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Is harmonic scalpel an effective tool for oesophagectomy?
International Journal of Surgery 7 (2009) 330–333
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.theijs.com
Is harmonic scalpel an effective tool for oesophagectomy?q Naseem Waraich a, *, Javed Ahmed a, Farhan Rashid a, David Mulvey b, Paul Leeder a, Syed Y. Iftikhar a a b
Oesophago-Gastric Centre, Derby Hospitals NHS Foundation Trust, Derby DE1 2QY, UK Department of Anaesthesiology, Derby Hospitals NHS Foundation Trust, Derby DE1 2QY, UK
a r t i c l e i n f o
a b s t r a c t
Article history: Received 24 August 2007 Received in revised form 6 March 2009 Accepted 7 March 2009 Available online 28 March 2009
Introduction: Use of electrocautery in oesophagectomy is standard; however, the introduction of the harmonic scalpel (HS) and its use has changed the methodology of oesophagectomy in recent years. We have assessed the efficiency of HS in oesophageal cancer surgery. The parameters studied were blood loss, transfusion rates, and postoperative complications. Methods: Our cohort included 142 patients who underwent elective oesophagectomy from January 1999 to December 2004. The control group was the patients undergoing electrocautery oesophagectomy (n ¼ 98) between 1999 and 2002. Furthermore, 44 patients who were operated with the HS were included in the study group. Results: The numbers of units transfused were significantly less in HS group (median 0) in comparison with controls (median 2), p ¼ 0.003. Median blood loss in HS and the controls was 500 and 700 ml respectively (p ¼ 0.123). Mortality in HS group was 2.27%compared to 3.06% in controls (p ¼ 0.14). The complication (principally respiratory) rate was only 13.6% of patients in HS group compared to 17.3% in the controls. Conclusion: Our study shows that HS reduces transfusion rates and postoperative complications, highlighting it as a safe and effective alternative to traditional electrocautery. Ó 2009 Published by Elsevier Ltd on behalf of Surgical Associates Ltd.
Keywords: Harmonic scalpel Oesophagectomy Perioperative blood loss and transfusion
1. Introduction Oesophageal cancer is the fifth most common cause of cancer death in the world.1,2 The prognosis of oesophageal carcinoma both squamous and adenocarcinoma, is dismal with frequent metastasis and low survival rate despite surgical resection.3 Despite improvements in multimodality therapy, especially chemotherapy survival has not improved significantly, suggesting the alternative strategies for treating the disease.4 Therefore the mainstay of the treatment remains the surgical resection with improvement in recent years.5 However surgery carries a major risk of insult to physiological status of the patient as well as increased morbidity and mortality. Griffin et al. highlighted the importance of facilities and expertise available for careful selection of a patient, in order to reduce the morbidity and mortality.6 Until the introduction of harmonic scalpel (HS) in the 1990’s, traditionally electrocautery was widely used in surgical practise. HS
q Note: This paper was presented at the 10th World Congress of the European Association for Endoscopic Surgery. * Corresponding author. Oesophago-Gastric Centre, Derbyshire Royal Infirmary, London Road, Derby DE1 2QY, UK. Tel.: þ44 013 3234 7141; fax: þ44 013 3225 4637. E-mail address: [email protected] (N. Waraich).
(transmits a high frequency ultrasonic energy), for tissue cutting and coagulation at low temperature and in selective manner causing less tissue injury and is an effective replacement to electrocautery and laser.7 The principle behind its operation is transformation of the electric power into longitudinal movement of the working part of the instrument, by a piezoelectric transducer situated in the hand piece.8 Its mechanism of action in varying degrees involves: cavitations, heat generation and protein denaturation. The process of cavitation arises from the creation, expansion and implosion of cavities in liquids. Mechanical oscillation of the instrument causes rapid rise and fall in temperature of the tissues. Once pressure falls below the level of vapour pressure of cellular fluid, vapour filled cavities are formed within cells. It is the force generated by expansion and contraction of these that results in tissue dissection. Heat generated by HS is the result of internal tissue fraction caused by high frequency vibrations. In addition coagulation is produced by denaturing proteins through mechanical disruption of tertiary hydrogen bonds.9 HS causes minimal tissue charring and dissection and eliminates thermal injury in thoracic surgery.10 In addition HS has been designated as less hazardous because of bloodless operative field and not arrhythmogenic to the heart.11 Moreover one experimental study showed significantly less necrosis in nerves12 and therefore less postoperative neuralgia.
