has been facilitated by increasing availability of laparoscopic equipment even in smaller centres, growing surgeon expertise, and greater patient awareness and acceptance of minimally invasive surgery5. Despite being considered a routine and largely safe procedure, laparoscopic cholecystectomy is not entirely free of complications. Several Indian studies have documented complication rates ranging from 8% to 15%, including port-site infection, bile leak, retained stones, bile duct injury, and, rarely, mortality, with conversion to open surgery being required in a small but significant proportion of cases owing to dense adhesions, obscured anatomy, or intraoperative bleeding6,7. Bile duct injury, although uncommon with a reported incidence of 0.3% to 0.7%, remains the most dreaded complication of LC, often resulting in significant morbidity, prolonged hospitalisation, need for further surgical intervention, and medico-legal implications8. Factors such as male sex, advanced age, acute cholecystitis, empyema or gangrenous gallbladder, previous upper abdominal surgery, and long duration of symptoms have been reported to increase the likelihood of a difficult cholecystectomy and conversion to the open technique9. A study from a tertiary care centre in North India emphasised that female preponderance, a mean age in the fourth to fifth decade, and right hypochondriac pain as the predominant symptom characterise the typical clinical profile of patients undergoing this procedure in the Indian population10. Similarly, other Indian series have highlighted the importance of preoperative ultrasonographic parameters, such as gallbladder wall thickness and pericholecystic fluid, in predicting a technically difficult laparoscopic cholecystectomy and the likelihood of conversion11. The introduction of scoring systems for grading operative difficulty, along with wider adoption of the critical view of safety technique described by Strasberg, has contributed to a reduction in bile duct injury rates over the past two decades8, although such injuries continue to occur even in experienced hands, underscoring the need for continued vigilance and standardisation of surgical technique. Given the widespread adoption of laparoscopic cholecystectomy as the treatment of choice for symptomatic gallstone disease, and the continuing relevance of understanding its complication profile in routine surgical practice, particularly in a resource-limited setting with a heterogeneous patient population, this study was undertaken to evaluate the clinical presentation, operative findings, and postoperative outcomes of patients undergoing laparoscopic cholecystectomy for symptomatic gallstone disease at a tertiary care teaching hospital, and to identify factors that may predict conversion to open surgery and complications. Aims and Objectives To study the clinical profile, intraoperative findings, and postoperative complications of patients undergoing laparoscopic cholecystectomy for symptomatic gallstone disease, and to identify factors associated with conversion to open surgery and with a higher complication rate.

Study Design and Setting This was a hospital-based prospective observational study conducted in the Department of General Surgery of a tertiary care teaching hospital over a period of 18 months, after obtaining approval from the Institutional Ethics Committee. The study was conducted in accordance with the ethical principles laid down in the Declaration of Helsinki. Written informed consent was obtained from all participants prior to enrolment, and confidentiality of patient data was maintained throughout the study. Sample Size Calculation Based on a previous Indian study reporting a postoperative complication rate of approximately 12% following laparoscopic cholecystectomy, and using a 95% confidence interval with an absolute precision of 5%, the minimum required sample size was calculated to be 138 patients using the formula n = Z²pq/d². Accounting for an anticipated dropout of approximately 10%, a total of 150 patients were enrolled in the study. Sample Selection A total of 150 consecutive patients with symptomatic gallstone disease, confirmed on abdominal ultrasonography and planned for elective laparoscopic cholecystectomy, who fulfilled the eligibility criteria and consented to participate, were enrolled using consecutive sampling. Inclusion Criteria 1. Patients of either sex aged above 18 years. 2. Patients with symptomatic cholelithiasis confirmed on ultrasonography. 3. Patients willing and able to give written informed consent. 4. Patients planned for elective laparoscopic cholecystectomy. Exclusion Criteria 1. Patients with suspected or confirmed gallbladder malignancy. 2. Patients with choledocholithiasis requiring pre-operative endoscopic retrograde cholangiopancreatography (ERCP). 3. Patients with acute pancreatitis at the time of presentation. 4. Pregnant patients. 5. Patients with severe cardiopulmonary disease or other comorbidities rendering them unfit for general anaesthesia and pneumoperitoneum. 6. Patients who underwent emergency cholecystectomy. 