Covid-19 infection in pregnant women: Auditory evaluation in infants.

 Recent studies showed that COVID-19 infection can affect cochleo-vestibular system. The possibility of a vertical transmission is controversial. Some studies suggested that it is possible but unlikely, others find no evidence of vertical transmission. The objective of this study was to investigate whether exposure to COVID-19 during pregnancy or at birth has an impact on the hearing of the offspring. As part of the national hearing screening program, we performed in all newborns between January 2022 and February 2023, TEOAEs (Transient Evoked Otoacoustic Emissions) at birth and at 3 months. For those "REFER" at the third month test, we performed aABR (Automatic Auditory Brainstem Response) at 6 months. We analysed separately result between infants born to COVID-positive mothers during pregnancy and those born to COVID-negative mothers. To statistical verify differences we performed "Chi-square test". We enrolled a total of 157 infants, of whom 16 were born to mothers who had a molecular PCR test positive for COVID-19. In the latter we tested a total of 32 ears and only 1 ear (3,1%) resulted "REFER". On the other hand, in the control group we tested a total of 282 ears and 22 (7,8%) were found to be "REFER". Our study showed no significant differences in audiological assessment between newborns exposed to COVID-19 infection during pregnancy or at birth compared to the unexposed group. However, further studies with a larger patient's sample will be necessary for a more comprehensive evaluation.

Adolescent inguinal hernia repair: a review of the literature and recommendations for selective management.

BACKGROUND: The choice of how to repair inguinal hernias in adolescents has historically been a matter of experience and differed between pediatric surgeons who traditionally performed a high ligation of the sac and general surgeons who typically perform a repair using mesh. This up-to-date review thoroughly examines the subject and discusses the suitability of both types of repairs in this unique age group. METHODS: A 20-year Pub Med search was performed for the following terms: adolescent hernia repair including reports of mesh hernia repair in adolescents and postoperative complications including chronic inguinal pain and recurrences. RESULTS: The evidence in the literature suggests that while there appears to be no difference between the two types of repairs with regards to recurrence and complications, changes in the pelvic floor physiology in adolescents suggest that a selective, individualized approach can be recommended depending on the size and nature of the presenting pathology. CONCLUSIONS: A selective approach to the inguinal hernia in adolescent patients based on the size of the defect appears justified.

[The management of confirmed cases of Covid-19 infection in schools: the experience of the prevention Department of the Azienda Sanitaria Friuli occidentale in the Pordenone area]. / L'attività del Dipartimento di prevenzione ASFO nella gestione dei casi confermati di Covid-19 nelle scuole del territorio pordenonese.

The SARS-Cov-2 pandemic that exploded in 2020 resulted in an exceptional school closure involving at least 188 countries worldwide, leaving more than 90% of children at home. This event excluded children and teenagers from the opportunity to learn, socialize, experiment and increased early school leaving. In light of these premises, during the summer months of 2020 the Azienda sanitaria Friuli Occidentale (AsFO) decided to set up a working group to accompany schools in the prevention and containment of the spread of the SARS-CoV-2 infection in the course of the school year 2020-21, with the aim of guaranteeing the right to study and favoring teaching activities in presence in the highest conditions of health and safety. The school reality of the Pordenone area is made up of 40 Comprehensive Institutes for a total of about 206 school complexes of all levels (public, equal and private). In total, the local school population is about 33,000 pupils and 4,000 units of school staff (teachers, ATA, etc ...). The activities of the Schools Group were analyzed by monitoring all interventions with carrying out rapid antigen tests at school and by assessing the incidence of infections within schools. From September 2020 to June 2021, the AsFO Schools Group participated in about 35 teaching colleges and more than 10 dedicated meetings with the families of school pupils of all levels. In total, 170 interventions with rapid antigen tests were carried out at school, involving all the schools in the Pordenone area and a total of 206 classes. During the interventions at school, a total of 6,370 rapid antigen tests were carried out, of which 70% concerned pupils (4,458 total tests) and 30% concerned school staff (1,912 total tests). The antigen tests carried out at school found 173 total positivity (equal to 3% of all tests carried out at school). Out of 173 positives found, 121 are students (70% of the total) and 52 are school staff (30% of the total). During the observation period, the results of the interventions with rapid antigen tests carried out at school led to the continuation of the teaching activity in the presence (with respect to the hygiene and behavioral measures defined by the DP) in 69% of cases (118 interventions). In 9% of cases (15 interventions) the "cross" quarantine was carried out, while in 17% of cases (29 interventions) the quarantine was established for the entire class / section. In 7 circumstances, following the intervention at school, quarantine was established for several classes. Only in 4 circumstances was the institution of quarantine for all school staff, a situation that led to the interruption of all educational activities for the quarantine period.

