The iBRA (implant breast reconstruction evaluation) study: protocol for a prospective multi-centre cohort study to inform the feasibility, design and conduct of a pragmatic randomised clinical trial comparing new techniques of implant-based breast reconstruction.

BACKGROUND: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK. The introduction of techniques to augment the subpectoral pocket has revolutionised the procedure, but there is a lack of high-quality outcome data to describe the safety or effectiveness of these techniques. Randomised controlled trials (RCTs) are the best way of comparing treatments, but surgical RCTs are challenging. The iBRA (implant breast reconstruction evaluation) study aims to determine the feasibility, design and conduct of a pragmatic RCT to examine the effectiveness of approaches to IBBR. METHODS/DESIGN: The iBRA study is a trainee-led research collaborative project with four phases:Phase 1 - a national practice questionnaire (NPQ) to survey current practicePhase 2 - a multi-centre prospective cohort study of patients undergoing IBBR to evaluate the clinical and patient-reported outcomesPhase 3- an IBBR-RCT acceptability survey and qualitative work to explore patients' and surgeons' views of proposed trial designs and candidate outcomes.Phase 4 - phases 1 to 3 will inform the design and conduct of the future RCT All centres offering IBBR will be encouraged to participate by the breast and plastic surgical professional associations (Association of Breast Surgery and British Association of Plastic Reconstructive and Aesthetic Surgeons). Data collected will inform the feasibility of undertaking an RCT by defining current practice and exploring issues surrounding recruitment, selection of comparator arms, choice of primary outcome, sample size, selection criteria, trial conduct, methods of data collection and feasibility of using the trainee collaborative model to recruit patients and collect data. DISCUSSION: The preliminary work undertaken within the iBRA study will determine the feasibility, design and conduct of a definitive RCT in IBBR. It will work with the trainee collaborative to build capacity by creating an infrastructure of research-active breast and plastic surgeons which will facilitate future high-quality research that will ultimately improve outcomes for all women seeking reconstructive surgery. TRIAL REGISTRATION: ISRCTN37664281

The Influence of Patient Exposure to Breast Reconstruction Approaches and Education on Patient Choices in Breast Cancer Treatment.

BackgroundThe landscape of surgical and medical management and patient choices for breast cancer treatment changes as breast reconstruction and oncoplastic approaches improve and diversify. Increased access to breast reconstruction, in addition to patient education, influences the breast cancer patient. Therefore, the examination of the possible impact of reconstructive surgery on all stages of the breast cancer management per se seemed timely.MethodsPlastic surgery consults were arranged for 520 new patients diagnosed with breast cancer (2012-2016) including patients with noninvasive breast cancer but at high risk of further cancer development. To test the plastic surgery impact on patient choices regarding the management of the cancer, a subset of 90 patients was identified to test the plastic surgery impact on patient choices. These patients were referred to plastic surgery, following the first round of consultations by surgical and medical oncologists with only the preliminary oncological management plan defined. After a plastic surgery consultation, but prior to finalization of the overall oncological management plan, they were surveyed on the subject of modification of their personal choices and requests pertaining to their cancer management.ResultsIn this subset of 90 patients 40 (44%) returned to their surgical or medical oncologist considering changes of the primary management plan after their plastic surgery consultation. Twenty-six (28%) ultimately altered their plan, and the following patient-driven changes were made: mastectomy as opposed to lumpectomy (18 patients [20%]), contralateral prophylactic mastectomy (11 patients [12%]), nipple/areola removal as opposed to nipple/areola sparing suggested by the oncologists (5 patients [6%]), oncoplastic breast reduction as part of lumpectomy (5 patients [6%]), and other modifications (3 patients [3%]).ConclusionsDecisions for altering the preliminary oncologic plan or choosing a specific alternative (eg, lumpectomy plus radiation vs mastectomy) resulted from patient education on (1) reconstructive options, (2) aesthetic pitfalls and results. and (3) their interfacing with the oncological outcomes. Ultimately, plastic surgeons influence the multispecialty breast cancer management and patient decision-making process. Therefore, oncological literacy for plastic surgeons is essential to provide state-of-the-art breast cancer care and avoidance of suboptimal patient decisions

Bronchial and arterial sleeve resection for centrally-located lung cancers

The use of bronchial and arterial sleeve resections for the treatment of centrally-located lung cancers, when available, has become the option of choice in comparison with pneumonectomy (PN). Technical expertise, in particular in vascular reconstruction, and perioperative management improved over time allowing excellent short-term and long-term results. This is even truer if considering literature data from the main experiences published in the last years. These evidences have given to such lung sparing reconstructive procedures more and more acceptance among the surgical community. This article focuses on the main technical aspects and literature data regarding bronchovascular sleeve resections

