Additional value of cardiac magnetic resonance feature tracking parameters for the evaluation of the arrhythmic risk in patients with mitral valve prolapse.

OBJECTIVES: The identification of patients with mitral valve prolapse (MVP) presenting high arrhythmic risk remains challenging. Cardiovascular Magnetic Resonance (CMR) feature tracking (FT) may improve risk stratification. We analyzed the role of CMR-FT parameters in relation to the incidence of complex ventricular arrhythmias (cVA) in patients with MVP and mitral annular disjunction (MAD). METHODS: 42 patients with MVP and MAD who underwent 1.5 T CMR were classified as MAD-cVA (n = 23, 55%) in case of cVA diagnosed on a 24-h Holter monitoring and as MAD-noVA in the absence of cVA (n = 19, 45%). MAD length, late gadolinium enhancement (LGE), basal segments myocardial extracellular volume (ECV) and CMR-FT were assessed. RESULTS: LGE was more frequent in the MAD-cVA group in comparison with the MAD-noVA group (78% vs 42%, p = 0.002) while no difference was observed in terms of basal ECV. Global longitudinal strain (GLS) was reduced in MAD-cVA compared to MAD-noVA (- 18.2% ± 4.6% vs - 25.1% ± 3.1%, p = 0.004) as well as global circumferential strain (GCS) at the mid-ventricular level (- 17.5% ± 4.7% vs - 21.6% ± 3.1%, p = 0.041). Univariate analysis identified as predictors of the incidence of cVA: GCS, circumferential strain (CS) in the basal and mid infero-lateral wall, GLS, regional longitudinal strain (LS) in the basal and mid-ventricular inferolateral wall. Reduced GLS [Odd ratio (OR):1.56 (confidence interval (CI) 95%: 1.45-2.47; p < 0.001)] and regional LS in the basal inferolateral wall [OR: 1.62 (CI 95%: 1.22-2.13; p < 0.001)] remained independent prognostic factors in multivariate analysis. CONCLUSION: In patients with MVP and MAD, CMR-FT parameters are correlated with the incidence of cVA and may be of interest in arrhythmic risk stratification.

Laparoscopic treatment of ventral hernias: the Italian national guidelines.

Primary and incisional ventral hernias are significant public health issues for their prevalence, variability of professional practices, and high costs associated with the treatment In 2019, the Board of Directors of the Italian Society for Endoscopic Surgery (SICE) promoted the development of new guidelines on the laparoscopic treatment of ventral hernias, according to the new national regulation. In 2022, the guideline was accepted by the government agency, and it was published, in Italian, on the SNLG website. Here, we report the adopted methodology and the guideline's recommendations, as established in its diffusion policy. This guideline is produced according to the methodology indicated by the SNGL and applying the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) methodology. Fifteen recommendations were produced as a result of 4 PICO questions. The level of recommendation was conditional for 12 of them and conditional to moderate for one. This guideline's strengths include relying on an extensive systematic review of the literature and applying a rigorous GRADE method. It also has several limitations. The literature on the topic is continuously and rapidly evolving; our results are based on findings that need constant re-appraisal. It is focused only on minimally invasive techniques and cannot consider broader issues (e.g., diagnostics, indication for surgery, pre-habilitation).

Intracorporeal or extracorporeal ileocolic anastomosis after laparoscopic right colectomy: cost analysis of the Torino trial.

BACKGROUND: Intracorporeal (IIA) and extracorporeal anastomosis (EIA) are two well-established techniques for restoration of bowel continuity after laparoscopic right colectomy (LRC). Since no economic analysis comparing the two different anastomotic techniques has been performed yet, it is still unclear if IIA can reduce perioperative costs. The aim of the study was to compare costs of LRC with IIA or EIA for right-sided colon neoplasm. METHODS: This is a cost analysis of a single-institution double-blinded randomized controlled trial comparing the outcomes of LRC with IIA and LRC with EIA in patients with a right-sided colon neoplasm. All direct in-hospital costs related to patient's admission were recorded (intraoperative costs: operative room, surgical tools, blood units-postoperative costs: hospital stay, laboratory and microbiology analyses, diagnostic services, analgesic drugs and antibiotic therapy, blood units, reoperation-outpatient costs: post-discharge wound medications). This trial was registered with ClinicalTrials.gov, Number NCT03045107. RESULTS: A total of 140 patients were randomized and analyzed. Mean overall costs in the IIA group exceeded 349 € the mean overall costs of the EIA group (7926.87 ± 4617.23 € vs. 7577.45 ± 6131.17 €; P = 0.704). A mean extra charge of 608 € regarding total intraoperative costs was recorded in the IIA group (3058.84 ± 897.42 € vs. 2450.15 ± 558.90 €; P < 0.001). The cost of surgical instruments resulted in 542 € additional charge per patient in the IIA group compared to EIA group (1782.74 ± 541.26 € vs. 1240.55 ± 384.09 €; P < 0.001). The mean cost of operative room occupancy was comparable in IIA and EIA group: 1276.09 ± 514.94 € vs. 1209.60 ± 422.80 € (P = 0.405). No significant differences were observed in postoperative costs and in outpatient costs. CONCLUSION: This economic analysis showed that IIA and EIA after LRC had similar overall costs, even though there were intraoperative extra costs of IIA.