Continuous radon monitoring during seven years of volcanic unrest at Campi Flegrei caldera (Italy).

This is a seven-year study (1/7/2011-31/12/2017) of radon monitoring at two sites of Campi Flegrei caldera (Neaples, Southern Italy) that in the last 70 years experienced repeated phases of volcanic unrest. The sites are equipped with devices for radon detection, based on the spectrometry analysis of the α-particles of radon daughters. A hybrid method, as combination of three known methods, is applied for the identification of residuals (anomalies) and trends of the time series of Radon. The results are compared with the following indicators of current caldera unrest: the tremor caused by the major fumarolic vent registered by a seismic station; the cumulative of background seismicity; the maximum vertical deformation acquired by GPS networks during the current phase of uplift; the temperature-pressure of the hydrothermal system estimated based on gas geo-indicators. The comparisons show strong correlation among independent signals and suggest that the extension of the area affected by current Campi Flegrei crisis is larger than the area of seismicity and of intense hydrothermal activity from which the radon stations are 1-4 km away. These results represent an absolute novelty in the study of a such calderic area and mark a significant step forward in the use and interpretation of the radon signal.

Preventing transmission among operating room staff during COVID-19 pandemic: the role of the Aerosol Box and other personal protective equipment.

The COVID-19 pandemic is highly challenging for the operating room staff and healthcare workers in emergency departments. SARS-CoV-2 is a positive-sense single-stranded RNA beta-coronavirus that primarily targets the human respiratory system, with fever, cough, myalgia, and pneumonia as the most common manifestations. However, since SARS-CoV-2 RNA was detected in stool specimens much more attention has been paid to gastrointestinal symptoms such as loss of appetite, nausea, and diarrhea. Furthermore, the expression of ACE-2 receptors in absorptive enterocytes from ileum and colon suggests that these organs should also be considered as a potential high risk for SARS-CoV-2 infection. During aerosol-generating medical procedures (AGMP; e.g. intubating and extubating patients or any surgical procedures), the production of both airborne particles and droplets may increase the risk of infection. In this situation, the surgical staff is strongly recommended to wear personal protective equipment (PPE). A transparent plastic cube, the so-called "Aerosol Box" (AB), has been recently designed to lend further protection against droplets and aerosol exposure during the AGMP.

Mid-transverse colon cancer and extended versus transverse colectomy: Results of the Italian society of surgical oncology colorectal cancer network (SICO CCN) multicenter collaborative study.

INTRODUCTION: Transverse colon cancer (TCC) is poorly studied, and TCC cases are often excluded from large prospective randomized trials because of their complexity and their potentially high complication rate. The best surgical approach for TCC has yet to be established. The aim of this large retrospective multicenter Italian series is to investigate the advantages and disadvantages of both hemicolectomy and transverse colectomy in order to identify the best surgical approach. MATERIALS AND METHODS: This was a retrospective cohort study of patients with mid-transverse colon cancer treated with a segmental colon resection or an extended hemicolectomy (right or left) between 2006 and 2016 in 28 high-volume (more than 70 procedures/year) Italian referral centers for colorectal surgery. RESULTS: The study included 1529 patients, 388 of whom underwent a segmental resection while 1141 underwent an extended resection. A higher number of complications has been reported in the segmental group than in the extended group (30.1% versus 23.6%; p 0.010). In 42 cases the main complication was the anastomotic leak (4.4% versus 2.2%; p 0.020). Recovery outcomes also showed statistical differences: time to first flatus (p 0.014), time to first mobilization (p 0.040), and overall hospital stay (p < 0.001) were significantly shorter in the extended group. Even if overall survival were similar between the groups (95.1% versus 97%; p 0.384), 3-year disease-free survival worsened after segmental resection (78.1% versus 86.2%; p 0.001). CONCLUSIONS: According to our results, an extended right colon resection for TCC seems to be surgically safer and more oncologically valid.

Removal of polycyclic aromatic hydrocarbons during anaerobic biostimulation of marine sediments.

