Laparoscopic cholecystectomy (LC) is the gold standard for the treatment of gallstone disease. The titanium clips used for clipping the cystic artery and cystic duct have a risk of slippage, which may lead to bleeding, and an increased risk for bile leakage. In addition, it may act as a nidus for stone formation. Advanced energy sources, such as the harmonic scalpel, though expensive, may provide the advantage of shorter operating time by reducing smoke, bloodless dissection in the GB bed, lower risk of bleeding from the cystic artery due to secure vessel sealing, and avoiding the use of a larger number of titanium clips [1-3].

Total Clipless laparoscopic cholecystectomy by means of Harmonic shears have been used for closure and division of cystic artery and cystic duct but division of cystic duct with only harmonic shears is controversial. The fear that this is not enough to withstand the pressure and carry out a postoperative bile leakage could be a limiting factor for its widespread use, especially in large cystic duct (greater than 5mm). Therefore, by using absorbable suture we reduce the chances of biliary leakage [4-7].

Theoretical benefits for use of two clip-laparoscopic cholecystectomy and Clipless Laparoscopic Cholecystectomy technique using Absorbable suture material using harmonic scalpel technique are Less operative time, Less bleeding, Early post-operative recovery, Less spillage of stones, Less chances of converting into open cholecystectomy, Less pain post operatively and Less amount of CO2 used [1-7]. 

There is paucity of studies conducted for Comparison between Two clips laparoscopic cholecystectomy (TCLC) Vs Clipless Laparoscopic Cholecystectomy (TCLC). Thus, a study has undertaken to compare the advantages of two clips laparoscopic cholecystectomy (TCLC) and Clipless Laparoscopic Cholecystectomy (CLLC).

Aims and Objectives

To compare advantages of two clips and Clipless Laparoscopic Cholecystectomy

• Study Settings: A tertiary care hospital based study in the Department of General Surgery, IGMC Shimla

• Study Period: W.e.f. 1st July 2019 – 30 th June 2020

• Study Design: Prospective Randomised Study in a tertiary care center

• Study Population and Sample Size: All consecutive patients of symptomatic cholelithiasis confirmed by USG reporting and all patients were operated by same team of surgeons in a study period mentioned above. Sample size was 100 patients

• Approval of Ethical Committee of IGMC: After approval of ethical committee of IGMC Shimla data collection was started

Inclusion criteria for our study were patients between age between 21 and 80, ASA score of <3 and Symptomatic Gall stones.

Patient with BMI >40, Patient with choledocholithiasis with cholelithiasis, Previous upper abdominal surgery, Patient with bleeding disorder, Acute cholecystitis and Patient on warfarin were considered as high risk patients and were not included in the study.

All eligible patients were randomised into these two groups of 50 each using sealed opaque envelopes which will contain a computer-generated random number, Group-1 included patients undergoing dissection of gall bladder by harmonic scalpel with application of two titanium clip-on cystic duct except in patients with wide cystic duct and Group-2 included patients undergoing dissection of gall bladder by harmonic scalpel with application of absorbable PDS suture on cystic duct.

Before the surgery, all patients were undergoing basic investigations such as routine haematological and biochemical investigations, electrocardiogram, Ultrasonography of the abdomen and radiologic imaging such as chest radiograph. All operations were performed by same group of surgeons.

The Following Parameters were recorded in Each Group

Intraoperative Parameters 

• Operative findings including status of gall bladder, presence of adhesions, any intraoperative stone spillage. 

