European Journal of Cardiovascular Medicine

Laparoscopic cholecystectomy, a minimally invasive surgical technique first introduced in 1987, has now become the preferred and standard method for gallbladder removal [1]. This method has substantially changed the surgical treatment of gallbladder (GB) conditions, mainly by greatly lowering post-operative pain levels. Additionally, this development has resulted in a decreased occurrence of surgical site infections and lowers the risk of incisional hernias, which are typical complications linked to conventional open surgery [2,3]. Laparoscopic cholecystectomy presents several distinct advantages over the open cholecystectomy procedure, including a considerably shorter length of stay in the hospital, a faster return to work, and reduced healthcare costs [4].

Despite notable advancements, post-surgical pain remains a prevalent complaint among patients undergoing laparoscopic cholecystectomy and is frequently cited as the primary reason for extended hospital stays [5]. The pain originates from various factors, including the rupture of small blood vessels from peritoneal dissection, traumatic traction and nerve injury, trauma to the abdominal wall during port insertion and gallbladder extraction, and the physiological effects of the CO2 pneumoperitoneum [6]. Existing medical literature consistently reports that incisional pain is typically more intense than visceral pain and is the predominant source of discomfort during the first 48 hours following laparoscopic cholecystectomy [7].

The removal of the gallbladder is a crucial phase in the procedure and is acknowledged as a major factor in post-operative discomfort at the port sites. The gallbladder is typically extracted via either the umbilical port or the epigastric port [8,9,10]. The selection of the port is often based on the individual surgeon's preference and clinical judgment. This study is specifically designed to investigate and determine whether the extraction of the gallbladder (GB) through the umbilical port is associated with a greater degree of post-operative pain in comparison to GB extraction through the epigastric port.

Study Design and Location: A randomized controlled study was conducted over a period of 18 months. The data was gathered from individuals admitted to the Department of General Surgery at ESI-MC & PGIMSR, Bengaluru. The study protocol was reviewed and approved by the institutional ethics review committee.

The sample size was determined through a power analysis for a two-sample t-test, targeting 80% power with an alpha error of 0.05. The calculation was based on an expected mean difference of 1 in the Visual Analogue Scale (VAS) pain score between the two groups, with a standard deviation of 0.5. The initial required sample size was determined to be 29 patients for each group, which was rounded up to 30.[20]

The formula used for sample size calculation was:

n=(μ1​−μ2​)2(Zα/2​+Zβ​)2×2σ2​

The parameters are defined as follows: Zα/2 = 1.96, corresponding to a 95% confidence level for a two-tailed test; Zβ = 0.84, indicating an 80% power to detect a difference; σ = 1.5, representing the standard deviation of the pain scores; μ1 = 6.6, the mean pain score for the epigastric port; and μ2 = 5.5, the mean pain score for the umbilical port. These values are used to assess the statistical significance and power of detecting a difference in pain scores between the two port sites.

Inclusion Criteria

Patients eligible for inclusion in the study are those diagnosed with cholelithiasis who have provided written informed consent. Additionally, participants must be within the age range of 18 to 50 years and scheduled for laparoscopic cholecystectomy. These criteria ensure that the study focuses on a specific group of patients undergoing a planned, minimally invasive procedure for gallstone disease, with informed agreement to participate.

Exclusion Criteria

Patients are excluded from the study if they have been diagnosed with acute cholecystitis, gallbladder empyema, or gallbladder mucocele, as these conditions represent more severe or complicated gallbladder diseases. Other exclusion criteria include gallstones larger than 2 cm, suspected or confirmed gallbladder malignancy, or cases where laparoscopic cholecystectomy is converted to open surgery. Additionally, patients undergoing emergency laparoscopic cholecystectomy or those on long-term steroid or analgesic medication are excluded to avoid confounding factors related to urgent procedures or chronic medication use.

METHODOLOGY
Patients meeting the inclusion criteria were randomly assigned to one of two groups using a computer-generated randomization method. Group A consisted of patients in whom the gallbladder (GB) was extracted through the umbilical port, whereas in Group B, the GB was extracted through the epigastric port. Informed consent was obtained from all participants prior to the procedure. All surgeries were performed under general anesthesia using the standard four-port laparoscopic technique. Two 10 mm ports were inserted in the umbilical and epigastric regions. Following dissection, the gallbladder was placed inside a sterile plastic retrieval bag and extracted through the designated port based on the assigned group.

Outcome Assessment: The primary outcome, post-operative port site pain, was assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Patients were educated about the VAS preoperatively. A trained nurse, who was blinded to the intervention, assessed pain at both port sites at 1, 6, 12, 24, and 36 hours post-operatively.

