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"Baldazzi, G"
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ASO Visual Abstract: A Randomized Phase III Trial of Complete Mesocolic Excision in Comparison with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-In Trial)
by
Persiani, R.
,
Pirozzi, B.
,
Anania, G.
in
ASO Visual Abstract
,
Clinical Trials, Phase III as Topic
,
Colectomy
2024
Journal Article
Treatment of true superficial femoral artery aneurysms: the 15-year experience of a single centre
2024
True superficial femoral artery aneurysms (SFAAs) are rare and traditionally treated by open repair. However, the endovascular approach excluding the aneurysm sac with a covered stent may be an alternative. This study aimed to compare the outcomes of the open and endovascular repair of SFAAs.
This is a retrospective, observational, monocentric study. The main endpoints were: technical success, limb salvage and primary patency rate, and hospitalisation time.
We identified 49 SFAAs in 40 patients; the mean age was 73.3±10.1 years, the mean diameter of SFAAs was 5.41±3.64cm, and 61.2% were symptomatic for ischaemic or compression-related signs. The indication for open repair was given mainly for complex SFAAs involving the distal third of the superficial femoral artery and with an ipsilateral popliteal aneurysm. Among the 36 open-repair patients, 33 underwent ligation and revascularisation via bypass or graft interposition, and 3 patients underwent simple ligation without revascularisation. The endovascular approach was adopted mainly for aneurysms located in the medial third of the SFAA, which underwent covered stenting in 12 patients and coil embolisation in 1 patient. The technical success was 100% in all cases. There were no statistical differences in terms of primary patency and limb salvage rate between groups at two and four years. The mean hospitalisation time was 10±4 and 3±1 days after open and endovascular treatment, respectively.
The endovascular approach may be a valid alternative for isolating SFAAs offering good results and shorter hospitalisation. Open repair remains a valid approach, particularly in complex aneurysms.
Journal Article
Feasibility of a tailored ERAS programme in octogenarian patients undergoing minimally invasive surgery for colorectal cancer
2020
BackgroundThe enhanced recovery after surgery (ERAS) is nowadays a widely accepted multimodal programme of care in colorectal surgery, but still there is some reluctance in its application to very elderly patients.AimThe aim of this study is to investigate short-term outcomes of laparoscopic resection for colorectal cancer in octogenarian patients within the ERAS programme.MethodsData on 162 consecutive patients aged ≥ 80 years receiving elective minimally invasive colorectal resections within ERAS programme were collected in a multicentre, retrospective database in the period 2008–2017 in Italy. Univariate and multivariate analyses were performed to assess possible risk factors for poor clinical outcomes.ResultsThe postoperative minor morbidity rate (Clavien–Dindo 1 and 2) was 25.9%. The incidence of postoperative major morbidity rate (severe medical and surgical complications defined as Clavien–Dindo 3 and 4) accounted 6.1% and only 1.8% had an anastomotic leakage. Reoperation rate was 5.5%, perioperative 30-day mortality was 1.8%, and 30-day readmission rate was 6.8%. On average, patients were released after 6 days. A univariate analysis showed that possible risk factors for severe medical complications were: low preoperative albumin level, high Charlson Age Comorbidity Index Score and number of days in the intensive care unit (ICU); risk factors for severe surgical complications were: low preoperative albumin level; risk factors for late hospital discharge were: multivisceral resections, number of days in ICU and body mass index (BMI) > 25 kg/m2. The multivariate analysis confirmed a low level of preoperative albumin and a longer ICU stay as independent risk factors for both postoperative severe surgical complications and late hospital discharge.DiscussionThe minimal invasive nature of the laparoscopic approach together with a multimodal analgesia therapy, the early resumption to oral diet and mobilisation could minimize the surgical stress and play an essential role in order to reduce medical morbidity in high-risk patients.ConclusionColorectal surgery within ERAS programme in octogenarians is a safe and flexible treatment in high-volume centres.
