NCT02923635

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
Last Updated

October 4, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

October 2, 2016

Last Update Submit

October 3, 2016

Conditions

Breast Cancer

Keywords

Oncoplastic breast surgeryStandard Wide Local Excision

Outcome Measures

Primary Outcomes (1)

  • Margins in all specimens measured in millimeters

    Two years

Secondary Outcomes (1)

  • Patient satisfaction assessed using questionnaire

    two years

Study Arms (2)

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

Standard wide local excision.PROCEDURE

Excision of breast cancer without integration of plastic technique

Standard Wide Local Excision group
oncoplastic breast surgery.PROCEDURE

Integration of plastic techniques with oncological surgery for resection of breast cancer.

Oncoplastic group

Eligibility Criteria

AgeUp to 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of General surgery

Study Record Dates

First Submitted

October 2, 2016

First Posted

October 4, 2016

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

June 1, 2016

Last Updated

October 4, 2016

Record last verified: 2016-10