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Research Article | Volume 3 Issue 1 (Jan-June, 2022) | Pages 1 - 4
A Randomized Control Study to Compare the Clipless Laparoscopic Cholecystectomy (CLLC) and Conventional Laparoscopic Cholecystectomy (CLC)
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1
Department of General Surgery, Civil Hospital, Theog, District Shimla, Himachal Pradesh, India
2
Department of Microbiology, National Health Mission, Shimla, Himachal Pradesh, India
3
Department of General Surgery, Indira Gandhi Medical College And Hospital, Himachal Pradesh, India
4
Department of Anesthesiology, Indira Gandhi Medical College And Hospital, Himachal Prades, India
Under a Creative Commons license
Open Access
Received
Jan. 3, 2022
Revised
Jan. 13, 2022
Accepted
Feb. 15, 2022
Published
March 10, 2022
Abstract

Background: Present study was undertaken to compare the advantages of Clipless Laparoscopic Cholecystectomy (CLLC) over Conventional Laparoscopic Cholecystectomy (CLC). Materials and Methods: This prospective randomized study was conducted in the Department of Surgery IGMC, Shimla over a period of 1 year starting from 1st July 2019 to 30th June 2020. In this study 100 consecutive patients of symptomatic cholelithiasis confirmed by USG reporting were participated and randomized into 2 groups of 50 each. Group 1 patients underwent CLC and Group 2 patients underwent CLLC. Outcomes were measured in terms of operative time, intra operative stone spillage, intra operative blood loss, amount of CO2 used, post-operative pain, conversion into open cholecystectomy and post-operative complications. Results: In the present study among 100 patients, 19 were males and 81 were females. Among them, 5 males and 45 females underwent CLC using electrocautery while 14 males and 36 females underwent CLLC. Mean age of males were 47.60±3.36 years and females were 45.20±15.82 years in CLC group and mean age of males were 53.07±18.96 and females were 44.44±15.41 in CLLC group. Present study showed that there was significant less Operative Time, Less Mean CO2 used, less Approx. Blood Loss, less Average pain score at 6 and 24 hours, less Average Length of hospital stay, less Intra Op. Stone spillage and less Use of Drain in CLLC as compared to CLC but there was no significant difference in Conversion to Open Cholecystectomy and Post op. Complications in both groups. Conclusion: Study concluded that CLLC had significant advantage over CLC in terms of operative time, intra operative stone spillage, intra operative blood loss, amount of CO2 used, post-operative pain and Use of Drain.

 

Keywords
INTRODUCTION

Conventionally 6 titanium clips are used for laparoscopic cholecystectomy, 3 for cystic duct and 3 for cystic artery before division. Advanced energy source, harmonic scalpel, provide the advantage of shorter operating time by reducing smoke, bloodless dissection in calot’s triangle, lower risk of bleeding from cystic artery due to secure vessel sealing and reducing use of large number of titanium clips [1-4]. 

 

Total Clipless laparoscopic cholecystectomy by means of Harmonic shears have also 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 [1,5].

 

Theoretical benefits for use of Clipless Laparoscopic Cholecystectomy (CLLC) technique using Absorbable suture material and harmonic scalpel are Less operative time, Less bleeding, Early post-operative recovery, Cost factor (using 1 clips instead of 6), Less spillage of stones, Less chances of converting into open cholecystectomy, Less pain post-operatively and Less amount of CO2 used [1,5,6].

 

There is paucity of studies conducted for Comparison of Clipless Laparoscopic Cholecystectomy (CLLC) between Vs Conventional Laparoscopic Cholecystectomy (CLC). Thus, a study has undertaken to compare the advantages Clipless Laparoscopic Cholecystectomy (CLLC) over Conventional Laparoscopic Cholecystectomy (CLC).

 

Aims and Objectives

To compare advantages of Clipless Laparoscopic Cholecystectomy (CLLC) over Conventional Laparoscopic cholecystectomy.

MATERIALS AND METHODS

In Conventional Laparoscopic Cholecystectomy (CLC) mean operative time (min) was 43.10±9.68 and in Clipless Laparoscopic Cholecystectomy (CLLC) was 37.30±8.22 with mean difference of 5.80 min and p value of <0.002 respectively. About 2 patients of CLC group and 1 patient of CLLC group converted to open cholecystectomy due to frozen calots triangle. So the mean operative time markedly increased due to above mentioned three cases. Operating time was significantly less in the harmonic ace assisted LC group in the study conducted by Jain et al. [2] and Kadil et al. [7]. Rajnish et al. [1] suggested that there was no significant difference in operating time.