This study proposes the supplementation of digestate, fresh organic fraction of municipal solid waste (OFMSW) and a nutrient solution during the anaerobic biostimulation of marine sediments contaminated by polycyclic aromatic hydrocarbons (PAHs). The experimental activity was conducted with four PAHs (i.e. phenanthrene, anthracene, fluoranthene and pyrene) under controlled mesophilic conditions (37 ± 1 °C) in 100 mL serum bottles maintained at 130 rpm. After 120 days of incubation, the highest total PAH degradation of 53 and 55% was observed in the experiments with digestate + nutrients and OFMSW + nutrients, respectively. Phenanthrene was the most degraded PAH and the highest removal of 69% was achieved with OFMSW + nutrients. The anaerobic PAH degradation proceeded through the accumulation of volatile fatty acids and the production of hydrogen and methane as biogas constituents. The highest cumulative biohydrogen production of 80 mL H2·g VS-1 was obtained when OFMSW was used as the sole amendment, whereas the highest biomethane yield of 140 mL CH4·g VS-1 was obtained with OFMSW + nutrients. The evolution of PAH removal during anaerobic digestion revealed a higher impact of the methanogenic phase rather than acidogenic phase on PAH degradation.

Surgical treatment of a colon neoplasm of the splenic flexure: a multicentric study of short-term outcomes.

AIM: The optimal surgical treatment of splenic flexure neoplasm is still not well defined. Extended right hemicolectomy (ERH) and left colic resection (LCR) have been proposed but conclusive evidence concerning postoperative morbidity and oncological results is lacking. The aim of this study was to analyse the short-term outcomes after surgery for splenic flexure cancer with regard to surgical procedure and surgeon's specialty. METHODS: This was a multicentre study on patients who underwent surgery for primary colon cancer of the splenic flexure. RESULTS: From 2004 to 2015, 324 patients fulfilled the criteria for inclusion into the study; 270 (83.4%) had elective surgery while 54 (16.6%) had emergency resection: 158 (48.8%) underwent ERH and 166 (51.2%) LCR; 176 (54.3%) procedures were performed by colorectal surgeons, 148 (46.7%) by general surgeons. In the ERH group a significantly higher rate of emergency operations was carried out (P = 0.005). After elective surgery, no significant differences between ERH and LCR concerning 30-day mortality (3.3% vs 2.0%) and the need for reoperation (10.6% vs 7.4%) were found. Nodal harvesting was significantly higher in the ERH and colorectal surgeon groups in any clinical scenario. At multivariate analysis, age and smoking habit were predictive of the need for reoperation and major morbidity while the general surgeon group showed a higher risk of anastomotic failure (OR = 1.92; P = 0.168). CONCLUSION: We analysed the largest series in literature of curative resections for splenic flexure tumours. The optimal procedure still remains debatable as ERH and LCR appear to achieve comparable short-term outcomes. Surgeon's specialty seems to positively affect patient's outcomes.

From bench to bedside: in vitro and in vivo evaluation of a neonate-focused nebulized surfactant delivery strategy.

BACKGROUND: Non-invasive delivery of nebulized surfactant has been a neonatology long-pursued goal. Nevertheless, the clinical efficacy of nebulized surfactant remains inconclusive, in part, due to the great technical challenges of depositing nebulized drugs in the lungs of preterm infants. The aim of this study was to investigate the feasibility of delivering nebulized surfactant (poractant alfa) in vitro and in vivo with an adapted, neonate-tailored aerosol delivery strategy. METHODS: Particle size distribution of undiluted poractant alfa aerosols generated by a customized eFlow-Neos nebulizer system was determined by laser diffraction. The theoretical nebulized surfactant lung dose was estimated in vitro in a clinical setting replica including a neonatal continuous positive airway pressure (CPAP) circuit, a cast of the upper airways of a preterm neonate, and a breath simulator programmed with the tidal breathing pattern of an infant with mild respiratory distress syndrome (RDS). A dose-response study with nebulized surfactant covering the 100-600 mg/kg nominal dose-range was conducted in RDS-modelling, lung-lavaged spontaneously-breathing rabbits managed with nasal CPAP. The effects of nebulized poractant alfa on arterial gas exchange and lung mechanics were assessed. Exogenous alveolar disaturated-phosphatidylcholine (DSPC) in the lungs was measured as a proxy of surfactant deposition efficacy. RESULTS: Laser diffraction studies demonstrated suitable aerosol characteristics for inhalation (mass median diameter, MMD = 3 µm). The mean surfactant lung dose determined in vitro was 13.7% ± 4.0 of the 200 mg/kg nominal dose. Nebulized surfactant delivered to spontaneously-breathing rabbits during nasal CPAP significantly improved arterial oxygenation compared to animals receiving CPAP only. Particularly, the groups of animals treated with 200 mg/kg and 400 mg/kg of nebulized poractant alfa achieved an equivalent pulmonary response in terms of oxygenation and lung mechanics as the group of animals treated with instilled surfactant (200 mg/kg). CONCLUSIONS: The customized eFlow-Neos vibrating-membrane nebulizer system efficiently generated respirable aerosols of undiluted poractant alfa. Nebulized surfactant delivered at doses of 200 mg/kg and 400 mg/kg elicited a pulmonary response equivalent to that observed after treatment with an intratracheal surfactant bolus of 200 mg/kg. This bench-characterized nebulized surfactant delivery strategy is now under evaluation in Phase II clinical trial (EUDRACT No.:2016-004547-36).

