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Trial Title:
Evaluation of Ultrasonic Scissors and Diathermy for Axillary Clearance in Breast Cancer Patients
NCT ID:
NCT05901064
Condition:
Seroma
Conditions: Official terms:
Seroma
Conditions: Keywords:
Seroma
Axillary dissection
Complications
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Double blinded randomized prospective study
Primary purpose:
Treatment
Masking:
Double (Participant, Care Provider)
Masking description:
Neither the patients nor the health care providers know with whitch device (Harmonic
Focus or diathermy) the patient will be operated.
Intervention:
Intervention type:
Procedure
Intervention name:
Axillary clearance
Description:
Evaluating the use of Harmonic Focus in axillary clearance due to metastasis of breast
cancer in axilla
Arm group label:
Diathermy
Arm group label:
Harmonic Focus
Other name:
Axillary dissection
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18 years or older
- All patients who will undergo axillary evacuation
- Informed consent
Exclusion Criteria:
- Patients who have previously undergone axillary evacuation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University hospital of Linkoping
Address:
City:
Linköping
Zip:
58185
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Carlos Dussan, MD, PhD
Phone:
+46706390116
Email:
carlos.dussan.luberth@regionostergotland.se
Contact backup:
Last name:
Ervin Beka, MD, PhD-student
Phone:
+46738430968
Email:
ervin.beka@regionostergotland.se
Start date:
January 21, 2021
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University Hospital, Linkoeping
Agency class:
Other
Source:
University Hospital, Linkoeping
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05901064
