Conventional laparoscopic cholecystectomy is a safe established procedure and traditionally is performed using three or four small incisions but Laparoscopic cholecystectomy has been now accepted as the “gold standard” for the treatment of symptomatic gallstone disease [1,2].

Conventionally electrocautery is used as sole instrument for dissection of gall bladder, but nowadays use of harmonic ace for dissection of gall bladder is increasing with promising results. Ultrasonic dissection of the gallbladder bed during laparoscopic cholecystectomy has the potential to improve the quality of surgery by decreasing the incidence of gallbladder perforation and its intraoperative consequences [3].

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 [4]. 

Conventionally 6 titanium clips are used for laparoscopic cholecystectomy, 3 for cystic duct and 3 for cystic artery before division. Also, the cost for using 6 titanium clips is higher, therefore by using lesser number of titanium clips we reduce cost as well as time used in laparoscopic cholecystectomy [4,5].

Theoretical benefits for use of one clip laparoscopic cholecystectomy using harmonic scalpel technique are Less operative time, less bleeding, Early post operative recovery, Cost factor (using 1 clip instead of 6), Less spillage of stones, less chances of converting into open cholecystectomy, less pain post operatively and Less amount of CO₂ used [4-6].

There is paucity of studies conducted for Comparison between Single clip laparoscopic cholecystectomy (SCLC) Vs Conventional Laparoscopic cholecystectomy (CLC). Thus, a study has undertaken to compare the advantages of Single clip laparoscopic cholecystectomy (SCLC) over conventional laparoscopic cholecystectomy (CLC).

Aims and Objectives

To compare advantages of Single clip over Conventional 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 one titanium clip on cystic duct except in patients with wide cystic duct and Group 2 included patients undergoing gall bladder dissection by conventional method. 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 hours 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, 15 were males and 85 were females. Among them,5 males and 45 females underwent conventional laparoscopic cholecystectomy (CLC) using electrocautery while 10 males and 40 females underwent single clip laparoscopic cholecystectomy (SCLC).

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 48.50±14.49 and females were 46.73±16.16 in SCLC group (Table 1). In between the two groups, mean operative time (min) of CLC group was 43.10±9.68 and SCLC was 26.80±8.44 with mean difference of 16.30 min and P value is <0.001. Mean CO₂ used in CLC group was 31.52±9.28 litres and SCLC was 20.46±7.09 litres with mean difference of 11.06 litres and P value is <0.001. Approx. blood loss in CLC group was 28.90±11.71 ml and SCLC group was 7.8±3.06 ml with mean difference of 21.10 ml and P value is <0.001.

In term of pain, average pain score at 6 hours in CLC group was 6.44±1.16 and SCLC was 5.96±0.86 with mean difference of 0.48 and P value is 0.021. Average pain score at 24 hours in CLC group was 2.68±1.25 and SCLC group was 2.12±0.48 with mean difference of 0.56 and P value is 0.004. In term of length of hospital stay, average stay in Conventional CLC group was 1.98±1.97 and SCLC group was 1.08±0.44 with mean difference of 0.90 and p value is 0.002 (Table2).

In terms of stone spillage, 14 patients of CLC group and 2 patients of SCLC group had intraoperative stone spillage with P value is 0.001. In this study, among 16 patients of CLC group and 2 patients of SCLC group, intra operatively drain was used. p value is < 0.001. In terms of conversion, 2 patients of CLC group and 1 patient of SCLC group converted to open cholecystectomy with P value is 0.558. In the present study, 4 patients of CLC group and no patient of SCLC group had postoperative complication with P value is 0.041 (Table3). 