 

Intra operative blood loss is measured with the help of gauge visual analogue method and in terms of approximate blood loss, blood loss in CLC was 28.90±11.71 mL and in CLLC was 8.40±3.70 mL with mean difference of 20.50 mL and p value is <0.001. Huscher et al. [8] and Bessa et al. [9] suggest a significant reduction in blood loss in four port laparoscopic cholecystectomy. Rajnish et al. [1] and Guanqun et al. [10] suggested that there was no significant difference in blood loss.

 

In our study, in terms of stones spillage, 14 patients of CLC group had intraoperative stone spillage and 4 patients of CLLC group had intraoperative stone spillage, P value is 0.009. Kandil et al. [7], 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]. Janssen et al. [12] reported that the gallbladder perforation with stone spillage was 6 times higher in the electrocautery group than the ultrasonic dissection group. Guanqun et al. [10] reported no statistical significance between two groups in terms of gall bladder perforation.

 

In our study mean COused in CLC was 31.52±9.28 litres and in CLLC was 24.90±4.26 litres with mean difference of 6.62 litres and P value is <0.001. Amount of CO2 used depends directly on operative time. No study to our knowledge has compared amount of COused. But various studies had compared mean operative time which reflect indirectly amount of COused. Blood loss, intraoperative stone spillage require use of suction intra operatively which also indirectly reflect amount of CO2 used.

 

In our study average pain score at 6 hours in CLC was 6.44±1.16 and in CLLC was 5.96±0.49 with mean difference of 0.48 and P value is 0.008 .Average pain score at 24 hours in CLC was 2.68±1.25 and in CLLC was 2.04±0.28 with mean difference of 0.64 and p value is 0.001. Jain et al. [2] 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. [3] 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. [7] as well (4.48±1.89 vs. 3.12±1.84; p = 0.000)24 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 to OC, 2 patients of CLC group and 1 patient of CLLC group converted to open cholecystectomy, p value is 0.558.Reason for conversion was frozen calots triangle along with intraoperative stone spillage and intraoperative bleed. Kandil et al. [7] suggest less conversion rate in HA group but that was not statistically significant. Bessa et al. [9], Guanqun et al. [10] and Rajnish et al. [1] report no statiscally significant difference in between two groups.

 

In our study average stay in CLC was 1.98±1.97 and in CLLC was 1.10±0.46 with mean difference of 0.88 and P value is 0.003. 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 our study 4 patients of CLC group and 1 patient of CLLC group had postoperative complication with P value of 0.169 which is not significant. 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. Rajnish et al. [1] study post-operative complications in term of surgical site infection and intra-abdominal collection there was no statistically significant difference in between two groups. Guanqun et al. [10] showed no significant post-operative complications in two groups.

RESULTS

Out of 100 patients, 19 were males and 81 were females. Among them, 5 males and 45 females underwent Conventional Laparoscopic Cholecystectomy (CLC) using electrocautery while 14 males and 36 females underwent Clipless Laparoscopic Cholecystectomy (CLLC)

 

In between two groups, mean age of males were 47.60±3.36 years and females were 45.20±15.82 years in CLC group and mean age of males were 53.07±18.96 and females were 44.44±15.41 in clipless laparoscopic cholecystectomy group (Table 1).

 

Table 1: Age and Gender Distribution

Groups

Male

Female

Total 

 

N

%

N

%

N

%

CLC

5

10

45

90

50

100

CLLC

14

28

36

72

50

100

 

Mean

SD

Mean

SD

Mean

SD

CLC

47.60

3.36

45.20

15.82

45.44

15.04

CLLC

53.07

18.96

44.44

15.41

46.86

16.74

 

In between the two groups, Mean operative time (min) of CLC was 43.10±9.68 and CLLC was 37.30±8.22 with mean difference of 5.80 min with p value of <0.002. 

 

Mean COused CLC was 31.52±9.28 litres and CLLC was 24.90±4.26 litres with mean difference of 6.62 litres and P value of <0.001. Approx. blood loss in CLC was 28.90±11.71 ml and CLLC was 8.40±3.70 mL with mean difference of 20.50 mL and p value of <0.001.

 

Average pain score at 6 hours in CLC was 6.44±1.16 and CLLC was 5.96±0.49 with mean difference of 0.48 and P value of 0.008. Average pain score at 24 hours in CLC was 2.68±1.25 and CLLC was 2.04±0.28 with mean difference of 0.64 and P value of 0.001. Average stay in CLC was 1.98±1.97 and CLLC was 1.10±0.46 with mean difference of 0.88 and p value is 0.003 (Table 2).