• Operative time calculated (in minutes) for all cases from skin incision to skin closure 

• Bleeding –Assessed through gauge visual analogue method

• Quantity of CO₂ used 

• Use of drain 

• Conversion to Open Cholecystectomy 

Postoperative Parameters

• Postoperative pain at 6h and 24h after surgery using visual analogue scale (VAS) used and the requirement of post-operative analgesics was noted 

• Length of Hospital Stay (in days) 

• Any postoperative complications 

Data Compilation

At the end of study data was compiled and outcome parameters were studied as Duration of surgery, Quantity of CO2 used, Intra operative stone spillage, Intra operative blood loss, Post-operative pain at 6 hour and 24 hour after the surgery, Duration of hospital stay and Any postoperative complications

Statistical Methods

Data collected, cleaned and entered into excel spread sheet. Expressions of discrete variables were as percentages or proportions. Chi-Square test was used to study difference in distribution of discrete variables. Expression of continuous variables were as Mean+SD or median+Interquartile range. Significance of difference in continuous variables were analysed using Student T test or Wilcoxon Signed Rank Test depending on distribution of variables. For all statistical analysis two tailed tests were used. Data was analysed using Epi–info version 7.2.2. p-value <0.05 was considered as statistically significant.

Out of 100 patients (Table 1), 28 were males and 72 were females. Among them, 14 males and 36 females underwent Two clips laparoscopic cholecystectomy (TCLC) while 14 males and 36 females underwent Clipless laparoscopic cholecystectomy (CLLC). In between two groups, mean age of males were 45.36±14.53 and females were 45.25±15.97 in TCLC group-while mean age of males were 53.07±18.96 and females were 44.44±15.41 in CLLC group.

In between the two groups (Table 2), mean operative time (min) of TCLC group-was 28.76± 8.23 and CLLC group-was 37.30±8.22 with mean difference of 8.47 min and p-value of <0.001. Mean CO₂ used in TCLC was 21.52±5.97 litres and CLLC group-was 24.90±4.26 with mean difference of 3.28 litres and p-value of 0.001.Approx. blood loss in TCLC group-was 8.10±3.18 ml and CLLC group-was 8.40±3.70with mean difference of 0.3 ml and p-value of 0.66.

In term of pain, average pain score at 6 hours in TCLC was 5.92±0.90 and CLLC group-was 5.96±0.49 with mean difference of 0.04 and p-value of 0.78. Average pain score at 24 hours in TCLC group-was 2.08±0.40 and CLLC group-was 2.04±0.28 with mean difference of 0.04 and p-value of 0.56. In term of length of hospital stay, average stay in TCLC group-was 1.04±0.28 and CLLC group-was 1.10±0.46 with mean difference of 0.06 and p-value of 0.43.

In terms of stone spillage (Table 3), 2 patients of TCLC group-and 4 patients in CLLC group-had intraoperative stone spillage with p-value is 0.71. In this study, among 3 patients of TCLC group-and 4 patients in CLLC group-, intra operatively drain was used with p-value is 0.71. In terms of conversion, 1 patient each of TCLC group-CLLC group-converted to open cholecystectomy with p-value is 0.99. In the present study, none of patient of TCLC and 1 patient of CLLC groups had postoperative complication with p-value is 0.50

Table 1: Age and Gender Distribution

Table 2: Inter-Group-Comparison of Various Quantitative Variables

Statistical Analysis: Independent sample t test. Statistically significant if p<0.05

Table 3: Inter-Group-Comparison of Various Qualitative Variables

Statistical Analysis: Chi-square test. Statistically significant if p<0.05

In the present study, mean operative time (min) of TCLC group-was 28.76±8.23 and CLLC group-was 37.30±8.22 with mean difference of 8.47 min and p-value of <0.001. In terms of conversion, 1 patient each of TCLC group-CLLC group-converted to open cholecystectomy due to frozen calots triangle. So the mean operative time markedly increased due to above mentioned two cases. Operating time was significantly less in the harmonic ace assisted LC group-in the study conducted by Jain et al. [7] (64.7±13.74 vs. 50±9.36, p = 0.001) and Kadil et al. [8] (61.88 ±.17 16vs. 52.14±9.8, p<0.0001) The Harmonic scalpel allows dissection and closure of the cystic artery and ducts 4–5 mm in diameter without requiring clipping [9] so significantly reducing operative time. Rajnish et al. [1] and Guanqun et al. [10] suggest that there was no significant difference in operating time.

