European Journal of Cardiovascular Medicine

Cholelithiasis, commonly referred to as gallstone disease, represents one of the most prevalent digestive disorders globally, with a significant impact on public health.[1] In the United States alone, an estimated 20 million individuals are affected by gallstones, with approximately 1 million new diagnoses occurring annually.[2] This condition exhibits considerable geographical and demographic variability, with studies indicating a prevalence of around 4% in the Indian population—a figure that is on the rise in parallel with the westernization of dietary habits and lifestyle. The pathophysiology of cholelithiasis is multifactorial, incorporating genetic predispositions, metabolic disorders, and environmental influences. Central to its development is the interplay between dietary inputs and physiological responses during and after meals, which,

when disrupted, can lead to the supersaturation of bile and the formation of cholesterol crystals.[3]

Clinically, cholelithiasis is often characterized by episodic biliary colicky pain, typically localized to the right upper quadrant and frequently radiating to the epigastric region, back, or shoulder.[4] While a considerable proportion of individuals with gallstones remain asymptomatic, it is noteworthy that approximately 20–25% may develop serious complications, including acute cholecystitis, choledocholithiasis, cholangitis, biliary pancreatitis, or even gallstone ileus, necessitating prompt medical intervention.[5]

Historically, open cholecystectomy (OC) was the conventional approach to treating gallbladder disease. However, the evolution of laparoscopic techniques has revolutionized the management of cholelithiasis, offering a less invasive alternative with numerous clinical advantages.[6] The National Institutes of Health (NIH) Consensus Development Conference has recognized laparoscopic cholecystectomy (LC) as the most effective modality for managing this condition, underscoring its benefits, which include reduced surgical trauma, decreased postoperative pain, shorter hospital stays, and hastened recovery.[7] Nevertheless, challenges associated with LC, such as prolonged operative time, bile or stone spillage, and the potential need for conversion to open surgery, warrant a thorough understanding of predictive factors that may complicate the procedure. Identifying these factors can aid surgeons in effective preoperative planning, optimize resource allocation, and ultimately enhance patient safety during laparoscopic interventions.[8]

This article aims to explore the epidemiological trends, clinical manifestations, and therapeutic advancements in cholelithiasis while emphasizing the importance of understanding predictive variables that influence the difficulty of LC. By equipping healthcare professionals with such knowledge, we can improve surgical outcomes, streamline operational processes, and mitigate complications associated with this prevalent medical condition.

The present study was a prospective study was conducted in Department of General surgery, Rajindra hospital, Government Medical College, Patiala. A total of 75 cases who were admitted for elective LC over a period of year were enrolled. Informed written consent was taken from all the patients/ attendants. The enrollment was based on following selection criteria:

Inclusion criteria-

1.       Only patients who provided informed consent to participate were enrolled in this study.

2.       The patients above 18 years of age.

3.       Elective LC.

4.       No acute attack in last 6 weeks (no history of hospitalization for more than 24 hours).

5.       Negative murphy’s sign at the time of admission.

Exclusion Criteria-

1.       Pregnancy and children

2.       Deranged LFT

a)       Obstructive jaundice (increased Bilirubin)

b)       Patients with concomitant bile duct stones (increased ALP).

c)       Patients with positive serology for hepatitis B or C virus / cirrhosis (increased OT/PT)

d)       Patients suspected of having CBD obstruction (increased ALP)

3.       Patients having history of collagen disorders, bile duct injury, gall bladder mass suspected of carcinoma, and acute attack of cholecystitis less than 6 weeks ago.

4.       Patient on Hepatotoxic drugs.

5.       Patients having obesity (BMI>30).

6.       Patients who refused for consent or those who withdrew their consent at any stage of this study were excluded from this study.

7.       Patients who develop any complications due to anaesthesia and other pre-existing renal, pulmonary, and cardiac complications.

Operative Procedure: In this study, patients scheduled for LC were kept nil per oral (NPO) for eight hours prior to surgery. The procedure utilized CO2 pneumoperitoneum at a pressure of 12 mm Hg, with two 10 mm and two 5 mm ports. The surgical duration was recorded from the initial incision to the closure of the last port. Dissection was performed in the safe zone to achieve critical view of safety, and all intraoperative events were documented. The surgeries were conducted under general anesthesia by experienced surgeons, each having performed over 150 LC procedures. Intraoperative data, including adhesions, bile spillage, and surgical duration, were collected, and cases were categorized as easy, difficult, or very difficult. Postoperatively, patients were transferred to the ward and discharged after drain removal, provided there were no complications. A comparison of preoperative factors and intraoperative difficulty levels was conducted to enhance understanding of surgical outcomes.

