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  1. Article ; Online: Which lesions with a radiological or core biopsy diagnosis of fibroadenoma should be excised?

    Lee, Ahs / James, J / Whisker, L / Rakha, E A / Ellis, I O

    Annals of the Royal College of Surgeons of England

    2021  Volume 104, Issue 5, Page(s) 361–366

    Abstract: Introduction: A recent Association of Breast Surgery summary statement on fibroadenoma management recommends excision only for cellular fibroepithelial lesions and rapidly growing lesions with a core biopsy diagnosis of fibroadenoma; persistent pain is ... ...

    Abstract Introduction: A recent Association of Breast Surgery summary statement on fibroadenoma management recommends excision only for cellular fibroepithelial lesions and rapidly growing lesions with a core biopsy diagnosis of fibroadenoma; persistent pain is a relative indication for excision.
    Methods: This retrospective study looked at the impact this approach would have on the diagnosis of phyllodes tumours.
    Results: From 2014 to 2018, there were 1,058 core biopsy diagnoses of fibroadenoma; 112 lesions were excised, of which 98 were fibroadenomas, 4 were hamartomas and 10 were phyllodes tumours. In this group, an excision diagnosis of phyllodes tumour was associated with size more than 40 mm, age more than 40 years and radiological suspicion of phyllodes tumour or carcinoma. One hundred and sixty-six excised fibroepithelial lesions with no previous core biopsy included eight phyllodes tumours; in this group, rapid growth was associated with phyllodes tumour diagnosis. Twelve of the 26 fibroepithelial lesions classified as B3 (cellular fibroepithelial lesion or phyllodes tumour) were diagnosed as phyllodes tumours on excision. Using a combination of radiological, clinical and pathological features it was possible to create an excision policy that would recommend excision of 22 of the 31 phyllodes tumours in this period. Eight of the nine 'missed' phyllodes tumours were benign.
    Conclusion: The Association of Breast Surgery summary statement will reduce the number of fibroadenomas excised, but may also result in delayed diagnosis of some phyllodes tumours. Appropriate safety netting advice should be provided to identify rapidly growing lesions.
    MeSH term(s) Adult ; Biopsy, Large-Core Needle ; Breast Neoplasms/diagnosis ; Breast Neoplasms/pathology ; Breast Neoplasms/surgery ; Diagnosis, Differential ; Female ; Fibroadenoma/diagnosis ; Fibroadenoma/pathology ; Fibroadenoma/surgery ; Humans ; Phyllodes Tumor/diagnosis ; Phyllodes Tumor/pathology ; Phyllodes Tumor/surgery ; Retrospective Studies
    Language English
    Publishing date 2021-12-23
    Publishing country England
    Document type Journal Article
    ZDB-ID 80044-2
    ISSN 1478-7083 ; 0035-8843
    ISSN (online) 1478-7083
    ISSN 0035-8843
    DOI 10.1308/rcsann.2021.0208
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Current practice and provision of oncoplastic breast-conserving surgery in the UK: results of the ANTHEM national practice questionnaire.

    Davies, Charlotte / Whisker, Lisa / Skillman, Joanna / Macmillan, Douglas / Holcombe, Christopher / Fairbrother, Patricia / Potter, Shelley

    Breast cancer research and treatment

    2023  Volume 200, Issue 2, Page(s) 163–170

    Abstract: Purpose: Oncoplastic breast-conserving surgery (OPBCS) may be a better option than mastectomy ± immediate breast reconstruction (IBR) for women with breast cancer but studies directly comparing the techniques are lacking. We surveyed UK breast units to ... ...

