Download harmonic_scalpel - Cairo University Scholars

Ultrasonic dissection Versus Electrocautery in
Modified Radical Mastectomy
Abdel Hamid H.Ezzat M.D and Ahmed Abbas MRCS M.D,
Department of Surgical Oncology - National Cancer Institute Cairo University.
Correspondence: Dr. Abdel Hamid H.Ezzat
E-mail: [email protected]
Mobile phone: 0100 521 40 33
Abstract
Purpose: The aim of this work was to perform a prospective randomized
clinical trial aiming at comparing the usage of ultrasonic scissors versus
electrocautery in modified radical mastectomy regarding intraoperative
and postoperative complications.
Patients and Methods: This prospective randomized clinical trial had
been carried out in the National Cancer Institute (NCI), Cairo University
over a period of ten months from 1st June 2006 till 31 March 2007. It
included sixty cases with operable breast cancer all of them were
subjected to modified radical mastectomy. Patients were randomly
divided into 2 groups: each group included thirty patients:
In group A, rising skin flaps, shaving of pectoral fascia and
axillary dissection had been done using ultrasonic scissor (US)
coagulation shear without the use of any sutures.
In group B, rising skin flaps, shaving of pectoral fascia and
axillary dissection had been done using electrocautery with
ligation of tributaries of the axillary vein.
Results: In our study, US dissection was associated with a significant
reduction in the intraoperative blood loss, duration of axillary drainage,
the total amount of the drainage, incidence of seroma formation, the
number of aspirations required and the incidence of infection compared
with the conventional electrocautery. But the cost of the US dissection
was significantly higher than electrocautery. Regarding the advantages of
the US dissection in modified radical mastectomy, this technique should
be taken into consideration at least on personal scale and as the cost of
this technique gets cheaper it could be popularized on a wider scale.
Conclusion: Modified radical mastectomy using the US dissection is
feasible and an easy technique. Its advantages over electrocautery include
reduction in the intraoperative blood loss, the total amount and duration
of axillary drainage as well as incidence of seroma formation.The only
disadvantage was its higher cost.
Keywords: ultrasonic dissection - electrocautery - Modified radical
mastectomy.
Introduction
In spite of the emergence of breast conservation therapy, modified
radical mastectomy still remains the most common surgical procedure
performed for breast cancer. Modified radical mastectomy performed
with scalpel and electrocautery is associated with some blood loss and
morbidity in the form of prolonged axillary drainage, seroma, wound
infection, flap necrosis and haematoma. (Porter et al., 1998 and Adwani
et al., 2006)
Seroma formation following axillary dissection is a common
wound complication of both modified radical mastectomy and breastconserving surgery. The incidence of such occurrence varies widely,
according to the type of surgical treatment and the operative techniques
used, ranging from less than 10% to more than 50 %. (Pogson et al.,
2003)
Traditionally, seroma is thought to contain lymphatic fluid from
transected lymphatic channels after axillary dissection. Examination of
the fluid has shown that it contains such elements as IgG, granulocytes
and leucocytes which are normally present in acute inflammatory
exudates, there are surprisingly few lymphocytes. This suggests that
technical factors may be imported in the formation of seroma.
(Woodworth et al., 2000)
The optimal way to reduce seroma formation and its pathophysiology are still unknown. Several etiological factors have been
suggested, including patient ’s age, breast size, number of involved
nodes, or use of electrocautery, and there are widely
varying
recommendations to prevent the development of a seroma. (Pogson et al.,
2003)
Several attempts have been made to reduce exudation from the
wound. Suction drains are used to facilitate adhesion between wound
surfaces. Closure of the anatomical dead space has been described.
Seroma may be surgeon dependent. (Conveny et al., 1993)
Use of electrocautery may reduce blood loss but it seems to
increase seroma formation. In contrast argon beam coagulation has
been reported to decrease frequency of seroma formation. (Porter et
al., 1998 and Ridings et al., 1998)
Recently, ultrasonic energy is emerging as an alternative to
electrical and laser energies as a tool of surgical dissection and
haemostasis. The
ultrasonic scissor uses high frequency ultrasonic
waves for dissection and haemostasis, and the initial reports from
laparoscopic and cardiovascular surgical fields are encouraging.