Multicentre randomized clinical trial of colonic J pouch or straight stapled colorectal reconstruction after low anterior resection for rectal cancer.

BACKGROUND: Colonic J pouch reconstruction has been found to be associated with a lower incidence of anastomotic leakage than straight anastomosis. However, studies on this topic are underpowered and retrospective. This randomized trial evaluated whether the incidence of anastomotic leakage was reduced after colonic J pouch reconstruction compared with straight colorectal anastomosis following anterior resection for rectal cancer. METHODS: This multicentre RCT included patients with rectal carcinoma who underwent low anterior resection followed by colorectal anastomosis. Patients were assigned randomly to receive a colonic J pouch or straight colorectal anastomosis. The main outcome measure was the occurrence of major anastomotic leakage. The incidence of global (major plus minor) anastomotic leakage and general complications were secondary outcomes. Risk factors for anastomotic leakage were identified by regression analysis. RESULTS: Of 457 patients enrolled, 379 were evaluable (colonic J pouch arm 190, straight colorectal arm 189). The incidence of major and global anastomotic leakage, and general complications was 14·2, 19·5 and 34·2 per cent respectively in the colonic J pouch group, and 12·2, 19·0 and 27·0 per cent in the straight colorectal anastomosis group. No statistically significant differences were observed between the two arms. In multivariable logistic regression analysis, male sex (odds ratio 1·79, 95 per cent c.i. 1·02 to 3·15; P = 0·042) and high ASA fitness grade (odds ratio 2·06, 1·15 to 3·71; P = 0·015) were independently associated with the occurrence of anastomotic leakage. CONCLUSION: Colonic J pouch reconstruction does not reduce the incidence of anastomotic leakage and postoperative complications compared with conventional straight colorectal anastomosis. Registration number NCT01110798 (http://www.clinicaltrials.gov).

Expression of RAD21 immunoreactivity in myenteric neurons of the human and mouse small intestine.

BACKGROUND: RAD21 is a double-strand-break repair protein and component of the cohesin complex with key roles in cellular functions. A RAD21 loss-of-function mutation was found in cases of chronic intestinal pseudo-obstruction (CIPO) with associated enteric neuronal loss. Analysis of RAD21 expression in the enteric nervous system is lacking, thus we aimed to characterize RAD21 immunoreactivity (IR) in myenteric ganglia. METHODS: Double labeling immunofluorescence in mouse and human jejunum was used to determine colocalization of RAD21 with HuC/D, PGP9.5, neuronal nitric oxide synthase (nNOS), neuropeptide Y (NPY), choline acetyl transferase (ChAT), Kit, platelet-derived growth factor receptor-α (PDGFRα), and glial fibrillary acid protein (GFAP) IRs. RESULTS: A subset of PGP9.5- and HuC/D-IR neuronal cell bodies and nerve fibers in the myenteric plexus of human and mouse small intestine also displayed cytoplasmic RAD21-IR Cytoplasmic RAD21-IR was found in 43% of HuC/D-IR neurons in adult and neonatal mice but did not colocalize with nNOS. A subset of ChAT-positive neurons had cytoplasmic RAD21-IR Punctate RAD21-IR was restricted to the nucleus in most cell types consistent with labeling of the cohesin complex. Cytoplasmic RAD21-IR was not detected in interstitial cells of Cajal, fibroblast-like cells or glia. Subsets of neurons in primary culture exhibited cytoplasmic RAD21-IR Suppression of RAD21 expression by shRNA knockdown abolished RAD21-IR in cultured neurons. CONCLUSIONS: Our data showing cytoplasmic RAD21 expression in enteric neurons provide a basis toward understanding how mutations of this gene may contribute to altered neuronal function/survival thus leading to gut-motor abnormalities.

