Is harmonic scalpel during laparoscopic cholecystectomy superior than clips and cautery technique?

Is harmonic scalpel  during laparoscopic cholecystectomy superior than clips and cautery technique?

Mohamed  A Khalfalla, MD; Mohamed Zaki Elkelani, MD; Rania AI Ahmady,

MD; Waleed lbrahem,  MD; Waal abd El Azem, MD

Department of General Surgery, Ain Shams University, Cairo, Egypt.

Abstract

The  standard laparoscopic cholecystectomy is  usually performed using a monopolar electrocautery for dissection and clips for occlusion of the cystic duct and cystic  artery. Some pitfalls are associated with the use of the monopolar cautery and clips, therefore other alternative techniques have been described. Ultrasonically activated  devices  have been used for dissection and cystic  duct ligation during  laparoscopic cholecystectomy (LC)  with encouraging results, however it does not gain widespread acceptance among  surgeons. The aim of the present  study was to compare the surgical outcome of LC performed  by the harmonic scalpel to that peiformed by the conventional diathermy and clips.

Material and methods:  This prospective randomized comparative study included 30 patients (group A) in whom LC was conducted using the conventional method by clipping both the cystic duct and artery with dissection of gallbladder from liver bed by monopolar electrocautery (clips and cautery method = CCM), and 30 patients (group B) who were operated on using laparoscopic harmonic scalpel  (LHS) for closure and division  of cystic duct and artery and for dissection of gallbladder from liver bed. Our primary  end point was the biliary complications; however other intraoperative and postoperative parameters were included: bleeding, duration of operation, postoperative pain, and other complications.

Results: Demographic data was similar in both groups. The operative duration was shorter in LHS than CCM  (56.3  min vs. 63.3 respectively, p < 0.01), with a significant less incidence of gallbladder peiforation (6.66% vs. 20%, p < 0.001).No postoperative bile leak was encountered in LHS, but it occurred in 3% of patients in CCM   No patient developed  post operative bleeding in both groups however the amount  of postoperative drainage was significantly less in LHS (29 vs. 47.7, p = 0.001). Most of patients  were discharged from hospital on 2nd postoperative day; however the delayed  discharge was statistically higher  in CCM  (16.6% vs. 6.66%, p < 0.01).

Conclusion: LHS is a reliable, effective and safe tool in LC. It is a good alternative to standard

monopolar electrocautery dissection with clipping of cystic duct and artery. It provides a shorter operative duration, less incidence of  gallbladder perforation, and  less hospital stay.

Abbreviations: CCM= Clip and cautery method, LC= Laparoscopic cholecystectomy, LHS= laparoscopic harmonic scalpel, HFMC= high frequency monopolar cautery, BDI=  bile duct injury, CBC= complete blood picture, INR= international normalized  ratio, LFT= liver function

test, UIS= ultrasonography.

Introduction:

Laparoscopic cholecystectomy  (LC) is the gold  standard for the surgical treatment of symptomatic gallstones. The advantages of this surgical approach have included a positive impact  on the postoperative quality of the patient's life as well as optimal short- and long­ term results.I

The standard laparoscopic cholecystectomy is commonly performed by means of monopolar electrocautery and titanium clips. The  electrosurgical hook,  spatula, and/or scissors, using  high-frequency monopolar technology, have been used for gallbladder dissection while the clips are the most frequently used technique to achieve both cystic duct  and  artery closure in most  centers.2

However several reports have pointed out special injuries and postoperative complications related to usage of cautery and clips: These include deep thermal damage to distant tissues and bile leakage due to slippage of the clips.3

Alternative techniques for  gall  bladder dissection  and cystic duct closure have been described; however, these alternatives were used infrequently.2 The ultrasonically activated (Harmonic) scalpel  was designed as a safe alternative to electrocautery for the hemostatic dissection  of tissue and was introduced into clinical use nearly a decade ago. Recently some centers are using harmonic  scalpel  not only for tissue dissection but also  for closure  of both cystic duct and artery during laparoscopic cholecystectomy,4,5 however this application is still not favored  in many centers  and till now, there is still no consensus about the best way of tissue dissection and cystic duct closure during cholecystectomy.

The objective of this study was to compare outcome of the traditional method ofLC using monopolar diathermy and cystic duct clipping versus LC using harmonic scalpel as regards the biliary complication, bleeding, operative time and hospital stay.

Patients and methods:

60 consecutive patients  with gallbladder stones planned to do  laparoscopic cholecystectomy (LC)  were  included in a prospective comparative manner  and  were randomly assigned by using  the  sealed­ envelope technique to 2 groups:

1- Group(A) that included 30 patients who were subjected to traditionallaparoscopic cholecystectomy using monopolar cautery and clip applier.

2- Group(B) that included  30 patients  who were operated on using LHS that replaced both cautery and  clips (Ethicon Endosurgery Ultracision harmonic scalpel, Generator 300).

Patients were  recruited from  authors' hospital at Ain Shams University  Hospitals, Cairo,  Egypt  and  Doctor Soliman Fakeeh Hospital, Jeddah, Saudi Arabia. Patients' age, sex, body mass index (BMI), and associated comorbidities were  recorded. Preoperative investigations included: Pelvi-abdominal ultrasound, CBC,  LFT, renal function, prothrombin time, INR, OR screening, ECG, and plain X-ray chest.

Patients    who   were   excluded: Cases associated with common  bile duct stone(s), empyema of the gallbladder, unfavourable intraoperative anatomy e.g , sessile gallbladder, very short cystic duct, wide cystic duct 5mm and  abnormal laboratory investigation e.g abnormal serum bilirubin, alkaline phosphatase, gamma  glutamil  transferase   (GOT).

Operative technique:

Laparoscopic cholecystectomy was performed as previously described .6 After the dissection of Calot's triangle, the cystic artery and proximal cystic  duct  were sealed  with titanium surgical clips in group(A); this was followed  by gall bladder dissection  from its hepatic bed by electrocautery. In the second group(B) the artery and duct were sealed with harmonic scalpel and  the gallbladder was removed using the same instrument. Harmonic scalpel was set at the power level "2" to give less cutting and more coagulation effect with powerful sealing. At the start, it was ascertained that there were no micro-calculi in the lumen of the cystic duct by moving the jaws of the harmonic scalpel up and down. The cystic duct was inserted between the jaws at a safe distance from common  bile duct to avoid its damage then the jaws were closed  until a click  was heard. The harmonic was activated with great care to avoid stretching or rotating cystic duct but rather to keep it still until the gallbladder was detached from the cystic duct. The cutting points of the cystic duct were checked for any bile leakage.Finally, a closed intra abdominal drain in hepatorenal space was left in all patients Figure(!).

(A)                                                  (B)                                               (C)

Figure(l)(A): It was ascertained that there were no micro-calculi in the lumen of the cystic duct

by moving the jaws of the harmonic ACE up and down.

(B): The cystic duct was inserted between the jaws at a safe distance from common bile duct

to  avoid  damage to  this  structure then  the  jaws  were  closed until  a click  was  heard.

(C): The   cutting points of   the   cystic  duct were checked for  any   bile leakage.

Patients were postoperatively reviewed and analyzed regarding: Clinical  general  and abdominal examination with daily chart for abdominal drain till discharge;U/S on 3rd and

1Oth postoperative days with special attention

to the presence or absence of any sub-hepatic

collection and laboratory investigation namely CBC and LFT. The operative time, intra­ operative difficulties, and  postoperative complications were recorded.

Statistical analysis:

All data analyses were performed with the

Statistical  Package for the Social Sciences

version 11.5 software (SPSS, Inc. Chicago, IL).TheStudent's t test was used for continuous variables.A value ofP < 0.05 was considered statistically significant.

Results:

Patients' demographics data: in this work

60 patients were included, 51 females (85%) and 9 males (15%) with symptomatic gallstone disease, with a mean age 45 years (range 22-

74 years).No statistically significant difference

was found in age, sex, BMI and associated co­

morbidities between both groups Table(l).

Table (1): Demographic data,clinical characteristics and associated co-morbidities.

*BMI:BodyMass Index, "D.M: Diabetes Mellitus.

