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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05901064
Acronym
SEROM
Enrollment
150
Registered
2023-06-13
Start date
2021-01-21
Completion date
2025-12-31
Last updated
2023-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seroma

Keywords

Seroma, Axillary dissection, Complications

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.

Detailed description

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.

Interventions

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

Sponsors

University Hospital, Linkoeping
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

Neither the patients nor the health care providers know with whitch device (Harmonic Focus or diathermy) the patient will be operated.

Intervention model description

Double blinded randomized prospective study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patients who have previously undergone axillary evacuation.

Design outcomes

Primary

MeasureTime frameDescription
Economic comparison between the use of ultrasonic scissors and diathermy for axillary dissection in breast cancer patients.12 monthsUnit of measures: Costs of extra visits with nurse, physiotherapist or surgeon, antibiotics, PICO, re-interventions due to complications, microbiological cultures, incapacity to work, hospitalizations

Secondary

MeasureTime frameDescription
Function before and after breast cancer treatment. Lymph-ICF Survey12 monthsQuestionnaire
Complication frequency between the use of ultrasonic scissors and diathermy for axillary12 monthsComlplication frequency comparison

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026