In terms of stone spillage, 2 patients of TCLC group-and 4 patients in CLLC group-had intraoperative stone spillage with p-value is 0.71. Kandil et al. [8], in their study, showed that the risk of GB perforation was significantly higher in the traditional group-than in the harmonic group-(18.6% vs. 7.1%, respectively, p = 0.04). Risk of GB perforation was not found significant in the study conducted by Mukesh et al. [11].

Intra operative blood loss is measured with the help-of gauge visual analogue method and Approx. blood loss in TCLC group-was 8.10±3.18 ml and CLLC group-was 8.40±3.70with mean difference of 0.3 ml and p-value of 0.66. In their studies, Jain et al. [7] and Kandil et al. [8] have observed a significant reduction in blood loss, which was measured indirectly by means of a fall in hemoglobin and haematocrit. Rajnish et al. [1] and Guanqun et al. [10] suggest that there was no significant difference in blood loss.

Mean CO₂ used in TCLC was 21.52±5.97 litres and CLLC group-was 24.90±4.26 with mean difference of 3.28 litres and p-value of 0.001. Amount of CO₂ used depends directly on operative time. No study to our knowledge has compared amount of CO₂ used. But various studies had compared mean operative time which reflect indirectly amount of CO₂ used. Blood loss, intraoperative stone spillage requires use of suction intra operatively which also indirectly reflect amount of CO₂ used.

In term of pain, average pain score at 6 hours in TCLC was 5.92±0.90 and CLLC group-was 5.96±0.49 with mean difference of 0.04 and p-value of 0.78. Average pain score at 24 hours in TCLC group-was 2.08±0.40 and CLLC group-was 2.04±0.28 with mean difference of 0.04 and p-value of 0.56. Jain et al. [4] noted that post-operative pain was significantly less in the harmonic shear group. This is due to less release of inflammatory mediators, as there is less lateral tissue and nerve damage. Also, the duration of peritoneal distension is less due to the shorter surgery duration, thereby directly affecting the duration and degree of traction to vessels and nerve. Mahabaleshwar et al. [4] also concluded that the postoperative pain is less in the harmonic scalpel group. Post-operative pain scores after 24 hours were found to be significantly better in harmonic ace assisted LC by Kandil et al. [8] as well (4.48±1.89 vs. 3.12±1.84, p = 0.000) Guanqun et al. [10] and Rajnish et al. [1] suggest there is no significant pain reduction in post-operative pain and analgesic requirement in both groups.

In terms of conversion, 1 patient each of TCLC group-CLLC group-converted to open cholecystectomy with p-value is 0.99. Kandil et al. [8] suggest less conversion rate in HA group-but that was not statistically significant. Bessa et al. [12], Guanqun et al. [10] and Rajnish et al. [1] report no statiscally significant difference in between two groups.

In term of length of hospital stay, average stay in TCLC group-was 1.04±0.28 and CLLC group-was 1.10±0.46 with mean difference of 0.06 and p-value of 0.43. Guanqun et al. [10] shows mean stay in hospital after surgery as 3.0 ±0.4 in Harmonic ace group-and 2.9±0.4 in Electrocautery group-with p-value of 0.315. Gelmini et al. [13] shows mean post-operative hospital stay in both group-as 2 days and p-value is 0.799.

In the present study, none of patient of TCLC and 1 patient of CLLC groups had postoperative complication with p-value is 0.50. These complications in the form of bile leak were managed with ERCP-stenting and surgical site infection were managed with daily aseptic dressings and secondary suturing. In Rajnish et al. [1] study post-operative complications in term of surgical site infection and intra-abdominal collection there was no statiscally significant difference in between two groups. Guanqun et al. [10] show no significant post-operative complications in two groups.

Present study concluded that there was significant more Operative Time and more Mean CO2 used in CLLC group-as compared to TCLC group. In the study although there was more Approx. Blood Loss, more Intra Op. Stone spillage & more Use of Drain, more Average Length of hospital stay, more Post Op. Complications, more Average pain score at 6 but less Average pain score at 24 hours in CLLC group-as compared to TCLC group-but this difference was not statistically significant. Similarly, in both groups equal number of patients Converted to Open Cholecystectomy.

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