The procedure was completed laparoscopically in both groups. The mean operative time was significantly longer in group (A)  than  group(B) (mean = 63.3min vs.

56.3min,  p<O.Ol) with a higher incidence of

gallbladder perforation in Group(A) (20% vs.

6.66%, p<O.OOl).Gallbladder perforation has been found to lengthen the operative time in both  studied groups Figure(l), Table(l).

• Operative time (min.)

62.3

Group (A)                     Group (B)

Figure(2):Graph showing operative time.

Tabk (2): Operllti11e datil.

*G.B=Gallbladder ''NS= Non-significant.

Postoperative biliary leak was encountered in one patient inGroup  A, who was discovered by biliary staining of the drain's discharge and was managed conservatively till cessation of discharge at 5th day. Chest infection was higher in Group A than Group  B (6.66%  vs. 3%, P=0.3).

Discharge from  hospital on 1st and 2nd postoperative day was  higher in Group B (6.66% vs.0, P value <0.01) (86.6% vs.83.3%, p value 0.3) respectively. Delayed discharge

(more than 2 days) was statistically higher in

Group  A than Group  B (16.6% vs. 6.66%, p  value  <0.01)  Figure(3),  Table(3).

Group B

Group A

Figure(3):Graph of hospital discharge.

Table (3): Hospital stay.

Discussion:

Laparoscopic cholecystectomy was first reported in the 1980s; thereafter it led to broad dissemination of minimally invasive surgery. The standard laparoscopic cholecystectomy is usually performed using a monopolar electrosurgical  hook for dissection  and clips for occlusion of the cystic  duct  and cystic artery.4,7  Alternative techniques for  duct ligation have included linear stapler, endoloops, or sutures. The clips are known to slip, dislodge, ulcerate, migrate, embolize, and give rise to necrosis of the cystic duct with resultant bile leak and other complications and the monopolar electrocautery is associated with high risk of thermal injuries and significantly more common postoperative biliary complications.8,9, 10

The ultrasonically activated scalpel  was introduced into clinical use for tissue dissection more than a decade ago. Its technology relies on the application of ultrasound within the harmonic frequency range to tissues and allows

3 effects that act synergistically: Coagulation, cutting,  and cavitation.l-3 The  temperature obtained and the lateral energy spreadare lower than those detected when the monopolar hook is used, thus reducing the risk of tissue damage.s Some investigators have used Harmonic Scalpel (HS) in the closure of the cystic duct and artery instead of clips, this technique was called "clipless cholecystectomy".5,7,8 The use of HS as a single instrument during the whole procedure avoids   the frequent instrument exchange and replacement through the trocars which is sometimes performed without optic guidance and  consequently, reducing the possibility of causing  injuries to the intra­ abdominal organs.J,5,9 Several studiesl-3 have demonstrated the effectiveness and safety of the use of the HS for  dissection of the gallbladder, but until now and for unknown reasons  "clipless cholecystectomy" did not

gain popularity in Egypt and other countries.

In  our  study, the  use  of  the  HS  was associated with lower incidence of gallbladder perforation, compared  to traditional method. This  could  be  explained by  the  fact  that cavitation effect aids in tissue plane dissection that enhances visibility in the operative field, minimal local thermal injury and the lack of electrical current  with risk of distant  tissue damage.11 Operative  time was prolonged in operations complicated by gallbladder perforation in both groups  as stone spillage and  bile  loss  which  led  to  obstruction of laparoscopic visual field with   frequent exchange in instruments and led to time loss in abdominal lavage and spilled stones retrieval.

Similar to others,ll  in this study, operative time was shorter in Group(B) than Group(A). This has many potential advantages, including reducing the  overall anesthetic time  and increasing the number  of cases  that can be done  on  an average operative list. Shorter operative time in Group(B) can be attributed to lower incidence of gallbladder perforation and cavitational effect ofHS on the surrounding pericholecystic tissues  that  allowed easier mobilization of  the  gallbladder. HS  is  a multifunctional instrument: It replaces  four instruments used  in the CCM  laparoscopic cholecystectomy, namely, the dissector, clip applier, scissors, and electrosurgical  hook or spatula.Its use, therefore, prevents the frequent blind  extraction and reinsertion of these different instruments with  the  subsequent avoidance of time loss.12

