|Year : 2021 | Volume
| Issue : 2 | Page : 148-152
A randomised controlled trial comparing ultrasonic dissection with electrocautery for axillary dissection in breast cancer
Siva Ranjith, Arun Peter, Madhu Muralee, Paul Augustine, Jem Prabhakar
Division of Surgical Oncology, Regional Cancer Centre, Trivandrum, Kerala, India
|Date of Submission||06-Sep-2021|
|Date of Decision||20-Sep-2021|
|Date of Acceptance||26-Sep-2021|
|Date of Web Publication||15-Nov-2021|
Dr. Siva Ranjith
Division of Surgical Oncology, Regional Cancer Centre, Trivandrum - 695 011, Kerala
Source of Support: None, Conflict of Interest: None
Background: Morbidity of axillary dissection includes prolonged lymphatic drainage, surgical site infections, haematoma, flap necrosis and seroma. These complications are likely to delay wound healing and thereby delay administration of adjuvant treatments. Ultrasonic dissection device, the Harmonic Scalpel@, is a recent addition into the breast. Ultrasonic dissection reduces blood loss and reduces post-operative drain and seroma formation, without the use of surgical clips and ties. We hypothesised that axillary lymph node dissection (ALND) performed with ultrasonic dissection will decrease post-operative drain volume and number of days the patient is put on drain. Here, we present our randomised controlled trial study to compare the outcomes of ALND using ultrasonic dissection (harmonic scalpel) with standard electrocautery. Methods: A total of 113 patients were randomised to two arms - the control arm underwent ALND by standard electrocautery dissection and the experimental arm underwent axillary dissection with ultrasonic scalpel. The primary objectives were (1) to measure the total post-operative drainage volume and (2) the total number of days with drain. Results: The total drainage was significantly less in the intervention arm with a P = 0.015. However, the total number of days on drain was not significantly different in both the arms. The drainage on the 1st post-operative day, which indirectly measures haemostatic capacity, was also not different between the two groups. Conclusion: Although ultrasonic dissection of the axilla significantly reduces the total drain output, the total days the patients spent with drain in situ was not significantly different. The operating time was significantly increased with ultrasonic dissection. Hence, with this study, the routine use of ultrasonic dissection could not be recommended.
Keywords: Axillary dissection, harmonic scalpel, ultrasonic dissection
|How to cite this article:|
Ranjith S, Peter A, Muralee M, Augustine P, Prabhakar J. A randomised controlled trial comparing ultrasonic dissection with electrocautery for axillary dissection in breast cancer. Kerala Surg J 2021;27:148-52
|How to cite this URL:|
Ranjith S, Peter A, Muralee M, Augustine P, Prabhakar J. A randomised controlled trial comparing ultrasonic dissection with electrocautery for axillary dissection in breast cancer. Kerala Surg J [serial online] 2021 [cited 2021 Nov 30];27:148-52. Available from: http://www.keralasurgj.com/text.asp?2021/27/2/148/330409
| Introduction|| |
Axillary dissection is a standard component of surgical therapy for breast cancer. Morbidity of axillary dissection includes prolonged lymphatic drainage, surgical site infections (SSIs), haematoma, flap necrosis and seroma. These complications are likely to delay wound healing and thereby delay administration of adjuvant treatments. Electrocautery is the most commonly used device for resection purposes in breast surgery as it significantly reduces blood loss compared to conventional scalpel use. However, electrocautery has its own drawback that it increases risks of seroma and flap necrosis. Inadequate sealing of lymphatics during dissection with electrocautery seems to be the reason for lymphatic leaks, seromas and lymphoedema.
Ultrasonic dissection device, the Harmonic scalpel@, is a recent addition into the breast surgeon's armamentarium., These use ultrasonic energy to cut and coagulate soft tissue simultaneously, sealing vessels up to 5 mm, as well as lymphatics. This device has been shown to produce minimal collateral thermal damage, in various animal studies. This may play a role in reducing prolonged drainage following axillary dissection for breast cancer. Ultrasonic dissection reduces blood loss and reduces post-operative drain and seroma formation, without the use of surgical clips and ties.,
We hypothesised that axillary lymph node dissection (ALND) performed with ultrasonic dissection will decrease post-operative drain volume and number of days the patient is put on drain. Here, we present our randomised controlled trial study to compare the outcomes of ALND using ultrasonic dissection (harmonic scalpel) with standard electrocautery.
| Materials and Methods|| |
All female patients undergoing ALND for proven carcinoma of the breast, from March 2014 to November 2015 in Division of Surgical Oncology, Regional Cancer Center, Trivandrum, were recruited. Patients undergoing both modified radical mastectomy (MRM) and breast conservation surgery (BCS) were included. Assuming a power of 80% and 5% alpha error, 113 patients were randomised to two arms.
Patients in the control arm underwent ALND by standard electrocautery dissection. Patients in the experimental arm underwent axillary dissection with ultrasonic scalpel from the point of opening of clavipectoral fascia to the completion of ALND including the level III clearance. The surgical techniques using both electrocautery and ultrasonic shears were standardised, and the surgeries were done by the same surgical team. Institutional ethical clearance was obtained. Informed consent was taken from all patients.
The primary objectives were:
- To measure the total post-operative drainage volume, which was defined as cumulative drain volume in the drain bellow from post-operative day 1 till the day of drain removal. This was charted out by the patient or the caretaker in a format given to the patient at the time of discharge
- Total number of days with drain – for the purpose of this study, the drain was removed in all patients when the drain volume is less than 30 ml for 2 consecutive days.