Oral neomycin and bacitracin are effective in preventing surgical site infections in elective colorectal surgery: a multicentre, randomized, parallel, single-blinded trial (COLORAL-1).

Several regimens of oral and intravenous antibiotics (OIVA) have been proposed with contradicting results, and the role of mechanical bowel preparation (MBP) is still controversial. This study aims to assess the effectiveness of oral antibiotic prophylaxis in preventing Surgical Site Infections (SSI) in elective colorectal surgery. In a multicentre trial, we randomized patients undergoing elective colorectal resection surgery, comparing the effectiveness of OIVA versus intravenous antibiotics (IVA) regimens to prevent SSI as the primary outcome (NCT04438655). In addition to intravenous Amoxicillin/Clavulanic, patients in the OIVA group received Oral Neomycin and Bacitracin 24 h before surgery. MBP was administered according to local habits which were not changed for the study. The trial was terminated during the COVID-19 pandemic, as many centers failed to participate as well as the pandemic changed the rules for engaging patients. Two-hundred and four patients were enrolled (100 in the OIVA and 104 in the IVA group); 3 SSIs (3.4%) were registered in the OIVA and 14 (14.4%) in the IVA group (p = 0.010). No difference was observed in terms of anastomotic leak. Multivariable analysis indicated that OIVA reduced the rate of SSI (OR 0.21 / 95% CI 0.06-0.78 / p = 0.019), while BMI is a risk factor of SSI (OR 1.15 / 95% CI 1.01-1.30 p = 0.039). Subgroup analysis indicated that 0/22 patients who underwent OIVA/MBP + vs 13/77 IVA/MBP- experienced an SSI (p = 0.037). The early termination of the study prevents any conclusion regarding the interpretation of the data. Nonetheless, Oral Neomycin/Bacitracin and intravenous beta-lactam/beta-lactamases inhibitors seem to reduce SSI after colorectal resections, although not affecting the anastomotic leak in this trial. The role of MBP requires more investigation.

Long-term Oncologic Results After Stenting as a Bridge to Surgery Versus Emergency Surgery for Malignant Left-sided Colonic Obstruction: A Multicenter Randomized Controlled Trial (ESCO Trial).

OBJECTIVE: To assess overall (OS), time to progression (TTP), and disease-free survival (DFS) at 3 years after treatment, comparing stenting as bridge-to-surgery (SBTS) versus emergency surgery (ES) in neoplastic left colon obstruction, secondary endpoints of the previously published randomized controlled trial. BACKGROUND: While SBTS in neoplastic colon obstruction may reduce morbidity and need for a stoma compared with ES, concern has been raised, about long-term survival. METHODS: Individuals affected by left-sided malignant large-bowel obstruction were enrolled from 5 European hospitals and randomly assigned (1:1 ratio) to receive SBTS or ES. The computer-generated randomization sequence was stratified by center on cT and concealed by the use of a web-based application. Investigators and participants were unmasked to treatment assignment. The secondary outcomes analyzed here were OS, TTP, and DFS. Analysis was by intention to treat. This study is registered, ID-code NCT00591695. RESULTS: Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 115 (SBTS n = 56, ES n = 59) were eligible for analysis, while 20 participants were excluded for a benign disease, 1 for unavailability of the endoscopist while 8 withdrew from the trial. With a median follow-up of 37 months (range 1-62), no difference was observed in the SBTS group compared with ES in terms of OS (HR 0.93 (95% CI 0.49-1.76), P = 0.822), TTP (HR 0.81 (95% CI 0.42-1.54), P = 0.512), and DFS (HR 1.01 (95% CI 0.56-1.81), P = 0.972). Planned subgroup analysis showed no difference in respect to age, sex, American Society for Anesthesiology score, body mass index, and pT between SBTS and ES groups. Those participants randomized for the SBTS group whose obstruction was located in the descending colon had a better TTP compared with ES group (HR 0.44 (95% CI 0.20-0.97), P = 0.042), but no difference was observed in terms of OS (HR 0.73 (95% CI 0.33-1.63), P = 0.442) and DFS (HR 0.68 (95% CI 0.34-1.34), P = 0.261) in the same individuals. CONCLUSIONS: This randomized controlled trial shows that, although not powered for these seconday outcomes, OS, TTP, and DFS did not differ between groups at a minimum follow-up of 36 months.