Performance of mesenchymal cell-scaffold constructs in human oral reconstructive surgery: a systematic review

Background: Different sources of cultured cells combined with different scaffolds (allogenic, xenogeneic, alloplastic or composite materials) have been tested extensively in vitro and in preclinical animal studies, but there have been only a few clinical trials involving humans. Aim: This study reviewed all of the English language literature published between January 1990 and December 2015 to assess the histological performance of different mesenchymal cell-scaffold constructs used for bone regeneration in human oral reconstructive procedures. Methods: An electronic search of the MEDLINE and Cochrane Central Register of Controlled Trials databases complemented by manual searching was conducted to identify studies involving histological evaluation of mesenchymal cell-scaffold constructs in human oral surgical procedures. The methodological quality of randomized controlled clinical trials and controlled clinical trials was assessed using the Cochrane Collaboration tool for assessing the risk of bias. Heterogeneity was assessed using Review Manager software. Considering the heterogeneity, the data collected were reported by descriptive methods and a meta-analysis was applied only to the articles that reported the same outcome measures. The articles were classified and described based on the material scaffolds used. Results: The search identified 1030 titles and 287 abstracts. Full-text analysis was performed for 32 articles, revealing 14 studies that fulfilled the inclusion criteria. Three randomized controlled clinical trials were identified as potentially eligible for inclusion in a meta-analysis. The studies were grouped according to the scaffold materials used: bone allograft (three studies), polyglycolic-polylactic scaffold (four studies), collagen sponge (two studies), and bovine bone matrix (five studies). The stem cells used in these studies had been sourced from the iliac crest, periosteum, dental pulp and intraoral sites. Conclusions: The very small amount of available data makes it impossible to draw any firm conclusions regarding the increase in bone formation in human oral reconstructive procedures when using graft materials engineered with autogenous stem cells

Changes in and predictors of length of stay in hospital after surgery for breast cancer between 1997/98 and 2004/05 in two regions of England: a population-based

BACKGROUND Decreases in length of stay (LOS) in hospital after breast cancer surgery can be partly attributed to the change to less radical surgery, but many other factors are operating at the patient, surgeon and hospital levels. This study aimed to describe the changes in and predictors of length of stay (LOS) in hospital after surgery for breast cancer between 1997/98 and 2004/05 in two regions of England. METHODS Cases of female invasive breast cancer diagnosed in two English cancer registry regions were linked to Hospital Episode Statistics data for the period 1st April 1997 to 31st March 2005. A subset of records where women underwent mastectomy or breast conserving surgery (BCS) was extracted (n = 44,877). Variations in LOS over the study period were investigated. A multilevel model with patients clustered within surgical teams and NHS Trusts was used to examine associations between LOS and a range of factors. RESULTS Over the study period the proportion of women having a mastectomy reduced from 58% to 52%. The proportion varied from 14% to 80% according to NHS Trust. LOS decreased by 21% from 1997/98 to 2004/05 (LOSratio = 0.79, 95%CI 0.77-0.80). BCS was associated with 33% shorter hospital stays compared to mastectomy (LOSratio = 0.67, 95%CI 0.66-0.68). Older age, advanced disease, presence of comorbidities, lymph node excision and reconstructive surgery were associated with increased LOS. Significant variation remained amongst Trusts and surgical teams. CONCLUSION The number of days spent in hospital after breast cancer surgery has continued to decline for several decades. The change from mastectomy to BCS accounts for only 9% of the overall decrease in LOS. Other explanations include the adoption of new techniques and practices, such as sentinel lymph node biopsy and early discharge. This study has identified wide variation in practice with substantial cost implications for the NHS. Further work is required to explain this variation

Decision for reconstructive interventions of the upper limb in individuals with tetraplegia: the effect of treatment characteristics

