European Journal of Cardiovascular Medicine

Gallstone disease is one of the most common gastrointestinal diseases which imposes a significant financial strain on healthcare systems and is expected to rise among geriatric populations who are at risk.¹ Gallstones are solid, pebble-like structures that get formed either inside the gallbladder or the biliary tract. They can vary in size and shape from as small as a grain of sand to as large as a golf ball.²

Five primary defects play a critical role in the pathogenesis of cholesterol gallstones:

1. LITH genes and genetic factors;
2. Hypersecretion of cholesterol by the liver, resulting in supersaturation of the bile in the gallbladder;
3. Rapid phase transition of cholesterol from supersaturated hepatic bile and formation of solid cholesterol crystals;
4. Gallbladder motility disorder with hypersecretion of mucin gel and accumulation in the lumen of the gallbladder with ongoing local immune mediated inflammation;
5. Gut factors, which include increased intestinal cholesterol absorption, slow gut motility, and alteration of gut microbiota.³

Excessive cholesterol biosynthesis, the main lithogenic mechanism in obese individuals, can lead to cholesterol supersaturation which is necessary for the cholesterol gallstones‟ formation. In non-obese individuals, insufficient cholesterol metabolism and bile acid synthesis may occur when there is decreased activity of cholesterol 7α hydroxylase, the enzyme that controls the synthesis of bile acids and elimination of cholesterol. This potentially leads to increased cholesterol secretion. In conclusion, the enterohepatic circulation was blocked may lead to higher levels of bile saturation. During overnight fasting, a temporary halt in the enterohepatic bile acid circulation results in an increased cholesterol/phospholipid ratio in the vesicles released by the liver.^2,4

High prevalence for gallstones is seen in female gender, geriatric age, pregnancy, sedentary lifestyle, obesity and overnutrition.^5,6 About 10-15% of adults are believed to have gallstone disease, with the majority of them not experiencing any symptoms. A few individuals with gallstone disease may experience discomfort, infection, and inflammation due to stones irritating the gallbladder or blocking the biliary system.^7,8

Cholecystectomy is one of the most frequently conducted abdominal surgery in Western countries.⁹ For over a century, open cholecystectomy was the preferred treatment for symptomatic gallbladder stones after Carl Langenbuch's successful procedure in 1882. During the year 1987, Philippe Mouret of France introduced laparoscopic cholecystectomy, which rapidly transformed how gallstone disease was treated.^10,11 It not only replaced open cholecystectomy but also essentially put an end to efforts for noninvasive treatment of gallstones (such as extracorporeal shock wave or cholangioscopic lithotripsy) or medical therapies (such as bile salts). Laparoscopic cholecystectomy provides a solution for gallstones through a less intrusive method, minimal discomfort and scarring, and a quick return to normal activities. Currently, laparoscopic cholecystectomy is the gold standard procedure for treating symptomatic gallstones and complications related to gallstone disease.¹²

Conversion to open may be required if the patient is unable to tolerate pneumoperitoneum, important anatomic structures cannot be clearly identified, or when no progress is made over a set period of time. In elective cases, approximately 5-10% of patients require conversion to an open cholecystectomy. For emergent cases or those with complex gallstone disease, the conversion rate is higher, ranging from 10% to 30%. Before surgery, it is crucial to talk to the patient about the option of switching to an open procedure.^13,14

The aim of the present study was to evaluate merits and demerits of drainage over non-drainage techniques in patients undergoing elective laparoscopic cholecystectomy.

This prospective study was carried out in the Department of General Surgery, Government Medical College and Rajindra Hospital, Patiala from January 2023 to March 2024. A total of hundred patients of cholelithiasis were included in the study for analysis. The informed consent was obtained from all the patients before surgery after taking permission from Ethics Committee of Government Medical College, Patiala.

INCLUSION CRITERIA

1. The patients above 18 years of age and below 60 years.
2. Elective laparoscopic cholecystectomy
3. Normal Liver function test profile.
4. Uneventful Laparoscopic cholecystectomy.

EXCLUSION CRITERIA

1. Pregnancy.
2. Obstructive jaundice
3. Conversion to open surgery
4. Patient with concomitant bile duct stones.
5. Patient with positive serology for hepatitis B or C virus will also be excluded.
6. Presence of collagen disorders.
7. Patient on Hepatotoxic drugs.
8. Patients who develop any complications due to anaesthesia and other preexisting renal, pulmonary and cardiac complications.
9. Patients suspected of having CBD obstruction underwent preoperative endoscopic retrograde cholangiopancreatography (ERCP).