    Abstract Purpose: Oncoplastic breast-conserving surgery (OPBCS) may be a better option than mastectomy ± immediate breast reconstruction (IBR) for women with breast cancer but studies directly comparing the techniques are lacking. We surveyed UK breast units to determine the current practice of OPBCS to inform the design of a future comparative study.
    Methods: An electronic survey was developed to explore the current practice of OPBCS. This included the local availability of volume displacement and/or replacement techniques; number of cases performed; contraindications and approach to contralateral symmetrisation. Summary data for each survey item were calculated and overall provision of care examined.
    Results: 58 UK centres completed the survey, including 43 (74%) stand-alone breast and 15 (26%) combined breast/plastics units. Over 40% of units (n = 24) treated more than 500 cancers/year. Most units offered volume displacement techniques (TMs) (97%). Over two-thirds (n = 39. 67%) of units offered local perforator flaps (LPF). Approximately a half of units (10/19) not performing LPF were planning to introduce them in the next 12-24 months. A third (n = 19, 33%) of units routinely performed simultaneous contralateral symmetrisation mostly with two-surgeon operating. There were limited oncological restrictions to OPBCS with no contraindications for multifocal cancers in most centres; 65% of units (36/55) offered OPBCS for multicentric disease. Extensive DCIS was a contraindication in a minority of units.
    Conclusions: OPBCS is widely available in the UK but contraindications and approaches to contralateral symmetrisation were variable. Work is now needed to prospectively evaluate the outcomes of OPBCS vs mastectomy ± IBR to support informed decision-making.
    MeSH term(s) Female ; Humans ; Mastectomy, Segmental/methods ; Mastectomy/methods ; Breast Neoplasms/surgery ; Mammaplasty/methods ; Perforator Flap ; Surveys and Questionnaires ; United Kingdom/epidemiology
    Language English
    Publishing date 2023-05-22
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 604563-7
    ISSN 1573-7217 ; 0167-6806
    ISSN (online) 1573-7217
    ISSN 0167-6806
    DOI 10.1007/s10549-023-06924-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Experiences of implant loss after immediate implant-based breast reconstruction: qualitative study.

    Mahoney, B / Walklet, E / Bradley, E / Thrush, S / Skillman, J / Whisker, L / Barnes, N / Holcombe, C / Potter, S

    BJS open

    2020  Volume 4, Issue 3, Page(s) 380–390

    Abstract: Background: Immediate implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK, but almost one in ten women experience implant loss and reconstructive failure after this technique. Little is known ... ...

    Abstract Background: Immediate implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK, but almost one in ten women experience implant loss and reconstructive failure after this technique. Little is known about how implant loss impacts on patients' quality of life. The first phase of the Loss of implant Breast Reconstruction (LiBRA) study aimed to use qualitative methods to explore women's experiences of implant loss and develop recommendations to improve care.
    Methods: Semistructured interviews were conducted with a purposive sample of women who experienced implant loss after immediate IBBR, performed for malignancy or risk reduction across six centres. Interviews explored decision-making regarding IBBR, and experiences of implant loss and support received. Thematic analysis was used to explore the qualitative interview data. Sampling, data collection and analysis were undertaken concurrently and iteratively until data saturation was achieved.
    Results: Twenty-four women were interviewed; 19 had surgery for malignancy and five for risk reduction. The median time between implant loss and interview was 42 (range 22-74) months. Ten women had undergone secondary reconstruction, two were awaiting surgery, and 12 had declined further reconstruction. Three key themes were identified: the need for accurate information about the risks and benefits of IBBR; the need for more information about 'early-warning' signs of postoperative problems, to empower women to seek help; and better support following implant loss.
    Conclusion: Implant loss is a devastating event for many women. Better preoperative information and support, along with holistic patient-centred care when complications occur, may significantly improve the experience and outcome of care.
    MeSH term(s) Adult ; Aged ; Breast Implantation/methods ; Breast Implants/adverse effects ; Breast Neoplasms/psychology ; Breast Neoplasms/surgery ; Female ; Humans ; Interviews as Topic ; Mammaplasty/adverse effects ; Mammaplasty/methods ; Middle Aged ; Postoperative Complications/etiology ; Prosthesis Failure ; Qualitative Research ; Quality of Life ; United Kingdom
    Language English
    Publishing date 2020-03-17
    Publishing country England
    Document type Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
    ISSN 2474-9842
    ISSN (online) 2474-9842
    DOI 10.1002/bjs5.50275
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Angiosarcoma arising in the capsule of a mammary silicone implant.

    Rajan, Sreekumar Sundara / Haider, Asma / Burrell, Helen / Whisker, Lisa / Tamimy, Muhammad / McCulloch, Tom / Lee, Andrew H S

    Diagnostic cytopathology

    2022  Volume 50, Issue 5, Page(s) E119–E122

    Abstract: A 40-year-old woman with silicone implants inserted 21 years before presented with sudden onset of painful right breast swelling. Clinical examination revealed a firm swollen breast with appearance of old bruising. Ultrasound showed fluid around the ... ...

