23 research outputs found

    High-Volume Transanal Surgery with CPH34 HV for the Treatment of III-IV Degree Haemorrhoids: Final Short-Term Results of an Italian Multicenter Clinical Study

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    The clinical chart of 621 patients with III-IV haemorrhoids undergoing Stapled Hemorrhoidopexy (SH) with CPH34 HV in 2012-2014 was consecutively reviewed to assess its safety and efficacy after at least 12 months of follow-up. Mean volume of prolapsectomy was significantly higher (13.0 mL; SD, 1.4) in larger prolapse (9.3 mL; SD, 1.2) (p < 0.001). Residual or recurrent haemorrhoids occurred in 11 of 621 patients (1.8%) and in 12 of 581 patients (1.9%), respectively. Relapse was correlated with higher preoperative Constipation Scoring System (CSS) (p = 0.000), Pescatori's degree (p = 0.000), Goligher's grade (p = 0.003), prolapse exceeding half of the length of the Circular Anal Dilator (CAD) (p = 0.000), and higher volume of prolapsectomy (p = 0.000). At regression analysis, only the preoperative CSS, Pescatori's degree, Goligher's grade, and volume of resection were significantly predictive of relapse. A high level of satisfaction (VAS = 8.6; SD, 1.0) coupled with a reduction of 12-month CSS (Δ preoperative CSS/12 mo CSS = 3.4, SD, 2.0; p < 0.001) was observed. The wider prolapsectomy achievable with CPH34 HV determined an overall 3.7% relapse rate in patients with high prevalence of large internal rectal prolapse, coupled with high satisfaction index, significant reduction of CSS, and very low complication rates

    Imaging features and ultraearly hematoma growth in intracerebral hemorrhage associated with COVID-19

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    Purpose: Intracerebral hemorrhage (ICH) is an uncommon but deadly event in patients with COVID-19 and its imaging features remain poorly characterized. We aimed to describe the clinical and imaging features of COVID-19-associated ICH. Methods: Multicenter, retrospective, case-control analysis comparing ICH in COVID-19 patients (COV19\u2009+) versus controls without COVID-19 (COV19\u2009-). Clinical presentation, laboratory markers, and severity of COVID-19 disease were recorded. Non-contrast computed tomography (NCCT) markers (intrahematoma hypodensity, heterogeneous density, blend sign, irregular shape fluid level), ICH location, and hematoma volume (ABC/2 method) were analyzed. The outcome of interest was ultraearly hematoma growth (uHG) (defined as NCCT baseline ICH volume/onset-to-imaging time), whose predictors were explored with multivariable linear regression. Results: A total of 33 COV19\u2009+\u2009patients and 321 COV19\u2009-\u2009controls with ICH were included. Demographic characteristics and vascular risk factors were similar in the two groups. Multifocal ICH and NCCT markers were significantly more common in the COV19\u2009+\u2009population. uHG was significantly higher among COV19\u2009+\u2009patients (median 6.2&nbsp;mL/h vs 3.1&nbsp;mL/h, p\u2009=\u20090.027), and this finding remained significant after adjustment for confounding factors (systolic blood pressure, antiplatelet and anticoagulant therapy), in linear regression (B(SE)\u2009=\u20090.31 (0.11), p\u2009=\u20090.005). This association remained consistent also after the exclusion of patients under anticoagulant treatment (B(SE)\u2009=\u20090.29 (0.13), p\u2009=\u20090.026). Conclusions: ICH in COV19\u2009+\u2009patients has distinct NCCT imaging features and a higher speed of bleeding. This association is not mediated by antithrombotic therapy and deserves further research to characterize the underlying biological mechanisms

    Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

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    Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

    Inferior Pedicle Reduction Mammoplasty as Corrective Surgery after Breast Conserving Surgery and Radiation Therapy

