Gallbladder disease has become a major cause of abdominal symptoms and one of the most common reasons for surgical procedures. There are several variables that contribute to the development of gallstones such as genetics, metabolic disorders, age, gender, and lifestyle. Lammert et al. (2016) stated that gallstone disease is a multivariable condition which presents a high degree of clinical impact. Shaffer (2006) reviewed the epidemiology of gallstone disease, risk factors for gallstone disease, and geographic variations in prevalence.1,2 In addition to reviewing the above topics, Stinton and Shaffer (2012) presented additional information regarding the clinical implications of gallbladder disease. A study conducted by Everhart et al. (1999) using population based data showed that there were significant differences in the distribution of gallbladder disease within different demographic groups; therefore it was concluded that when assessing clinical studies that include demographic characteristics of populations should always be taken into account.3,4 Pathologically, gallbladder disease encompasses both inflammation and non-inflammation processes. Acute inflammation of the gallbladder can manifest itself as either an acute or chronic condition or as an acute flare-up of a chronic inflammatory process. Histological evaluation of gallbladder tissue samples can reveal a variety of pathological processes such as cholesterosis, adenomyomatosis, dysplastic changes, metaplasia, and neoplastic changes. These pathological processes will ultimately determine the patient's clinical manifestation and histological demonstration. Beena et al. (2017) documented the numerous types of histological evidence found in gallbladders; while Datta et al. (2017) investigated the correlation between cholelithiasis and various types of gallbladder morphology.5,6 Diagnostic ultrasound (ultrasonography) is utilized to evaluate patients who are being evaluated for suspected gallbladder pathology. Ultrasonography allows clinicians to visualize gallstones, abnormalities in the thickness of the walls of the gallbladder, pericholecystic fluid, and other ultrasonographic findings that aid in clinical decision making. While the presence of certain ultrasonographic findings may suggest a specific diagnosis, these findings alone cannot be relied upon to make a definitive diagnosis without taking into account the patient's clinical manifestations and results from laboratory studies. Yokoe et al. (2018) developed guidelines for the diagnosis and grading of acute cholecystitis utilizing the Tokyo Guidelines.7 Additionally, Pisano et al. (2020) published updated guidelines for the diagnosis and treatment of acute calculous cholecystitis.8 Gutt et al. (2013) reported on issues related to the timing of elective surgical procedures in patients with gallbladder disease.9 Lastly, Strasberg (2008) published a review article on how to clinically diagnose and manage acute calculous cholecystitis.10 Post-operative histopathologic examination of the excised gallbladder provides clinicians with a means to establish the pathologic diagnosis of the diseased gallbladder. This examination can provide clinicians with a more detailed analysis of inflammation present in the diseased gallbladder and potentially identify additional pathologic features that may not have been identified prior to surgery. The post-operative histopathologic examination is also critical for identifying any potential malignancies present within the diseased gallbladder. As reported by Bray et al. (2024), cancer continues to be a major public health concern worldwide; thus understanding the incidence of this disease is vital to our ability to provide optimal care to our patients.11 The interval between preoperative ultrasonography and cholecystectomy may be relevant when interpreting the relationship between imaging findings and the final histopathological diagnosis. Clinical findings and inflammatory changes may evolve between imaging and surgery, meaning that the pathological findings at the time of surgery may not fully correspond to the earlier clinical or imaging assessment. Although the diagnostic performance of ultrasonography in cholecystitis has been evaluated, the association between the ultrasound-to-surgery interval and histopathological evidence of acute inflammation represents a distinct question. The present study therefore evaluated the association between the ultrasound-to-surgery interval and histopathological evidence of acute inflammation in patients undergoing cholecystectomy. Secondary objectives were to describe the demographic characteristics, surgical status, histopathological diagnoses, and distribution of acute inflammation in the study population.