Moreover,  activation of the HS does not form smoke - although mist may be generated by vibration-  therefore allowing the surgeon to work in a clear operative field throughout the operation.The use of electrocautery causes smoke formation in the abdominal cavity and decreases visibility. Moreover, smoke must be

evacuated by opening the valves of the trocars, thus causing repeated loss of  the pneumoperitoneum and a subsequent loss of time.B

The incidence of bile duct injury is (0-2%)

when the harmonic scalpel has been used.12-16

In our study no patients developed  bile duct injury in LHS vs 3% in CCM. Factors known to predispose to bile-duct damage have included the use of diathermy, producing what became known  as "the  diathermy-induced bile duct injury.l2 Ultrasonic instruments were developed to eliminate the collateral damage associated with electrosurgery.l3 With HS, the lateral energy spread is minimal, and the risk of distant tissue damage is lower than that of high­ frequency electrosurgery.14 Further, ultrasonic devices can  coagulate and  cut  at a lower temperature (100°C) than that  during electrosurgery (150°C) or laser surgery (200°C). The absence of bile-duct injuries in the present study adds further evidence to the safety of ultrasonic  devices in the dissection of biliary structures in the laparoscopic cholecystectomy, the  same  findings were reported by others_l5,16

Effective sealing of the cystic-duct stump by the harmonic  shears has been confirmed histologically.3,15 All morphologic changes were found within 1.5 mm of the cutting edge, and the airtight  pressure of the sealed cystic duct was calculated to be higher than 320 mm Hg. Wise and coworkers17 demonstrated that simple titaniwn clips applied to the cystic duct could not be displaced by a pressure of 300 mm  Hg. However, the  literature provides various examples of cystic-duct  leakage due to inadequate closure of the duct  due to mismatch of the clip arms, necrosis of the duct at the site of clipping, or slippage of the clips off the end of the duct and migration into the biliary tract.l&

In our study neither minor nor major bile leaks were encountered  throughout the study period in Group(B),  this could be explained partially by small number of patients, although similar findings were reported by Tebala.s Huscher  and associates15 reported bile leaks in7 of the 331 patients (2.1%), in whom closure and division of the cystic duct was achieved by the harmonic shears alone, compared  to 3

of the 130 patients (2.3%) in whom the closure was achieved by the harmonic shears and endo­ loop of absorbable suture materia1.151bis 2.1% cystic-duct  leakage rate is comparable  to the

2% rate reported in the literature when using other cystic-duct closure techniques.17 Huscher and associatesIs applied the blades first more proximally for a few seconds  to achieve  a simple sealing of the lumen, then they were applied a few millimeters distal to the previous application  site, holding the grasper until the division of  the  duct  was  accomplished.15

In view of the facts that the instrument has

no feedback sensors capable of differentiating between  simple  sealing and the sealing  and division of  the  cystic  duct,  and  that  such differentiation can only be made on a visual basis,  we presumed that it would  be rather difficult to determine the amount and type of damage done to the cystic duct by applying the harmonic shears for a few seconds to the site of proximal application. Whether the sites of proximal  application were the source  of some bile leaks in their study remains uncertain, although the possibility theoretically exists.t5

In the present study, as well as in the Tebala5 and Westervelt7 studies, the harmonic shears were applied to only one site on the cystic duct where sealing and division were achieved with no bile leaks from the cystic-duct stump encountered  in any of the three studies.  Like others,5 it is our belief that a double application of the harmonic shears to the cystic duct is unnecessary  and may be an unsafe practice.

Jannsen and  coworkers19 reported that harmonic scalpel was associated with shorter operative times, fewer overnight hospital stay and lower pain scores.In our study the overall hospital stay  in Group(B) was  less  than Group(A). The greater cost of the harmonic scalpel, when compared  with the cost of an electro-cautery probe, has been regarded as a potential disadvantage. However, we feel that LC,using the harmonic scalpel, is cost-effective when considering the shorter stay, using fewer overall instruments and shorter operative time.

Conclusion:

The  use  of HS  during laparoscopic cholecystectomy is safe and effective. It provides a superior alternative to the currently