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    Background/Aim—Twenty patients had corrective reconstruction surgery by means of a reduction mammaplasty or mastopexy after a previous BCS (Breast Conserving Surgery) and RT (Radiation Therapy); the risk factors and post-operative complications were reported in order to define a safe and effective technique for reduction mammaplasty in previously irradiated breast cancer patients. Materials and Methods—From June 2011 to December 2019, 20 pts. were operated on at the Breast Surgery Clinic of San Martino Policlinic Hospital, Genoa, Italy. Pre- and post-operative parameters included clinic-pathological features of the primary tumor; a lapse of time from primary radio-surgery; the extent of follow-up; the rate of post-operative wound infections; the persistence of breast asymmetry, and a post-operative patient satisfaction index by means of a BREAST-Q questionnaire. Results—Three patients (15%) developed minor complications in the irradiated breast, but no complication was observed into the non-irradiated breast. No statistically significant correlation was found between the post-operative complications and the risk factors. The statistical analysis of BREAST-Q questionnaire responses gave an average patient’s satisfaction index that was equal to 90.8/100 (range: 44 to 100). Conclusions—Inferior pedicle reduction mammoplasty is an effective reduction mammoplasty technique in regard to the extent of breast tissues that are to be removed both in irradiated and contralateral breast; moreover, the incidence of post-operative complications is clearly limited when a careful technique is adopted, and it can be reasonably applied also in patients with co-morbidity factors

    “<i>No Ink on Tumor</i>” in Breast-Conserving Surgery after Neoadjuvant Chemotherapy

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    Background/Aim: Patients with Stage I-II breast cancer undergoing breast-conserving surgery after neoadjuvant chemotherapy (BCS-NAC) were retrospectively assessed in order to evaluate the extent of a safe excision margin. Materials and Methods: Between 2003 and 2020, 151 patients underwent risk-adapted BCS-NAC; margin involvement was always assessed at definitive histology. Patients with complete pathological response (pCR) were classified as the RX group, whereas those with residual disease and negative margins were stratified as R0 1 mm (margin > 1 mm). Results: Totals of 29 (19.2%), 64 (42.4%), and 58 patients (38.4%) were included in the R0 1 mm, and RX groups, respectively, and 2 patients with margin involvement had a mastectomy. Ten instances of local recurrence (6.6%) occurred, with no statistically significant difference in local recurrence-free survival (LRFS) between the three groups. A statistically significant advantage of disease-free survival (p = 0.002) and overall survival (p = 0.010) was observed in patients with pCR. Conclusions: BCS-NAC was increased, especially in HER-2-positive and triple-negative tumors; risk-adapted BCS should be preferably pursued to highlight the cosmetic benefit of NAC. The similar rate of LRFS in the three groups of patients suggests a shift toward the “no ink on tumor” paradigm for patients undergoing BCS-NAC

    No Axillary Lymph Node Dissection in Breast Cancer Patients with Sentinel Lymph Node Micrometastasis

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    Follow-up data of a series of 75 breast cancer patients with sentinel node (SN) micrometastases only (between 0.2 and 2 mm) and favorable histopathological features of the primary tumor (well-differentiated, T1 tumors without lymphovascular invasion) who refused completion axillary lymph node dissection (ALND) or who were unsuitable for surgery were assessed in order to detect the rate of axillary recurrence after an adjuvant chemoand/or hormonal adjuvant treatment was given. The great majority of patients (81.3%) did not undergo ALND due to the existence of favorable histopathologic factors while the rest were equally distributed among over 75-year-old women (10.6%) and patients at a high surgical risk due to comorbid conditions (9.3%). Sixty-six patients (88%) underwent conservative treatment (lumpectomy followed by adjuvant breast radiotherapy) while the remaining nine patients (12%) had total mastectomy; 72 out of 75 patients (96%) received some forms of adjuvant chemo- and/or hormone-therapy. After a median follow-up of 38 months (range 12 - 84 months), nine out of 75 patients (12%) had a disease relapse, only one of them (1.3%) being affected by an axillary recurrence in the untreated axilla three years after primary surgery. On these grounds, completion ALND could be safely omitted in patients with SN micrometastasis and favorable histopathological characteristics of the primary neoplasm due to the very low rate of axillary recurrence with no detrimental effect on survival