1743-9191/$ – see front matter Ó 2009 Published by Elsevier Ltd on behalf of Surgical Associates Ltd. doi:10.1016/j.ijsu.2009.03.001
N. Waraich et al. / International Journal of Surgery 7 (2009) 330–333
Other advantages of HS are, being faster, less clip or knot requirement, less postoperative blood loss therefore subsequently less reexploration rate.13 Another experimental study describes further advantages of HS including less muscle damage, easier operation due to less muscle twitching, bloodless and smokeless operative field and good haemostasis.14 In patients with cancer, many factors in addition to allogenic blood transfusion, such as time of surgery, amount of blood loss, stage of disease and magnitude of the surgical procedure, relate to outcomes.15 HS has widely been used in different procedures including CABG, harvesting of internal mammary artery and radial artery,16 gynaecological procedures,17 head and neck surgery and lung surgery.18 However its use in surgery for malignant diseases of oesophagus has not been assessed so far. HS is a costly piece of machinery and the approximate prevailing price is £12,000. However it is commonly used in all hospitals of the UK. The aim of the study was to assess the efficiency of HS in oesophageal cancer surgery. The parameters studied were blood loss, transfusion rates, and postoperative complications. 2. Materials and methods All patients were divided into two age-controlled groups. Control group (Group 1) consists of patients who had oesophagectomy by using conventional electrocautery. Study group (Group 2) patients were operated on with the HS. 2.1. Patients selection All the patients who underwent curative oesophageal resection for cancer of the oesophagus at Derby upper GI cancer services (DUGICS) were included in the study. A dedicated team of surgeons, anaesthetists and pathologists managed all the patients. All cases were discussed preoperatively and postoperatively in a multidisciplinary team (MDT) meeting to decide the optimal treatment for each individual patient. All patients had upper GI endoscopy, staging computed tomography (CT) scan, preoperative assessment and staging laparoscopy prior to surgical resection. Data was collected for patients who underwent elective oesophagectomy from 1999 to 2004. Harmonic scalpel (HS) was introduced at Derbyshire Royal Infirmary in January 2003. All the patients were selected from single surgeons practice. He was operating as consultant since 1995. In order to exclude experience gained or learning curve bias patients selected from 1999 onwards. 2.1.1. Inclusion criteria Patients with operable cancer of the oesophagus. Patients with gastro-oesophageal junction (GOJ) cancer. Patients who underwent elective, potentially curative resection.
2.1.2. Exclusion criteria Patients who had fixed unresectable tumour peroperatively. Patients underwent oesophagectomy for non-cancer disease. Patients with high-grade dysplasia.
anterior splitting of the diaphragmatic hiatus and transhiatal exposure of the lower posterior mediastinum. All the patients had standard level II of lymph node clearance and postoperative management. 2.3. Data collection Data (age, sex, blood loss, blood transfusion, operation types, date of operation and date of death) was ascertained from hospital notes and theatre records. Patients follow up and date of death was determined from the hospital notes and PA System. 2.4. Blood loss and transfusion Preoperative haemoglobin of 10 mg/dl or above was an acceptable level for elective curative oesophagectomy. Any patient with postoperative haemoglobin of 8 mg/dl or less and symptomatic with this level had a blood transfusion. Blood loss was measured directly from suction collection and by measuring the weight difference of surgical swabs before and after use. 2.5. Recurrence Local, regional, transcoelomic (pleural or peritoneal) and distant (haematogenous) metastasis are considered as manifestation of recurrence of the disease. Recurrence at cervical, celiac, mediastinal and paraaortic lymph nodes was classified as loco-regional recurrence. Recurrence of disease was only diagnosed on clinical grounds picked up on OGD or CT depending on the symptomatic presentation of the postoperative patient. 2.6. Follow up All patients were seen at the outpatient clinic at 3 monthly intervals for the first year and then every 6 months thereafter for 5 years. After 5 years, an annual follow up has been carried out on all patients. Radiological modalities, haematological and endoscopic interventions were not used routinely during follow up. However when recurrence was suspected, additional investigations were performed when clinically indicated. 2.7. Statistical analysis Statistical package for social science (SPSS) version 13.0 was used to perform statistical analyses of the available data. Time to event was measured from the date of first definitive treatment (surgical) till the date of recorded death. Any cause of death is recorded as an event, which may be directly related or unrelated to disease progression or relapse. Mann–Whitney U-test was used to compare the amount of blood loss and the median number of units transfused for both HS and HS control. Survival analysis was performed by Cox Regression (backward stepwise log ratio) with all variables. Death within 30 days of the surgical resection and survival time were used as endpoints for assessing postoperative death and prognostic factors. Table 1 T-stage and N-stage of tumours.
2.2. Surgical approach We used a left thoracotomy only approach (LTO) and standard Ivor–Lewis approach (IL) depending on the location of the tumour measured during gastroscopy to achieve curative resection. Left thoracotomy only approach (LTO) was achieved after a wide
331
T1 T2 T3 N0 N1
Harmonic scalpel
Electrocautery
n ¼ 05 n ¼ 14 n ¼ 25 n ¼ 14 n ¼ 30
n ¼ 03 n ¼ 13 n ¼ 80 n ¼ 45 n ¼ 53
332
N. Waraich et al. / International Journal of Surgery 7 (2009) 330–333
Table 2 LTO versus Ivor–Lewis approach.