Study Design, Duration and Setting A prospective observational study was conducted in the Department of General Surgery at Santiniketan Medical College & Hospital, West Bengal, India. The study evaluated the association between the interval from preoperative ultrasonography to cholecystectomy and histopathological evidence of acute inflammation in the gallbladder. The study was designed to assess the relationship between the timing of surgery following ultrasonography and the histopathological findings in the surgically removed gallbladder specimens. The study followed routine clinical practice, and decisions regarding surgical management and the timing of cholecystectomy remained with the treating surgical team. The study was conducted over six months, from August 2024 to January 2025. Patients undergoing cholecystectomy during this period were assessed for eligibility. Demographic information, relevant clinical records, ultrasonography dates, surgical details, and postoperative histopathological findings were collected for analysis. The ethical principles outlined in the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants issued by the Indian Council of Medical Research (ICMR, 2017) were considered in the conduct of the study.12 Institutional Ethics Committee approval and informed consent procedures were to be documented in accordance with the approved study protocol. Confidentiality was maintained during data collection and analysis. Study records were organised using study-specific identifiers, and patient-identifying information was excluded from the analytical dataset. The study involved no alteration of routine clinical management for research purposes. Sample Size The study was planned for a total duration of six months. During the first three months of the study period, 115 eligible patients undergoing cholecystectomy were identified and enrolled. Accordingly, a sample size of 115 patients was considered feasible within the planned study period, based on the observed recruitment rate and availability of eligible cases at the study centre. Recruitment was based on consecutive eligible patients rather than a predetermined statistical sample-size calculation. The recruited patients were evaluated to describe the histopathological spectrum of gallbladder disease and to examine the association between the ultrasound-to-surgery interval and histopathological evidence of acute inflammation. Inclusion Criteria Patients were included if they had undergone cholecystectomy at Santiniketan Medical College & Hospital during the study period, had documented preoperative ultrasonography, and had sufficient information to establish the interval between ultrasonography and surgery. Availability of a postoperative histopathological report was also required for classification of the primary outcome. Exclusion Criteria Patients were excluded if the date of ultrasonography or surgery was unavailable or unreliable, if the postoperative histopathological report was unavailable, or if the report did not permit classification of acute inflammation as present or absent. Records with insufficient information to establish the principal study variables were also excluded. Outcomes and Study Variables The primary outcome was the presence or absence of acute inflammation on histopathological examination of the gallbladder specimen following cholecystectomy. Histopathological diagnoses were classified into two groups for the primary analysis. The acute-inflammation-present group comprised specimens diagnosed as acute cholecystitis or acute-on-chronic cholecystitis. The acute-inflammation-absent group comprised specimens diagnosed as chronic cholecystitis without an acute component and other nonacute conditions, including cholesterosis and adenomyomatosis. Individual histopathological diagnoses, including cholesterosis and adenomyomatosis, were retained as separate categories for descriptive analysis. The primary exposure variable was the ultrasound-to-surgery interval, defined as the number of calendar days between the date of preoperative ultrasonography and the date of cholecystectomy. The interval was calculated by subtracting the ultrasonography date from the date of surgery. The interval was analysed as a continuous variable to preserve the information contained in the recorded dates. It was compared between patients with and without histopathological evidence of acute inflammation. Secondary outcomes included the distribution of histopathological diagnoses, the distribution of ultrasound-to-surgery intervals, and the proportion of patients with and without acute inflammation. The distribution of acute inflammation according to surgical status was also examined. The demographic variables included age and sex. Surgical status was classified as elective or emergency according to the clinical and operative records. Histopathological diagnoses were recorded from the final pathology reports and subsequently grouped according to the study definitions. Study Procedures and Data Collection Eligible participants were identified from the surgical department during the time frame of this research. All consecutive eligible participants that could be enrolled. Participant demographics (age & sex) along with clinical data were retrieved from all available patient medical records. Each participant's age and sex were documented. Participant preoperative ultrasound exam dates were retrieved by reviewing both the