NCT03273348

Brief Summary

Role of Oncoplastic Breast Surgery In Breast Cancer Treatement

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

September 28, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2019

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

August 25, 2017

Last Update Submit

September 2, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • oncological safety

    the pathological report postoperative reveals safety free margins

    for 2 weaks

Secondary Outcomes (3)

  • postoperative recurrence of malignany

    assess for 1 year postoperative

  • mortality rate

    up to 3 months postoperative for each case

  • post operative skin edge ischemia

    assess for 1 month postoperative

Study Arms (1)

oncoplastic breast surgery

OTHER

This study aim to evaluate the outcome on oncological side and patient satisfaction on the aesthetic side with skin-sparing mastectomy and immediate breast reconstruction for patients with early breast cancer .

Procedure: Oncoplastic breast surgery

Interventions

Oncoplastic breast surgeryPROCEDURE

, Skin sparing mastectomy and immediate breast reconstruction will be conducted to all women included in the study, transverse rectus abdominis musculocutaneous flap recostruction and latissimus dorsi myocutaneous pedicle-flap with and without implant

Also known as: breast reconstruction
oncoplastic breast surgery

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The study will include 30 women with early-stage breast cancer treated at general surgery department, Assuit University Hospitals
  • Selection criteria include women with a pre-operative diagnosis (clinical examination, imaging and needle biopsy) of Tis, T1 and T2 tumours without extensive skin involvement.

You may not qualify if:

  • contraindaction for general anesthesia
  • Positive margin requiring mastectomy
  • Insufficient remaining breast volume
  • Diffuse microcalcifications
  • Multicentric tumor?
  • Inflammatory breast cancer
  • Previous radiotherapy
  • Concomitant disease ( Diabetes, smoking )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (3)

  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

    PMID: 21351269BACKGROUND

  • Veiga DF, Veiga-Filho J, Ribeiro LM, Archangelo I Jr, Balbino PF, Caetano LV, Novo NF, Ferreira LM. Quality-of-life and self-esteem outcomes after oncoplastic breast-conserving surgery. Plast Reconstr Surg. 2010 Mar;125(3):811-7. doi: 10.1097/PRS.0b013e3181ccdac5.

    PMID: 20195109BACKGROUND

  • Losken A, Dugal CS, Styblo TM, Carlson GW. A meta-analysis comparing breast conservation therapy alone to the oncoplastic technique. Ann Plast Surg. 2014 Feb;72(2):145-9. doi: 10.1097/SAP.0b013e3182605598.

    PMID: 23503430BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammaplasty

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsPlastic Surgery ProceduresSurgical Procedures, Operative

Central Study Contacts

Alaa mohammed sebaiy, MSc

CONTACT

01142950929ams_2100@yahoo.com

faculty of medicine assiut university

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study aim to evaluate the outcome on oncological side and patient satisfaction on the aesthetic side with skin-sparing mastectomy and immediate breast reconstruction for patients with early breast cancer . . The obtained results may contribute to the formulation of guidelines achieving low morbidity, high levels of patient satisfaction and oncological safety in breast cancer patients.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
general surgery specialist

Study Record Dates

First Submitted

August 25, 2017

First Posted

September 6, 2017

Study Start

September 28, 2017

Primary Completion

September 28, 2019

Study Completion

October 28, 2019

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations

EG(1)