Ivor–Lewis oesophagectomy Left thoracotomy only
Table 4 Median blood transfusion. Harmonic scalpel
Electrocautery
n ¼ 19 (43%) n ¼ 25 (53%)
n ¼ 38 (39%) n ¼ 60 (61%)
3. Results Our cohort included a total of 142 patients who underwent elective oesophagectomy from 1999 to 2004. Group 1 included 98 patients and Group 2 consisted of 44 patients. Median age was 66 years in the 1st group (range 44–84 years) and it was 64 years in the 2nd group (range 39–80 years). Males have clearly dominated both the groups with male:female ratio of 11:3 and 41:3 in Groups 1 and 2 respectively. Majority of patients in both groups had T3-stage and N1-stage of tumour according to TNM classification (Table 1). Patients who had oesophagectomy via LTO approach dominated both the groups and Ivor–Lewis oesophagectomy was comparable among the groups (Table 2). Mann–Whitney U-test was applied for assessment of blood loss and blood transfusion. The median blood loss in the HS group was 500 ml (range 26–1500 ml) and 700 ml (range 300–3000) in electrocautery group (Table 3). However the median number of units of blood transfused in HS (Group 2) was 0 (range 0–2 units) and was significantly less than Group 1 (p < 0.003) (Table 4). Complication rate was 13.6% in Group 2 and it was 17.3% in Group 1. Most common complication was respiratory/pulmonary. The survival in harmonic group was far better than electrodiathermy group which was in parallel with the blood transfusion (Table 5). One, 2 and 3 year survival rates in harmonic group were 77%, 50% and 45% respectively. Whereas survival rates in 1, 2, 3 and 5 year in electrocautery group were 67%, 45%, 31% and 28% (Kaplan–Meier curve)(Graph 1). Mortality rate was 2% in the harmonic group and it was 3% in the electrocautery group with p-value ¼ 0.14 (Table 4). 4. Discussion Bleeding following major surgery remains a major potential problem. Numerous approaches to altering, modifying, or augmenting haemostatic system activation are used perioperatively to treat patients. Therefore increasingly, studies are being conducted and published to help clinicians further improve patient management. Perioperative allogenic blood transfusion is associated with tumour recurrence and decreased survival in surgery for gastrointestinal malignancies as well as an increased incidence of postoperative infection.19–21 Murata et al. conducted their study on the effect of perioperative blood transfusion in the surgery of gastric cancer patients and they concluded that CD4/CD8 ratio at 3 months after surgery was significantly lower in the transfused group than in the non-transfused group. The higher CD4/CD8 ratio in the nontransfused group supports the notion that transfusion causes a broad spectrum of immunosuppression.22
Table 3 Median blood loss in both groups.
Blood loss (median) p-value Note Blood loss is in millilitres.
Harmonic scalpel
Electrocautery
500 (26, 1500)
700 (300, 3000) 0.123
Blood transfused (median) p-value
Harmonic scalpel
Electrocautery
0 (0, 2)
2 (0,4) 0.003
Our data has demonstrated the less blood loss and subsequent less blood transfusion in a group of patients who had oesophagectomy done with HS. Collision and colleagues in tonsillectomy patients previously described this. They showed less intraoperative bleeding among patients who underwent HS tonsillectomy versus conventional tonsillectomy.23 Our study also shows less mortality and better survival in the HS group that may not be directly related to the device used. However an obvious reason of less blood loss and less transfusion seems to have an indirect relationship with survival as well as a mortality rate. This is well supported by Vallejo and his colleagues highlighted factors affecting both cellular and humoral immune functions. Possible immunosuppressive factors during perioperative period include anaesthetic agents, opioids, surgery, blood transfusion, temperature changes, pain and psychological stress. It is mediated via decreased activity of the natural killer cells, which subsequently increased risk mortality and cancer.24 Takemura et al. demonstrated an adverse affect of allogenic blood transfusion on survival of patients with oesophageal cancer. Furthermore they also suggested that the avoidance of blood transfusion may reduce the incidence of postoperative infections and has a favourable effect on the survival of patients at high risk for recurrence.15 Similarly Kinoshita and colleagues proved that the autologus blood transfusion lessens the need of allogenic blood transfusion, which subsequently reduces the risk of infection in oesophageal cancer surgery. Blood loss itself is not an independent indicator of better survival. However blood transfusion does have impact on survival.25,26 HS is not electrically but ultrasonically activated therefore it can be safely and effectively used in pacemaker-dependent patients without adverse temporary or permanent effects to the patients pacemaker system.27 Also there is no danger from stray currents or capacitative coupling, and there is no nerve stimulation, electrical interference, requirements for ground pad, nor is there a production of toxic smoke which occurs with electrosurgery.9 Other benefits of HS includes less postoperative pain.28 Electrocautery, laser tissue ablation and HS tissue dissection all create a gaseous by-product known as smoke that can be seen and smelled. Electrocautery creates particles with the smallest mean aerodynamic size 0.07 mm, laser produces 0.31 mm and the largest of all is produced by the HS, size 0.35–6.5 mm. Smaller particles are more of a concern from a chemical point of view and larger particles are more of a concern from a biological stand point.29 Therefore surgical smoke is a biohazard and cannot be ignored. One can argue the size of particles produced by HS and their viability. This has already been dealt with by Nduka et al., who performed morphological examination of cellular debris and collected smoke during cancer surgery in rats. They showed that cellular debris is composed largely of amorphous cell fragments liberated as a result of the cavitational effect. In their study they finally concluded that although tissue ablation with HS liberates Table 5 Comparing mortality rate in both groups.