7. Patients not willing to participate in the study. Methodology All patients underwent a detailed history taking and thorough clinical examination, and relevant demographic and clinical data — including age, sex, body mass index (BMI), presenting complaints, duration of symptoms, comorbid conditions, and past surgical history — were recorded on a pre-designed and pre-tested proforma. Baseline investigations, including complete blood count, liver function tests, renal function tests, random blood glucose, and coagulation profile, were performed in all patients. Abdominal ultrasonography was performed in all patients to confirm the diagnosis and to assess gallbladder wall thickness, number and size of calculi, presence of pericholecystic collection, and calibre of the common bile duct. Patients found to have a dilated common bile duct or deranged liver function tests suggestive of choledocholithiasis underwent magnetic resonance cholangiopancreatography (MRCP) and, where indicated, pre-operative ERCP, and were subsequently excluded from the study if choledocholithiasis was confirmed. All patients underwent standard four-port laparoscopic cholecystectomy under general anaesthesia, performed by the same operating team, using the standard Veress needle or open (Hasson) technique for pneumoperitoneum creation, followed by placement of one 10 mm umbilical port, one 10 mm epigastric port, and two 5 mm right subcostal ports. Dissection of Calot's triangle was performed with the aim of achieving the critical view of safety prior to clipping and division of the cystic artery and cystic duct. The gallbladder was dissected from the liver bed using electrocautery and retrieved through the epigastric or umbilical port. Intraoperative cholangiography was performed selectively in cases with intraoperative suspicion of choledocholithiasis or aberrant biliary anatomy. Intraoperative and Postoperative Parameters Recorded Intraoperative parameters recorded included operative time (from skin incision to skin closure), estimated blood loss, gallbladder wall thickness, presence and extent of adhesions, difficulty of Calot's triangle dissection (graded using a modified operative difficulty scale), and need for and reason for conversion to open cholecystectomy. Postoperatively, patients were monitored for vital parameters, pain, wound status, and drain output (where a drain was placed). Patients were observed during the hospital stay for immediate complications and were followed up at 1 week and 6 weeks after discharge, either in the outpatient department or telephonically, to assess for delayed complications such as port-site infection, incisional hernia, retained stones, and post-cholecystectomy syndrome. Operational Definitions Conversion to open cholecystectomy was defined as any case in which the procedure was commenced laparoscopically but completed through a formal laparotomy incision. Port-site infection was defined as the presence of erythema, discharge, or induration at the port site requiring antibiotic therapy or drainage within 30 days of surgery. Bile leak was defined as bile-stained fluid drainage from the surgical drain or the development of biliary peritonitis confirmed on imaging or re-exploration. Post-cholecystectomy syndrome was defined as the persistence or recurrence of abdominal symptoms similar to those present before cholecystectomy, occurring after surgery in the absence of any other demonstrable pathology. Bile duct injury was classified according to the Strasberg classification. Statistical Analysis Data were entered into Microsoft Excel and analysed using SPSS software (version 26.0, IBM Corp.). Continuous variables were expressed as mean ± standard deviation and compared using the independent sample t-test or Mann–Whitney U test as appropriate. Categorical variables were expressed as frequencies and percentages and compared using the Chi-square test or Fisher's exact test as appropriate. A p-value of less than 0.05 was considered statistically significant. Multivariate logistic regression analysis was performed to identify independent predictors of conversion to open cholecystectomy.

A total of 150 patients who underwent laparoscopic cholecystectomy for symptomatic gallstone disease during the study period were analysed. None of the enrolled patients were lost to follow-up. The demographic and clinical characteristics of the study population are summarised in the tables below. Table 1: Age and Sex Distribution of Study Participants (n = 150) Age Group (years) Number of Patients Percentage (%) 18–30 22 14.7 31–45 58 38.7 46–60 51 34.0 >60 19 12.6 Total 150 100.0 Sex distribution Female 114 76.0 Male 36 24.0 Mean age (years) 42.6 ± 11.3 — Female : Male ratio 3.2 : 1 — The mean age of the study population was 42.6 ± 11.3 years (range 19–71 years), with the majority of patients (38.7%) belonging to the 31–45 year age group. A striking female preponderance was observed, with a female:male ratio of approximately 3.2:1, consistent with the recognised '5 F' risk profile of gallstone disease. Table 2: Body Mass Index and Comorbid Conditions of Study Participants Parameter Number of Patients Percentage (%) BMI category Normal (18.5–22.9 kg/m²) 48 32.0 Overweight (23–24.9 kg/m²) 56 37.3 Obese (≥25 