The secondary objectives were:
- Operative time – Defined as the time from the start of incision to the start of skin suturing/stapling
- Drain on 1st postoperative day
- Haematoma in the postoperative period – Defined as post-operative haematoma warranting an exploration
- Seroma development after drain removal – Defined as any collection in the axilla, developing after the drain removal and requiring an aspiration.
- Wound complications in terms of SSI, flap necrosis will be taken into account.
All the data pertaining to the primary and secondary end points were captured using a standard pro forma.
Harmonic scalpel is a registered trade name of ultrasonic dissecting device manufactured by Ethicon Endo-Surgery a subsidiary of Johnson and Johnson and is currently the only such device available in the institution.
A total of 252 patients were assessed for eligibility (n = 252), out of which 139 were excluded: not meeting inclusion criteria (n = 47), declined to participate (n = 11), nonavailability of instrument (n = 29), time restrains (n = 49) and other reasons (n = 3) [Figure 1].
Finally, 113 were randomised.
Arm 1 was control arm which consisted of cautery dissection of axillary lymph node clearance: cautery (n = 58) and Arm 2 was the intervention arm, to which 61 were allocated: ultrasonic (n = 61). In the interventional arm, 52 received allocated intervention (n = 52) and 9 did not receive allocated intervention (device malfunction)
In Arm 1, 18 patients were lost to follow-up (non-compliance with the pro forma), and in 4 patients, drain accidentally dropped off early (drain dropouts). In Arm 2, 19 patients were lost to follow-up (non-compliance with pro forma), and in 1 patient, drain dropped off early (drain dropout). Hence, a total of 77 patients were included for the final analysis (N = 77); Arm 1 had 36 patients (n = 36) and Arm 2 had 41 patients (n = 41) [Figure 2].
Statistical test for analysis of difference between two different groups was done with Student's t-test, Fisher exact test, and logistic regression analysis. A P < 0.05 was considered statistically significant.
| Results|| |
All demographics such as age, body mass index, number of MRM and BCS, post-chemotherapy status, nodal status and stage were comparable in both groups [Figure 3].
The total drainage was significantly less in the intervention arm with a P = 0.015 (mean: 1311.2 ml [range: 640–3700, standard deviation (SD): 632.8] vs. mean: 1697.1 ml [range: 550–3035 ml, SD: 721.4]) [Figure 4]. The total number of days on drain was not significantly different in both the arms (cautery arm: mean: 17.8, range: 11–36 days, SD: 4.4 vs. ultrasonic arm: mean: 14.5, range: 10–25 days, SD: 3.4).
The drainage on the 1st post-operative day, which indirectly measures haemostatic capacity, was also not different between the two groups: cautery arm - mean: 143.1, range: 50–270 ml, SD: 53.0 and ultrasonic arm - mean: 139.8, range: 50–350 ml SD: 57.8, with a P = 0.796 [Figure 5].
However, the operative time was significantly higher for the ultrasonic dissection arm; cautery arm - mean: 16.5, range: 10-28 min, SD: 4.0; ultrasonic arm - mean: 24.2, range: 14–40 min, SD: 6.8, with a P < 0.0001 [Figure 6].
Subset analysis of MRM and BCS separately revealed no significant difference in ultrasonic dissection in BCS patients, whereas MRM patients had a significant difference in total drainage volume and total number of days with drain in situ [Figure 7].
|Figure 7: Results of Analysis. MRM: Modified radical mastectomy, BCS: Breast conservation surgery|
Click here to view
Post-operative complications were almost similar in both arms. No patient in either group had post-operative hematoma. Wound complications were noted in 3 patients in the cautery arm and 2 patients in the ultrasonic arm. Four patients in cautery arm developed seroma after drain removal, while 3 patients in the ultrasonic arm developed seroma. One case of intraoperative injury to the nerve to latissimus dorsi muscle was noted in the harmonic arm.
| Discussion|| |
Ultrasonic dissector has been in use for axillary clearance for carcinoma of breast. Various studies in the past have shown varying results for ultrasonic dissection when compared to electro cautery dissection for axillary clearance for breast cancer.,,, One study has shown superiority of ultrasonic dissection with regard to diminished operative time, blood loss, total drainage volume, days of stay and visual analogue scale as compared with traditional electrocautery. However, another Indian study did not show any significant added benefits with ultrasonic dissection. A meta-analysis conducted in 2012 also did not show any significant superiority for ultrasonic dissection. Recent randomised trials also demonstrated decreased drainage volume and blood loss with ultrasonic dissection.,
In our randomised trial, we observed a statistically significant decrease in the total drain output volume with the ultrasonic dissection. However, the number of days the patient was with drain in situ was not significantly different, with an absolute difference of only 2 days. Operative time was significantly higher with ultrasonic dissection, probably because it is a relatively new method and instrument. The drain in the 1st postoperative day, which indirectly marks the haemostatic effect, was also not significantly different between the two groups. Immediate surgical complications, such as wound infection and seroma, were not different between the two groups. In the subset analysis, no statistically significant difference was seen in BCS subset.
| Conclusion|| |
Although ultrasonic dissection of the axilla significantly reduces the total drain output, this did not translate into a decrease in the total number of days the patients spent with drain in situ. No difference was observed in haemostatic effect or post-operative complications. Operating time was significantly increased with ultrasonic dissection. Hence, with this study, routine use of ultrasonic dissection could not be recommended.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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