(Schmidbauer et al., 2002and Galatius et al., 2003)
Experimental
studies have shown that the thermal injury with ultrasonic scissors is less
in comparison to electrocautery .The ultrasonic scissors cause breakdown
of hydrogen bonds and form a protein coagulum to occlude the vascular
and lymphatic channels. (Hoenig et al., 1996 and Rodd et al., 2007)
Ultrasound scissors was used as an attempt to reduce blood loss
during surgery for breast cancer. It was noticed that it is associated
with apparent reduction in postoperative seroma in patients who
underwent this procedure. (Doe S & Shukla N, 2000 and Deo SV et al.,
2002)
Minimization of this complication would benefit patients by
decreasing the number of postoperative visits as well as reducing
anxiety about treatment delay, the incidence of infection and other
difficulties related to wound healing. (Lumachi et al., 2004)
Purpose of the study
The aim of this work was to perform a prospective randomized clinical
trial aiming at comparing the usage of ultrasonic scissors versus
electrocautery in modified radical mastectomy regarding intraoperative
and postoperative complications.
Patients and methods
This prospective randomized clinical trial had been carried out in the
National Cancer Institute (NCI), Cairo University over a period of ten
months from 1st June 2006 till 31 March 2007. It included sixty cases
with operable breast cancer all of them were subjected to modified radical
mastectomy.
All the patients were subjected to routine preoperative laboratory and
radiological investigations including full labs (complete blood count,
liver and kidney function tests, fasting blood sugar and prothrombin time
and concentration), ECG , Chest x-ray, Ultrasound for the abdomen and
pelvis, Bone scan.
All the patients were diagnosed preoperative by a triple assessment:
clinical examination, bilateral soft tissue mammography and either FNAC
or true-cut biopsy .For patients to whom lumpectomy was done outside
our surgical oncology department at the NCI, pathological revision of the
slides and/or block was done.
Patients were randomly divided into 2 groups: each group included
thirty patients:
In group A, rising skin flaps, shaving of pectoral fascia and
axillary dissection had been done using ultrasonic scissor (US)
coagulation shear without the use of any sutures.
In group B, rising skin flaps, shaving of pectoral fascia and
axillary dissection had been done using electrocautery with
ligation of tributaries of the axillary vein.
In both groups dissection of levels I, II, III axillary lymph
nodes were done and 2 suction drains were used one in the axilla
and the other one under the flaps. A standard non compressive
dressing was used in all patients at the end of the operation. The
total amount of drainage, which included all postoperative
drainage up to the time of drain removal, was carefully measured.
Drains were removed only when the daily drainage volume were
less than 50 ml for 48hours. The patients were followed up
weekly for 4 weeks then monthly for at least 3 months.
Seroma was defined as a clinically evident collection of
fluid, either symptomatic or asymptomatic, which developed after
drain removal in the axillary dead space requiring aspiration. Days
of drain removal was defined as the duration that the drain was
left in place.
Patients, receiving neoadjuvant chemotherapy or candidate for
radical, conservative or simple mastectomy, were excluded from the
study.
Data were collected and analyzed regarding:
 Patient’s factors e.g. age, menopausal status, body mass index
(BMI) and diabetes mellitus (DM).
 Intraoperative factors e.g. Operative time and blood loss.
 Pathological factors e.g. tumor size, number of lymph nodes
removed and number of lymph node metastases.
 Postoperative complications e.g. seroma, haematoma, wound
infection and flap necrosis.
Statistical analysis:
Data were analyzed using SPSS win statistical package version 12.
Numerical data were expressed as mean± standard deviation (SD),
median, minimum and maximum. Qualitative data were expressed as
frequency and percentage. Chi-square test (Fischer’s Exact test) was used
to examine the relation between qualitative variables. For quantitative
data, comparison between two groups was done using Mann-Whitney test
(non-parametric student t-test for variables not normally distributed).
Probability (p-value) ≤ 0.05 was considered significant and less than
0.001 was considered highly significant.
Results
Sixty patients with operable breast cancer candidate for modified
radical mastectomy were included in the study. Thirty patients were done
using the ultrasound scissors and were considered as group (A) and thirty
patients were done using the electrocautery and were considered as group
(B).