Mortality rate p-value
Harmonic scalpel
Electrocautery
2%
3% 0.14
N. Waraich et al. / International Journal of Surgery 7 (2009) 330–333
Survival Functions method electric harmonic electric-censored harmonic-censored
1.0
Cum Survival
0.8 0.6 0.4 0.2 0.0 0
12
24
36
48
60
72
84
96
survival time (months)
GROUPS 0 electric 0.98 harmonic 0.98
Survival time (months) 12 24 36 48 0.67 0.47 0.32 0.29 0.77 0.50 0.46
60 0.28 -
Graph 1. Kaplan–Meier survival curve for both groups.
a number of cellular particles but is devoid of viable air borne cancer cells.9 We did not directly measure the cost effectiveness of HS in this study. However Cakir et al. previously has compared the cost effectiveness of HS with the diathermy in spinal surgery. They analysed blood loss and over all costs for blood products in 100 patients divided into HS and electrocautery group. Blood loss was less in the HS group with p < 0.001 and the cost of blood products p < 0.001. The overall costs, including costs for HS, remained neutral.30 In different studies it was found that HS offers many benefits to the patients including smaller incision, less damage to the tissue, reduced scarring, less pain (decreased lateral thermal injury 0–1.5 mm deep at surgical site which subsequently causes less pain), quick recovery and a shorter hospital stay.31 However in our study both groups have a comparable duration of hospital stay. None of the patients in the HS group had a wound infection. 5. Conclusion In conclusion we suggest HS can reduce blood loss and transfusion perioperatively. This affects the surgical outcome and reduces the complications too. HS may have an indirect role in improving survival. Therefore HS is a safe and effective alternative to electrocautery in oesophageal surgery.
Conflict of interest statement None declared. Funding None. Ethical approval Not required. References 1. Dietzsch E, Laubscher R, Parker MI. Esophageal cancer risk in relation to GGC and CAG trinucleotide repeat lengths in the androgen receptor gene. Int J Cancer 2003;107:38–45.
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2. Fiorica F, Di Bona D, Licata A, Shahied L, Venturi A, Falchi AM, et al. Pre operative chemoradiotherapy for oesophageal cancer: a systematic review and meta analysis. Gut 2004;53:925–30. 3. Tihan T, Harmon JW, Wan X, Younes Z, Nass P, Duncan KLK, et al. Evidence of androgen receptor expression in squamous and adenocarcinoma of the esophagus. AntiCancer Res 2001;21:3107–14. 4. Jankowski JA, Perry I, Harrison RF. Gastro-oesophageal cancer: death at the junction. BMJ 2000;321:463–4. 5. Wong J, Fok M. Oesophageal cancer. J Hong Kong Med Assoc 1992;44(4):241–3. 6. Griffin SM, Shaw IH, Dresner SM. Early complications after Ivor Lewis subtotal esophagectomy with two-field lymphadenectomy: risk factors and management. J Am Coll Surg 2002 Mar;194(3):285. 7. Mc Carus SD. Physiologic mechanism of ultrasonically activated scalpel. J Am Assoc Gynaecol Laparoscop 1996;3:601–8. 8. Perko Z, Mimica Z, Druzijanic N, Kraljevic D, Petricevic A, Depolo A, et al. Harmonic scalpel in laparoscopic surgery. Lijec Vjsen 2004 Sep–Oct;126(9– 10):246–50. 9. Nduka CC, Poland N, Kennedy M, Dye J, Darzi A. Does the ultrasonically activated scalpel release viable airborne cancer cells? Surg Endosc 1998;12:1031–4. 10. Hayashi A, Takamori S, Matsuo T, Tayama K, Mitsuoka M, Shirouzu K. Experimental and clinical evaluation of the harmonic scalpel in thoracic surgery. Kurume Med J 1999;46(1):25–9. 11. Di Luozzo G, Moussa F, Schor J, Traad E, Williams D, Carrillo R. Harmonic scalpel for pericardiectomy: novel approach to an old cardiac dilemma. Heart Surg Forum 2004;7(5):E525–7. 12. Antonutti R, Fontes-Dislaire I, Rumeau JL, Mutter D, Fourtanier G. Experimental study of monopolar electrical and ultrasonic dissection. Ann Chir 2001;126(4):330–5. 13. Tanemoto K, Kanaoka Y, Murakami T, Kuroki K. Harmonic scalpel in coronary artery bypass surgery. J Cardiovasc Surg (Torino) 1998 Aug;39(4):493–5. 14. Inaba H, Kaneko Y, Ohtsuka T, Ezure M, Tanaka K, Ueno K, et al. Minimal damage during endoscopic latissimus dorsi muscle mobilization with harmonic scalpel. Ann Thorac Surg 2000;69:1399–401. 15. Takemura M, Osugi H, Higashino M, Takada N, Lee S, Kinshita H. Effect of substituting allogenic blood transfusion with autologus blood transfusion on outcomes after radical oesophagectomy for cancer. Ann Thorac Cardiovasc Surg 2005;11(5):293–300. 16. Lamm P, Juchem G, Weyrich P, Schutz A, Reichart B. The harmonic scalpel: optimizing the quality of mammary artery bypass graft. Ann Thor Surg 2000;69:1833–5. 