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NCT03012152 Clinical Trial

A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction

Breastcancer Clinical Trial

Official title:
A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction Among Egyptian Females

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03012152
Other study ID # 16379
Secondary ID
Status Completed
Phase N/A
First received January 3, 2017
Last updated January 4, 2017
Start date September 2012
Est. completion date September 2016

Study information
Verified date January 2017
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This non randomized study is a comparative study between standard conservative breast surgery and oncoplastic surgery as regard margin status and patient satisfaction.

Description:

This planned study was conducted on 70 female patients presented to our tertiary referral breast unit at Ain Shams University hospitals with breast cancer amid the period from September 2012 to May 2013 .

Every one of them signed an informed consent to partake in this study that was approved in a meeting held by the ethical committee on august 2012 at Ain Shams University. All patients sharing in the study received closed envelope before surgery in a randomized way in which the surgical technique is written either standard conservative surgery or oncoplastic surgery(Double Blind).

Our patients were partitioned into 2 equal groups: group A (35patients) who underwent standard conservative surgery, group B (35patients) who underwent oncoplastic surgery.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date September 2016
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Female
Age group N/A to 60 Years
Eligibility Inclusion Criteria:

- Female Patients with stage 1,2 breast cancer.

Exclusion Criteria:

- Patients >60 years.

- Patients with previous breast surgery.

- patients candidate for mastectomy or palliative excision. Patients with collagen disease.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Standard conservative breast surgery

• Oncoplastic breast surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Outcome
Type Measure Description Time frame Safety issue
Primary Margins in all specimens measured in millimeters 2. 2 years Yes
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