HARMONIC SCALPEL OVER ELECTROCAUTERY , EVALUATION OF PEROPERATIVE BLOOD LOSS IN SELECTIVE NECK DISSECTION

1. Lecturer, Department of Oral and Maxillofacial Surgery, Birat Medical College and Teaching Hospital, Biratnagar, Nepal 2. Lecturer, Department of Otorhinolaryngology, Head & Neck Surgery, Nobel Medical College and Teaching Hospital, Biratnagar, Nepal 3. Professor and Chairman, Department of Oral and Maxillofacial Surgery, Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka. 4. Dental Surgeon, Biratnagar Hospital Pvt. Ltd., Biratnagar, Morang, Nepal 5. Dental Surgeon, Golden Hospital Pvt. Ltd., Biratnagar, Morang, Nepal


Objec ve
To evaluate the amount of peropera ve blood loss in cancer pa ent undergoing selec ve neck dissec on (Levels I, II and III) with Harmonic Scalpel (HS) and Electrocautery (EC).

Methodology
The study was performed in the Department of Oral and Maxillofacial Surgery, Faculty of Den stry, Biratnagar Hospital PVT LTD and Birat Medical College and Teaching Hospital, Nepal from June 2012 to February 2018.A total of 40 pa ents, 27 male and 13 female, aged 45 to 70 years diagnosed with oral cavity cancer were included in this prospec ve study.Two groups were formed, 20 pa ents in each group based on the surgical instrument used; Harmonic Scalpel (HS) and Electrocautery (EC).Data for age and sex of the pa ents were collected preopera vely.The surgery was performed under general anesthesia with endotracheal intuba on and standard protocol was maintained during surgery.Amount of peropera ve blood loss was measured and recorded.Data was processed and analyzed using SPSS and was compiled and test of significance was done using unpaired't' test.

Results
The amount of peropera ve blood loss was significantly lower in Harmonic Scalpel (HS) group then in Electrocautery (EC) group.

INTRODUCTION
In Head and Neck region, squamous cell carcinoma (SCC) is the most common form of malignancy.Management of primary lesion, regional nodes and distant metastasis is the three major components of the treatment of the oral cancer.Wide three dimensional (3D) surgical excision of primary lesion followed by neck dissec on is s ll main protocol of treatment for all operable cases.Harmonic Scalpel (HS) added a new dimension in addi on to Electrocautery (EC) with minimal blood loss specially in case of tongue and neck.Cancer is the end product of an unregulated prolifera on of cells resul ng from muta ons The pa ents were categorized into 2 groups, 20 pa ents in each group based on surgical device used, HS and EC.Group I comprised 20 pa ents undergoing selec ve neck dissec on with HS.Group II comprised 20 pa ents undergoing selec ve neck dissec on with conven onal EC.
The surgery was performed by same opera ng team of experienced Oral and Maxillofacial Surgeons under general anaesthesia with endotracheal intuba on.Standard protocol was used giving submandibular incision and raising subplatysmal skin flap.A closed suc on drain was placed in all the pa ents at the end of the surgery for 24-48 hrs postopera vely.The wound was closed in layers with absorbable sutures and skin with stapples.Amount of peropera ve blood loss was measured and recorded.Blood loss was measured as follows; 1) Gauzes were weighed before and a er surgery.2) Volume of drainage in the suc on container minus any irriga on used during dissec on (1g = 1ml of blood).
The data were analyzed with the help of so ware program SPSS.The evalua on was done by unpaired't' test.The results were considered significant if p value was <0.05.Tables and bar diagram were used to show the results.

RESULTS
Out of 40 pa ents (Group I = 20 pa ents and Group = 20 pa ents).The youngest pa ent was 45 years old and the oldest pa ent was 70 years old, 27 (67.5%)pa ents were male and 13 (32.5%)pa ents were female.The mean age of the pa ents was 56.45+7.17years with most common range of 56-60 years in Group I and 56.55+7.22 years with most common range of 51-55 years in Group II (Table -1).
The majority of pa ents were > 50 years.Peropera ve blood loss was measured in rela on to 2 groups.Blood loss was measured as follows; 1) Gauzes were weighed before and a er use.2) Volume of drainage in the suc on container minus any irriga on used during dissec on (Table -2) (1gm = 1ml of blood).Peropera ve blood loss (Table -2) of Group I vs Group II was 19.60ml vs 74ml respec vely, p<0.001 which was sta s cally significant thus the blood loss with HS was less when compared to EC in selec ve neck dissec on.forceps of the device.Harmonic ACE is a second genera on HS which is even more appropriate for clogging 13 vessels up to 5mm in diameter.The advancement in technologies used in surgical prac ce have made the surgery simple with the use of a wide variety of energy sources for ssue dissec on likewise HS is a new surgical device that cuts and coagulates by conver ng electrical energy into ultrasonic mechanical vibra ons and the device is composed of a power generator, an ultrasonic acous c 25 system and a surgical blade.Urquhart et al demonstrated in a period of three years that total peropera ve blood loss is an indicator for the amount and dura on of postopera ve 26 drainage in neck dissec on.HS was ini ally developed for laparoscopic surgery alone later on some authors reported its effec veness in head and neck surgery, neck dissec ons, paro d, submandibular and thyroid gland surgery also.Few authors reported that the peropera ve blood loss was 29 around 58 ml vs 24 ml in HS vs EC respec vely.In a prospec ve study, the pa ents in the HS group has significantly less peropera ve bleeding, 5.0 ml vs 16.5 ml HS 30 vs EC respec vely; p<0.001.Blood loss and opera ve me was significantly reduced in HS vs EC group, 127ml vs 210ml 31 respec vely, hence, p>0.05.The study conducted by us showed that the peropera ve blood loss (Table -2) in Group I vs Group II was 19.60ml vs 74ml respec vely, p<0.001 which was sta s cally significant hence the blood loss with HS was reduced in compared to EC in selec ve neck dissec on.There was a 60.8% reduc on in peropera ve bleeding when 13 HS was used.Hallgrimsson et al reported that peropera ve blood loss in HS and EC group was 69 ml and 79 ml respec vely, p=0.42, hence there was minimum difference 32 in peropera ve bleeding between two groups.Walen et al showed blood loss of 62 ml vs 158 ml in HS vs EC group respec vely, p=0.02, hence the difference was sta s cally 33 significant.Ali et al reported mean age of pa ents was 28.07+7.35years, range (18-42) years and 29.43+1.22years, range (18-68) years, p = 0.573 whereas mean peropera ve blood loss was 2.40+2.74ml and 3.43+3.42ml, in HS and EC group respec vely, no significant difference was observed whereas our study showed that the mean age of the pa ents was 56.45+7.17years, range (56-60) years in Group I and 56.55+7.22years, range (51-55) years in 34 Group II.The simultaneous coagula on and cu ng of vessels and ssue without the need to change the instruments is most likely the primary reason for significant decrease in opera ve me and peropera ve blood loss.HS generates rela vely low temperature and transfer low level of thermal energy to the surrounding ssues, that avoids the necrosis of the surgical margins and therefore poten ally reduce the risk of postopera ve complica ons.