imaging report and clinical documentation. Participant postoperative cholecystectomy dates were retrieved from the operative note. Both dates were then utilized to determine the number of days from ultrasound examination to surgery. Type of surgery performed (elective vs. emergent) was documented. Final pathology reports from each participant's postoperative cholecystectomy were reviewed and the diagnoses noted. Diagnoses were manually documented and later categorized into previously specified categories for descriptive statistical analysis and binary outcomes for primary comparisons. A structured database was created to house all participant data. All data was verified for completion and consistency; specifically, verification of the dates recorded and the calculated intervals for each participant, in addition to verification of the histopathologic diagnoses and the categorization of those diagnoses based on their corresponding outcome category. Ultrasonography and Surgical Assessment Preoperative ultrasonography was an integral part of the initial patient work-up for all patients diagnosed with gallbladder disease. Ultrasonic imaging was conducted in accordance with the institution's standard clinical practices at that time. There was no need to perform any additional ultrasonographic studies specifically for research purposes. The date of the first available preoperative ultrasound image was utilized to establish how many days prior to surgery the study examined. This study analyzed the number of days between the available preoperative ultrasound images and the final histopathologic diagnosis findings. It is important to note that this number of days was not considered a measure of the degree of gallbladder disease. Surgery (cholecystectomy) was completed based on the treating physician's clinical judgment and their standard operating procedure for performing cholecystectomies. The study included both emergency and planned surgeries. Histopathological Examination Gallbladder specimens obtained following cholecystectomy were submitted for routine histopathological examination. The specimens were fixed in 10% formalin, processed routinely, and embedded in paraffin. Representative tissue sections were prepared, stained with haematoxylin and eosin (H&E), and examined under a light microscope. This processing and examination approach was consistent with methods reported in Indian studies of gallbladder specimens following cholecystectomy.13,14 The final histopathological diagnoses were recorded from the pathology reports. Acute cholecystitis and acute-on-chronic cholecystitis were classified as evidence of acute inflammation. Chronic cholecystitis without an acute component and other nonacute diagnoses were classified as absence of acute inflammation for the primary analysis. Individual diagnoses were retained for the descriptive analysis of the histopathological spectrum. Statistical Analysis Continuous variables were summarised as mean and standard deviation or median and interquartile range, as appropriate. Categorical variables were expressed as frequencies and percentages. The ultrasound-to-surgery interval was compared between patients with and without acute inflammation using the Mann–Whitney U test. The association between surgical status and acute inflammation was assessed using Fisher's exact test. All tests were two-sided, and a p-value <0.05 was considered statistically significant. No

A total of 115 patients were included in the analysis. The mean age was 46.43 ± 13.59 years, with an age range of 18–82 years. Females constituted 73.0% of the study population, while males accounted for 27.0%. The demographic characteristics are presented in Table 1. Table 1. Demographic characteristics of the study population (n = 115) Characteristic Value Age, years, mean ± SD 46.43 ± 13.59 Age range, years 18–82 Female, n (%) 84 (73.0) Male, n (%) 31 (27.0) Total 115 (100.0) Most patients underwent elective cholecystectomy, accounting for 77.4% of the study population. Emergency procedures accounted for the remaining 22.6%. The distribution according to surgical status is shown in Table 2. Table 2. Distribution of patients according to surgical status Surgical status Number (n) Percentage (%) Elective 89 77.4 Emergency 26 22.6 Total 115 100.0 The mean interval between preoperative ultrasonography and cholecystectomy was 7.89 ± 6.52 days. The median interval was 6 days, with an interquartile range of 3–11 days. The observed interval ranged from 0 to 28 days. These findings are summarized in Table 3. Table 3. Ultrasound-to-surgery interval in the study population Parameter Value Number of patients 115 Mean ± SD, days 7.89 ± 6.52 Median, days 6 IQR, days 3–11 Minimum, days 0 Maximum, days 28 Chronic cholecystitis was the predominant histopathological diagnosis, observed in 86 patients (74.8%). Acute-on-chronic cholecystitis was identified in 11 patients (9.6%), while acute cholecystitis alone was reported in 9 patients (7.8%). Other non-acute findings, cholesterosis, and adenomyomatosis accounted for the remaining cases. The distribution of histopathological diagnoses is presented in Table 4. Table 4. Distribution of histopathological diagnoses Histopathological diagnosis Number (n) Percentage (%) Chronic cholecystitis 86 74.8 Acute-on-chronic cholecystitis 11 9.6 Acute cholecystitis 9 7.8 Other non-acute finding 5 4.3 Cholesterosis 3 2.6 Adenomyomatosis 1 0.9 Total 115 100.0 For the primary