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

NCT ID: NCT03012152

Last Updated: 2017-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Breastcancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard conservative group

Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .

.

Group Type ACTIVE_COMPARATOR

Standard conservative breast surgery

Intervention Type PROCEDURE

Oncoplastic group

Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures

Group Type ACTIVE_COMPARATOR

Oncoplastic breast surgery

Intervention Type PROCEDURE

Interventions

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Standard conservative breast surgery

Intervention Type PROCEDURE

Oncoplastic breast surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Yasser Mohamed Abdel-samii

Lecturer of General surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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16379

Identifier Type: -

Identifier Source: org_study_id

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