Characteristics of patients undergoing modified radical
mastectomy by ultrasonic scissors and by electrocautery are presented in
table (1). There were no statistical differences between the two groups.
Table (1): Characteristics of patients
Characteristics
No. of patients
Age *
BMI *
postmenopausal **
group (A)
30
54.07 ± 11.57
33 ± 4.59
22(73.3%)
group (B)
30
55.8 ± 9.31
32.5 ± 3.92
23(76.7%)
p-value
0.373
0.372
0.766
8(26.7%)
7(23.3%)
0.766
DM **
6(20%)
5(16.6%)
0.754
Side (left / right)
18 / 12
16 / 14
0.95
premenopausal **
*Mean ± standard deviation.
** Number and percentage.
Factors related to surgery are presented in table (2)
regarding the duration of surgery (operative time) and the
intraoperative blood loss (operative bleeding). There was no
statistical differences as regarding operative time however,
operative bleeding was much less in group (A) (p-value <0.001).
Table (2):
Operative factors
Factors
group (A)
group (B)
p-value
No. of patients
30
30
Operating time (min) *
117 ± 21.679
108 ± 14.716
0.065
Operative bleeding (ml)* 328.33 ± 97.45 510.67 ± 88.74 <0.001
*Mean ± standard deviation.
The operative time in group (A) is presented in figure (1).
Slight increase in the operative time was evident in the 1st two
cases done by each surgeon which was followed by decreasing
and almost stabilization of the operative time after that.
Figure (1): operative time in group (A).
Pathological features of the 2 groups are presented in table (3)
including tumor size, number of nodes removed and number of positive
nodes for metastases. There were no statistical differences between the
two groups.
Table (3) : Pathological features
Features
No. of patients
Tumor size (mm) *
No. of nodes
removed *
Nodes with
metastases *
*Mean ± standard deviation.
group (A)
30
41.7 ± 10
21 ± 4.39
group (B)
30
41.8 ± 19.4
20.5 ± 5.37
P-value
0.152
0.737
5 ± 4.51
4.8 ± 5.84
0.434
Postoperative drainage volume and duration of the 2 groups
are presented in table (4). There was highly significant decrease in
the drainage volume and duration in group (A) (p-value <0.001).
Table (4):
Postoperative drainage
Drainage
No. of patients
Drainage
volume
(ml) *
Duration of drainage
(days) *
Drainage in 1st 48
hours (ml) *
group (A)
30
1139.17 ±
425.49
9.17 ± 2.07
group (B)
30
1667 ± 557.63
P-value
<0.001
12.53 ± 1.83
<0.001
245 ± 78.51
537 ± 241.29
<0.001
*Mean ± standard deviation.
Postoperative complications in the 2 groups are presented in
table (5). There was significant decrease in the incidence of
seroma and wound infection in group (A) (p-value 0.045& 0.044
respectively).
Table(5): Postoperative complications
Complications
group (A)
group (B)
pNumber
Percentage Number Percentage value
No. of patients
30
100%
30
100%
Seroma
5
16.7%
12
40%
0.045
Wound infection
1
3.3%
5
16.6%
0.044
*
Flap necrosis
0
0%
1
3.3%
*
Lymphedema
0
0%
1
3.3%
*
Wound
0
0%
1
3.3%
haematoma
*the test is not valid.
The number of seroma punctures needed to treat
postoperative seroma is presented in table (6). Fewer numbers of
punctures was needed in group (A) (p-value 0.043).
Table(6): Number of seroma punctures
No. of patients with
seroma
No. of seroma
punctures*
group (A)
group (B)
5
12
Pvalue
0.045
2.2 ± 1.64
3.8 ± 1.59
0.043
*Mean ± standard deviation.
The mean operative cost in Egyptian Pounds (L.E) was 400 ±
00.00 in group (A) and 96.2 ± 24.52 L.E in group (B). The cost was much
higher in group (A) (p-value <0.001). This included the cost of the ACE
shear (the resterilized one shear was used for ten patients) in group (A)
and the absorbable sutures (Vicryl®) used for ligation of axillary vein
tributaries and other bleeding vessels that could not be controlled by
electrocautery in group (B) (the mean number of sutures used 2.47 ±
0.73). The cost of the sutures and/or clips used for skin closure and
fixation of the drain were not included as it was similarly used for both
two groups.