    Residual Prolapse in Patients with III-IV Degree Haemorrhoids Undergoing Stapled Haemorrhoidopexy with CPH34 HV. Results of an Italian Multicentric Clinical Study

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    Patientswith haemorrhoids and large internal rectal prolapse are at high risk of relapse after stapled haemorrhoidopexy (SH) due to the limited prolapse resection achievable with currently available staplers. Stapled transanal rectal resection (STARR) was tested to overcome such technological limitations, although it requires a double rectal resection. A novel stapler device, CPH34 HV, with a high volume stapler casing, was tested in a multicenter clinical study in order to assess its safety and efficacy in this clinical setting. Patients and Methods. The clinical chart of 430 patients (209 males and 221 females; mean age of 51 years; SD, 13.4 years) with third- to fourth-degree haemorrhoids undergoing SH in 2012-2013 was consecutively reviewed. Patients with symptoms of obstructed defecation syndrome (ODS), second-degree rectocele (2–4 cm), and a Wexner’s constipation score over 15 were excluded. Follow-up was scheduled at six and 12 months after the operation. Results. Three hundred forty-one patients (79.3%) had an internal rectal prolapse exceeding more than half of CAD. One technical failure of the device was reported (0.2%) without any untoward effect as for the operation; 1.3 stitch/patient (SD, 1.7) was required to achieve complete haemostasis of the suture line. The mean in-hospital stay was 1.6 days (SD, 1; range, 1–4). The mean volume of the doughnuts was significantly higher (13.8 mL; SD, 1.5) in patients with a large rectal prolapse than with smaller one (8.9 mL; SD, 0.7) (-value < 0.05). Residual and recurrent haemorrhoids occurred in eight out of 430 patients (1.8%) and in five out of 254 patients (1.9%), respectively, withmost of them having originally a large rectal prolapse. A high index of patient satisfaction (visual analogue scale = 8.9; SD, 0.9) coupled with a persistent reduction of constipation scores (CSS = 5.0, SD, 2.2) was observed. Conclusions.The wider prolapse resection well correlated with a clear-cut reduction of haemorrhoidal relapse, a high index of patient satisfaction, and clinically-relevant reduction of constipations scores coupled with satisfactory haemostatic properties of CPH34 HV

    Axillary ultrasound and Fine-Needle Aspiration Cytology in the preoperative staging of axillary node metastasis in breast cancer patients

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    Objective A prospective observational clinical study was undertaken to assess the accuracy of preoperative Axillary Ultrasound (AUS) plus Fine-Needle Aspiration Cytology (FNAC) as well as and its clinical utility, that is the capacity of the information supplied by the test to guide the clinical decision-making. Materials and methods from January 2013 to August 2015, 400 female patients with pT1-3 cN0 operable breast cancer underwent AUS with FNAC at the Breast Unit of the \u201cIRCCS San Martino-IST\u201d in Genoa (Italy). Results 127 out of 400 patients (31.7%) had axillary lymph node metastases; in 69 out of 127 node-positive patients (54.3%) AUS detected at least one abnormal lymph node, and in 56 out of 127 patients (44.1%) the abnormal sonographic pattern of the lymph node was coupled with a positive FNAC finding. No false-positive finding by both AUS-alone or combined AUS/FNAC was observed. AUS-alone had sensitivity of 54.3% (69/127), specificity of 100% (273/273), PPV of 100% (69/69), NPV of 82.5% (273/331), and accuracy of 85.5% (342/400). Combined AUS/FNAC had sensitivity of 44.1% (56/127), specificity of 100% (273/273), PPV of 100% (56/56), NPV of 79.4% (273/344), and accuracy of 82.2% (329/400). Conclusions AUS-alone or combined AUS/FNAC had a high accuracy rate coupled with a more than satisfactory efficiency due to their low costs and easy access for the preoperative staging of the axilla. Notably, AUS-alone might be suggested for the preoperative staging of patients with early stage breast cancer because FNAC did not increased the specificity but reduced the sensitivity of the technique. Patients with negative findings might undergo either SLNB or close observation while waiting for the definitive results of ongoing SOUND randomized clinical trial
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