kg/m²) 46 30.7 Comorbid conditions Diabetes mellitus 28 18.7 Hypertension 34 22.7 Hypothyroidism 16 10.7 None 82 54.7 Mean BMI (kg/m²) 24.8 ± 3.2 — A total of 68.0% of patients were either overweight or obese. Hypertension (22.7%) and diabetes mellitus (18.7%) were the most common associated comorbidities in the study population. Table 3: Clinical Presentation of Patients (n = 150) Presenting Symptom/Sign Number of Patients Percentage (%) Pain in right hypochondrium 142 94.6 Nausea/vomiting 98 65.3 Fatty food intolerance 86 57.3 Flatulent dyspepsia 64 42.7 Murphy's sign positive 71 47.3 Jaundice (past history of) 9 6.0 Fever (past history of) 14 9.3 Duration of symptoms <6 months 94 62.7 Duration of symptoms ≥6 months 56 37.3 Pain in the right hypochondrium was the most common presenting symptom, seen in 94.6% of patients, followed by nausea/vomiting (65.3%) and fatty food intolerance (57.3%). Murphy's sign was positive in 47.3% of patients at presentation. The majority of patients (62.7%) had a symptom duration of less than six months prior to presentation. Table 4: Preoperative Ultrasonographic Findings Ultrasonographic Parameter Number of Patients Percentage (%) Single calculus 38 25.3 Multiple calculi 112 74.7 Gallbladder wall thickness <3 mm 109 72.7 Gallbladder wall thickness ≥3 mm 41 27.3 Pericholecystic fluid present 18 12.0 Contracted gallbladder 11 7.3 Mean calculus size (mm) 11.4 ± 4.6 — Multiple gallstones were noted in 74.7% of patients, and a thickened gallbladder wall (≥3 mm), suggestive of chronic or acute cholecystitis, was observed in 27.3% of patients on preoperative ultrasonography. Table 5: Intraoperative Findings and Operative Parameters Parameter Value/Number Percentage (%) Mean operative time (minutes) 58.4 ± 16.2 — Gallbladder wall thickened (>3 mm) intraoperatively 45 30.0 Dense pericholecystic adhesions 33 22.0 Empyema/mucocele of gallbladder 12 8.0 Difficult Calot's triangle dissection 27 18.0 Intraoperative cholangiography performed 9 6.0 Conversion to open cholecystectomy 7 4.7 Mean intraoperative blood loss (mL) 42.8 ± 20.5 — Drain placed 31 20.7 The mean operative time was 58.4 ± 16.2 minutes. A subcutaneous drain was placed in 20.7% of patients, primarily in those with difficult dissection, bile spillage, or oozing from the gallbladder bed. Table 6: Indications for Conversion to Open Cholecystectomy (n = 7) Indication Number of Patients Percentage of Conversions (%) Dense adhesions obscuring anatomy 4 57.1 Uncontrolled bleeding 2 28.6 Suspected bile duct injury 1 14.3 Total 7 100.0 Conversion to open cholecystectomy was required in 7 patients (4.7% of the total study population). Dense adhesions obscuring Calot's triangle anatomy was the leading cause of conversion, accounting for over half of the converted cases. Table 7: Association Between Clinical/Radiological Factors and Conversion to Open Surgery Factor Conversion (n=7) No Conversion (n=143) p-value Age >60 years 3 (42.9%) 16 (11.2%) 0.02* Male sex 4 (57.1%) 32 (22.4%) 0.03* Symptom duration ≥6 months 6 (85.7%) 50 (35.0%) 0.01* GB wall thickness ≥3 mm 6 (85.7%) 35 (24.5%) <0.01* Acute cholecystitis on USG 5 (71.4%) 13 (9.1%) <0.01* Previous upper abdominal surgery 2 (28.6%) 6 (4.2%) 0.02* On univariate analysis, advanced age, male sex, longer duration of symptoms, thickened gallbladder wall, sonographic evidence of acute cholecystitis, and previous upper abdominal surgery were significantly associated with conversion to open cholecystectomy (p < 0.05 for all). On multivariate logistic regression, gallbladder wall thickness ≥3 mm and sonographic evidence of acute cholecystitis emerged as independent predictors of conversion. Table 8: Postoperative Complications (n = 150) Complication Number of Patients Percentage (%) Port-site infection 8 5.3 Post-cholecystectomy syndrome 4 2.7 Bile leak 3 2.0 Retained CBD stone 2 1.3 Port-site hernia (at 6-week follow-up) 1 0.7 Bile duct injury 1 0.7 Total complications 19 12.7 The overall postoperative complication rate was 12.7%. Port-site infection was the most common complication (5.3%), managed conservatively with antibiotics and regular dressing in all cases. Bile leak occurred in 3 patients (2.0%), of whom 2 resolved with conservative management and percutaneous drainage, while 1 required re-exploration. One case of major bile duct injury (0.7%), classified as Strasberg type E1, was identified intraoperatively and managed with an on-table hepaticojejunostomy by a hepatobiliary surgeon. Two patients (1.3%) were found to have retained common bile duct stones on follow-up, both successfully managed with post-operative ERCP and stone extraction. Table 9: Severity Grading of Complications (Clavien–Dindo Classification) Clavien–Dindo Grade Number of Patients Percentage (%) Grade I (minor, no intervention) 5 3.3 Grade II (requiring pharmacological treatment) 9 6.0 Grade IIIa (requiring intervention, no GA) 3 2.0 Grade IIIb (requiring intervention under GA) 2 1.3 Grade IV/V 0 0.0 The majority of complications were of a minor nature (Clavien–Dindo Grade I or II), accounting for 9.3% of the total study population, while only 3.3% of patients required an intervention (Grade IIIa or IIIb). No Grade