analysis, acute cholecystitis and acute-on-chronic cholecystitis were classified as evidence of acute inflammation. This outcome was present in 20 patients (17.4%), while 95 patients (82.6%) had no histopathological evidence of acute inflammation. The classification is shown in Table 5. Table 5. Distribution according to histopathological evidence of acute inflammation Acute inflammation status Number (n) Percentage (%) Present 20 17.4 Absent 95 82.6 Total 115 100.0 The ultrasound-to-surgery interval was compared between patients with and without histopathological evidence of acute inflammation using the Mann–Whitney U test. The median interval was 6 days in both groups. The interquartile range was 3–12 days in patients with acute inflammation and 3–11 days in those without acute inflammation. The difference was not statistically significant (U = 1014.5, p = 0.636). The comparison is presented in Table 6. Table 6. Comparison of ultrasound-to-surgery interval according to acute inflammation status Acute inflammation status Number (n) Median interval (days) IQR (days) Present 20 6 3–12 Absent 95 6 3–11 Mann–Whitney U test: U = 1014.5; two-sided p = 0.636. Histopathological acute inflammation was present in 18 of 89 elective cases (20.2%) and 2 of 26 emergency cases (7.7%). Fisher’s exact test did not demonstrate a statistically significant association between surgical status and acute inflammation (p = 0.237). Given the small number of patients with acute inflammation in the emergency group, this comparison should be interpreted cautiously. The findings are shown in Table 7. Table 7. Association between surgical status and histopathological acute inflammation Surgical status Acute inflammation present, n (%) Acute inflammation absent, n (%) Total Elective 18 (20.2) 71 (79.8) 89 Emergency 2 (7.7) 24 (92.3) 26 Total 20 (17.4) 95 (82.6) 115 Fisher’s exact test: two-sided p = 0.237.

The present study examined the association between the interval from preoperative ultrasonography to cholecystectomy and histopathological evidence of acute inflammation in 115 patients. Acute inflammation, defined by the presence of acute or acute-on-chronic cholecystitis, was identified in 20 patients (17.4%), whereas 95 (82.6%) had no acute inflammatory component. The median ultrasound-to-surgery interval was 6 days in both groups. The difference in interval distributions was not statistically significant (Mann–Whitney U = 1014.5, p = 0.636). Thus, within this study population, the time elapsed between ultrasound and surgery was not significantly associated with the presence of acute inflammation on histopathological examination. This finding should be interpreted as an absence of statistically significant evidence of an association in the present sample, rather than proof that the interval has no relationship with inflammation. Chronic cholecystitis was the predominant histopathological diagnosis in the present study, accounting for 86 cases (74.8%). Acute cholecystitis was reported in nine cases (7.8%), and acute-on-chronic cholecystitis in 11 (9.6%). The remaining specimens comprised other nonacute diagnoses, cholesterosis and adenomyomatosis. This distribution broadly reflects the predominance of chronic inflammatory pathology described in several studies of cholecystectomy specimens, although the reported proportions vary across settings and diagnostic classifications. Mondal et al. (2016),15 in a study of 786 cholecystectomy specimens from rural West Bengal, reported chronic cholecystitis in 79.8% and acute-on-chronic cholecystitis in 6.1% of cases. The predominance of chronic inflammation in their series is consistent with the principal finding of the present study. Similarly, Thukral et al. (2018)16 reported chronic calculous cholecystitis in 49.64% of 141 specimens, while Savanur et al. (2022)17 found chronic calculous cholecystitis in 59.4% and chronic acalculous cholecystitis in 33.1% of 471 specimens. Patil et al. (2018),18 in a five-year analysis of 1,096 cholecystectomies, reported chronic cholecystitis in 93.1% of cases and acute cholecystitis in 2.91%. Other studies have similarly reported chronic inflammatory diagnoses as common findings in cholecystectomy specimens. Kulkarni et al. (2020)13 reported chronic calculous cholecystitis in 57.76% of 161 specimens, with additional cases classified as chronic acalculous or acute-on-chronic cholecystitis. Hajong et al. (2022),14 in a series of 1,683 routine cholecystectomy specimens, identified chronic cholecystitis and cholesterosis among the most common findings. Benkhadoura et al. (2019)19 reported chronic cholecystitis in 81.6% and acute cholecystitis in 6.9% of 3,423 specimens. These findings provide descriptive context for the predominance of chronic pathology in the present series. However, differences in case selection and diagnostic classification limit direct comparison of the reported proportions. The principal finding of the present study was that the ultrasound-to-surgery interval did not differ significantly between patients with and without histopathological evidence of acute inflammation. The median interval was 6 days in both groups, and the comparison yielded a p-value of 0.636. The similarity in median values indicates that the observed data did not demonstrate a clear separation between the groups based on the interval alone. Room et al. (2022)20 provide relevant evidence concerning the relationship between ultrasonography and gallbladder