Objective: To determine the effect of treatment characteristics on the\ud decision for reconstructive interventions for the upper extremities (UE) in\ud subjects with tetraplegia. - \ud Setting: Seven specialized spinal cord injury centres in the Netherlands. - \ud Method: Treatment characteristics for UE reconstructive interventions were\ud determined. Conjoint analysis (CA) was used to determine the contribution\ud and the relative importance of the treatment characteristics on the decision\ud for therapy. Therefore, a number of different treatment scenarios using these\ud characteristics were established. Different pairs of scenarios were presented\ud to subjects who were asked to choose the preferred scenario of each set. - \ud Results: forty nine subjects with tetraplegia with a stable C5, C6 or C7\ud lesion were selected. All treatment characteristics significantly influenced\ud the choice for treatment. Relative importance of treatment characteristics\ud were: intervention type (surgery or surgery with FES implant) 13%, number\ud of operations 15%, in patient rehabilitation period 22%, ambulant\ud rehabilitation period 9%, complication rate 15%, improvement of elbow\ud function 10%, improvement of hand function 15%. In deciding for therapy\ud 40% of the subjects focused on one characteristic. - \ud Conclusion: CA is applicable in Spinal Cord Injury medicine to study the\ud effect of health outcomes and non-health outcomes on the decision for\ud treatment. Non-health outcomes which relate to the intensity of treatment\ud are equally important or even more important than functional outcome in the\ud decision for reconstructive UE surgery in subjects with tetraplegia

Oncological safety of stromal vascular fraction enriched fat grafting in two-stage breast reconstruction after nipple sparing mastectomy: long-term results of a prospective study

OBJECTIVE: Autologous fat transfer (AFT) is commonly used to treat implant palpability and prevent fibrosis and thinning in mastectomy skin flaps. A major limit to this procedure is volume retention over time, leading to the introduction of fat enrichment with stromal vascular fraction (SVF+AFT). Oncological concerns have been raised over the injection of an increased concentration of progenitors cells (ASCs) in the SVF. The aim of the study is to evaluate the long-term cancer recurrence risk of SVF+AFT cases compared to AFT, in patients undergoing Nipple Sparing Mastectomy (NSM). PATIENTS AND METHODS: A prospective study was designed to compare three groups of patients undergoing NSM followed by SVF+AFT, AFT or none (control group), after a two-stage breast reconstruction. Patients were strictly followed-up for at least 5-years from the second stage reconstructive procedure. Loco-regional and systemic recurrence rate were evaluated over time as the primary outcome. Logistic regression was used to investigate which factors were associated with recurrence events and independent variables of interest were: surgical technique, age above 50 years old, lympho-vascular invasion, oncological stage, adjuvant or neoadjuvant chemotherapy, adjuvant radiotherapy and adjuvant hormone therapy. RESULTS: 41 women were included in G1 (SVF+AFT), 64 in G2 (AFT), and 64 in G3 (control group). Loco-regional recurrence rate was 2.4% for G1, 4.7% for G2, and 1.6% for G3. Systemic recurrence was 7.3%, 3.1%, and 3.1%, respectively. Among the variables included, there were no significant risk factors influencing a recurrence event, either loco-regional or systemic. In particular, SVF+AFT (G1) did not increase the oncological recurrence. CONCLUSIONS: Our data suggest that both centrifuged and SVF-enhanced fat transfer have a similar safety level in comparison to patients who did not undergo fat grafting in breast reconstruction after NSM

Robotic total gastrectomy with intracorporeal robot-sewn anastomosis. A novel approach adopting the double-loop reconstruction method

Gastric cancer constitutes a major health problem. Robotic surgery has been progressively developed in this field. Although the feasibility of robotic procedures has been demonstrated, there are unresolved aspects being debated, including the reproducibility of intracorporeal in place of extracorporeal anastomosis. Difficulties of traditional laparoscopy have been described and there are well-known advantages of robotic systems, but few articles in literature describe a full robotic execution of the reconstructive phase while others do not give a thorough explanation how this phase was run. A new reconstructive approach, not yet described in literature, was recently adopted at our Center. Robotic total gastrectomy with D2 lymphadenectomy and a socalled ‘‘double-loop’’ reconstruction method with intracorporeal robotsewn anastomosis (Parisi’s technique) was performed in all reported cases. Preoperative, intraoperative, and postoperative data were collected and a technical note was documented. All tumors were located at the upper third of the stomach, and no conversions or intraoperative complications occurred. Histopathological analysis showed R0 resection obtained in all specimens. Hospital stay was regular in all patients and discharge was recommended starting from the 4th postoperative day. No major postoperative complications or reoperations occurred. Reconstruction of the digestive tract after total gastrectomy is one of the main areas of surgical research in the treatment of gastric cancer and in the field of minimally invasive surgery. The double-loop method is a valid simplification of the traditional technique of construction of the Roux-limb that could increase the feasibility and safety in performing a full hand-sewn intracorporeal reconstruction and it appears to fit the characteristics of the robotic system thus obtaining excellent postoperative clinical outcome