 

Table 2: Inter-Group Comparison of Various Quantitative Variables

 

CLC

CLLC

Mean difference

t value

p-value

Result

Operative Time (min)

43.10± 9.68

37.30±8.22 

5.80

3.22

0.002

Significant

Mean COused(litres)

31.52±9.28

24.90±4.26

6.62

4.58

<0.001

Significant

Approx. Blood Loss (mL)

28.90±11.71

8.40±3.70

20.50

11.80

<0.001

Significant

Average pain score at 6 hours

6.44±1.16

5.96±0.49 

0.48

2.68

0.008

Significant

Average pain score at 24 hours

2.68±1.25

2.04±0.28 

0.64

3.52

0.001

Significant

Average Length of hospital stay (Days)

1.98±1.97

1.10±0.46 

0.88

3.06

0.003

Significant

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

 

In terms of stone spillage, 14 patients of CLC group and 4 patients of CLLC group had intraoperative stone spillage with p value of 0.009. In this study, among 16 patients of CLC group and 4 patients of CLLC group, intra operatively drain was used with p value of 0.003.

 

In terms of conversion, 2 patients of CLC group and 1 patient of CLLC group converted to open cholecystectomy with p value of 0.558. In the present study, 4 patients of CLC group and 1 patient of CLLC group had postoperative complication with p value of 0.169 (Table 3).

 

Table 3: Inter-Group Comparison of Various Qualitative Variables

  CLC [n = 50]CLLC [n = 50]p-value

N

%

N

%

Intra Op. Stone spillage

Yes

14

28

4

8

0.009

Significant

No

36

72

46

92

Use of Drain

Yes

16

32

4

8

0.003 

Significant

No

34

68

46

92

Conversion to Open Cholecystectomy 

Yes

2

4

1

2

0.558

Not Significant

No

48

96

49

98

Post op. Complications

Yes

4

8

1

2

0.169

Not Significant

No

46

92

49

98

Statistical Analysis: Chi-Square Test. Statistically Significant if p<0.05

DISCUSSION

In Conventional Laparoscopic Cholecystectomy (CLC) mean operative time (min) was 43.10±9.68 and in Clipless Laparoscopic Cholecystectomy (CLLC) was 37.30±8.22 with mean difference of 5.80 min and p value of <0.002 respectively. 2 patients of CLC group and 1 patient of CLLC group converted to open cholecystectomy due to frozen calots triangle. So the mean operative time markedly increased due to above mentioned three cases. Operating time was significantly less in the harmonic ace assisted LC group in the study conducted by Jain et al. [2] and Kadil et al. [7].  Rajnish et al. [1] suggested that there was no significant difference in operating time.

 

Intra operative blood loss is measured with the help of gauge visual analogue method and in terms of approximate blood loss, blood loss in CLC was 28.90±11.71 mL and in CLLC was 8.40±3.70 mL with mean difference of 20.50 mL and p value is <0.001. Huscher et al. [8] and Bessa et al. [9] suggest a significant reduction in blood loss in four port laparoscopic cholecystectomy. Rajnish et al. [1] and Guanqun et al. [10] suggested that there was no significant difference in blood loss.

 

In our study, in terms of stones spillage, 14 patients of CLC group had intraoperative stone spillage and 4 patients of CLLC group had intraoperative stone spillage, p value is 0.009. Kandil et al. [7], 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]. Janssen et al. [12] reported that the gallbladder perforation with stone spillage was 6 times higher in the electrocautery group than the ultrasonic dissection group. Guanqun et al. [10] reported no statistical significance between two groups in terms of gall bladder perforation.

 

In our study mean COused in CLC was 31.52±9.28 litres and in CLLC was 24.90±4.26 litres with mean difference of 6.62 litres and p value is <0.001. Amount of CO2 used depends directly on operative time. No study to our knowledge has compared amount of COused. But various studies had compared mean operative time which reflect indirectly amount of COused. Blood loss, intraoperative stone spillage require use of suction intra operatively which also indirectly reflect amount of CO2 used.

