Comparison of simple cyst recurrence following breast FNA in patients with complete evacuation of the cyst and patients with complete evacuation and air injection into the cyst in women
The aim of this study was to compare simple cyst recurrence following breast FNA in patients with complete evacuation of the cyst and patients with complete evacuation and air replacement. This study was a single-blind randomized clinical trial. Inclusion criteria: female at the age of 18 years and more; presence of breast simple cyst. Exclusion criteria: history of breast masses (benign or malignant); history of mastectomy and treatment for malignant tumors; cyst’s size less than 1 centimeter. Sixty patients with simple breast cyst randomly selected for FNA alone and 60 patients with simple cyst for FNA and air replacement under the guidance of ultrasound. Two groups were matched according to age and size of cysts. All the patient were followed up for 3 months. We record cysts’ sizes before procedure and after 3 months. We evaluated cyst recurrence rate after 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020720258N32
Registration date:2017-03-22, 1396/01/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-22, 1396/01/02
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2015-08-01, 1394/05/10
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of simple cyst recurrence following breast FNA in patients with complete evacuation of the cyst and patients with complete evacuation and air injection into the cyst in women
Public title
Treatment of breast's simple cyst
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: female at the age of 18 years and over; simple cyst.
Exclusion criteria: history of breast masses that have been studied (history of benign or malignant); history of mastectomy and other treatments for malignant tumors; cyst's size less than 1 centimeter
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomize by table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar Azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2015-07-27, 1394/05/05
Ethics committee reference number
IR.ARAKMU.REC.1394.104
Health conditions studied
1
Description of health condition studied
Simple cyst breast
ICD-10 code
N60.0
ICD-10 code description
Solitary cyst of breast
Primary outcomes
1
Description
remission rates of cyst
Timepoint
after 3 months
Method of measurement
sonogeraphy
2
Description
Size of cyst
Timepoint
before aspiration and after 3 months
Method of measurement
sonogeraphy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 60 patients with simple breast cyst were selected for treatment by FNA alone under the guidance of ultrasound.
Category
Diagnosis
2
Description
Intervention group 2: 60 patients with simple cysts select for treatment by FNA and air replacement under the guidance of ultrasound.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza clinic
Full name of responsible person
Dr Fatemeh Safi
Street address
Shahid Shirodi street,Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences