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

U

University Hospital, Linkoeping

Status

Enrolling

Conditions

Seroma

Treatments

Procedure: Axillary clearance

Study type

Interventional

Funder types

Other

Identifiers

NCT05901064
LinkoepingU

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Patients who have previously undergone axillary evacuation.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups

Harmonic Focus
Active Comparator group
Description:
Patients that are operated with Harmonic Focus
Treatment:
Procedure: Axillary clearance
Diathermy
Active Comparator group
Description:
Patients that are operated with conventional diathermy
Treatment:
Procedure: Axillary clearance

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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