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Role of Oncoplastic Breast Surgery In Breast Cancer Treatement

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Oncoplastic breast surgery
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • The study will include 30 women with early-stage breast cancer treated at general surgery department, Assuit University Hospitals
  • For all patients an informed consent for their inclusion in the study including the use of images will be obtained.
  • 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.

Exclusion Criteria:

  • • 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 )

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

oncoplastic breast surgery

Arm Description

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 .

Outcomes

Primary Outcome Measures

oncological safety
the pathological report postoperative reveals safety free margins

Secondary Outcome Measures

postoperative recurrence of malignany
follow up any malignancy recurrence post operative by MRI , Mammograghy and look for any new skin nodule appearance
mortality rate
number of deaths intraoperative and postoperative related to surgery
post operative skin edge ischemia
look for any postoperative ischemia appear in the skin flap as appearance of dark unhealthy tissue in the edge

Full Information

First Posted
August 25, 2017
Last Updated
September 2, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03273348
Brief Title
Role of Oncoplastic Breast Surgery In Breast Cancer Treatement
Official Title
Role of Oncoplastic Breast Surgery In Breast Cancer Treatement
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 28, 2017 (Anticipated)
Primary Completion Date
September 28, 2019 (Anticipated)
Study Completion Date
October 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Role of Oncoplastic Breast Surgery In Breast Cancer Treatement
Detailed Description
Breast cancer is the most common cancer in women throughout the world (FerlayJ.,2010) . The overarching principle guiding surgical management of women with breast cancer remains the oncological safety. The mainstay of satisfactory local control continues to be adequate clearance of the primary tumour and involved axillary lymph nodes. Improvements in understanding of tumour biology have enabled the risk of loco-regional recurrence and distant events to be further reduced by adjuvant, or neo-adjuvant, radiotherapy and systemic treatments. In keeping with this, breast conserving therapy has become well established as the treatment of choice for most women with early breast cancer . However, approximately one-third of women still undergo mastectomy, either due to patient preference or in cases where breast conservation is not oncologically or aesthetically compatible with the size or distribution of disease. (Reefy et al; 2010) The primary aim of BCS is preservation of the breast while adhering to oncologic principles, with the secondary objective to provide breast aesthetics. In recent years, with advances in early detection and adjuvant therapy life expectancy has prolonged in breast cancer prolonged and quality of life issues have gained importance (Veiga DF.,2010) Skin sparing mastectomy involves the en-bloc removal of all glandular tissue including the nipple-areola complex and in some cases adjacent biopsy scars and skin overlying superficial tumours. In contrast to conventional mastectomy, there is maximal preservation of the remaining breast skin envelope and infra-mammary fold that facilitate immediate breast reconstruction with autologous tissue and/or prosthetic implants by utilising the native skin envelope to optimise the contour, texture, colour and scarring of the reconstructed breast. (Cunnick and Mokbel; 2004). Due to the positive results obtained in the surgical treatment of breast cancer, the prevalence of this technique is increasing throughout the world and our country. There was an approximately 2.3-fold increase in OBS publications over the last five years (Losken A et al.,2014) Surgical planning and timing of reconstruction should include breast volume, tumor location, the extent of glandular tissue resected, enabling each patient to receive an individual "custom-made" reconstruction. With immediate oncoplastic approach, the surgical process is smooth since oncological and reconstructive surgery can be associated in one operative setting. Additionally, because there is no scar and fibrosis tissue, breast reshaping is easier, and the aesthetic is improved (Munhoz AM et al .,2011) When considering a patient for an oncoplastic breast conserving procedure, the following points must be considered: volume of tissue to be excised; tumour location; breast size and glandular density; patient related risk factors, particularly smoking, obesity, diabetes, previous surgery; adjuvant therapies. Excision volume is the single, most predictive factor for breast deformity (Clough KB et al .,2010). Recently, several studies have contributed to the evidence base supporting the oncological adequacy of skin sparing mastectomy in selected early-stage breast cancer , excluding inflammatory breast cancer and tumours with extensive involvement of the skin. In this study the oncological safety, post-operative morbidity and patients' satisfaction with skin sparing mastectomy and immediate breast reconstruction will be evaluated in a prospective cohort of women with early-stage breast cancer. (Cunnick and Mokbel; 2004) Skin sparing mastectomy and immediate breast reconstruction is particularly attractive for women with ductal Carcinoma In-Situ in view of the fact that post-mastectomy radiotherapy is not given to the reconstructed breast and the risk of loco-regional recurrence is very low. (Spiegel and Butler; 2003) Most women who will undergo skin sparing mastectomy and immediate breast reconstruction for early-stage breast cancer will not require post-mastectomy radiotherapy. However, post-mastectomy radiotherapy has been shown to reduce loco-regional recurrence and improve survival for patients with three or more involved regional lymph nodes or tumors >5 cm. (Recht and Edge; 2003) Mastectomy can also be indicated in several non-invasive conditions. Ductal Carcinoma In-Situ may necessitate mastectomy when the lesions are extensive, multi-centric or recurrent, however, patients request to be managed in this way. Mastectomy for ductal Carcinoma In-Situ is associated with cure rates in excess of 98%. (Mokbel; 2003)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
oncoplastic breast surgery
Arm Type
Other
Arm Description
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 .
Intervention Type
Procedure
Intervention Name(s)
Oncoplastic breast surgery
Other Intervention Name(s)
breast reconstruction
Intervention Description
, 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
Primary Outcome Measure Information:
Title
oncological safety
Description
the pathological report postoperative reveals safety free margins
Time Frame
for 2 weaks
Secondary Outcome Measure Information:
Title
postoperative recurrence of malignany
Description
follow up any malignancy recurrence post operative by MRI , Mammograghy and look for any new skin nodule appearance
Time Frame
assess for 1 year postoperative
Title
mortality rate
Description
number of deaths intraoperative and postoperative related to surgery
Time Frame
up to 3 months postoperative for each case
Title
post operative skin edge ischemia
Description
look for any postoperative ischemia appear in the skin flap as appearance of dark unhealthy tissue in the edge
Time Frame
assess for 1 month postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The study will include 30 women with early-stage breast cancer treated at general surgery department, Assuit University Hospitals For all patients an informed consent for their inclusion in the study including the use of images will be obtained. 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. Exclusion Criteria: • 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 )
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa mohammed sebaiy, MSc
Phone
01142950929
Email
ams_2100@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
faculty of medicine assiut university
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
postoperative imaging such as mammogram, ultrasound and MRI studies
Citations:
PubMed Identifier
21351269
Citation
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.
Results Reference
background
PubMed Identifier
20195109
Citation
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.
Results Reference
background
PubMed Identifier
23503430
Citation
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.
Results Reference
background

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Role of Oncoplastic Breast Surgery In Breast Cancer Treatement

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