Effect of Total Breast Reconstruction With Autologous Fat Transfer Using an Expansion Device vs Implants on Quality of Life Among Patients With Breast Cancer: A Randomized Clinical Trial.

Importance: There is a need for a new, less invasive breast reconstruction option for patients who undergo mastectomy in their breast cancer treatment. Objective: To investigate quality of life (QoL) among patients undergoing a new breast reconstruction technique, autologous fat transfer (AFT), compared with that among patients undergoing implant-based reconstruction (IBR). Design, Setting, and Participants: The BREAST trial was a randomized clinical trial conducted between November 2, 2015, and October 31, 2021, performed in 7 hospitals across the Netherlands. Follow-up was 12 months. Referrals could be obtained from general practitioners and all departments from participating or nonparticipating hospitals. The patients with breast cancer who had undergone mastectomy and were seeking breast reconstruction were screened for eligibility (radiotherapy history and physique) by participating plastic surgeons. Patients receiving postmastectomy radiotherapy were excluded. Interventions: Breast reconstruction with AFT plus expansion or 2-phased IBR. Randomization was done in a 1:1 ratio. Main Outcomes and Measures: The statistical analysis was performed per protocol. The predefined primary outcome was QoL at 12 months after final surgery. This was measured by the BREAST-Q questionnaire, a validated breast reconstruction surgery questionnaire. Questions on the BREAST-Q questionnaire are scored from 0 to 100, with a higher score indicating greater satisfaction or better QoL (depending on the scale). Secondary outcomes were breast volume and the safety and efficacy of the techniques. Results: A total of 193 female patients (mean [SD] age, 49.2 [10.6] years) 18 years or older who desired breast reconstruction were included, of whom 91 patients in the AFT group (mean [SD] age, 49.3 [10.3] years) and 80 in the IBR group (mean age, 49.1 [11.0] years) received the allocated intervention. In total, 64 women in the AFT group and 68 women in the IBR group completed follow-up. In the IBR group, 18 patients dropped out mainly due to their aversion to implant use while in the AFT group 6 patients ended their treatment prematurely because of the burden (that is, the treatment being too heavy or tiring). The BREAST-Q scores were higher in the AFT group in all 5 domains and significantly higher in 3: satisfaction with breasts (difference, 9.9; P = .002), physical well-being: chest (difference; 7.6; P = .007), and satisfaction with outcome (difference, 7.6; P = .04). Linear mixed-effects regression analysis showed that QoL change over time was dependent on the treatment group in favor of AFT. The mean (SD) breast volume achieved differed between the groups (AFT: 300.3 [111.4] mL; IBR: 384.1 [86.6] mL). No differences in oncological serious adverse events were found. Conclusions and Relevance: This randomized clinical trial found higher QoL and an increase in QoL scores over time in the AFT group compared with the IBR group. No evidence was found that AFT was unsafe. This is encouraging news since it provides a third, less invasive reconstruction option for patients with breast cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02339779.

BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial.

INTRODUCTION: Pioneers have shown that it is possible to reconstruct a full breast using just autologous fat harvested by liposuction or autologous fat transfer (AFT). This study describes the first multicentre randomised study protocol to thoroughly investigate the effectiveness of AFT to reconstruct full breasts following mastectomy procedures (primarily and delayed). METHODS AND ANALYSIS: This study is designed as a multicentre, randomised controlled clinical superiority trial with a 1:1 allocation ratio. A total of 196 patients (98 patients per treatment arm) are aimed to be included. Patients who wish to undergo breast reconstruction with either one of the two techniques are randomly allocated into the AFT group (intervention) or the tissue-expander/prosthesis group (control). The primary outcome measure for the quality of life is measured by the validated BREAST-Q questionnaire. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethics committee of Maastricht University Medical Centre/Maastricht University; the trial has been registered at ClinicalTrials.gov. The results of this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peer-reviewed journals. TRIAL STATUS: Enrolment into the trial has started in October 2015. Data collection and data analysis are expected to be completed in December 2021. TRIAL REGISTRATION NUMBER: NCT02339779.

Different physical forms of one diet fed to growing pigs induce morphological changes in mandubular glands and local leptin (Ob) production and receptor (ObR) expression.

The physical form of the diet plays an important role for morphological adaptations of organs in the gastrointestinal tract. It was hypothesized that different physical forms of one diet could exert extra-enteric effects, under local and systemic neuroendocrine regulation. Gross morphology, fresh mass and cytoarchitecture of mandibular glands (MG) were studied in growing pigs fed with one diet processed under four different physical forms. Four dietary treatments were offered for 4 weeks to 32 growing pigs (initial BW: 8.30 ± 0.83 kg) allotted into 4 experimental groups: FP, finely ground pellet (dMean, 0.46 mm); CM, coarsely ground meal (dMean, 0.88 mm); CP, coarsely ground pellet (dMean, 0.84); CE, coarsely ground extruded (dMean, 0.66). Conventional and immuonohistochemical techniques were used to immunolocalize, in particular, leptin (Ob) and its receptor (ObR). A significant effect was observed on the relative mass of the MG, depending on the diet (p < 0.03) and on the BW (p < 0.04), with no interactions (diet*BW). The immunohistochemical reactions for Ob and ObR showed a marked positivity in the MG from the group fed with the CM diet, displaying Ob-positive acinar cells and ObR-positive cells in the striated ducts, together with endocrine-like cells. The intensity of chromogenic reactions positively testing to ObR was used to evaluate the cytoarchitecture of the MG and its possible correlations. Pearson's correlation coefficient resulted to positively link (p < 0.0001) the ObR expression with the absolute mass of MG in the 61.1% of pigs. The physical form of the diet is related to extra-enteral effects, inducing changes in gross and microscopic morphology of the MG in the growing pig. The local production of Ob and the expression of the respective ObR in the striated duct cells shed a new light on the mitogenic activity of Ob in extra-enteral organs, like the MG, in relation to the physical form of the diet.