Comparison of endoscopic vacuum therapy versus endoscopic stenting for esophageal leaks: systematic review and meta-analysis.

Esophageal leaks remain a life-threatening postoperative complication of esophagectomy. Currently, self-expanding metal stents (SEMS) represent the endoscopic mainstay of treatment. Recently, endoscopic vacuum therapy (EVT) has emerged and shown promising results in these patients. We conducted an electronic systematic search using MEDLINE databases (PubMed, EMBASE, and Web of Science) looking for studies comparing EVT and SEMS for the treatment of esophageal leak and/or perforation. Four studies including 163 patients matched the inclusion criteria. Esophageal leak closure rate is significantly higher with EVT than SEMS [pooled odds ratio 5.51 (95% CI 2.11-14.88; P < 0.001)]. Additionally, EVT has a shorter treatment duration [pooled mean difference -9.0 days (95% CI 16.6-1.4; P = 0.021)], lower major complication (P = 0.011), and in-hospital mortality (P = 0.002) rate compared to SEMS. EVT for esophageal leak is feasible and safe. It has the potential to become the new gold standard in the endoscopic treatment of esophageal leaks and perforations. However, further comparative studies with SEMS are needed to strengthen the current evidence.

INPP4B overexpression and c-KIT downregulation in human achalasia.

BACKGROUND: Achalasia is a rare motility disorder characterized by myenteric neuron and interstitial cells of Cajal (ICC) abnormalities leading to deranged/absent peristalsis and lack of relaxation of the lower esophageal sphincter. The mechanisms contributing to neuronal and ICC changes in achalasia are only partially understood. Our goal was to identify novel molecular features occurring in patients with primary achalasia. METHODS: Esophageal full-thickness biopsies from 42 (22 females; age range: 16-82 years) clinically, radiologically, and manometrically characterized patients with primary achalasia were examined and compared to those obtained from 10 subjects (controls) undergoing surgery for uncomplicated esophageal cancer (or upper stomach disorders). Tissue RNA extracted from biopsies of cases and controls was used for library preparation and sequencing. Data analysis was performed with the "edgeR" option of R-Bioconductor. Data were validated by real-time RT-PCR, western blotting and immunohistochemistry. KEY RESULTS: Quantitative transcriptome evaluation and cluster analysis revealed 111 differentially expressed genes, with a P ≤ 10-3 . Nine genes with a P ≤ 10-4 were further validated. CYR61, CTGF, c-KIT, DUSP5, EGR1 were downregulated, whereas AKAP6 and INPP4B were upregulated in patients vs controls. Compared to controls, immunohistochemical analysis revealed a clear increase in INPP4B, whereas c-KIT immunolabeling resulted downregulated. As INPP4B regulates Akt pathway, we used western blot to show that phospho-Akt was significantly reduced in achalasia patients vs controls. CONCLUSIONS & INFERENCES: The identification of altered gene expression, including INPP4B, a regulator of the Akt pathway, highlights novel signaling pathways involved in the neuronal and ICC changes underlying primary achalasia.

Patterned tungsten disulfide/graphene heterostructures for efficient multifunctional optoelectronic devices.

One of the major issues in graphene-based optoelectronics is to scale-up high-performing devices. In this work, we report an original approach for the fabrication of efficient optoelectronic devices from scalable tungsten disulfide (WS2)/graphene heterostructures. Our approach allows for the patterned growth of WS2 on graphene and facilitates the realization of ohmic contacts. Photodetectors fabricated with WS2 on epitaxial graphene on silicon carbide (SiC) present, when illuminated with red light, a maximum responsivity R ∼220 A W-1, a detectivity D* ∼2.0 × 109 Jones and a -3 dB bandwidth of 250 Hz. The retrieved detectivity is 3 orders of magnitude higher than that obtained with graphene-only devices at the same wavelength. For shorter illumination wavelengths we observe a persistent photocurrent with a nearly complete charge retention, which originates from deep trap levels in the SiC substrate. This work ultimately demonstrates that WS2/graphene optoelectronic devices with promising performances can be obtained in a scalable manner. Furthermore, by combining wavelength-selective memory, enhanced responsivity and fast detection, this system is of interest for the implementation of 2d-based data storage devices.