17. Jun L, Xinmei Z, Kaihong XU. Application of ultrasonic scalpel in gynaecologic operative laparoscopy. Chin Med J 2001;114(12):1283–5. 18. Eichfeld U, Tannapfel A, Steinert M, Freidrich T. Evaluation of ultracision in lung metastatic surgery. Ann Thor Surg 2000;70:1181–4. 19. Klein HG. Allogenic transfusion risks in the surgical patient. Am J Surg 1995;170(6A Suppl):S21–6. 20. Greenburg AG. Benefits and risks of blood transfusion in surgical patients. World J Surg 1996;20:1189–93. 21. Bentzen SM, Balslev I, Pedersen M, Teglbjaerg PS, Hanberg-Sorensen F, Bone J. Blood transfusion and prognosis in Dukes’ B and C colorectal cancer. Eur J Cancer 1990;26:457–63. 22. Murata N, Idezuki Y, Konishi T, Watanabe H, Ushirokoji Y, Shinohara K, et al. Influence of perioperative blood transfusion on the prognosis of patients with gastric cancer receiving anticancer chemotherapy. Gastric Cancer 2000 Aug 4;3(1):24–7. 23. Collison PJ, Weiner R. Harmonic scalpel versus conventional tonsillectomy. A double blind clinical trial. Ear Nose Throat J 2004 Oct;83(10):707–10. 24. Vallejo R, Hord ED, Barna SA, Santiago-Palma J, Ahmed S. Perioperative immunosuppression in cancer patients. J Environ Pathol Toxicol Oncol 2003;22(2):139–46. 25. Kinoshita Y, Udagawa H, Tsutsumi K, Ueno M, Nakamura T, Akiyama H. Usefulness of autologous blood transfusion for avoiding allogenic transfusion and infectious complications after oesophageal cancer resection. Surgery 2000;127:185–92. 26. Duffy G, Neal KR. Differences in post-operative infection rates between patients receiving autologous and allogenic blood transfusion: a meta analysis of published randomized and non randomized studies. Transfus Med 1996;6:325–8. 27. Epstein MR, Mayer JE, Duncan BW. Use of an ultrasonic scalpel as an alternative to electrocautery in patients with pacemaker. Ann Thorac Surg 1998;65:1802–4. 28. Potts KL, Augenstein A, Goldman JL. A parallel group analysis of tonsillectomy using the harmonic scalpel vs electrocautery. Arch Otolaryngol Head Neck Surg 2005;131:49–51. 29. Barrett WL, Garber SM. Surgical smoke – a review of literature. Is this just a lot of hot air? Surg Endosc 2003;17:979–87. 30. Cakir B, Ulmar B, Schmidt R, Kelsch G, Geiger P, Mehrkens HH, et al. Efficacy and cost effectiveness of harmonic scalpel compared with electrocautery in posterior instrumentation of the spine. Eur Spine J 2006 Jan;15(1):48–54. Epub 2005 Feb 15. 31. Ramadan E, Vishne T, Dreznik Z. Harmonic scalpel haemorrhoidectomy: preliminary results of a new alternative method. Tech Coloproctol 2002;6: 89–92.
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.theijs.com
Is harmonic scalpel an effective tool for oesophagectomy?q Naseem Waraich a, *, Javed Ahmed a, Farhan Rashid a, David Mulvey b, Paul Leeder a, Syed Y. Iftikhar a a b
Oesophago-Gastric Centre, Derby Hospitals NHS Foundation Trust, Derby DE1 2QY, UK Department of Anaesthesiology, Derby Hospitals NHS Foundation Trust, Derby DE1 2QY, UK
a r t i c l e i n f o
a b s t r a c t
Article history: Received 24 August 2007 Received in revised form 6 March 2009 Accepted 7 March 2009 Available online 28 March 2009
Introduction: Use of electrocautery in oesophagectomy is standard; however, the introduction of the harmonic scalpel (HS) and its use has changed the methodology of oesophagectomy in recent years. We have assessed the efficiency of HS in oesophageal cancer surgery. The parameters studied were blood loss, transfusion rates, and postoperative complications. Methods: Our cohort included 142 patients who underwent elective oesophagectomy from January 1999 to December 2004. The control group was the patients undergoing electrocautery oesophagectomy (n ¼ 98) between 1999 and 2002. Furthermore, 44 patients who were operated with the HS were included in the study group. Results: The numbers of units transfused were significantly less in HS group (median 0) in comparison with controls (median 2), p ¼ 0.003. Median blood loss in HS and the controls was 500 and 700 ml respectively (p ¼ 0.123). Mortality in HS group was 2.27%compared to 3.06% in controls (p ¼ 0.14). The complication (principally respiratory) rate was only 13.6% of patients in HS group compared to 17.3% in the controls. Conclusion: Our study shows that HS reduces transfusion rates and postoperative complications, highlighting it as a safe and effective alternative to traditional electrocautery. Ó 2009 Published by Elsevier Ltd on behalf of Surgical Associates Ltd.
