comparison of oncoplastic breast surgery methods VS standard breast conserving surgery methods considering oncologic results and the patients satisfaction
Design
In this research, 60 eligible patients referring to Imam reza hospital of Mashad were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
All Patients in the early stage of breast cancer who reffed to Imam Reza hospital(Mashhad- Iran) are included.The Inform Consent will be obtained. The randomly, patients divide into two groups to preserve the breast with the standard method or oncoplastic method.the outcomes and variables of two groups will be registered, Analyzed and compared with each other. the oncologic results will be evaluated by a surgeon and oncologist. Moreover the patients satisfaction will be assess by a psychologist. Investigating the satisfaction and data gathering will be done by the student because the result will not be affected by facing a patient with doctor.
Participants/Inclusion and exclusion criteria
including criteria:
- All the patients who are candidate for breast conserving surgery
Excluding Criteria:
- chemotherapy before surgery; no postoperative radiotherapy; receiving radiotherapy during surgery; Breast cancer family history; bilateral Breast cancer; secondary breast cancer.
Intervention groups
participants will be divided randomly into 2 groups intervention group, Control group.for control group standard breast conserving surgery methods will be performed and for intervention group oncoplastic breast surgery methods will be performed
Main outcome variables
weight and volume of samples; Margin free samples based on millimeter; Patient satisfaction measurement questionnaire based on Harris scale for Cosmetic Results System.
General information
Reason for update
Acronym
BCS
IRCT registration information
IRCT registration number:IRCT20111207008316N4
Registration date:2018-02-06, 1396/11/17
Registration timing:registered_while_recruiting
Last update:2018-02-06, 1396/11/17
Update count:0
Registration date
2018-02-06, 1396/11/17
Registrant information
Name
Mehdi Asadi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 5255
Email address
asadimh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-10-18, 1396/07/26
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic results and patients' satisfaction of oncoplastic techniques in surgery of breast cancer
Public title
Evaluation of outcomes of oncoplastic techniques in surgery of breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the Patients who are candidate for Breast conserving surgery
Exclusion criteria:
Chemotherapy before surgery
no postoperative radiotherapy
receiving radiotherapy during surgery
Breast cancer family history
Bilateral Breast cancer
Secondary Breast cancer
Age
No age limit
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random table method
Blinding (investigator's opinion)
Single blinded
Blinding description
All of the patients who are candidate for breast conserving surgery will be included in this study and divided (Random table method) in 2 groups. Based on BMI and Age matching will be performed for this 2 groups (Group matching Method)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Mashhad University of Medical sciences
Secondary trial Id
95157
Registration date
1396-05-17, 777/01/-671
Ethics committees
1
Ethics committee
Name of ethics committee
mashad university of medical sciences
Street address
mashad, university st, next to cinema hoveyzeh, mashad university of medical sciences, the Vice Chancellor for Research of Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
...IR.MUMS.fm.REC.1396.19721.04.96
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
Z85.3
ICD-10 code description
Malignant neoplasm
Primary outcomes
1
Description
free margin based on milimeter
Timepoint
Just after performing surgery based on pathologic report
Method of measurement
Based on pathologic studies on the tumor samples and free margin (millimeter) and evaluation of hormon receptors and biologic markers for tumors
Secondary outcomes
1
Description
Patient satisfaction measurement questionnaire
Timepoint
first week after surgery، First month after surgery, 6 Month after surgery
Method of measurement
Satisfaction with Harris scoring system is collected from all patients as follows in the first week, the first month and the sixth month after surgery.
Intervention groups
1
Description
Intervention group: performing oncoplastic surgery methods for intervention group participants
Category
Treatment - Surgery
2
Description
Control group: performing standard breast conserving surgery methods