Comparison of the correctness of the excised lesions (with pathology and sonography) in patients with a non-palpable benign breast lesion under the guidance of us-guided skin-marking and lesion local coordinates or guide-wire insertion
Comparison of excision of non-palpable benign breast lesions under the guidance of US-guided (ultra sound guided) skin-marking and lesion local coordinates or guide-wire insertion from the view of surgery time, specimen weight, and the convenience of the surgeon and radiologist
Design
A pragmatic, two arms parallel group non-blind randomized clinical trial
Settings and conduct
This study will be conducted as a randomized clinical trial. Participants include women who are candidate for non-palpable benign breast lesion excision. After the simple randomization with sealed envelope, lesion excision in the intervention group will be performed under the guide of us-guided skin-marking and in control group, the lesion will be excised using guide-wire insertion as a routine protocol. The correctness of the excised tumor, time of surgery, the weight of the excised specimen, and the convenience of the surgeon and radiologist will be compared between two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with non-palpable benign breast lesions; candidate for lesion excision.
Non-inclusion criteria: women who had malignant breast lesions.
Intervention groups
Intervention group: Excision of the lesion will be performed under the guidance of us-guided skin-marking.
Control group: Lesion excision will be performed using guide-wire insertion (routine protocol).
Main outcome variables
Surgery time; Specimen weight; The convenience of surgeon and radiologist.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100706004329N8
Registration date:2019-04-06, 1398/01/17
Registration timing:prospective
Last update:2019-04-06, 1398/01/17
Update count:0
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Sadaf Alipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982177888751 - 00982177883195
Email address
salipour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the correctness of the excised lesions (with pathology and sonography) in patients with a non-palpable benign breast lesion under the guidance of us-guided skin-marking and lesion local coordinates or guide-wire insertion
Public title
Surgery of non-palpable benign lesion with skin-marking
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Benign breast lesion
Non-palpable lesion
Exclusion criteria:
Malignancy in the breast
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with individual unit and sealed envelops tool
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
6th floor of Vice chancellor for Research, Central Building of University, Ghods Ave., Kehsvarz Blvd.,
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-02-02, 1397/11/13
Ethics committee reference number
IR.TUMS.VCR.REC.1397.874
Health conditions studied
1
Description of health condition studied
Benign breast lesions
ICD-10 code
N64.9
ICD-10 code description
Disorder of breast, unspecified
Primary outcomes
1
Description
The correctness of the excised lesion
Timepoint
After surgery
Method of measurement
With pathology and sonography
Secondary outcomes
1
Description
Time of surgery
Timepoint
During surgery
Method of measurement
Measuring time with clock in minutes
2
Description
Wight of excised specimen
Timepoint
After surgery
Method of measurement
Measuring weight with digital weighting device in grams
3
Description
The convenience of Surgeon
Timepoint
After surgery
Method of measurement
Questionnaire (Likert scale)
4
Description
The convenience of radiologist
Timepoint
After radiology
Method of measurement
Questionnaire (Likert scale)
Intervention groups
1
Description
Intervention group: Skin-marking of benign breast lesions with a pen under the guidance of ultrasonography
Category
Treatment - Surgery
2
Description
Control group: Marking the lesion with guide-wire insertion (routine protocol)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Sadaf Alipour
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
salipour@sina.tums.ac.ir
Web page address
http://arash.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
6th floor, Central University, Qods St, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8838 8988
Fax
+98 21 8838 8988
Email
resdeputy@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sadaf Alipour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash Women 's Hospital, No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
salipour@sina.tums.ac.ir
Web page address
http://arash.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sadaf Alipour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash womens' Hospital, No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway,
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
salipour@sina.tums.ac.ir
Web page address
http://arash.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sadaf Alipour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash Women 's Hospital, No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
salipour@sina.tums.ac.ir
Web page address
http://arash.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available