METHODOLOGY

Patients were randomized using chit method. 50 chits labeled "Group A" and another 50 labeled "Group B" were prepared, ensuring that all chits were identical in size and shape. These chits were placed into a box and mixed thoroughly to guarantee randomization. As each patient enrolled in the study, they drew one chit from the container. The patient was then assigned to the corresponding group based on the chit they selected.

According to whether a prophylactic drain was employed or not during the operation, the patients were divided into two groups-

Group A (n=50): Patients undergoing Laparoscopic cholecystectomy with drainage.

Group B (n=50): Patients undergoing Laparoscopic cholecystectomy without drainage.

PRE-OPERATIVE SCREENING

The detailed history of the patient was taken and clinical examination was done. Various relevant hematological and biochemical investigations (Hb, TLC, DLC, Platelet count, Blood urea, S. Creatinine, S Bilirubin, SGOT, SGPT, Alkaline Phosphatase, RBS/ FBS, serum electrolytes (Na+,K+), PTI, HbsAg, HCV, HIV) were done. All the patients underwent ECG, X-ray chest, transabdominal ultrasound, and CECT Abdomen, if required.

PREOPERATIVE PROCEDURE

Patients were kept nil per oral (NPO) 8 hour prior to surgery.

OPERATIVE PROCEDURE

All patients underwent laparoscopic cholecystectomy by experienced consultant surgeon. The standard surgical procedure included the following steps:

• Pneumoperitoneum and port placement
• Proper retraction of the gallbladder
• Identification of operative landmarks and dissection planes
• Achieving “Critical View of Safety”
• Ligation/clipping and division of the cystic artery and duct
• Dissection of the gallbladder and extraction
• Removal of ports and fascial closure

If drainage was performed, a drain tube made of PVC (polyvinyl chloride) was placed in subhepatic space at the end of the LC through the trocar (5 mm) at the anterior axillary line. The criterion for drain removal was considered as output less than 20ml in last 24 hours. The protocol of the postoperative analgesia was the same for all the patients.

POST-OPERATIVE ANALYSIS

Patients who were converted to open cholecystectomy intra – operatively due to dense adhesions, hemorrhage, bile duct injury or spillage of stones have been excluded from the study.

Outcome measures

• The duration of the procedure was recorded from the initial incision at the first port site to the closure of the last port.
• Post-operative fever is typically defined as a body temperature of greater than 38°C (100.4°F) following surgery.
• Hospital stay was calculated by counting the number of days between the day of surgery and the day of discharge.
• In the present study, post-operative sub hepatic collection of 10-15 ml at 24 hours was considered as minimal post-operative sub hepatic collection, while <10 ml collection at 24 hours was considered as no collection.
• Port site and drain site infection after laparoscopic cholecystectomy is diagnosed based on signs like redness, swelling, pain, and tenderness at the port site. Purulent or foul-smelling discharge from the incision also indicates infection.
• Pain was recorded using Visual Analog Scale (VAS): A line (usually 10 cm) with endpoints representing "no pain" and "worst pain imaginable." Participants mark a point on the line that corresponds to their pain level.

The results of observations of individual patients were pooled in two groups and analyzed. Statistical analysis was performed using Statistical Program for Social Sciences (SPSS) software version 20.0 Chicago, Illinois, USA. All the analyses were performed on an intention to treat basis. For categorical variables chi-square test was used for analysis. p’ value: A difference between two groups which would have arisen by chance is „p‟ value. If it was less than 0.05, it was considered significant. p‟ value less than 0.01 was considered highly significant. If it was more than 0.05, it was considered non-significant.

Table 1: Baseline characteristics

The mean age in group A was 40.24±12.41 years and the mean age in group B was 44.30±11.56 years. Maximum number of patients was in the age group of 31-40 years in group A and in 41-50 years in group B. there were 40 (80%) females and 10 (20%) males. In the group B, there were 43 (86%) females and 7 (14%) males. The mean operative time in group A was 34.64±3.97 minutes and the mean operative time in group B was 31.72±4.79 minutes. Maximum number of patients had operative time of 31-40 minutes in both the groups.

Table 2: Post operative abdominal pain and clinical complications

At 0 hour, 35 (21+14) patients (70%) in group A and 16 (9+7) patients (32%) in group B experienced abdominal pain. The mean VAS score was 2.94±2.31 and 1.38±2.20 in group A and B, respectively (highly significant; p value 0.0008). At 6 hours, abdominal pain was experienced by 23 patients (46%) in group A and 10 patients (20%) in group B.  The mean VAS score was 1.38±1.51 and 0.60±1.21 in group A and B, respectively (highly significant; p value 0.0053). After 24 hours, abdominal pain was experienced by 8 patients (16%) in group A and 2 patients (4%) in group B. The mean VAS score was 0.48±1.11 and 0.12±0.59 in group A and B, respectively (significant; p value 0.0456). In group A, 1 patient (2%) and in group B, 8 patients (16%) experienced shoulder tip pain (p value 0.0007; highly significant). Fever was experienced by 10 patients (20%) in group A, and 2 patients (4%) in group B (p value 0.0009; highly significant). Nausea was experienced by 23 patients (46%) in group A, and 11 patients (22%) in group B (p value 0.0035; significant). Vomiting was experienced by 9 patients (18%) in group A, and 4 patients (8%) in group B (p value 0.0522; significant).

Table 3: Duration of hospital stay and port site infection

The mean duration of hospital stay was 1.50±0.51 days in group A and 1.08±0.27 days in group B. Statistically, there was highly significant difference (p< 0.0001). Port site infection was present in 2 patients (4%) in group A and in no patient (0%) in group B (non-significant difference; p= 0.1552).

Table 4: Post-operative mobility

At 6 hours, mobility was achieved in 47 patients (94%) in group A, and 49 patients (98%) in group B (p= 0.0637; non- significant). After 24 hours, mobility was achieved in 49 patients (98%) in group A, and 50 patients (100%) in group B (p= 0.3173; non-significant).

Table 5: Drain output, drain site pain and drain site infection in group A

The mean volume of drain output in 24 hours was 17±6.30 mL. The colour of drain output was serous in all the patients (100%). Drain site pain within 24 hours was present in 5 patients (10%) in group A. Drain site infection was present in 1 patient (2%) in group A.

Table 6: Post operative USG-collection at 24 hours

In the present study, post operative subhepatic collection of 10-15 ml at 24 hours was considered as minimal post operative subhepatic collection, while <10 ml collection at 24 hours was considered as no collection. This table shows that in group A, 13 patients (26%) had minimal post operative USG-collection at 24 hours, while in 37 patients (74%), there was no post operative collection. In group B, 10 patients (20%) had minimal post operative USG-collection at 24 hours, while in 40 patients (80%), there was no post operative collection. Statistical analysis showed that the difference between the two groups was not significant (p value 0. 4781).

Gall Bladder stone problems are very common nowadays. The prevalence of gallstones is on the rise because of lifestyle and dietary habit changes, particularly in developing countries. LC is currently the preferred technique for removing the gallbladder.⁸ The debate over the necessity of routine drainage after LC to reduce postoperative complications remains a significant issue. Using drains in laparoscopic cholecystectomy helps prevent the need for open procedures due to bile and blood buildup and also helps lower postoperative shoulder tip pain. Cholecystectomy without sub hepatic drainage was first reported in 1913, and ever since then, surgeons have been split on whether to utilize it as a standard practice in uncomplicated cases. Most surgeons still use sub-hepatic drains as a standard practice due to concerns about bile leakage and bleeding. Regardless of sub hepatic drainage, these complications always arose. The benefits of not having drainage included quicker recovery, lower complication rates, and shorter hospital stays.¹⁵

The mean age in group A was 40.70±13.47 years and the mean age in group B was 44.30±11.56 years. Maximum number of patients was in the age group of 31-40 years in group A and in 41-50 years in group B (non-significant difference; p= 0.0937). Shams A et al (2022) conducted found that the mean age was 38.6±0.2 years.¹⁶ Our findings were similar to the study conducted by Shah SF et al (2014) who reported that the mean age in both groups was 47.2 years.¹⁷ In group A, there were 40 (80%) females and 10 (20%) males. In the group B, there were 43 (86%) females and 7 (14%) males (non-significant difference; p value 0. 2587). The results of our study were comparable to the study conducted by Rathi PK et al (2011) in which male female ratio was 1:3.54 (with male 22% and females 78%) out of 100 patients.¹⁸ Nagpal A et al (2012) also reported that Male: female ratio in both the groups was 1:3.5 and 1:4.¹⁹

The mean operative time in group A was 34.64±3.97 minutes and the mean operative time in group B was 31.72±4.79 minutes. Maximum number of patients had operative time of 31-40 minutes in both the groups (high significant difference; p= 0.0013). Shams A et al (2022) reported that the mean time of surgery in drainage group was 44.2±10.3 minutes compared to 45.4±10.3 minutes in non- drainage group.¹⁶ Sarkar S et al (2023) reported that the mean duration of surgery in drainage group was 108 min which was significantly more than the non-drainage group (88 min).²⁰ In our study, at 0 hour, 12 patients (24%) in group A and 26 patients (32%) in group B experienced post operative abdominal pain (non-significant; p value 0.2892). At 6 hours, abdominal pain was experienced by 23 patients (46%) in group A and 21 patients (42%) in group B (non-significant; p value 0.6717). After 24 hours, abdominal pain was experienced by 16 patients (32%) in group A and 4 patients (8%) in group B (highly significant; p value 0.0001). Probably the higher incidence of post operative abdominal pain in drain group is due to irritation of peritoneum due to drain. In group A, 1 patient (2%) and in group B, 8 patients (16%) experienced shoulder tip pain (p value 0.0007; highly significant). Fever was experienced by 10 patients (20%) in group A, and 2 patients (4%) in group B (p value 0.0009; highly significant). Nausea was experienced by 23 patients (46%) in group A, and 11 patients (22%) in group B (p value 0.0035; significant). Vomiting was experienced by 9 patients (18%) in group A, and 4 patients (8%) in group B (p value 0.0522; significant). Nagpal A et al (2012) reported at 12th postoperative hour, 90% of patients of drainage group and 95% of patients of non-drainage group had pain in abdomen.¹⁹ Picchio M et al (2014) found that abdominal pain at 24 hours after surgery was less severe in the no drain group (P < .0001).²¹

In the present study, post operative subhepatic collection of 10-15 ml within 24 hours was considered as minimal post operative subhepatic collection, while <10ml collection within 24 hours was considered as no collection. In group A, 13 patients (26%) had minimal post operative subhepatic collection, while in 37 patients (74%), there was no post operative collection. In group B, 10 patients (20%) had minimal post operative USG-collection within 24 hours, while in 40 patients (80%), there was no post operative collection. Statistical analysis showed that the difference between the two groups was not significant (p value 0. 4781). Sharma R et al (2019) found that the mean volume of collected fluid was 6.6±5.2 ml in drain group and 7.0±3.5 ml in non-drain group.²² The mean duration of hospital stay was 1.74±0.44 days in group A and 1.06±0.24 days in group B. Statistically, there was highly significant difference (p< 0.0001). The results of our study were comparable to the study conducted by Shah SF et al (2014) in which the mean hospital stay was 1.7 days in drain group and 1.3 days in no drain group.¹⁷ Shams A et al (2022) reported that the mean time of hospital stay in patients of drainage group was 2.3±1.0 days compared to 2.3±0.9 days in non-drainage group.¹⁶

Port site infection was present in 3 patients (6%) in group A and in 1 patient (2%) in group B. Statistically, there was no significant difference (p= 0.1797). Shams A et al (2022) reported that 11.8% patients in drain group developed wound infection compared to 16.2% in no drain group.¹⁶ Dharamdev D et al (2021) noted that the wound infection was present in 14% with drain and 2% without drain group, hence p value was 0.007.²³ At 6 hours, mobility was achieved in 47 patients (94%) in group A, and 49 patients (98%) in group B (p= 0.0637; non-significant). After 24 hours, mobility was achieved in 49 patients (98%) in group A, and 50 patients (100%) in group B (p= 0.3173; non-significant). Shah SF et al (2014) reported that in drain group, 8.3%, and 91.6% patients achieved mobility at 6 hours, and 24 hours respectively in group A. While in non-drain group, 25%, and 100% patients achieved mobility at 6 hours, and 24 hours respectively.¹⁶

The mean volume of drain output in 24 hours was 17±6.30 mL. The colour of drain output was serous in all the patients (100%). Chauhan HR et al (2016) found that the drain volume in 24 hour was 3.99± 5.28 ml.²⁴ Metwally MF et al (2024) noted that concerning color of fluid drained, 70% had serous fluid.²⁵ Drain site pain at 12 hours was present in 17 patients (34%) in group A. Abdulhassan B (2021) reported that 93.3% patients had pain at the drain site after 24th hours and the pain was persisting in 83.33% patients even at 48th hour after surgery.²⁶ The drain itself as a foreign body causes mild pain at drain site due to irritation of peritoneum and skin at the point of exit of drain. Drain site infection was present in 1 patient (2%) in group A. Gadhvi UI et al (2018) reported that drain site infection was present in 16.6% of patients in drain group.²⁷ Singh M et al (2017) reported that 20% patients in drain group developed drain site infection.²⁸

This study revealed that not having a drain was highly beneficial in terms of PONV, surgical duration, postoperative discomfort, and length of hospital stay. Nonetheless, there was a reduction in shoulder tip pain within the drain group. This research was not able to demonstrate the effectiveness of drains in decreasing complications in LC. Therefore, routine drains placement under the liver post- laparoscopic cholecystectomy is unnecessary for uncomplicated cases.

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