NCT03012152

Brief Summary

This non randomized study is a comparative study between standard conservative breast surgery and oncoplastic surgery as regard margin status and 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 P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

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
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 3, 2017

Last Update Submit

January 4, 2017

Conditions

Breastcancer

Keywords

Oncoplastic surgeryStandard conservative surgeryPatient satisfactionMargin Status

Outcome Measures

Primary Outcomes (1)

  • Margins in all specimens measured in millimeters 2.

    2 years

Study Arms (2)

Standard conservative group

ACTIVE COMPARATOR

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

Procedure: Standard conservative breast surgery

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 conservative breast surgeryPROCEDURE
Standard conservative group
Oncoplastic breast surgeryPROCEDURE
Oncoplastic group

Eligibility Criteria

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

You may qualify if:

  • Female Patients with stage 1,2 breast cancer.

You may not qualify if:

  • Patients \>60 years.
  • Patients with previous breast surgery.
  • patients candidate for mastectomy or palliative excision. Patients with collagen disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of General surgery

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 6, 2017

Study Start

September 1, 2012

Primary Completion

May 1, 2013

Study Completion

September 1, 2016

Last Updated

January 6, 2017

Record last verified: 2017-01