Effects of the Physical Form of Diet on the Outcome of an Artificial Salmonella Infection in Broilers.

To prove the hypothesis that the physical form of diet affects the outcome of an artificial infection with Salmonella Enteritidis in broilers, 7-day-old birds were allotted to one of four groups and fed botanically, and nearly also chemically identical diets, differing in grinding and further compaction. In total, two birds from each group (age 14 days) were administered on average 1.06 x 10(8) colony-forming units (CFU) of Salmonella Enteritidis directly into the crop by gavage and immediately put back as "seeder birds" into their respective groups. The salmonella status of each bird was analyzed by cloacal swabs, and at postmortem examination, cecal content and liver tissue samples were taken. Shedding (measured by cloacal swabs) was reduced significantly (P < 0.05) in groups offered the coarsely ground and pelleted diet and the diet including whole wheat compared with the groups fed the finely ground and pelleted and the coarsely ground and extruded diet. Nevertheless, only broilers fed the diet containing whole wheat showed a significantly (P < 0.05) lower frequency of Salmonella Enteritidis isolation in the cecal content and liver tissue. This diet was characterized by the highest percentage of particles > 2 mm. In this study the physical form of diet affected the outcome of an artificial infection with Salmonella Enteritidis significantly.

The influence of grinding intensity and compaction of diets on the microbial community in the gastrointestinal tract of young pigs.

Sixty weaned piglets (33 d, 7.96 ± 1.09 kg BW) were divided into 4 groups with 15 pigs each and fed identical diets in which meal was coarsely ground (CM), coarsely ground and pelleted (CP), finely ground and pelleted (FP), or coarsely ground and extruded (CE) for 4 wk. At the end of the trial the pigs were killed and samples of the digesta were taken from the stomach, the end of the small intestine, and the cecum for microbiological, DM, pH, and lactic acid analyses. Differences (P < 0.05) regarding the counts of bacteria were mainly found between the CM and the FP group, but the CP and the CE diet mostly resulted in intermediate values. Pigs fed the CM diet had the highest numbers of lactobacilli in the stomach content (P < 0.01) and the cecal digesta (P < 0.05). Perhaps due to a more efficient stomach barrier, characterized by high lactobacilli counts and a marked pH gradient in the stomach content (cardia, 5.15 ± 0.475; pylorus, 2.83 ± 1.06; P < 0.01), the lowest counts of coliform bacteria were found in the distal part of the small intestine in pigs fed the CM diet (P < 0.05).

Effect of grinding intensity and feed physical form on in vitro adhesion of Salmonella Typhimurium and mannose residues in intestinal mucus receptors for salmonellae.

The hypothesis of this study was that feeding a fine, pelleted diet (FP) compared to a coarse meal diet (CM) results in a higher mannose content in the intestinal mucus of pigs and therefore an increased in vitro adhesion of Salmonella Typhimurium DT104 L to the mucus. The 2 diets were fed to a total of 24 weaned pigs for 6 wk after which mannose content in the mucus was evaluated histochemically using the α1-3-d-mannose-specific lectin Galanthus nivalis agglutinin. The crypt width was determined as an indirect measure for the amount of secreted mucus. Ileal and cecal tissue samples were incubated with approximately 7.77 × 10(7) cfu Salmonella Typhimurium and numbers of salmonellae adhering to the mucus and/or mucosa were determined by culture techniques. There was no effect of feed physical form on the in vitro adhesion of S. Typhimurium either in the ileum (7.1 ± 0.19 log(10) cfu/g tissue) or in the cecum (6.8 ± 0.26 log(10) cfu/g). The mannose content of the mucus also did not differ between the treatment groups. The crypts of the duodenum, jejunum, and cecum were wider (P < 0.05) after feeding the CM diet. This might be an indication for a higher mucus production in these pigs.

Effect of diet grinding and pelleting fed either dry or liquid feed on dry matter and pH in the stomach of pigs and the development of gastric ulcers.

The physical form of diets has a marked impact on the development of gastric ulcers in pigs. Earlier studies showed effects of fine grinding and pelleting on the integrity of gastric mucosa as well as on local intragastric milieu. This study was conducted to evaluate the effects of dry or liquid feeding on intragastric milieu (DM and pH) in pigs. The 23 piglets were housed individually and fed with test diets and water ad lib for 6 wk. Both experimental diets [coarsely ground diet fed as mash (CM) vs. finely ground pelleted diet (FP)] were identical in ingredients (39.5% wheat, 34% barley, 20% soybean meal) and chemical composition and were either offered dry or in liquid (25% DM) form. At the end of the trial the animals were slaughtered; the stomach was removed and samples were taken from different localizations. Feeding diets dry or liquid had no effect on the pH (P > 0.05). The diet noticeably affected the gastric content. The FP diets resulted in a more liquid chyme (P < 0.05), and the intragastric pH did not differ between regions. Feeding CM caused marked effects of localization regarding pH (highest values: pars nonglandularis; lowest values: fundus). None of the pigs fed CM showed signs of gastric ulcers, but the score was markedly higher (P < 0.05) when pigs were fed FP. Therefore the predominant factor for development of gastric ulcers seems to be the structure (particle size) of the diet.