A total of 60 patients diagnosed with cholelithiasis were included in the study and categorized into two groups of thirty.

Demographics:

• Group A (Umbilical): Consisted of 5 men (16.7%) and 25 women (83.3%). The average age was 35.3 years.
• Group B (Epigastric): Included 10 men (33.33%) and 20 women (66.67%). The average age was 38.33 years.

The difference in gender distribution between the two groups was not statistically significant (P = 0.06). The difference in age distribution was statistically significant (P = 0.009).

Pain Assessment (VAS Scores): At every assessment point, Group B consistently showed higher mean pain scores than Group A. The p-values were less than 0.0001 at all-time intervals, indicating a statistically significant difference.

Table 1: Gender Distribution of Patients

Figure 1: Bar Graph for Gender wise distribution of patients of laparoscopic cholecystectomy in both the groups.

Figure 2: Distribution of patients based on gender Group A

Figure 3: Distribution of patients based on gender Group B

Table 2: Age Distribution of Patients

Figure 4: Bar Graph for Age distribution of patients of in both the groups.

Table 3:Visual Analogue Scale (VAS) For Pain in Both Groups at Different Time Intervals in the Postoperative Period

Figure 5: Visual Analogue Scale for pain in both Groups at Different Time

Complications: Incision site infection was noted in 2 patients of Group A and 1 patient of Group B, which is statistically not significant.

This research involved sixty people who had gallbladders taken out through a procedure called cholecystectomy. The patients were put into two groups of thirty each. In Group A, the gallbladder was removed through the umbilical port, and this group included five men (16.7%) and twenty-five women (83.3%), with a mean age of 35.3 years. In Group B, the gallbladder was removed through an incision below the ribcage (the epigastric port), and this group consisted of ten men (33.3%) and twenty women (66.7%), with an average age of 38.33 years.

These numbers-like the fact that there were more women than men and the age ranges-line up pretty well with what other studies have shown. For instance, Siddique et al. reported 76% [11],Shakya et al. had 75% women [12]. The ages in our study (35.33 years for Group A and 38.33 for Group B) also fit with what Siddique et al. (47.69 ± 9.4 vs. 40.6 ± 12.6) [11] though our participants were a little younger overall.

After the surgery, we wanted to know how much pain people felt, so we used a tool called the Visual Analogue Scale (VAS), where patients rated their pain from 0 to 10 at both the umbilical port and ribcage spots. In Group A, the umbilical port area always hurt more than the ribcage spot whenever we checked. For Group B, it was the opposite-the ribcage area was the one that hurt more compared to the umbilical port. What this tells us is that the spot where the gallbladder was taken out seemed to be the one causing more discomfort, no matter which location was used.

Then we compared the pain at the extraction sites between the groups: the umbilical port pain in Group A versus the ribcage pain in Group B. The ribcage spot in Group B consistently came out as more painful, and this wasn’t just a small difference-it was statistically significant when we checked at one, six, twelve, twenty-four, and thirty-six hours post-surgery. Other studies, like those by Siddique et al. [11] and Shakya et al. [12], saw something similar and suggested that using the umbilical port might be the better choice if you want to keep pain levels down after the operation.

On the other hand, Abbas et al. [13] leaned toward the ribcage spot-not because of pain-but because they noticed fewer wound infections there, though they admitted the pain itself wasn’t much different between the two options.

Not everyone agrees, though. Bashir et al. [14] found that pain levels were about the same whether the gallbladder came out through the umbilical port or the ribcage, so they figured it might just boil down to what the surgeon feels more comfortable doing.

When it came to complications like infections at the surgery sites, we didn’t see any big differences between Group A and Group B. This matches up with what Shakya et al. found too-no major variation in problems regardless of which spot was used [12].

Now, our study isn’t without its flaws. We only worked with sixty people, and everything was done at one hospital. As noted by Hajong R et al., similar studies with small sample sizes and limited locations face comparable limitations [15]. To really nail down which spot is best for taking out the gallbladder, we’d need bigger studies with more participants from different places to back up these findings and give clearer advice.

The results of this study indicate that pulling the gallbladder out through the umbilical port during laparoscopic cholecystectomy leads to noticeably less pain afterward compared to the epigastric port. This difference in discomfort was clear and statistically meaningful at every time point checked—1, 6, 12, 24, and 36 hours after surgery.

Because of this, the research points to the umbilical port as the better choice for gallbladder removal when it is an option, since it seems to make the recovery less painful for patients. That said, the surgeon in charge should still have the final say, weighing factors like the patient’s unique situation and what they see during the operation itself. To solidify these findings and build stronger recommendations, more studies with bigger groups of people and input from multiple hospitals would be a smart next step.

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