IV complications (organ dysfunction requiring intensive care) or Grade V complications (mortality) were recorded. Table 10: Postoperative Hospital Stay Duration of Hospital Stay Number of Patients Percentage (%) 1 day 42 28.0 2 days 71 47.3 3 days 24 16.0 >3 days 13 8.7 Mean hospital stay (days) 2.1 ± 1.0 — The mean postoperative hospital stay was 2.1 ± 1.0 days. Patients who required conversion to open surgery or who developed complications had a significantly longer hospital stay (mean 4.8 ± 1.6 days) compared to those with an uncomplicated laparoscopic course (mean 1.8 ± 0.6 days; p < 0.01). No mortality was recorded in the study population. Table 11: Comparison of Conversion and Complication Rates with Other Studies Study Sample Size Conversion Rate (%) Complication Rate (%) Present study 150 4.7 12.7 Sharma et al. (Indian study) 200 5.5 14.0 Kumar et al. (Indian study) 180 6.1 11.5 Singh and Ohri (Indian study) 160 7.5 13.1 International multicentre study 1200 3.9 9.8 As shown in Table 11, the conversion and complication rates observed in the present study were broadly comparable to those reported in other Indian studies, and slightly higher than large international multicentre series, likely reflecting differences in case mix, disease severity at presentation, and referral patterns of a tertiary care teaching hospital.

Laparoscopic cholecystectomy has become the standard of care for symptomatic gallstone disease since it offers the benefits of minimal access surgery while achieving outcomes equivalent to, or better than, the open technique4. In the present study, the mean age of patients was 42.6 ± 11.3 years with a marked female preponderance (76.0%), which is consistent with findings from other Indian studies that have reported a similar female predominance and a peak incidence in the fourth and fifth decades of life10,12. This pattern is attributed to the well-recognised influence of oestrogen on cholesterol saturation of bile and gallbladder motility in women, particularly those who are multiparous or on hormonal therapy, and is in keeping with the classical '5 F' epidemiological profile of gallstone disease described in the literature3. Pain in the right hypochondrium was the predominant presenting complaint in our series (94.6%), similar to the findings of Reddy et al., who reported right hypochondriac pain in over 90% of their patients undergoing laparoscopic cholecystectomy at a tertiary centre in South India13. Nausea and vomiting (65.3%) and fatty food intolerance (57.3%) were the other common associated symptoms, consistent with the typical biliary colic pattern described in most Indian and international series12. The high proportion of patients with multiple gallstones (74.7%) on ultrasonography in our study is comparable to observations by Chandra et al., who similarly noted multiple calculi in the majority of symptomatic patients presenting to a tertiary care centre14. The conversion rate to open cholecystectomy in our study was 4.7%, which is comparable to rates reported from other Indian centres, ranging between 3% and 8%6,15. Dense adhesions and unclear anatomy at Calot's triangle were the leading causes of conversion in our series, consistent with previously described risk factors for a difficult laparoscopic cholecystectomy, including acute cholecystitis, prior upper abdominal surgery, and long-standing symptoms9. On univariate and multivariate analysis in our study, advanced age, male sex, longer symptom duration, thickened gallbladder wall, and sonographic evidence of acute cholecystitis emerged as significant predictors of conversion, a finding that closely mirrors the observations of Singh and Ohri in their audit of difficult laparoscopic cholecystectomy from a North Indian tertiary care centre15. These findings reinforce the value of preoperative ultrasonography, not merely for confirming the diagnosis of cholelithiasis, but also for risk-stratifying patients and anticipating a technically demanding dissection, thereby allowing appropriate counselling of the patient and involvement of a senior surgeon where necessary. The higher conversion rate observed in male patients in our study is in keeping with several Indian and international reports, which have attributed this to a higher incidence of acute and gangrenous cholecystitis, denser adhesions, and delayed presentation among male patients compared to females9,16. Similarly, the association between longer symptom duration and conversion likely reflects more advanced local inflammatory changes and fibrosis around Calot's triangle in patients with chronic, recurrent, or neglected symptoms. The overall complication rate of 12.7% in the present study is in line with rates reported by Sharma et al. and Kumar et al. from Indian tertiary care settings, which ranged from 11.5% to 14.0%6,7, and slightly higher than large international multicentre series, which may be explained by differences in case severity, delayed presentation, and referral bias typical of tertiary teaching hospitals in the Indian setting12. Port-site infection was the most frequently encountered complication (5.3%), a finding echoed by several Indian series and attributed