    Abstract A 40-year-old woman with silicone implants inserted 21 years before presented with sudden onset of painful right breast swelling. Clinical examination revealed a firm swollen breast with appearance of old bruising. Ultrasound showed fluid around the implant. Cytology of the fluid showed cells with large pleomorphic nuclei with prominent nucleoli including elongated forms and very occasional vacuoles. The cell block also contained small fragments with atypical spindle cells around slit-like spaces that were positive for CD31 and CD34. MRI showed a 25 mm serpiginous area of enhancement on the inner aspect of the fibrous capsule with haematoma between the capsule and the implant. The capsule and adjacent area were excised. Histology showed angiosarcoma extending from the inner aspect of the capsule into the cavity around the implant. The location of the tumour on the inner aspect of the capsule is the same site that breast implant associated anaplastic large cell lymphomas arise and suggests a possible causal link between the implant and the angiosarcoma. This case emphasises the value of cytological assessment of fluid around breast implants and the role of cell blocks and immunohistochemistry.
    MeSH term(s) Adult ; Breast Implantation/adverse effects ; Breast Implants/adverse effects ; Breast Neoplasms/complications ; Female ; Hemangiosarcoma/etiology ; Humans ; Lymphoma, Large-Cell, Anaplastic/diagnostic imaging ; Lymphoma, Large-Cell, Anaplastic/etiology ; Silicones
    Chemical Substances Silicones
    Language English
    Publishing date 2022-01-07
    Publishing country United States
    Document type Case Reports ; Journal Article
    ZDB-ID 632710-2
    ISSN 1097-0339 ; 8755-1039
    ISSN (online) 1097-0339
    ISSN 8755-1039
    DOI 10.1002/dc.24919
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Patient-reported outcomes of immediate implant-based breast reconstruction with and without biological or synthetic mesh.

    Sewart, E / Turner, N L / Conroy, E J / Cutress, R I / Skillman, J / Whisker, L / Thrush, S / Barnes, N / Holcombe, C / Potter, S

    BJS open

    2021  Volume 5, Issue 1

    Abstract: Background: Biological and synthetic meshes may improve the outcomes of immediate implant-based breast reconstruction (IBBR) by facilitating single-stage procedures and improving cosmesis. Supporting evidence is, however, limited. The aim of this study ... ...

    Abstract Background: Biological and synthetic meshes may improve the outcomes of immediate implant-based breast reconstruction (IBBR) by facilitating single-stage procedures and improving cosmesis. Supporting evidence is, however, limited. The aim of this study was to explore the impact of biological and synthetic mesh on patient-reported outcomes (PROs) of IBBR 18 months after surgery.
    Methods: Consecutive women undergoing immediate IBBR between February 2014 and June 2016 were recruited to the study. Demographic, operative, oncological and 3-month complication data were collected, and patients received validated BREAST-Q questionnaires at 18 months. The impact of different IBBR techniques on PROs were explored using mixed-effects regression models adjusted for clinically relevant confounders, and including a random effect to account for clustering by centre.
    Results: A total of 1470 participants consented to receive the questionnaire and 891 completed it. Of these, 67 women underwent two-stage submuscular reconstructions. Some 764 patients had a submuscular reconstruction with biological mesh (495 women), synthetic mesh (95) or dermal sling (174). Fourteen patients had a prepectoral reconstruction. Compared with two-stage submuscular reconstructions, no significant differences in PROs were seen in biological or synthetic mesh-assisted or dermal sling procedures. However, patients undergoing prepectoral IBBR reported better satisfaction with breasts (adjusted mean difference +6.63, 95 per cent c.i. 1.65 to11.61; P = 0.009). PROs were similar to those in the National Mastectomy and Breast Reconstruction Audit 2008-2009 cohort, which included two-stage submuscular procedures only.
    Conclusion: This study found no difference in PROs of subpectoral IBBR with or without biological or synthetic mesh, but provides early data to suggest improved satisfaction with breasts following prepectoral reconstruction. Robust evaluation is required before this approach can be adopted as standard practice.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Breast Implantation/adverse effects ; Breast Implantation/methods ; Breast Neoplasms/pathology ; Breast Neoplasms/surgery ; Female ; Humans ; Linear Models ; Logistic Models ; Mastectomy/adverse effects ; Mastectomy/methods ; Middle Aged ; Patient Reported Outcome Measures ; Patient Satisfaction ; Postoperative Complications/etiology ; Postoperative Complications/psychology ; Prospective Studies ; Surgical Mesh ; United Kingdom ; Young Adult
    Language English
    Publishing date 2021-02-20
    Publishing country England
    Document type Comparative Study ; Journal Article ; Multicenter Study ; Observational Study ; Research Support, Non-U.S. Gov't
    ISSN 2474-9842
    ISSN (online) 2474-9842
    DOI 10.1093/bjsopen/zraa063
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Oncoplastic techniques: Attitudes and changing practice amongst breast and plastic surgeons in Great Britain.