CONCLUSION
Harmonic Scalpel (HS) is an effec ve device to reduce peropera ve blood loss during selec ve neck dissec on.Decreased blood loss, enhanced visibility and be er postopera ve outcomes are the strong reasons to consider HS as a step forward over conven onal Electrocautery in selec ve neck dissec on.

RECOMMENDATION
Further studies with more advanced technology and modern instruments can be done to obtain more accurate results and greater logis c support are required to determine whether the HS has an advantage over EC in reducing peropera ve blood loss during selec ve neck dissec on.Management of oral carcinoma should always be coordinated by a mul disciplinary team including Oral & Maxillofacial Surgeons, Oncologists, Radiotherapists, Speech Therapists and ENT Surgeons.

LIMITATION OF THE STUDY
Presence of irriga ng fluids, evapora on and loss of blood on the floor of opera ng room complicates to carefully and exactly measure the total amount of blood loss per and postopera vely.Thus, comparison of peropera ve blood loss from one ins tu on to another or from one surgeon to another can vary accordingly.

Figure 1 :
Figure 1: Showing sex distribu on between Group I and Group II.
To denature protein HS break ter ary hydrocarbon bonds by transferring adequate mechanical energy using ultrasonic vibra on whereas EC 11 form coagulum by hea ng ssues to denature protein.Tissue dissec on and clogging of minor blood vessel occurs at same me with HS hence reduc on in thermal damage of adjacent structures.The lateral ssue injury, for HS ranges from 0 to 1000 µm whereas for EC ranges from 240 µm to 8increased length of hospital stay.Advanced surgical technology has proposed one of the promising surgical device, HS, to treat metasta c head and neck cancer that improves several nega ve consequences of the surgery and leads to early pa ent recovery, reduc on in dura on of surgery and minimal peropera ve blood loss.HS is an ultrasonically ac vated surgical instrument where high frequency mechanical energy or vibra on at 55.5 kHz is used to cut and coagulate the vessels or ssues o simultaneously at low temperature (80 C) without any 9 electrical current.EC is a surgical device that produces smoke and is used to cut and coagulate the vessels or o ssues at high temperature (200 C) that leads to 10 carboniza on of the adjoining ssues.Ultarsonic coagula on achieved by HS is similar to that of EC but the mechanism by which the ssue proteins become denatured is completely different.5whenHSwasused.Therefore the present study is designed to evaluate the amount of peropera ve blood loss in cancer pa ent undergoing selec ve neck dissec on (Levels I, II and III) with Harmonic Scalpel (HS) and Electrocautery (EC) in our se ng.METHODOLOGYThe prospec ve interven onal study was performed in the Department of Oral and Maxillofacial Surgery, Faculty of Den stry, Birat Medical College and Teaching Hospital, Biratnagar, from June 2012 to February 2018.All the pa ents signed wri en, informed consent.A total of 40 pa ents, 27 male and 13 female, aged 45 to 70 years diagnosed with cancer of oral cavity requiring selec ve neck dissec on (Levels I, II and III) were included in this study.Diagnosis was made by accurate history, clinical examina ons, imaging and histopathological examina on.Preopera ve characteris cs for all enrolled pa ents including age, sex, primary tumor loca on and staging of cancer (TNM) were collected at the me of their enrollment.Inclusion criteria: Oral cavity cancer (T -T ), clinically

Table 2 :
Comparision of peropera ve blood loss between Group I and Group II s=significant, Sta s cal analysis was done by unpaired 't' test.

DISCUSSION
Blood transfusion and prolonged dura on of surgery are always associated with unwanted effects in those pa ents undergoing major head and neck surgery.It is worth inves ga ng the procedure to reduce the bleeding, hence, this study shows that the surgery performed by HS significantly reduces blood loss in pa ents undergoing selec ve neck dissec on for oral cavity cancer.Our study was performed to evaluate if HS is superior to EC. Bleeding causes confusion of the anatomic and surgical planes, increases opera ve me and necessitates the placement of drains.HS has an advantage over EC, it increases visibility, decrease blood loss peropera vely, reduces opera ve me 23,24noma, prostate and colorectal.United States Food and Drug Administra on has approved the use of HS for the liga on of vessels up to 3mm in diameter.Thermal damage is limited to 0-2 mm beyond the ssue grasped within the23,24