 

In our study average pain score at 6 hours in CLC was 6.44±1.16 and in CLLC was 5.96±0.49 with mean difference of 0.48 and P value is 0.008 .Average pain score at 24 hours in CLC was 2.68±1.25 and in CLLC was 2.04±0.28 with mean difference of 0.64 and P value is 0.001. Jain et al. [2] 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. [3] 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. [7] as well (4.48±1.89 vs. 3.12±1.84; p = 0.000)24 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 to OC, 2 patients of CLC group and 1 patient of CLLC group converted to open cholecystectomy, p value is 0.558. Reason for conversion was frozen calots triangle along with intraoperative stone spillage and intraoperative bleed. Kandil et al. [7] suggest less conversion rate in HA group but that was not statistically significant. Bessa et al. [9], Guanqun et al. [10] and Rajnish et al. [1] report no statiscally significant difference in .between two groups.

 

In our study average stay in CLC was 1.98±1.97 and in CLLC was 1.10±0.46 with mean difference of 0.88 and P value is 0.003. 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 our study 4 patients of CLC group and 1 patient of CLLC group had postoperative complication with p value of 0.169 which is not significant. 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. Rajnish et al. [1] study post-operative complications in term of surgical site infection and intra-abdominal collection there was no statistically significant difference in between two groups. Guanqun et al. [10] showed no significant post-operative complications in two groups.

CONCLUSION

This study concluded that CLLC had significant advantages over CLC in terms of operative time, intra operative stone spillage, intra operative blood loss, amount of CO2 used, post-operative pain , hospital stay and Use of Drain making CLLC a feasible procedure in Himalayan terrain patients where patients have to travel long distance to health care facilities. Further multicenter randomized trials with large sample size t are required to substantiate a clear advantage of CLLC over CLC.

REFERENCES
  1. Rajnish, K. et al. “Harmonic scalpel-assisted laparoscopic cholecystectomy vs. conventional laparoscopic cholecystectomy: A non-randomized control trial.” Cureus, vol. 10, no. 1, 2018, e2084.

  2. Jain, S.K. et al. “A prospective randomized study of comparison of clipless cholecystectomy with conventional laparoscopic cholecystectomy.” Journal of Laparoendoscopic and Advanced Surgical Techniques, vol. 21, 2011, pp. 203–208.

  3. Mahabaleshwar, V. et al. “Monopolar electrocautery versus ultrasonic dissection of the gallbladder from the gallbladder bed in laparoscopic cholecystectomy: a randomized controlled trial.” Canadian Journal of Surgery, vol. 55, 2012, pp. 307–311.

  4. Hong, T. et al. “Choledochoduodenal fistula caused by migration of Endoclip after laparoscopic cholecystectomy.” World Journal of Gastroenterology, vol. 28, 2014, pp. 4827–4829.

  5. Ramos, A.C. et al. “Total clipless cholecystectomy by means of harmonic sealing.” Arquivos Brasileiros de Cirurgia Digestiva, vol. 28, no. 1, January–March 2015, pp. 53–56.

  6. Fulum, T. et al. “laparoscopic dome-down cholecystectomy with the LCS-5 harmonic scalpel.” Society of Laparoendoscopic Surgeons Journal, vol. 9, 2005, pp. 51–57.

  7. Kandil, T. et al. “Comparative study between clipless laparoscopic cholecystectomy by harmonic scalpel versus conventional method: A prospective randomized study.” Journal of Gastrointestinal Surgery, vol. 14, 2010, pp. 323–328.

  8. Huscher, C.G.S. et al. “Laparoscopic cholecystectomy by ultrasonic dissection without cystic duct and artery ligation.” Surgical Endoscopy, vol. 17, 2003, pp. 442–451.

  9. Bessa, S.S. et al. “Clipless Laparoscopic Cholecystectomy by Ultrasonic Dissection.” Journal of Laparoendoscopic & Advanced Surgical Techniques A, vol. 18, 2008, pp. 593–598.

  10. Liao, G. et al. “Harmonic scalpel versus monopolar electrocauterization in cholecystectomy.” JSLS, vol. 20, no. 3, 2016, e2016.00037.

  11. Mukesh, K.S. et al. “Triple ligation technique of clipless laparoscopic cholecystectomy: A spanner especially for complicated cholecystitis.” International Journal of Advanced Medicine, vol. 4, 2017, pp. 1358–1363.

  12. Janssen, I.M. et al. “Randomized clinical trial of ultrasonic versus electrocautery dissection of the gallbladder in laparoscopic cholecystectomy.” British Journal of Surgery, vol. 90, no. 7, July 2003, pp. 799–803.

  13. Gelmini, R. et al. “Laparoscopic cholecystectomy with harmonic scalpel.” JSLS, vol. 14, no. 1, 2010, pp. 14–19.

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