    Challoner, T / Skillman, J / Wallis, K / Vourvachis, M / Whisker, L / Hardwicke, J

    Breast (Edinburgh, Scotland)

    2017  Volume 34, Page(s) 58–64

    Abstract: Purpose: The availability, acceptability and practice of oncoplastic surgery has increased over the last 5 years. This study aims to describe how the breast and plastic surgical workforce has adapted to provide oncoplastic breast surgery.: Methods: A ...

    Abstract Purpose: The availability, acceptability and practice of oncoplastic surgery has increased over the last 5 years. This study aims to describe how the breast and plastic surgical workforce has adapted to provide oncoplastic breast surgery.
    Methods: A questionnaire was distributed to members of the Association of Breast Surgery and BAPRAS, and results compared to a survey completed in 2010.
    Results: In 2010, 228 respondents completed the survey compared to 237 in 2015, of whom 204 were consultants (105 General or Breast Surgeons and 99 Plastic Surgeons). The range of procedures performed by Plastic Surgeons has remained static, the General and Breast Surgeons are performing proportionally more therapeutic mammaplasty (p < 0.001), breast reduction/mastopexy, and latissimus dorsi reconstructions. In 2015, surgeons are less concerned about the risks of lipomodelling than in 2010, with an increase the proportion of breast (55% vs. 26%) and plastic (91% vs. 58%) surgeons performing the technique.
    Discussion: Specific concerns about oncoplastic surgery have decreased over the last five years, with a greater proportion of surgeons performing oncoplastic surgery including lipomodelling. The majority of breast surgeons in 2015 remain interested in further training in oncoplastic techniques (75%) but over the last 5 years, plastic surgeons interest in further training in oncoplastic surgery has dropped from 62% to 27%. About half of all breast and plastic surgeons felt that oncoplastic surgery should be available for all women and oncological and wound healing concerns had significantly reduced between 2010 and 2015 (p < 0.05).
    Language English
    Publishing date 2017-08
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1143210-x
    ISSN 1532-3080 ; 0960-9776
    ISSN (online) 1532-3080
    ISSN 0960-9776
    DOI 10.1016/j.breast.2017.04.010
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Current practice and short-term outcomes of therapeutic mammaplasty in the international TeaM multicentre prospective cohort study.

    O'Connell, R L / Baker, E / Trickey, A / Rattay, T / Whisker, L / Macmillan, R D / Potter, S

    The British journal of surgery

    2018  Volume 105, Issue 13, Page(s) 1778–1792

    Abstract: Background: Therapeutic mammaplasty, which combines breast reduction and mastopexy techniques with tumour excision, may extend the boundaries of breast-conserving surgery and improve outcomes for patients, but current practice is unknown and high- ... ...

    Abstract Background: Therapeutic mammaplasty, which combines breast reduction and mastopexy techniques with tumour excision, may extend the boundaries of breast-conserving surgery and improve outcomes for patients, but current practice is unknown and high-quality outcome data are lacking. This prospective multicentre cohort study aimed to explore the practice and short-term outcomes of the technique.
    Methods: Consecutive patients undergoing therapeutic mammaplasty at participating centres between 1 September 2016 and 30 June 2017 were recruited to the study. Demographic, preoperative, operative, oncological and complication data were collected. The primary outcome was unplanned reoperation for complications within 30 days of surgery. Secondary outcomes included re-excision rates and time to adjuvant therapy.
    Results: Overall, 880 patients underwent 899 therapeutic mammaplasty procedures at 50 centres. The most common indications were avoidance of poor cosmetic outcomes associated with standard breast-conserving surgery (702 procedures, 78·1 per cent) or avoidance of mastectomy (379, 42·2 per cent). Wise-pattern skin incisions were the most common (429 of 899, 47·7 per cent), but a range of incisions and nipple-areola pedicles were used. Immediate contralateral symmetrization was performed in one-third of cases (284 of 880, 32·3 per cent). In total, 205 patients (23·3 per cent) developed a complication, but only 25 (2·8 per cent) required reoperation. Median postoperative lesion size was 24·5 (i.q.r. 16-38) mm. Incomplete excision was seen in 132 procedures (14·7 per cent), but completion mastectomy was required for only 51 lesions (5·7 per cent). Median time to adjuvant therapy was 54 (i.q.r. 42-66) days.
    Conclusion: Therapeutic mammaplasty is a safe and effective alternative to mastectomy or standard breast-conserving surgery. Further work is required to explore the impact of the technique on quality of life, and to establish cost-effectiveness.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Breast Neoplasms/surgery ; Carcinoma, Ductal, Breast/surgery ; Clinical Decision-Making ; Female ; Humans ; Italy ; Mammaplasty/methods ; Mammaplasty/statistics & numerical data ; Mastectomy/methods ; Mastectomy/statistics & numerical data ; Middle Aged ; Patient Care Planning ; Patient Readmission/statistics & numerical data ; Perforator Flap/statistics & numerical data ; Postoperative Complications/etiology ; Postoperative Complications/surgery ; Practice Patterns, Physicians'/statistics & numerical data ; Preoperative Care ; Prospective Studies ; Reoperation/statistics & numerical data ; Treatment Outcome ; United Kingdom ; Young Adult
    Language English
    Publishing date 2018-08-22
    Publishing country England
    Document type Journal Article ; Multicenter Study ; Observational Study
    ZDB-ID 2985-3
    ISSN 1365-2168 ; 0263-1202 ; 0007-1323 ; 1355-7688
    ISSN (online) 1365-2168
    ISSN 0263-1202 ; 0007-1323 ; 1355-7688
    DOI 10.1002/bjs.10959
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Therapeutic mammaplasty is a safe and effective alternative to mastectomy with or without immediate breast reconstruction.