Discussion
Most studies comparing surgical techniques in breast
surgery were retrospective and non- randomized. (Kurtz & Frost
1995 and Deo et al., 2002)
Electrocautery is universally used and
investigated. (Woodworth et al., 2000) This
reduce blood loss during operation, but no
formation had been found, even it may be
(Porter et al., 1998)
has been thoroughly
technique seems to
reduction in seroma
a cause of seroma.
Ultrasonic energy is emerging as an alternative to electrical
energies as a tool of surgical dissection and haemostasis. The
benefits of using ultrasonic energy are lesser thermal injury to the
tissues and better sealing of small vessels and lymphatic channels
with a protein coagulum owing to break down of hydrogen bonds.
(Hoenig et al., 1996 and Irshad & Campbell 2002)
In our study the intraoperative blood loss was lower in the US
dissection group (the mean intra-operative blood loss was 328 ± 97 ml) in
comparison to electrocautery group (the mean was 510 ± 88 ml) and the
p-value was highly significant (p <0.001). Our results were comparable
with the results of (Giovani L, 1999, Deo et al., 2002 and Lumachi et al.,
2004). However Hanne G and his colleagues (2003) reported that US
dissection didn’t reduce the intraoperative blood loss but this may be due
to the fact that in this study US dissection was used for flap dissection
and not for the axillary dissection.
In our study the operative time was longer in the US
dissection group (the mean was 117 ± 21 min) in comparison with
the electrocautery group (the mean was 108 ± 14 min) but the
difference was not significant (p=0.65). There was slight increase
in the operative time was evident in the 1 st two cases done by each
surgeon which was followed by decrease and almost stabilization
of the operative time denoting rapid learning curve of the
technique. Our results were comparable with results of (Deo et al.,
2002, Lumachi et al., 2004 and Hanne G et al., 2003).
In our study the total amount of drainage was significantly lower in
the US dissection group (the mean was 1139 ml ± 485) in comparison
with the electrocautery group (the mean was 1667 ml ± 557)
(p-value <0.001). The US dissection lowered the amount of drainage in
the 1st 48 hours by more than 50% (the mean was 245 ml ± 78.51 in
comparison to 537 ml± 241.29). Also the duration of drainage was
shorter in the US dissection group (the mean was 9 ± 2.07 days) in
comparison to the electrocautery group (the mean was 12.5 ± 1.83 days),
thus the drains were removed earlier with US dissection.These results
were comparable with the results of Deo and his colleagues (2002) ,
Lumachi and his colleagues (2004). They concluded that US dissection
decreased the total amount of drainage and shortened the hospital stay.
In our study the development of post operative seroma was
significantly lower in the US dissection group (5 cases, 16%) in
comparison to electrocautery group (12 cases, 40%) (P-value = 0.045).
Also the numbers of aspiration visits required for seroma were
significantly lower in the US dissection group (the mean was 2.2 ± 1.64)
in comparison to the electrocautery group (the mean was 3.8 ± 1.59)
(p-value = 0.043). So, the US dissection lowered the number of post
operative visits of the patients and there was no delay in the postoperative
therapy (chemotherapy & radiotherapy). These results were comparable
to results of Deo and his colleagues (2002) , Lumachi and his colleagues
(2004), but the results of our study differs from the results concluded by
Hanne G and his colleagues (2003) as they stated that there was no
difference between US dissection and electrocautery in the incidence of
postoperative seroma. However they referred that to their restrictive drain
policy as they routinely removed drains in the 5 th postoperative day
regardless to the daily drainage volume, but in our study we removed
drains after the daily drainage volume was less than 50 ml for two
consecutive days.
In our study the incidence of wound infection was lower in the US
dissection group (1 case, 3.3%) in comparison to the electrocautery group
(5 cases, 16%) (P-value = 0.045). This may be due to less injury to the
tissues associated with US dissection and fewer lateral spread of
coagulation which affects the vascularity of the flaps in comparison to
electrocautery.
