Evaluation of Ultrasonic Scissors and Diathermy for Axillary Clearance in Breast Cancer Patients

NCT05901064 | Unknown

• 1 other identifier: LinkoepingU
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Breast surgery plays an important role in the treatment of breast cancer. This study investigates if the use of Harmonic Focus has advantages than the use of conventional diathermy in axillary clearance due to metastatic breast cancer.

Conditions

Seroma

Keywords

Seroma; Axillary dissection; Complications

Outcome Measures

Primary Outcomes (1)

• Economic comparison between the use of ultrasonic scissors and diathermy for axillary dissection in breast cancer patients.

  Unit of measures: Costs of extra visits with nurse, physiotherapist or surgeon, antibiotics, PICO, re-interventions due to complications, microbiological cultures, incapacity to work, hospitalizations

  12 months

Secondary Outcomes (2)

• Function before and after breast cancer treatment. Lymph-ICF Survey

  12 months

• Complication frequency between the use of ultrasonic scissors and diathermy for axillary

  12 months

Study Arms (2)

Harmonic Focus

ACTIVE COMPARATOR

Patients that are operated with Harmonic Focus

Procedure: Axillary clearance

Diathermy

ACTIVE COMPARATOR

Patients that are operated with conventional diathermy

Procedure: Axillary clearance

Interventions

Axillary clearance PROCEDURE

Evaluating the use of Harmonic Focus in axillary clearance due to metastasis of breast cancer in axilla

Also known as: Axillary dissection

Diathermy; Harmonic Focus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• All patients who will undergo axillary evacuation
• Informed consent

You may not qualify if:

• Patients who have previously undergone axillary evacuation.

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

University hospital of Linkoping

Linköping, Östergötland County, 58185, Sweden

RECRUITING

Related Publications (9)

• Bohm D, Kubitza A, Lebrecht A, Schmidt M, Gerhold-Ay A, Battista M, Stewen K, Solbach C, Kolbl H. Prospective randomized comparison of conventional instruments and the Harmonic Focus((R)) device in breast-conserving therapy for primary breast cancer. Eur J Surg Oncol. 2012 Feb;38(2):118-24. doi: 10.1016/j.ejso.2011.11.003. Epub 2011 Dec 5.

  PMID: 22152942 BACKGROUND

• Faisal M, Fathy H, Shaban H, Abuelela ST, Marie A, Khaled I. A novel technique of harmonic tissue dissection reduces seroma formation after modified radical mastectomy compared to conventional electrocautery: a single-blind randomized controlled trial. Patient Saf Surg. 2018 May 17;12:8. doi: 10.1186/s13037-018-0155-3. eCollection 2018.

  PMID: 29796089 BACKGROUND

• Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90.

  PMID: 21304082 BACKGROUND

• Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11.

  PMID: 23491275 BACKGROUND

• de Boniface J, Frisell J, Andersson Y, Bergkvist L, Ahlgren J, Ryden L, Olofsson Bagge R, Sund M, Johansson H, Lundstedt D; SENOMAC Trialists' Group. Survival and axillary recurrence following sentinel node-positive breast cancer without completion axillary lymph node dissection: the randomized controlled SENOMAC trial. BMC Cancer. 2017 May 26;17(1):379. doi: 10.1186/s12885-017-3361-y.

  PMID: 28549453 BACKGROUND

• Sowa Y, Numajiri T, Kawarazaki A, Sakaguchi K, Taguchi T, Nishino K. Preventive effects on seroma formation with use of the harmonic focus shears after breast reconstruction with the latissimus dorsi flap. J Plast Surg Hand Surg. 2016 Dec;50(6):349-353. doi: 10.1080/2000656X.2016.1178129. Epub 2016 May 5.

  PMID: 27146859 BACKGROUND

• Selvendran S, Cheluvappa R, Tr Ng VK, Yarrow S, Pang TC, Segara D, Soon P. Efficacy of harmonic focus scalpel in seroma prevention after axillary clearance. Int J Surg. 2016 Jun;30:116-20. doi: 10.1016/j.ijsu.2016.04.041. Epub 2016 Apr 29.

  PMID: 27142863 BACKGROUND

• Hung SH, Chu D, Chen FM, Chen T, Chen RC. Evaluation of the harmonic scalpel in breast conserving and axillary staging surgery. J Chin Med Assoc. 2012 Oct;75(10):519-23. doi: 10.1016/j.jcma.2012.07.006. Epub 2012 Sep 15.

  PMID: 23089404 BACKGROUND

• He Q, Zhuang D, Zheng L, Fan Z, Zhou P, Zhu J, Lv Z, Chai J, Cao L. Harmonic focus versus electrocautery in axillary lymph node dissection for breast cancer: a randomized clinical study. Clin Breast Cancer. 2012 Dec;12(6):454-8. doi: 10.1016/j.clbc.2012.07.014. Epub 2012 Oct 3.

  PMID: 23040644 BACKGROUND

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Neither the patients nor the health care providers know with whitch device (Harmonic Focus or diathermy) the patient will be operated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double blinded randomized prospective study

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 13, 2023
• Study Start: January 21, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)