    Potter, S / Trickey, A / Rattay, T / O'Connell, R L / Dave, R / Baker, E / Whisker, L / Skillman, J / Gardiner, M D / Macmillan, R D / Holcombe, C

    The British journal of surgery

    2020  Volume 107, Issue 7, Page(s) 832–844

    Abstract: Background: Therapeutic mammaplasty (TM) may be an alternative to mastectomy, but few well designed studies have evaluated the success of this approach or compared the short-term outcomes of TM with mastectomy with or without immediate breast ... ...

    Abstract Background: Therapeutic mammaplasty (TM) may be an alternative to mastectomy, but few well designed studies have evaluated the success of this approach or compared the short-term outcomes of TM with mastectomy with or without immediate breast reconstruction (IBR). Data from the national iBRA-2 and TeaM studies were combined to compare the safety and short-term outcomes of TM and mastectomy with or without IBR.
    Methods: The subgroup of patients in the TeaM study who underwent TM to avoid mastectomy were identified, and data on demographics, complications, oncology and adjuvant treatment were compared with those of patients undergoing mastectomy with or without IBR in the iBRA-2 study. The primary outcome was the percentage of successful breast-conserving procedures in the TM group. Secondary outcomes included postoperative complications and time to adjuvant therapy.
    Results: A total of 2916 patients (TM 376; mastectomy 1532; mastectomy and IBR 1008) were included in the analysis. Patients undergoing TM were more likely to be obese and to have undergone bilateral surgery than those having IBR. However, patients undergoing mastectomy with or without IBR were more likely to experience complications than the TM group (TM: 79, 21·0 per cent; mastectomy: 570, 37·2 per cent; mastectomy and IBR: 359, 35·6 per cent; P < 0·001). Breast conservation was possible in 87·0 per cent of patients who had TM, and TM did not delay adjuvant treatment.
    Conclusion: TM may allow high-risk patients who would not be candidates for IBR to avoid mastectomy safely. Further work is needed to explore the comparative patient-reported and cosmetic outcomes of the different approaches, and to establish long-term oncological safety.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Female ; Humans ; Kaplan-Meier Estimate ; Logistic Models ; Mammaplasty/adverse effects ; Mammaplasty/methods ; Mastectomy/adverse effects ; Mastectomy/methods ; Middle Aged ; Postoperative Complications/epidemiology ; Postoperative Complications/etiology ; Proportional Hazards Models ; Treatment Outcome ; Young Adult
    Language English
    Publishing date 2020-02-19
    Publishing country England
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2985-3
    ISSN 1365-2168 ; 0263-1202 ; 0007-1323 ; 1355-7688
    ISSN (online) 1365-2168
    ISSN 0263-1202 ; 0007-1323 ; 1355-7688
    DOI 10.1002/bjs.11468
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Biological and synthetic mesh assisted breast reconstruction procedures: Joint guidelines from the Association of Breast Surgery and the British Association of Plastic, Reconstructive and Aesthetic Surgeons.