The other postoperative complications including haematoma, flap
necrosis and lymphedema could not be compared between the two groups
due to small number of cases (1 case for each complication in the
electrocautery group in comparison to no cases in the US dissection
group) which made the statistical tests not valid.
The US dissection was more expensive (the mean was 400 ±
00.00L.E. per case) in comparison to the electrocautery (the mean was 96
± 24.52 L.E.). The difference in the cost between the two groups was
highly significant (p-value <0.001).
In our prospective randomized controlled study, the two
groups were comparable in patients’ characteristics including age,
BMI, menopausal status and diabetes mellitus (the p-value was
not significant). Also, there were no differences between the two
groups in the pathological factors including tumor size, number of
nodes removed and metastatic lymph nodes (the p-value was not
significant).
Conclusions
Modified radical mastectomy using the US dissection is feasible
and an easy technique.
Its advantages over electrocautery include reduction in the
intraoperative blood loss, the total amount and duration of axillary
drainage as well as incidence of seroma formation.The only disadvantage
was its higher cost.
Conflict of interest
The authors declared that they had no conflict of interest.
References
Adwani A, Ebbs SR. Ultracision reduces acute blood loss but not seroma
formation after mastectomy and axillary dissection: a pilot study. Int J
Clin Pract. 2006;60(5):562-4.
Conveney E C, O’Dwyer P J, Geraghty J G, O’Higgins N J. Effect of
closing dead space on seroma formation after mastectomy a prospective
randomized clinical trial, Eur J Surg Oncol 1993; 19: 143-46.
Deo S V S, Shukla N K. Modified radical mastectomy using harmonic
scalpel. J Surg Oncol 2000; 74: 204-7.
Deo SV, Shukla NK, Asthana S, Niranjan B, Srinivas G. A
comparative study of modified radical mastectomy using harmonic
scalpel and electrocautery, Singapore Med J. 2002; 43(5):226-8.
Galatius H, Okholm M, Hoffmann J. Mastectomy using ultrasonic
dissection: effect on seroma formation. Breast. 2003;12(5):338-41.
Giovanni L. Reduction of blood loss and seroma after surgery for breast
cancer using ultrasound dissection. Surg round special supplement 1999;
10-15.
Hanne G, Mette O and Jack H. Mastectomy using ultrasonic dissection
effect on seroma formation, the breast 2003; 12: 338-41.
Hoenig DM, Chrostek CA, Amaral JF. Laparoscopic coagulation
shears: Alternative method of haemostatic control of unsupported tissue, J
Endo Urol 1996; 10: 431-33.
Irshad K, Campbell H. Use of harmonic scalpel in mastectomy and
axillary dissection for breast cancer. Eur J Cancer 2002; 38: 104.
Kurtz S B, Frost D B. A comparison of two surgical techniques for
performing mastectomy. Eur J Surg Oncol 1995; 21: 143-5.
Lumachi F, Burelli P, Basso SMM, Iacobone M, Ermani M.
Usefulness of ultrasound scissors in reducing serous drainage after
axillary dissection for breast cancer: a prospective randomized clinical
study. Am Surg. 2004; 70:80-4.
Pogson CJ, Adwani A, Ebbs SR. Seroma following breast cancer
surgery. Eur J Surg Oncol 2003; 29:711-7.
Porter KA, O’Conner S, Rimm E, Lopez M. Electrocautery as a factor
in seroma formation following mastectomy, Am J Surg1998; 176-8.
Ridings P, Bucknall T E, Bailey C. Argon beam coagulation as an
adjunct in breast-conserving surgery, Ann R Coll Surg Engl 1998; 80: 612.
Rodd CD, Velchuru VR, Holly-Archer F, et al. Randomized clinical
trial comparing two mastectomy techniques. World J Surg.
2007;31(6):1164-8.
Schmidbauer S, Hallfeldt KK, Sitzmann G, Kantelhardt T, Trupka
A. Experience with ultrasound scissors and blades (UltraCision) in open
and laparoscopic liver resection. Ann Surg 2002; 235:27-30.
Woodworth P A, Mcboyle M F, Helemer S D, Beamer R L. Seroma
formation after breast cancer surgery: incidence and predicting factors,
Am Surg 2000; 66: 444-51.