Journal Article
Lessons learned from 227 biological meshes used for the surgical treatment of ventral abdominal defects
2020
PurposeThe advantages of biological meshes for ventral hernia repair are still under debate. Given the high financial cost, the proper indications for biological meshes should be clarified to restrict their use to properly selected patients.MethodsA retrospective database was instituted to register all cases of abdominal wall defect treated with biological meshes from 1/2010 to 3/2016.ResultsA total of 227 patients (mean age: 64 years) whose ventral abdominal defects were reconstructed with a biological mesh were included in the study. Patients were divided according to the 2010 four-level surgical-site complication risk grading system proposed by the Ventral Hernia Working Group (VHWG): Grade 1 (G1, 12 cases), Grade 2 (G2, 68 cases), Grade 3 (G3, 112 cases), and Grade 4 (G4, 35 cases). The surgical site complication rate was higher in patients with one or more risk factors (33.6% vs 19% in patients with no risk factors) (P = 0.68). Statistically significant risk factors associated with the onset of one or more postoperative surgical site complications included: diabetes, coronary artery disease, immunosuppression, and obesity. Recurrence was more common in patients with surgical site complications and mainly associated with infection (38.9%) and wound necrosis (44.4%), and in cases of inlay positioning of the mesh (36%).ConclusionsDue to their high costs, biological mesh should not be used in G1 patients. In infected fields (G4), they should only be used if no other surgical solution is feasible. There is a clear need to prospectively evaluate the performance of biological meshes.
Journal Article
Development and tests of a new prototype detector for the XAFS beamline at Elettra Synchrotron in Trieste
2016
The XAFS beamline at Elettra Synchrotron in Trieste combines X-ray absorption spectroscopy and X-ray diffraction to provide chemically specific structural information of materials. It operates in the energy range 2.4-27 keV by using a silicon double reflection Bragg monochromator. The fluorescence measurement is performed in place of the absorption spectroscopy when the sample transparency is too low for transmission measurements or the element to study is too diluted in the sample. We report on the development and on the preliminary tests of a new prototype detector based on Silicon Drift Detectors technology and the SIRIO ultra low noise front-end ASIC. The new system will be able to reduce drastically the time needed to perform fluorescence measurements, while keeping a short dead time and maintaining an adequate energy resolution to perform spectroscopy. The custom-made silicon sensor and the electronics are designed specifically for the beamline requirements.
Journal Article
A flexible scintillation light apparatus for rare events searches
2016
FLARES (a Flexible scintillation Light Apparatus for Rare Event Searches) is a project for an innovative detector technology to be applied to rare event searches, and in particular to neutrinoless double beta decay experiments. Its novelty is the enhancement and optimization of the collection of the scintillation light emitted by ultra-pure crystals through the use of arrays of high performance silicon photodetectors cooled to 120 K. This would provide scintillation detectors with ~1% level energy resolution, with the advantages of a technology offering relatively simple low cost mass scalability and powerful background reduction handles, as requested by future neutrinoless double beta decay experimental programs.
Journal Article
The XGS instrument on-board THESEUS
by
Zampa, G.
,
Piemonte, C.
,
Bellutti, P.
in
Gamma spectroscopy
,
Image reconstruction
,
Image segmentation
2016
Consolidated techniques used for space-borne X-ray and gamma-ray instruments are based on the use of scintillators coupled to Silicon photo-detectors. This technology associated with modern very low noise read-out electronics allows the design of innovative architectures able to reduce drastically the system complexity and power consumption, also with a moderate-to-high number of channels. These detector architectures can be exploited in the design of space instrumentation for gamma-spectroscopy with the benefit of possible smart background rejection strategies. We describe a detector prototype with 3D imaging capabilities to be employed in future gamma-ray and particle space missions in the 0.002-100 MeV energy range. The instrument is based on a stack of scintillating bars read out by Silicon Drift Detectors (SDDs) at both ends. The spatial segmentation and the crystal double-side readout allow a 3D position reconstruction with ∼3 mm accuracy within the full active volume, using a 2D readout along the two external faces of the detector. Furthermore, one of the side of SDDs can be used simultaneously to detect X-rays in the 2-30 keV energy range. The characteristics of this instrument make it suitable in next generation gamma-ray and particle space missions for Earth or outer space observations, and it will be briefly illustrated.
