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Role of Oncoplastic Breast Surgery In Breast Cancer Treatement

2. september 2017 opdateret af: Alaa Mohammed Sebaiy, Assiut University
Role of Oncoplastic Breast Surgery In Breast Cancer Treatement

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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:

  1. volume of tissue to be excised;
  2. tumour location;
  3. breast size and glandular density;
  4. patient related risk factors, particularly smoking, obesity, diabetes, previous surgery;
  5. 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)

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: faculty of medicine assiut university

Studiesteder

      • Assiut, Egypten
        • Assiut University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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 )

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: oncoplastic breast surgery
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 .
, 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
Andre navne:
  • brystrekonstruktion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
oncological safety
Tidsramme: for 2 weaks
the pathological report postoperative reveals safety free margins
for 2 weaks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
dødeligheden
Tidsramme: op til 3 måneder efter operationen for hvert tilfælde
antal dødsfald intraoperativt og postoperativt relateret til operation
op til 3 måneder efter operationen for hvert tilfælde
postoperative recurrence of malignany
Tidsramme: assess for 1 year postoperative
follow up any malignancy recurrence post operative by MRI , Mammograghy and look for any new skin nodule appearance
assess for 1 year postoperative
post operative skin edge ischemia
Tidsramme: assess for 1 month postoperative
look for any postoperative ischemia appear in the skin flap as appearance of dark unhealthy tissue in the edge
assess for 1 month postoperative

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

28. september 2017

Primær færdiggørelse (Forventet)

28. september 2019

Studieafslutning (Forventet)

28. oktober 2019

Datoer for studieregistrering

Først indsendt

25. august 2017

Først indsendt, der opfyldte QC-kriterier

2. september 2017

Først opslået (Faktiske)

6. september 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 17200114

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

postoperative imaging such as mammogram, ultrasound and MRI studies

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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