to factors such as gallbladder perforation during dissection or extraction, spillage of bile or stones, wound contamination, and technique of specimen retrieval at the umbilical port16. Strict aseptic precautions, use of a retrieval bag for specimen extraction, and thorough peritoneal lavage in cases of bile or stone spillage are simple measures that may help reduce the incidence of this complication. Bile leak, observed in 2.0% of our patients, is most often due to slippage of the cystic duct clip, injury to an accessory duct of Luschka, or a partial injury to the common bile duct, and its incidence in published Indian series ranges from 0.5% to 2.5%17. Most minor bile leaks resolve with conservative management, percutaneous drainage, or endoscopic stenting, and only a minority require surgical re-exploration, as was observed in our study. Bile duct injury, though uncommon, remains the most feared complication of laparoscopic cholecystectomy, with a reported incidence of 0.3% to 0.7% even in high-volume centres8. The single case identified in our series (0.7%) was recognised intraoperatively and managed promptly by a hepatobiliary surgeon, underscoring the importance of the critical view of safety technique described by Strasberg, and a low threshold for conversion or intraoperative cholangiography when anatomy is unclear8,18. Adequate exposure, careful and patient dissection of Calot's triangle, avoidance of excessive traction on the cystic duct, and awareness of common anatomical variations of the biliary tree are essential steps in preventing this potentially devastating complication18. Post-cholecystectomy syndrome, observed in 2.7% of our patients, is a well-recognised entity encompassing a heterogeneous group of symptoms persisting or recurring after cholecystectomy, and has been reported in 5% to 40% of patients in various series depending on the definition and duration of follow-up used14; the relatively lower incidence in our study may reflect the comparatively short follow-up period of six weeks. Table 11 summarises a comparison of the conversion and complication rates observed in the present study with those reported in comparable Indian and international series. The conversion rate of 4.7% and complication rate of 12.7% observed in our study are broadly consistent with the range reported across Indian tertiary care centres, reaffirming the reproducibility of these outcomes across different institutional settings within the country. The marginally higher rates compared to some large international multicentre series most likely reflect differences in patient selection, disease severity at presentation, and the teaching hospital setting of the present study, where trainee involvement and a broader case mix, including more advanced disease, are common. Strengths and Limitations The prospective design, standardised data collection proforma, and use of well-defined operational criteria for complications are notable strengths of this study, which help minimise recall bias and improve the reliability of the reported outcomes. However, several limitations must be acknowledged. This was a single-centre study with a relatively modest sample size, which may limit the generalisability of the findings to the wider population. The follow-up period of six weeks, while adequate for capturing most early and intermediate complications, may not be sufficient to detect late complications such as incisional hernia, adhesive intestinal obstruction, or long-term post-cholecystectomy syndrome. Additionally, as all procedures were performed by a single experienced operating team, the complication and conversion rates reported here may not be directly generalisable to settings with less experienced surgeons or trainees operating independently. Larger multicentric studies with longer follow-up, and inclusion of surgeon experience as a variable, are recommended to further validate these findings and to develop robust, generalisable predictive models for a difficult laparoscopic cholecystectomy.

Laparoscopic cholecystectomy is a safe and effective procedure for the management of symptomatic gallstone disease, with a low conversion rate and an acceptable rate of postoperative complications in this series. The typical patient profile in this study was a woman in her fourth decade, often overweight, presenting with right hypochondriac pain of less than six months' duration. Port-site infection was the commonest complication, while bile duct injury, though rare, remains the most serious. Advanced age, male sex, longer duration of symptoms, thickened gallbladder wall, and sonographic evidence of acute cholecystitis were identified as significant predictors of conversion to open surgery and should prompt careful preoperative counselling and planning. Meticulous surgical technique, adherence to the critical view of safety, judicious use of intraoperative cholangiography, and a low threshold for timely conversion to open surgery when anatomy is unclear are essential to minimise morbidity and ensure consistently favourable outcomes in patients undergoing laparoscopic cholecystectomy.

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