For the evaluation, the results of various parameters from the individual patients were summarized in Microsoft excel sheet and were analyzed by SPSS software.

This study assessed the difficulty levels of LC among 75 participants, revealing distinct patterns based on demographic, clinical, and intraoperative factors. Of the participants, 54.7% (41 individuals) underwent an "Easy" procedure, while 30.7% (23 individuals) experienced a "Difficult" procedure, and 14.7% (11 individuals) encountered a "Very Difficult" procedure.

The gender distribution indicated a predominance of females, with 53 females (70.7%) and 22 males (29.3%). A significant difference in the perceived difficulty of the procedure was noted between genders, with a p-value of 0.042. In terms of age, 54 participants were below 50 years old, and 21 were aged 50 and above, reflecting a significant difference in perceived difficulty levels across age groups (p=0.036). Specifically, the mean ages for "Easy," "Difficult," and "Very Difficult" procedures were 37.24, 43.39, and 46.64 years, respectively.

Pain history among participants revealed that 48 individuals reported no continuous mild pain, highlighting variability in pain experiences, with a significant relationship found between pain history and difficulty level (p=0.010). Additionally, regarding acute attacks, 42.7% (32 individuals) reported no acute attacks, while 44.0% (33 individuals) experienced one acute attack, and 10 individuals experienced multiple episodes; a statistically significant relationship was indicated (p=0.016).

Analysis of recent acute pain episodes showed that among 75 participants, 32 reported no recent episodes. Among those who did, 32 had their last episode 2 months ago, 7 had it 3 months ago, and others reported last episodes from 1 to 10 months prior. A significant association was found between the timing of the last episode and the difficulty level of the procedure (p=0.026).

Regarding comorbidities, a significant majority of participants (70.7%, n=53) reported no comorbidities, while hypertension (HTN) and diabetes mellitus (DM) were the most common among those with comorbid conditions. Notably, 65.3% (49 individuals) had no prior surgical history, emphasizing that some participants had undergone various surgical procedures, with lower segment caesarean section (LSCS) being the most frequent. Additionally, 90.6% had a total leukocyte count (TLC) of less than 10, while 9.4% had a TLC greater than 10, with a p-value of 0.397 indicating no statistically significant difference in TLC values across differing difficulty levels.

Concerning gallbladder condition, 60% (45 individuals) had a distended gallbladder, 32.0% (24 individuals) had a contracted gallbladder, and 8.0% (6 individuals) had an over-distended gallbladder; significant associations were identified (p=0.043). Stone characteristics indicated that 25.3% (19 individuals) had a single stone and 74.7% (56 individuals) had multiple stones, with a significant correlation found between stone numbers and procedure difficulty (p=0.000). For cases with a single stone, only 3 found the procedure easy, while a majority found it difficult (10) or very difficult (6).

The location of gallstones was relevant, as 66 individuals had stones in the lumen of the gallbladder, 8 had stones in the neck, and 1 had stones in both locations; this presented a significant association (p=0.002). Stone size affected perceived difficulty, with 60 participants having stones smaller than 1.5 cm and 15 with larger stones; a significant difference was noted (p=0.0042). Furthermore, 62 individuals exhibited normal gallbladder wall thickness while 13 showed edema (>3 mm), yielding a highly significant difference in perceived difficulty (p=0.0036).

Regarding pericholecystic fluid, 93.3% (70 individuals) did not have any, with 6.7% (5 individuals) presenting with pericholecystic fluid, showing no significant association with difficulty levels (p=0.159). The common bile duct (CBD) status indicated that most participants had a normal CBD (up to 7 mm), while a smaller fraction had a dilated CBD (>7 mm), with no significant relationship to the difficulty level observed (p=0.099).

Intraoperative findings revealed that 68 participants had a normal gallbladder, with 5 having a mucocele and 2 a pyocele. The majority of surgeries (57.3%, n=43) lasted less than 1 hour, 30.7% (n=23) lasted between 1 to 1.5 hours, and 12.0% (n=9) exceeded 1.5 hours. The presence of adhesions was noted in 44 individuals, with 56.0% reporting no adhesions, 30.7% having flimsy adhesions (+), and 13.3% with dense adhesions (++).

The dissection difficulty revealed that 62.7% (47 individuals) found it easy, while 21.3% (16 individuals) experienced moderate difficulty and 16.0% (12 individuals) faced difficult dissections. Conversion to OC occurring in only 8% (n=6) of cases, indicating effective laparoscopic performance. The occurrence of bile spillage was minimal, with 85.3% (n=64) experiencing none.