Keywords: Harmonic scalpel Oesophagectomy Perioperative blood loss and transfusion
1. Introduction Oesophageal cancer is the fifth most common cause of cancer death in the world.1,2 The prognosis of oesophageal carcinoma both squamous and adenocarcinoma, is dismal with frequent metastasis and low survival rate despite surgical resection.3 Despite improvements in multimodality therapy, especially chemotherapy survival has not improved significantly, suggesting the alternative strategies for treating the disease.4 Therefore the mainstay of the treatment remains the surgical resection with improvement in recent years.5 However surgery carries a major risk of insult to physiological status of the patient as well as increased morbidity and mortality. Griffin et al. highlighted the importance of facilities and expertise available for careful selection of a patient, in order to reduce the morbidity and mortality.6 Until the introduction of harmonic scalpel (HS) in the 1990’s, traditionally electrocautery was widely used in surgical practise. HS
q Note: This paper was presented at the 10th World Congress of the European Association for Endoscopic Surgery. * Corresponding author. Oesophago-Gastric Centre, Derbyshire Royal Infirmary, London Road, Derby DE1 2QY, UK. Tel.: þ44 013 3234 7141; fax: þ44 013 3225 4637. E-mail address: [email protected] (N. Waraich).
(transmits a high frequency ultrasonic energy), for tissue cutting and coagulation at low temperature and in selective manner causing less tissue injury and is an effective replacement to electrocautery and laser.7 The principle behind its operation is transformation of the electric power into longitudinal movement of the working part of the instrument, by a piezoelectric transducer situated in the hand piece.8 Its mechanism of action in varying degrees involves: cavitations, heat generation and protein denaturation. The process of cavitation arises from the creation, expansion and implosion of cavities in liquids. Mechanical oscillation of the instrument causes rapid rise and fall in temperature of the tissues. Once pressure falls below the level of vapour pressure of cellular fluid, vapour filled cavities are formed within cells. It is the force generated by expansion and contraction of these that results in tissue dissection. Heat generated by HS is the result of internal tissue fraction caused by high frequency vibrations. In addition coagulation is produced by denaturing proteins through mechanical disruption of tertiary hydrogen bonds.9 HS causes minimal tissue charring and dissection and eliminates thermal injury in thoracic surgery.10 In addition HS has been designated as less hazardous because of bloodless operative field and not arrhythmogenic to the heart.11 Moreover one experimental study showed significantly less necrosis in nerves12 and therefore less postoperative neuralgia.
1743-9191/$ – see front matter Ó 2009 Published by Elsevier Ltd on behalf of Surgical Associates Ltd. doi:10.1016/j.ijsu.2009.03.001
N. Waraich et al. / International Journal of Surgery 7 (2009) 330–333
Other advantages of HS are, being faster, less clip or knot requirement, less postoperative blood loss therefore subsequently less reexploration rate.13 Another experimental study describes further advantages of HS including less muscle damage, easier operation due to less muscle twitching, bloodless and smokeless operative field and good haemostasis.14 In patients with cancer, many factors in addition to allogenic blood transfusion, such as time of surgery, amount of blood loss, stage of disease and magnitude of the surgical procedure, relate to outcomes.15 HS has widely been used in different procedures including CABG, harvesting of internal mammary artery and radial artery,16 gynaecological procedures,17 head and neck surgery and lung surgery.18 However its use in surgery for malignant diseases of oesophagus has not been assessed so far. HS is a costly piece of machinery and the approximate prevailing price is £12,000. However it is commonly used in all hospitals of the UK. The aim of the study was to assess the efficiency of HS in oesophageal cancer surgery. The parameters studied were blood loss, transfusion rates, and postoperative complications. 2. Materials and methods All patients were divided into two age-controlled groups. Control group (Group 1) consists of patients who had oesophagectomy by using conventional electrocautery. Study group (Group 2) patients were operated on with the HS. 2.1. Patients selection All the patients who underwent curative oesophageal resection for cancer of the oesophagus at Derby upper GI cancer services (DUGICS) were included in the study. A dedicated team of surgeons, anaesthetists and pathologists managed all the patients. All cases were discussed preoperatively and postoperatively in a multidisciplinary team (MDT) meeting to decide the optimal treatment for each individual patient. All patients had upper GI endoscopy, staging computed tomography (CT) scan, preoperative assessment and staging laparoscopy prior to surgical resection. Data was collected for patients who underwent elective oesophagectomy from 1999 to 2004. Harmonic scalpel (HS) was introduced at Derbyshire Royal Infirmary in January 2003. All the patients were selected from single surgeons practice. He was operating as consultant since 1995. In order to exclude experience gained or learning curve bias patients selected from 1999 onwards. 2.1.1. Inclusion criteria Patients with operable cancer of the oesophagus. Patients with gastro-oesophageal junction (GOJ) cancer. Patients who underwent elective, potentially curative resection.