In conventional laparoscopic cholecystectomy (CLC) mean operative time (min) was 43.10±9.68 and in single clip laparoscopic cholecystectomy (SCLC) was 26.80±8.44 with mean difference of 16.30 min and P value is <0.001. In our study, 2 patients of CLC group and 1 patient SCLC 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. [7] (64.7±13.74 vs. 50±9.36; p = 0.001) and Kadil et al. [8] (61.88±0.17 16 vs. 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. [4] and Guanqun et al. [10] suggest 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 group was  28.90±11.71 ml , in SCLC group was 7.8±3.06 ml  with mean difference of 21.10 ml and p value is <0.001.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. [4] and Guanqun et al. [10] suggest 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 2 patients of SCLC group had intraoperative stone spillage, P value is 0.001. 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]. 

In our study mean CO₂ used in CLC group was 31.52±9.28 litres, in SCLC group was 20.46±7.09 litres with mean difference of 11.06 litres and p value is <0.001.

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

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 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 group was 6.44±1.16 and SCLC group was 5.96±0.86 with mean difference of 0.48 and P value is 0.021. Average pain score at 24 hours in CLC group was 2.68±1.25 and SCLC group was 2.12±0.48 with mean difference of 0.56 and P value is 0.004. Jain et al⁷ 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. [12] 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. [4] 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 SCLC group converted to open cholecystectomy (OC), P value is 0.558. Reason for conversion was frozen calots triangle along with intraoperative stone spillage and intraoperative bleed. Meta-analysis conducted by Gurusamy analyzed the results of 5 RCT’s involving a total of 451 patients.  40% patients had undergone intra-operative conversion to an open procedure [13]. Kandil et al. [8] suggest less conversion rate in HA group but that was not statistically significant. Bessa et al. [14], Guanqun et al. [10] and Rajnish et al. [4] report no statiscally significant difference in between two groups.

In our study average stay in CLC group was 1.98±1.97 and in SCLC group was 1.08±0.44 with mean difference of 0.90 and P value is 0.002. 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. [15] 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 no patient of SCLC group had postoperative complication, p value is 0.041. 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. [4] 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.

This study concluded that SCLC was comparable to standard 6 clip laparoscopic cholecystectomy in all aspects. Study showed clear cut benefits of SCLC 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 post operative complications, making SCLC a feasible procedure in Himalayan terrain patients where patients have to travel long distance to health care facilities.  In addition, SCLC has a lower cost as compared to CLC. Further studies involving a large cohort of patients may lead to SCLC becoming the new standard of laparoscopic cholecystectomy.

1. EMedicine. “Laparoscopic Cholecystectomy.” Medscape, www.emedicine.medscape.com/article/1582292-overview. Accessed 15 Jan. 2022.

2. ScienceDirect. “Laparoscopic Cholecystectomy.” ScienceDirect, www.sciencedirect.com/topics/medicine-and-dentistry/laparoscopic-cholecystectomy. Accessed 16 Jan. 2022.

3. Amaral, J.F. “Laparoscopic cholecystectomy in 200 consecutive patients using an ultrasonically activated scalpel.” Surgical Laparoscopy, Endoscopy & Percutaneous Techniques, vol. 5, 1995, pp. 255–262.

4. 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.

5. Singal, R. et al. “The safety and efficacy of clipless versus conventional laparoscopic cholecystectomy: Our experience in an Indian rural center.” Maedica (Bucur), vol. 13, no. 1, 2018, pp. 34–43.

6. Nissar, Y. et al. “The use of harmonic scalpel for laparoscopic clipless cholecystectomy.” JMS SKIMS, vol. 23, no. 1, 2020, pp. 22–26.

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

8. 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.

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

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. 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, no. 5, 2012, pp. 307–311.

13. Catena, F. et al. “The HAC trial (harmonic for acute cholecystitis): A randomized, double-blind, controlled trial comparing the use of harmonic scalpel to monopolar diathermy for laparoscopic cholecystectomy in cases of acute cholecystitis.” World Journal of Emergency Surgery, vol. 9, no. 1, 2014, pp. 53.

14. Bessa, S.S. et al. “Clipless laparoscopic cholecystectomy by ultrasonic dissection.” Journal of Laparoendoscopic & Advanced Surgical Techniques A, vol. 18, 2008, pp. 593–598.

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