    Whisker, Lisa / Barber, Matthew / Egbeare, Donna / Gandhi, Ashu / Gilmour, Adam / Harvey, James / Martin, Lee / Tillett, Rachel / Potter, Shelley

    European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology

    2021  Volume 47, Issue 11, Page(s) 2807–2813

    Abstract: These guidelines have been produced with the involvement of the Association of Breast Surgery and the British Association of Plastic, Reconstructive and Aesthetic Surgeons. Recommendations have been derived after a review of published data regarding the ... ...

    Abstract These guidelines have been produced with the involvement of the Association of Breast Surgery and the British Association of Plastic, Reconstructive and Aesthetic Surgeons. Recommendations have been derived after a review of published data regarding the use of acellular dermal matrix (ADM), biological and synthetic mesh in breast reconstruction. The guidelines represent a consensus opinion on the optimal management of patients having biological or synthetic mesh assisted breast reconstruction informed by peer-review publications. The Guidelines should be used to inform clinical decision making. Ultimately, members of the MDT remain responsible for the treatment of patients under their care.
    MeSH term(s) Breast Implants ; Breast Neoplasms/surgery ; Esthetics ; Female ; Humans ; Mammaplasty/instrumentation ; Surgical Mesh
    Language English
    Publishing date 2021-05-25
    Publishing country England
    Document type Journal Article ; Practice Guideline
    ZDB-ID 632519-1
    ISSN 1532-2157 ; 0748-7983
    ISSN (online) 1532-2157
    ISSN 0748-7983
    DOI 10.1016/j.ejso.2021.05.036
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  10. Article ; Online: Best-BRA (Is subpectoral or prepectoral implant placement best in immediate breast reconstruction?): a protocol for a pilot randomised controlled trial of subpectoral versus prepectoral immediate implant-based breast reconstruction in women following mastectomy.

    Roberts, Kirsty / Mills, Nicola / Metcalfe, Chris / Lane, Athene / Clement, Clare / Hollingworth, William / Taylor, Jodi / Holcombe, Chris / Skillman, Joanna / Fairhurst, Katherine / Whisker, Lisa / Cutress, Ramsey / Thrush, Steven / Fairbrother, Patricia / Potter, Shelley

    BMJ open

    2021  Volume 11, Issue 11, Page(s) e050886

    Abstract: Background: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and ... ...

    Abstract Background: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure following mastectomy. IBBR techniques are evolving rapidly, with mesh-assisted subpectoral reconstruction becoming the standard of care and more recently, prepectoral techniques being introduced. These muscle-sparing techniques may reduce postoperative pain, avoid implant animation and improve cosmetic outcomes and have been widely adopted into practice. Although small observational studies have failed to demonstrate any differences in the clinical or patient-reported outcomes of prepectoral or subpectoral reconstruction, high-quality comparative evidence of clinical or cost-effectiveness is lacking. A well-designed, adequately powered randomised controlled trial (RCT) is needed to compare the techniques, but breast reconstruction RCTs are challenging. We, therefore, aim to undertake an external pilot RCT (Best-BRA) with an embedded QuinteT Recruitment Intervention (QRI) to determine the feasibility of undertaking a trial comparing prepectoral and subpectoral techniques.
    Methods and analysis: Best-BRA is a pragmatic, two-arm, external pilot RCT with an embedded QRI and economic scoping for resource use. Women who require a mastectomy for either breast cancer or risk reduction, elect to have an IBBR and are considered suitable for both prepectoral and subpectoral reconstruction will be recruited and randomised 1:1 between the techniques.The QRI will be implemented in two phases: phase 1, in which sources of recruitment difficulties are rapidly investigated to inform the delivery in phase 2 of tailored interventions to optimise recruitment of patients.Primary outcomes will be (1) recruitment of patients, (2) adherence to trial allocation and (3) outcome completion rates. Outcomes will be reviewed at 12 months to determine the feasibility of a definitive trial.
    Ethics and dissemination: The study has been approved by the National Health Service (NHS) Wales REC 6 (20/WA/0338). Findings will be presented at conferences and in peer-reviewed journals.
    Trial registration number: ISRCTN10081873.
    MeSH term(s) Breast Implantation ; Breast Implants ; Breast Neoplasms/surgery ; Female ; Humans ; Mammaplasty ; Mastectomy ; Pilot Projects ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2021-11-30
    Publishing country England
    Document type Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2021-050886
    Database MEDical Literature Analysis and Retrieval System OnLINE

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