pathology. In their prospective series of 795 laparoscopic cholecystectomies, ultrasound sensitivity was 75.7% for acute cholecystitis and 42.7% for cholecystitis overall. They also reported that ultrasound sensitivity declined as the interval between imaging and surgery increased. Their findings indicate that ultrasound sensitivity may decline as the interval between imaging and surgery increases. However, their analysis focused on ultrasound diagnostic performance and operative difficulty, rather than directly comparing the ultrasound-to-surgery interval between patients with and without histopathological acute inflammation. Consequently, their findings are relevant to the interpretation of imaging in relation to subsequent surgical findings but cannot be considered a direct contradiction of the present result. The two studies address related but distinct questions. The present study assessed whether the interval itself differed according to the histopathological inflammatory category, whereas Room et al.20 evaluated the ability of ultrasound to identify cholecystitis and its relationship with operative findings over time. The absence of a statistically significant association in the present study therefore does not establish that ultrasound findings remain equally accurate at all intervals. Nor does it establish that the interval is clinically irrelevant. The observed result is limited to the association examined in this sample. In the present study, acute inflammation was identified in 18 of 89 elective cases (20.2%) and two of 26 emergency cases (7.7%). The association between surgery status and acute inflammation was not statistically significant (Fisher’s exact test, p = 0.237). These findings should be interpreted cautiously because the emergency group was relatively small and contained only two cases with acute inflammation. The observed proportions alone are insufficient to establish a difference between elective and emergency surgery populations. Benkhadoura et al. (2019),19 utilized both elective and emergent cholecystectomies in their retrospective series; whereas Jha et al. (2021)21 solely focused on the histopathological examination of elective laparoscopic cholecystectomy specimens. This difference in patient selection should be taken into consideration when comparing the histopathologic distribution among studies. In this study, there was no statistical significance regarding the association of surgical type and histopathological acute inflammation (p = .237). The relatively few cases of acute inflammation within the emergency group limits the interpretation of the percentages found in this study. Although, histopathological examination remains relevant due to specimens may show a variety of abnormalities including non-inflammatory and inflammatory changes. The current study reports only inflammatory diagnoses. Several references have documented incidental malignancy. Jha et al. (2018)22 documented incidental gallbladder carcinoma in 20 out of 4800 cholecystectomy specimens. Jha et al. (2021)21 documented 17 incidental carcinomas among 921 specimens. Kalita et al. (2013)23 documented incidentally detected carcinoma in 0.44% of 4115 specimens. Kalita et al. (2013)23 noted that these 11 incidentally detected carcinomas accounted for 72% of all gallbladder carcinomas identified in their series. Sangwan et al. (2015)24 documented incidental carcinoma in 1.9% of their study population. While the percentage of each reference varies, they document the various types of changes that may be documented by histopathology. The present study was not designed to examine incidental malignancy; therefore these findings serve as background information for understanding what could potentially have been demonstrated in the present study. Strengths and limitations The investigators conducted an exploratory study of ultrasound findings compared to surgery to evaluate their association with pathologically diagnosed acute inflammation. Patients were included on a first-come basis, the investigation's primary comparisons were based upon the distribution of intervals from time of ultrasound examination to time of surgery in those who developed acute inflammation versus those who did not develop acute inflammation. The one-center nature of this study and the limited number of patients (including only 2 cases of acute inflammation) are likely to limit its generalizability. The authors did not control for potential confounders which may have influenced either when surgery is performed or the development of postoperative pathology; the research design used in this study does not allow the investigator to infer causation.

This prospective observational study found no statistically significant association between the interval from preoperative ultrasonography to cholecystectomy and histopathological evidence of acute inflammation. Although the median interval was six days in both groups, the findings do not establish that timing is unrelated to inflammatory changes. Chronic cholecystitis was the predominant histopathological diagnosis, while acute or acute-on-chronic inflammation was identified in 17.4% of patients. Surgical status was also not significantly associated with acute inflammation. These findings should be interpreted in the context of the single-centre design and modest sample size. Larger studies may clarify this relationship further.

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