Journal Article
A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial)
by
Muratore, Andrea
,
Persiani, Roberto
,
Biondi, Alberto
in
Clinical trials
,
Colectomy
,
Colon cancer
2024
Background
Although complete mesocolic excision (CME) is supposed to be associated with a higher lymph node (LN) yield, decreased local recurrence, and survival improvement, its implementation currently is debated because the evidence level of these data is rather low and still not supported by randomized controlled trials.
Method
This is a multicenter, randomized, superiority trial (NCT04871399). The 3-year disease-free survival (DFS) was the primary end point of the study. The secondary end points were safety (duration of operation, perioperative complications, hospital length of stay), oncologic outcomes (number of LNs retrieved, 3- and 5-year overall survival, 5-year DFS), and surgery quality (specimen length, area and integrity rate of mesentery, length of ileocolic and middle-colic vessels). The trial design required the LN yield to be higher in the CME group at interim analysis.
Results
Interim data analysis is presented in this report. The study enrolled 258 patients in nine referral centers. The number of LNs retrieved was significantly higher after CME (25 vs. 20;
p
= 0.012). No differences were observed with respect to intra- or post-operative complications, postoperative mortality, or duration of surgery. The hospital stay was even shorter after CME (
p
= 0.039). Quality of surgery indicators were higher in the CME arm of the study. Survival data still were not available.
Conclusions
Interim data show that CME for right colon cancer in referral centers is safe and feasible and does not increase perioperative complications. The study documented with evidence that quality of surgery and LN yield are higher after CME, and this is essential for continuation of patient recruitment and implementation of an optimal comparison.
Trial registration
The trial was registered at ClinicalTrials.gov with the code NCT04871399 and with the acronym CoME-In trial.
Journal Article
Laparoscopic right hemicolectomy: the SICE (Società Italiana di Chirurgia Endoscopica e Nuove Tecnologie) network prospective trial on 1225 cases comparing intra corporeal versus extra corporeal ileo-colic side-to-side anastomosis
by
Rubino, Serena
,
Petz, Wanda Luisa
,
Agresta, Ferdinando
in
Abdomen
,
Abdominal surgery
,
Body mass index
2020
BackgroundWhile laparoscopic approach for right hemicolectomy (LRH) is considered appropriate for the surgical treatment of both malignant and benign diseases of right colon, there is still debate about how to perform the ileo-colic anastomosis. The ColonDxItalianGroup (CoDIG) was designed as a cohort, observational, prospective, multi-center national study with the aims of evaluating the surgeons’ attitude regarding the intracorporeal (ICA) or extra-corporeal (ECA) anastomotic technique and the related surgical outcomes.MethodsOne hundred and twenty-five Surgical Units experienced in colorectal and advanced laparoscopic surgery were invited and 85 of them joined the study. Each center was asked not to change its surgical habits. Data about demographic characteristics, surgical technique and postoperative outcomes were collected through the official SICE website database. One thousand two hundred and twenty-five patients were enrolled between March 2018 and September 2018.ResultsICA was performed in 70.4% of cases, ECA in 29.6%. Isoperistaltic anastomosis was completed in 85.6%, stapled in 87.9%. Hand-sewn enterotomy closure was adopted in 86%. Postoperative complications were reported in 35.4% for ICA and 50.7% for ECA; no significant difference was found according to patients’ characteristics and technologies used. Median hospital stay was significantly shorter for ICA (7.3 vs. 9 POD). Postoperative pain in patients not prescribed opioids was significantly lower in ICA group.ConclusionsIn our survey, a side-to-side isoperistaltic stapled ICA with hand-sewn enterotomy closure is the most frequently adopted technique to perform ileo-colic anastomosis after any indications for elective LRH. According to literature, our study confirmed better short-term outcomes for ICA, with reduction of hospital stay and postoperative pain.Trial registrationClinical trial (Identifier: NCT03934151).
Journal Article