A Prospective Comparative Study Between Oncoplastic Breas... | NCT02923635

Studies
A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision

NCT02923635

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Oct 4, 2016Estimated

Enrollment

70Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Standard wide local excision.
oncoplastic breast surgery.

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Jun 2016Actual

First Submitted Date

Oct 2, 2016

First Submission Date that Met QC Criteria

Oct 3, 2016

First Posted Date

Oct 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2016

Last Update Posted Date

Oct 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yasser Mohamed Abdel-samii, Lecturer of General surgery, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and its impact on patient satisfaction.

Detailed Description

This non-randomized prospective trial was conducted on70 female patients presented to tertiary breast unit-Ain Shams University hospitals with breast cancer during the period from September 2012 to February 2013. All patients sharing in the study signed an informed consent that was approved in the ethical committee held on April 2012. Patients were classified in two groups each one 35 patients: group (A) standard wide local excision and group (B) oncoplastic group. Standard wide local excision done by general breast surgeons while oncoplastic surgeries done by breast surgeon assisted by plastic surgeon. The following data were recorded: Age, family history, margin length, weight and volume of the specimen, margin status and patient satisfaction.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard Wide Local Excision group	Active Comparator	Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques .	Procedure: Standard wide local excision.
Oncoplastic group	Active Comparator	Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures	Procedure: oncoplastic breast surgery.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard wide local excision.	Procedure	Excision of breast cancer without integration of plastic technique	Standard Wide Local Excision group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Margins in all specimens measured in millimeters		Two years

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfaction assessed using questionnaire		two years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with macromastia in oncoplastic group.
Tumors >20% of breast volume in oncoplastic group.
Young patients in oncoplastic group
Tumors in medial or central quadrants in oncoplastic group

Exclusion Criteria:

Patients >60 years.
Patients with co-morbidities in oncoplastic group.
Tumors >20% of breast volume in standard group.
Tumors in medial or central quadrants in standard group

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided