NCT02901223

Brief Summary

The aim of this study is to asses the oncological safety of oncoplastic breast surgery, its impact on patient satisfaction and is it worthy for general breast surgeon to learn different oncoplastic techniques.

Trial Health

87
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

Geographic Reach
1 country

1 active site

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
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

August 31, 2016

Last Update Submit

September 10, 2016

Conditions

Non Metastatic Breast Cancer

Keywords

Oncoplastic breast surgeryoncological safetypatient satisfaction

Outcome Measures

Primary Outcomes (2)

  • Margins in all specimens measured in millimeters.

    two years.

  • Patient satisfaction assessed using questionnaire.

    Two years.

Study Arms (2)

Quadrantectomy group

ACTIVE COMPARATOR

35 female patients with non metastatic breast cancer who had standard conservative breast surgery by general breast surgeons.

Procedure: Standard quadrantectomy

oncoplastic group

ACTIVE COMPARATOR

35 female patients with non metastatic breast cancer who had oncoplastic techniques for tumor resection by well trained oncoplastic breast surgeons.

Procedure: oncoplastic breast surgery

Interventions

Standard quadrantectomyPROCEDURE

standard conservative surgery with no use of any plastic techniques

Quadrantectomy group
oncoplastic breast surgeryPROCEDURE

Integration of plastic techniques with oncological procedures

oncoplastic group

Eligibility Criteria

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

You may qualify if:

  • Stage 1, 2 breast cancer
  • Non metastatic breast caner
  • Singing informed consent

You may not qualify if:

  • Metastatic breast cancer
  • Stage 3, 4 breast cancer
  • Inflammatory breast cancer
  • Multicentric/multifocal disease
  • Ductal carcinoma in situ
  • Patients older than 60 years
  • History of breast surgery in oncoplastic group
  • Co-morbidity in oncoplastic group
  • Patients more than 60 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasser mohamed abdel-samii El Ghamrini

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

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

August 31, 2016

First Posted

September 15, 2016

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

May 1, 2016

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

EG(1)