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

June 2, 2023 updated by: CLuberth, University Hospital, Linkoeping

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who have previously undergone axillary evacuation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Harmonic Focus
Patients that are operated with Harmonic Focus
Procedure: Axillary clearance
Evaluating the use of Harmonic Focus in axillary clearance due to metastasis of breast cancer in axilla
Other Names:
  • Axillary dissection
Active Comparator: Diathermy
Patients that are operated with conventional diathermy
Procedure: Axillary clearance
Evaluating the use of Harmonic Focus in axillary clearance due to metastasis of breast cancer in axilla
Other Names:
  • Axillary dissection

What is the study measuring?

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.
Time Frame: 12 months
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
Time Frame: 12 months
Questionnaire
12 months
Complication frequency between the use of ultrasonic scissors and diathermy for axillary
Time Frame: 12 months
Comlplication frequency comparison
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LinkoepingU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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