Microbiological surveillance of plasmid mediated colistin resistance in human Enterobacteriaceae isolates in Romagna (Northern Italy): August 2016-July 2017.

OBJECTIVES: To start a surveillance program to investigate the possible diffusion of mobilized colistin resistance genes in Enterobacteriaceae strains isolated in the Unit of Microbiology of the Great Romagna Hub Laboratory. METHODS: All the colistin resistant Enterobacteriaceae, isolated from August 1st 2016 to July 31st 2017, were prospectively evaluated for mcr-1 and mcr-2. Backdated survey of mcr-3, mcr-4 and mcr-5 was performed on the same group of isolates. Species identification was achieved by Vitek MS and the antibiotic susceptibility testing was performed both with Vitek-2 and Sensititre systems. Colistin resistant isolates were screened by PCR for the presence of the plasmid-mediated colistin resistance genes and amplicons were verified by sequencing. All mcr-1 positive isolates were subjected to MLST analysis. RESULTS: Over the total of 19053 isolates belonging to Enterobacteriaceae, 90 were colistin resistant. The presence of mcr-1 was detected in 26 Escherichia coli. The overall prevalence of mcr-1 was 0.14%. The mcr-1 positive E. coli strains were assigned to 13 distinct sequence types (STs) according to MLST. CONCLUSIONS: The prospective epidemiological survey carried out in our study gave a glimpse of the plasmid-mediated colistin resistance dissemination in Romagna. Since the prevalence rate of carbapenem resistant Enterobacteriaceae (CRE) in some hospital wards in our area is alarming, we underline the importance of a Surveillance Program to monitor the spread of the plasmid-mediated colistin resistance genes into MDR Gram-negative bacteria.

Mesenchymal stem cells from tumor microenvironment favour breast cancer stem cell proliferation, cancerogenic and metastatic potential, via ionotropic purinergic signalling.

Interaction between tumor cells and the microenvironment is key in initiation, progression, and invasiveness of cancer. In particular, mesenchymal stem cells (MSCs) are recruited to the sites of developing tumors, thus promoting metastasis formation. Although it is well known that MSCs migrate and integrate in the tumor microenvironment (TME), their fate and function inside the tumor is still not clear. In this study, we analyzed the role played by MSCs in breast cancer oncogenesis. Data indicate that interaction of breast cancer cells with MSCs results in an increased proliferation and metabolic activity of breast cancer cells, partially due to MSC-derived microvesicles that are shed in the TME. Moreover, we addressed the question of whether we could modulate such interaction by acting on P2X-mediated intercellular communication. By inhibiting P2X-mediated purinergic signaling, we succeeded in reducing both the cancerogenic as well as the metastatic potential of breast cancer cells co-cultured with MSCs, in 2D as well as in 3D in vitro models. Data obtained demonstrate for the first time that the trophic effect of MSCs on breast cancer cell growth is exerted via ionotropic purinergic signaling, thus suggesting the inhibition of the purinergic signaling system as a potential target for therapeutic intervention.

Rectal sparing approach after preoperative radio- and/or chemotherapy (RESARCH) in patients with rectal cancer: a multicentre observational study.

BACKGROUND: Rectum-sparing approaches appear to be appropriate in rectal cancer patients with a major (mCR) or complete clinical response (cCR) after neoadjuvant therapy. The aim of the present study is to evaluate the effectiveness of rectum-sparing approaches at 2 years after the completion of neoadjuvant treatment. STUDY DESIGN: Patients with rectal adenocarcinoma eligible to receive neoadjuvant therapy will be prospectively enrolled. Patients will be restaged 7-8 weeks after the completion of neoadjuvant therapy and those with mCR (defined as absence of mass, small mucosal irregularity no more than 2 cm in diameter at endoscopy and no metastatic nodes at MRI) or cCR will be enrolled in the trial. Patients with mCR will undergo local excision, while patients with cCR will either undergo local excision or watch and wait policy. The main end point of the study is to determine the percentage of rectum preservation at 2 years in the enrolled patients. CONCLUSION: This protocol is the first prospective trial that investigates the role of both local excision and watch and wait approaches in patients treated with neoadjuvant therapy for rectal cancer. The trial is registered at clinicaltrials.gov (NCT02710812).