2.1.2. Exclusion criteria Patients who had fixed unresectable tumour peroperatively. Patients underwent oesophagectomy for non-cancer disease. Patients with high-grade dysplasia.
anterior splitting of the diaphragmatic hiatus and transhiatal exposure of the lower posterior mediastinum. All the patients had standard level II of lymph node clearance and postoperative management. 2.3. Data collection Data (age, sex, blood loss, blood transfusion, operation types, date of operation and date of death) was ascertained from hospital notes and theatre records. Patients follow up and date of death was determined from the hospital notes and PA System. 2.4. Blood loss and transfusion Preoperative haemoglobin of 10 mg/dl or above was an acceptable level for elective curative oesophagectomy. Any patient with postoperative haemoglobin of 8 mg/dl or less and symptomatic with this level had a blood transfusion. Blood loss was measured directly from suction collection and by measuring the weight difference of surgical swabs before and after use. 2.5. Recurrence Local, regional, transcoelomic (pleural or peritoneal) and distant (haematogenous) metastasis are considered as manifestation of recurrence of the disease. Recurrence at cervical, celiac, mediastinal and paraaortic lymph nodes was classified as loco-regional recurrence. Recurrence of disease was only diagnosed on clinical grounds picked up on OGD or CT depending on the symptomatic presentation of the postoperative patient. 2.6. Follow up All patients were seen at the outpatient clinic at 3 monthly intervals for the first year and then every 6 months thereafter for 5 years. After 5 years, an annual follow up has been carried out on all patients. Radiological modalities, haematological and endoscopic interventions were not used routinely during follow up. However when recurrence was suspected, additional investigations were performed when clinically indicated. 2.7. Statistical analysis Statistical package for social science (SPSS) version 13.0 was used to perform statistical analyses of the available data. Time to event was measured from the date of first definitive treatment (surgical) till the date of recorded death. Any cause of death is recorded as an event, which may be directly related or unrelated to disease progression or relapse. Mann–Whitney U-test was used to compare the amount of blood loss and the median number of units transfused for both HS and HS control. Survival analysis was performed by Cox Regression (backward stepwise log ratio) with all variables. Death within 30 days of the surgical resection and survival time were used as endpoints for assessing postoperative death and prognostic factors. Table 1 T-stage and N-stage of tumours.
2.2. Surgical approach We used a left thoracotomy only approach (LTO) and standard Ivor–Lewis approach (IL) depending on the location of the tumour measured during gastroscopy to achieve curative resection. Left thoracotomy only approach (LTO) was achieved after a wide
331
T1 T2 T3 N0 N1
Harmonic scalpel
Electrocautery
n ¼ 05 n ¼ 14 n ¼ 25 n ¼ 14 n ¼ 30
n ¼ 03 n ¼ 13 n ¼ 80 n ¼ 45 n ¼ 53
332
N. Waraich et al. / International Journal of Surgery 7 (2009) 330–333
Table 2 LTO versus Ivor–Lewis approach.
Ivor–Lewis oesophagectomy Left thoracotomy only
Table 4 Median blood transfusion. Harmonic scalpel
Electrocautery
n ¼ 19 (43%) n ¼ 25 (53%)
n ¼ 38 (39%) n ¼ 60 (61%)
3. Results Our cohort included a total of 142 patients who underwent elective oesophagectomy from 1999 to 2004. Group 1 included 98 patients and Group 2 consisted of 44 patients. Median age was 66 years in the 1st group (range 44–84 years) and it was 64 years in the 2nd group (range 39–80 years). Males have clearly dominated both the groups with male:female ratio of 11:3 and 41:3 in Groups 1 and 2 respectively. Majority of patients in both groups had T3-stage and N1-stage of tumour according to TNM classification (Table 1). Patients who had oesophagectomy via LTO approach dominated both the groups and Ivor–Lewis oesophagectomy was comparable among the groups (Table 2). Mann–Whitney U-test was applied for assessment of blood loss and blood transfusion. The median blood loss in the HS group was 500 ml (range 26–1500 ml) and 700 ml (range 300–3000) in electrocautery group (Table 3). However the median number of units of blood transfused in HS (Group 2) was 0 (range 0–2 units) and was significantly less than Group 1 (p < 0.003) (Table 4). Complication rate was 13.6% in Group 2 and it was 17.3% in Group 1. Most common complication was respiratory/pulmonary. The survival in harmonic group was far better than electrodiathermy group which was in parallel with the blood transfusion (Table 5). One, 2 and 3 year survival rates in harmonic group were 77%, 50% and 45% respectively. Whereas survival rates in 1, 2, 3 and 5 year in electrocautery group were 67%, 45%, 31% and 28% (Kaplan–Meier curve)(Graph 1). Mortality rate was 2% in the harmonic group and it was 3% in the electrocautery group with p-value ¼ 0.14 (Table 4). 4. Discussion Bleeding following major surgery remains a major potential problem. Numerous approaches to altering, modifying, or augmenting haemostatic system activation are used perioperatively to treat patients. Therefore increasingly, studies are being conducted and published to help clinicians further improve patient management. Perioperative allogenic blood transfusion is associated with tumour recurrence and decreased survival in surgery for gastrointestinal malignancies as well as an increased incidence of postoperative infection.19–21 Murata et al. conducted their study on the effect of perioperative blood transfusion in the surgery of gastric cancer patients and they concluded that CD4/CD8 ratio at 3 months after surgery was significantly lower in the transfused group than in the non-transfused group. The higher CD4/CD8 ratio in the nontransfused group supports the notion that transfusion causes a broad spectrum of immunosuppression.22
Table 3 Median blood loss in both groups.
