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

Study Overview
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Brief Summary
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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.

Detailed Description
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Breast surgery plays an important role in the treatment of breast cancer. Sometimes cancer cells can spread to lymph nodes in the axill. The first lymph node affected in the armpit is called the sentinel node. Surgery to remove this node can answer the question of whether the cancer has spread to the axill. If the node is affected, further surgery is performed to remove most of the lymph nodes in the armpit, a so-called axillary clereance. The breast unit at Linköping University Hospital performs about 60 axillary clereance per year. Axillary clereance is associated with a number of complications, such as infections, bleeding, pain, loss of sensation and limited mobility in the arm. Accumulation of wound fluid in the surgical area is common, affecting about a quarter of patients undergoing surgery. Small amounts of wound fluid usually do not require treatment, but larger accumulations usually require drainage. Patients who have symptoms from armpit wound fluid have to make repeated return visits so that a nurse drains the fluid using a needle. This poses several risks to the patient such as infection and/or bleeding. This, in turn, can delay the start of additional treatment and can put a financial burden on both the patient and the healthcare system. Today, the investigators use a device with a weak electric current (diathermy) to remove lymph nodes from the armpit. Harmonic Focus ® is a pair of scissors that instead uses ultrasound waves to divide the tissue. There are scientific studies showing that the use of ultrasonic scissors reduces the risk of fluid accumulation and thus the risk of complications after surgery[1, 2]. The investigators want to conduct a prospective study, an economic analysis comparing the costs of using diathermy versus Harmonic Focus®. In addition, patients will complete a quality of life questionnaire before surgery, approximately 4-6 weeks after and one year after surgery. The results of the questionnaires will be compared between the Harmonic Focus® and the diathermy group.

Official Title
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Economic Comparison Between the Use of Ultrasonic Scissors and Diathermy for Axillary Clearance in Breast Cancer Patients

Conditions
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Seroma

Intervention / Treatment
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* Procedure: Axillary clearance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older All patients who will undergo axillary evacuation Informed consent Exclusion Criteria: Patients who have previously undergone axillary evacuation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blinded randomized prospective study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Harmonic Focus<br>Patients that are operated with Harmonic Focus | Procedure: Axillary clearance<br>* Evaluating the use of Harmonic Focus in axillary clearance due to metastasis of breast cancer in axilla<br>* Other names: Axillary dissection;|
| Active Comparator: Diathermy<br>Patients that are operated with conventional diathermy | Procedure: Axillary clearance<br>* Evaluating the use of Harmonic Focus in axillary clearance due to metastasis of breast cancer in axilla<br>* Other names: Axillary dissection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function before and after breast cancer treatment. Lymph-ICF Survey | Questionnaire | 12 months | 
| Complication frequency between the use of ultrasonic scissors and diathermy for axillary | Comlplication frequency comparison | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seroma, Axillary dissection, Complications