Table 1: Baseline characteristics of patients

Table 2: Lab data at different timelines

This study explored the various predictive variables that influence the difficulty of LC. The results indicated that 72% of the patients were below 50 years of age, while 28% were above, a trend attributed to lifestyle factors and dietary habits. A statistically significant difference in the difficulty of surgery across different age groups was noted (p = 0.036), with older patients being more likely to encounter increased surgical complexity due to factors such as decreased tissue elasticity and a higher tendency for bleeding, consistent with previous studies by Yang et al.^[9] and Karim et al.^[10]

Gender distribution revealed a female predominance (70.7%), aligning with findings from Vivek et al.^[11] and Philip et al.^[12], suggesting a higher prevalence of gallbladder diseases among women due to physiological and hormonal influences, particularly during reproductive age. Notably, a significant difference in surgical difficulty based on gender was found (p = 0.042), with males experiencing greater challenges, potentially due to later presentations in hospital settings, increased fibrosis around Calot’s triangle from recurrent acute attacks, and anatomical differences affecting the surgical approach.

Regarding other symptoms of cholelithiasis, the study found that 64% of participants had no history of continuous mild pain, while 36% did. A significant association between the history of continuous mild pain and surgical difficulty was identified (p = 0.010), which is supported by previous works from Strasberg et al.^[13] and Berci G et al.^[14] Furthermore, a statistically significant relationship was observed between the number of acute attacks and surgical complexity, corroborated by studies from Singh et al.^[15], Nassar et al.^[16], and Tongyoo et al.^[17], indicating that acute attacks lead to increased fibrosis and adhesions.

The timing of recent acute pain episodes showed a noteworthy association with surgical difficulty (p = 0.026), affirming findings from Singh et al.^[15], Bhandari et al.^[18], and Ramirez-Giraldo et al.^[19], which suggested that ongoing inflammation complicates surgical dissection. However, no significant association was observed between comorbidities, such as hypertension and diabetes, and surgical difficulty (p = 0.537), in line with Philip et al.'s findings. Additionally, total leukocyte count (TLC) did not predict surgical complexity, with no significant difference noted (p = 0.397).

Ultrasound findings revealed gallbladder statuses as follows: distended (60%), contracted (32%), and over-distended (8%). A significant difference in surgical difficulty based on gallbladder status was confirmed (p = 0.043), consistent with Singh et al.^[15], Elgammal et al.^[20], and Di Buono et al^[21]. The study emphasized that thicker gallbladder walls (p = 0.003) indicate chronic inflammation and fibrosis, complicating dissection, thus leading to increased intraoperative events such as longer operative times and conversions to open surgery.

Analysis of the number of stones showed a significant difference in surgical difficulty (p = 0.000), with participants having multiple stones experiencing less difficulty than those with a single stone, typically impacted. The location of gallstones also correlated significantly with surgical challenges (p = 0.002), where stones in the neck or both locations posed greater difficulties due to increased inflammation and potential complications like Mirizzi syndrome. The size of stones significantly impacted surgical difficulty as well (p = 0.004), with larger stones correlating with heightened surgical challenges, consistent with findings from Elgammal et al.^[20] and Al Zoubi et al^[22].

Out of the 75 participants, only 6.7% (5 participants) had pericholecystic fluid, with no statistically significant association observed between fluid presence and surgical difficulty (p = 0.159). The analysis of surgical complications indicated that shorter surgeries were generally linked to fewer complications, with 57.3% of operations lasting less than one hour. Adhesions were present in 30.7% of cases, and 13.3% had dense adhesions, which notably influenced the difficulty level. The study reported that 6 surgeries required conversion to an open procedure, typically due to complications preventing adequate laparoscopic visualization. Furthermore, bile spillage occurred in 14.7% of surgeries, indicating the necessity for careful management to minimize potential postoperative complications.

The limitations of this study include a limited timeframe and a relatively small sample size, which may affect the broader applicability of the findings. Consequently, larger-scale, prospective randomized trials are warranted to validate these findings.

This study identified significant correlations between surgical difficulty in LC and factors such as older age, male gender, and prolonged mild pain. Additionally, recent and frequent acute attacks were linked to increased surgical complexity. Ultrasound findings indicated that over-distended gallbladders, single large stones, stones in the neck, and increased gallbladder wall thickness significantly contributed to surgical challenges (p < 0.05). Recognizing these factors can help surgeons optimize their approach, potentially reducing operative times and intraoperative complications, thereby improving patient outcomes.

Sources of funding: There was no source of funding for our research.

Ethical approval and Consent

Approval was taken from the relevant ethics committee and written informed consent was taken from each patient to publish his details while maintaining confidentiality.

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