Blood loss (median) p-value Note Blood loss is in millilitres.
Harmonic scalpel
Electrocautery
500 (26, 1500)
700 (300, 3000) 0.123
Blood transfused (median) p-value
Harmonic scalpel
Electrocautery
0 (0, 2)
2 (0,4) 0.003
Our data has demonstrated the less blood loss and subsequent less blood transfusion in a group of patients who had oesophagectomy done with HS. Collision and colleagues in tonsillectomy patients previously described this. They showed less intraoperative bleeding among patients who underwent HS tonsillectomy versus conventional tonsillectomy.23 Our study also shows less mortality and better survival in the HS group that may not be directly related to the device used. However an obvious reason of less blood loss and less transfusion seems to have an indirect relationship with survival as well as a mortality rate. This is well supported by Vallejo and his colleagues highlighted factors affecting both cellular and humoral immune functions. Possible immunosuppressive factors during perioperative period include anaesthetic agents, opioids, surgery, blood transfusion, temperature changes, pain and psychological stress. It is mediated via decreased activity of the natural killer cells, which subsequently increased risk mortality and cancer.24 Takemura et al. demonstrated an adverse affect of allogenic blood transfusion on survival of patients with oesophageal cancer. Furthermore they also suggested that the avoidance of blood transfusion may reduce the incidence of postoperative infections and has a favourable effect on the survival of patients at high risk for recurrence.15 Similarly Kinoshita and colleagues proved that the autologus blood transfusion lessens the need of allogenic blood transfusion, which subsequently reduces the risk of infection in oesophageal cancer surgery. Blood loss itself is not an independent indicator of better survival. However blood transfusion does have impact on survival.25,26 HS is not electrically but ultrasonically activated therefore it can be safely and effectively used in pacemaker-dependent patients without adverse temporary or permanent effects to the patients pacemaker system.27 Also there is no danger from stray currents or capacitative coupling, and there is no nerve stimulation, electrical interference, requirements for ground pad, nor is there a production of toxic smoke which occurs with electrosurgery.9 Other benefits of HS includes less postoperative pain.28 Electrocautery, laser tissue ablation and HS tissue dissection all create a gaseous by-product known as smoke that can be seen and smelled. Electrocautery creates particles with the smallest mean aerodynamic size 0.07 mm, laser produces 0.31 mm and the largest of all is produced by the HS, size 0.35–6.5 mm. Smaller particles are more of a concern from a chemical point of view and larger particles are more of a concern from a biological stand point.29 Therefore surgical smoke is a biohazard and cannot be ignored. One can argue the size of particles produced by HS and their viability. This has already been dealt with by Nduka et al., who performed morphological examination of cellular debris and collected smoke during cancer surgery in rats. They showed that cellular debris is composed largely of amorphous cell fragments liberated as a result of the cavitational effect. In their study they finally concluded that although tissue ablation with HS liberates Table 5 Comparing mortality rate in both groups.
Mortality rate p-value
Harmonic scalpel
Electrocautery
2%
3% 0.14
N. Waraich et al. / International Journal of Surgery 7 (2009) 330–333
Survival Functions method electric harmonic electric-censored harmonic-censored
1.0
Cum Survival
0.8 0.6 0.4 0.2 0.0 0
12
24
36
48
60
72
84
96
survival time (months)
GROUPS 0 electric 0.98 harmonic 0.98
Survival time (months) 12 24 36 48 0.67 0.47 0.32 0.29 0.77 0.50 0.46
60 0.28 -
Graph 1. Kaplan–Meier survival curve for both groups.
a number of cellular particles but is devoid of viable air borne cancer cells.9 We did not directly measure the cost effectiveness of HS in this study. However Cakir et al. previously has compared the cost effectiveness of HS with the diathermy in spinal surgery. They analysed blood loss and over all costs for blood products in 100 patients divided into HS and electrocautery group. Blood loss was less in the HS group with p < 0.001 and the cost of blood products p < 0.001. The overall costs, including costs for HS, remained neutral.30 In different studies it was found that HS offers many benefits to the patients including smaller incision, less damage to the tissue, reduced scarring, less pain (decreased lateral thermal injury 0–1.5 mm deep at surgical site which subsequently causes less pain), quick recovery and a shorter hospital stay.31 However in our study both groups have a comparable duration of hospital stay. None of the patients in the HS group had a wound infection. 5. Conclusion In conclusion we suggest HS can reduce blood loss and transfusion perioperatively. This affects the surgical outcome and reduces the complications too. HS may have an indirect role in improving survival. Therefore HS is a safe and effective alternative to electrocautery in oesophageal surgery.
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