The effects of reduction mammoplasty and mastopexy on infra-mammary fold
Design
Clinical trial with control group, with parallel groups, without blinding and without randomization on 50 patients
Settings and conduct
In this study, 50 female patients in Shahid Modarres Hospital in Tehran, after reduction mammoplasty and mastopexy, measured the changes in the inframammary fold in standing and bent forward positions and compared with before surgery.
Participants/Inclusion and exclusion criteria
Including :
Patients who are candidates for surgery due to sagging and loose breasts
Patients who are candidates for surgery due to breast deformity to breasts shaping
Patients who are candidates for surgery due to the size of the breast to reduce the size and volume of the breast
Excluding:
Breast asymmetry
Existence of anomalies and deformities in the breasts
Existence of anomalies and deformities in the breast wall
Age<18 years old
Breast Cancer
Chemical therapy
Addiction
Intervention groups
Intervention group: Patients undergoing mammoplasty. In this method, surgery is performed by anchoring incisions on the patient's breast using the superomedial pedicle technique, then it is repaired with Vicryl and PDS suture. In this group, the location of the inframammary fold (IMF) before and after surgery is assessed and the amount of displacement is measured.
Control group: Patients undergoing mastopexy surgery. In this method, surgery is performed by anchoring incisions on the patient's breast using the superior and superomedial techniques, then it is repaired with Vicryl and PDS suture. In this group, the location of the inframammary fold (IMF) is also evaluated before and after surgery and the amount of displacement is measured.
Main outcome variables
The amount of inframammary fold (IMF) displacement postoperatively compared to preoperatively in standing and bent forward positions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200523047549N1
Registration date:2020-12-25, 1399/10/05
Registration timing:retrospective
Last update:2020-12-25, 1399/10/05
Update count:0
Registration date
2020-12-25, 1399/10/05
Registrant information
Name
Feizollah Niazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8956
Email address
feizollahniazi2015@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-16, 1398/08/25
Expected recruitment end date
2020-07-31, 1399/05/10
Actual recruitment start date
2019-11-16, 1398/08/25
Actual recruitment end date
2020-07-31, 1399/05/10
Trial completion date
2020-12-30, 1399/10/10
Scientific title
The Effects of Reduction Mammoplasty and Mastopexy Surgeries on Inframammary Fold
Public title
The Effects of Breast Surgeries on Inframammary Fold
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for surgery due to sagging and loose breasts
Patients who are candidates for surgery due to breast deformity to breasts shaping
Patients who are candidates for surgery due to the size of the breast to reduce the size and volume of the breast
Exclusion criteria:
Breast cancer
Age<18 years old
Chemical therapy
Addiction
Breast asymmetry
Existence of anomalies and deformities in the breasts
Existence of anomalies and deformities in the breast wall
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
Actual sample size reached:
50
More than 1 sample in each individual
Actual sample size in each individual:
2
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Chamran Highway - Yemen St. - Shahid Arabi St. - Next to Ayatollah Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.838
Health conditions studied
1
Description of health condition studied
Inframammary fold location
ICD-10 code
L99
ICD-10 code description
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Primary outcomes
1
Description
Displacement of the inframammary fold in a standing and bent position
Timepoint
Measurement of the location of the IMF at the beginning of the study, 1 month and 6 months after surgery
Method of measurement
Comparison of the distance between the crease below the breast and the crease in front of the elbow in standing and bent forward position (90 degrees) before and after mammoplasty and mastopexy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients undergoing mammoplasty. In this method, surgery is performed by anchoring incisions on the patient's breast using the superomedial pedicle technique, then it is repaired with Vicryl and PDS suture. In this group, the location of the inframammary fold (IMF) before and after surgery is assessed and the amount of displacement is measured.
Category
Treatment - Surgery
2
Description
Control group: Patients undergoing mastopexy surgery. In this method, surgery is performed by anchoring incisions on the patient's breast using the superior and superomedial techniques, then it is repaired with Vicryl and PDS suture. In this group, the location of the inframammary fold (IMF) is also evaluated before and after surgery and the amount of displacement is measured.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Faizollah Niazi
Street address
Shahid Modarres Hospital, above Kaj Square
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Email
niazi_sf@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Feizollah Niazi
Street address
Shahid Modarres Hospital, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Email
niazi_sf@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fezollah Niazi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres Hospital, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Email
niazi_sf@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Feizollah Nniazi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres Hospital, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Email
niazi_sf@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Feizollah Niazi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Modarres Hospital, Saadat Abad
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2206 9355
Email
niazi_sf@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Title and more details about the data/document
After collecting information and analyzing it, the results will be published through the article.
When the data will become available and for how long
1 year
To whom data/document is available
main author and coresponder author
Under which criteria data/document could be used
In any case, the results will be published both negatively and positively.
From where data/document is obtainable
main author
What processes are involved for a request to access data/document