Intraoperative use of fluorescence with indocyanine green reduces anastomotic leak rates in rectal cancer surgery: an individual participant data analysis.

BACKGROUND: Fluorescence imaging by means of Indocyanine green (ICG) has been applied to intraoperatively determine the perfusion of the anastomosis. The purpose of this Individual Participant Database meta-analysis was to assess the effectiveness in decreasing the incidence of anastomotic leak (AL) after rectal cancer surgery. METHODS: We searched PubMed, Embase, Cochrane Library and ClinicalTrial.gov, EU Clinical Trials and ISRCTN registries on September 1st, 2019. We considered eligible those studies comparing the assessment of anastomotic perfusion during rectal cancer surgery by intraoperative use of ICG fluorescence compared with standard practice. We defined as primary outcome the incidence of AL at 30 days after surgery. The studies were assessed for quality by means of the ROBINS-I and the Cochrane risk tools. We calculated odds ratios (ORs) using the Individual patient data analysis, restricted to rectal lesions, according to original treatment allocation. RESULTS: The review of the literature and international registries produced 15 published studies and 5 ongoing trials, for 9 of which the authors accepted to share individual participant data. 314 patients from two randomized trials, 452 from three prospective series and 564 from 4 non-randomized studies were included. Fluorescence imaging significantly reduced the incidence of AL (OR 0.341; 95% CI 0.220-0.530; p < 0.001), independent of age, gender, BMI, tumour and anastomotic distance from the anal verge and neoadjuvant therapy. Also, overall morbidity and reintervention rate were positively influenced by the use of ICG. CONCLUSIONS: The incidence of AL may be reduced when ICG fluorescence imaging is used to assess the perfusion of a colorectal anastomosis. Limitations relate to the consistent number of non-randomized studies included and their heterogeneity in defining and assessing AL. Ongoing large randomized studies will help to determine the exact role of routine ICG fluorescence imaging may decrease the incidence of AL in surgery for rectal cancer.

The use of 3D laparoscopic imaging systems in surgery: EAES consensus development conference 2018.

BACKGROUND: The use of 3D laparoscopic systems is expanding. The European Association of Endoscopic Surgery (EAES) initiated a consensus development conference with the aim of creating evidence-based statements and recommendations for the surgical community. METHODS: Systematic reviews of the PubMed and Embase libraries were performed to identify evidence on potential benefits of 3D on clinical practice and patient outcomes. Statements and recommendations were prepared and unanimously agreed by an international surgical and engineering expert panel which were presented and voted at the EAES annual congress, London, May 2018. RESULTS: 9967 abstracts were screened with 138 articles included. 18 statements and two recommendations were generated and approved. 3D significantly shortened operative time (mean difference 11 min (8% [95% CI 20.29-1.72], I2 96%)). A significant reduction in complications was observed when 3D systems were used (RR 0.75, [95 CI% 0.60-0.94], I2 0%) particularly for cases involving laparoscopic suturing (RR 0.57 [95% CI 0.35-0.90], I2 0%). In 69 box trainer or simulator studies, 64% concluded trainees were significant faster and 62% performed fewer errors when using 3D. CONCLUSION: We recommend the use of 3D vision in laparoscopy to reduce the operative time (grade of recommendation: low). Future robust clinical research is required to specifically investigate the potential benefit of 3D laparoscopy system on complication rates (grade of recommendation: high).

A structured light laser probe for gastrointestinal polyp size measurement: a preliminary comparative study.

BACKGROUND AND STUDY AIMS: Polyp size measurement is an important diagnostic step during gastrointestinal endoscopy, and is mainly performed by visual inspection. However, lack of depth perception and objective reference points are acknowledged factors contributing to measurement errors in polyp size. In this paper, we describe the proof-of-concept of a polyp measurement device based on structured light technology for future endoscopes. PATIENTS AND METHODS: Measurement accuracy, time, user confidence, and satisfaction were evaluated for polyp size assessment by (a) visual inspection, (b) open biopsy forceps of known size, (c) ruled snare, and (d) structured light probe, for a total of 392 independent polyp measurements in ex vivo porcine stomachs. RESULTS: Visual assessment resulted in a median estimation error of 2.2 mm, IQR = 2.6 mm. The proposed probe can reduce the error to 1.5 mm, IQR = 1.67 mm ( P  = 0.002, 95 %CI) and its performance was found to be statistically similar to using forceps for reference ( P  = 0.81, 95 %CI) or ruled snare ( P  = 0.99, 95 %CI), while not occluding the tool channel. Timing performance with the probe was measured to be on average 54.75 seconds per polyp. This was significantly slower than visual assessment (20.7 seconds per polyp, P  = 0.005, 95 %CI) but not significantly different from using a snare (68.5 seconds per polyp, P  = 0.73, 95 %CI). However, the probe's timing performance was partly due to lens cleaning problems in our preliminary design. Reported average satisfaction on a 0 - 10 range was highest for the proposed probe (7.92), visual assessment (7.01), and reference forceps (7.82), while significantly lower for snare users with a score of 4.42 ( P  = 0.035, 95 %CI). CONCLUSIONS: The common practice of visual assessment of polyp size was found to be significantly less accurate than tool-based assessment, but easy to carry out. The proposed technology offers an accuracy on par with using a reference tool or ruled snare with the same satisfaction levels of visual assessment and without occluding the tool channel. Further study will improve the design to reduce the operating time by integrating the probe within the scope tip.

Stent as bridge to surgery for left-sided malignant colonic obstruction reduces adverse events and stoma rate compared with emergency surgery: results of a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND AND AIMS: Twenty years after the first description of the technique, the debate is still open on the role of self-expandable metallic stent (SEMS) placement as a bridge to elective surgery for symptomatic left-sided malignant colonic obstruction. The aim was to compare morbidity rates after colonic stenting bridge to surgery (SBTS) versus emergency surgery (ES) for left-sided malignant obstruction. METHODS: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) on SBTS or ES for acute symptomatic malignant left-sided large bowel obstruction. The primary outcome was overall morbidity within 60 days after surgery. RESULTS: The meta-analysis included 8 RCTs and 497 patients. Overall mortality within 60 days after surgery was 9.6% in SBTS-treated patients and 9.9% in ES-treated patients (relative risk [RR], 0.99; P = .97). Overall morbidity within 60 days after surgery was 33.9% in SBTS-treated patients and 51.2% in ES-treated patients (RR, 0.59; P = .023). The temporary stoma rate was 33.9% after SBTS and 51.4% after ES (RR, 0.67; P < .001). The permanent stoma rate was 22.2% after SBTS and 35.2% after ES (RR, 0.66; P = .003). Primary anastomosis was successful in 70.0% of SBTS-treated patients and 54.1% of ES-treated patients (RR, 1.29; P = .043). CONCLUSIONS: SBTS was associated with lower short-term overall morbidity and lower rates of temporary and permanent stoma. Depending on multiple factors such as local expertise, clinical status including level of obstruction, and level of certainty of diagnosis, SBTS does offer some advantages with less risk than ES for left-sided malignant colonic obstruction in the short term.

Colonic stenting as a bridge to surgery versus emergency surgery for malignant colonic obstruction: results of a multicentre randomised controlled trial (ESCO trial).

BACKGROUND: The aim of colonic stenting with self-expandable metallic stents in neoplastic colon obstruction is to avoid emergency surgery and thus potentially reduce morbidity, mortality, and need for a stoma. Concern has been raised, however, about the effect of colonic stenting on short-term complications and long-term survival. We compared morbidity rates after colonic stenting as a bridge to surgery (SBTS) versus emergency surgery (ES) in the management of left-sided malignant large-bowel obstruction. METHODS: This multicentre randomised controlled trial was designed with the endorsement of the European Association for Endoscopic Surgery. The study population was consecutive patients with acute, symptomatic malignant left-sided large-bowel obstruction localised between the splenic flexure and 15 cm from the anal margin. The primary outcome was overall morbidity within 60 days after surgery. RESULTS: Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 29/144 (13.9%) were excluded post-randomisation mainly because of wrong diagnosis at computed tomography examination. The remaining 115 patients (SBTS n = 56, ES n = 59) were deemed eligible for analysis. The complications rate within 60 days was 51.8% in the SBTS group and 57.6% in the ES group (p = 0.529). Although long-term follow-up is still ongoing, no statistically significant difference in 3-year overall survival (p = 0.998) and progression-free survival rates between the groups has been observed (p = 0.893). Eleven patients in the SBTS group and 23 in the ES group received a stoma (p = 0.031), with a reversal rate of 30% so far. CONCLUSIONS: Our findings indicate that the two treatment strategies are equivalent. No difference in oncologic outcome was found at a median follow-up of 36 months. The significantly lower stoma rate noted in the SBTS group argues in favour of the SBTS procedure when performed in expert hands.

Systematic review and meta-analysis of endoscopic submucosal dissection versus transanal endoscopic microsurgery for large noninvasive rectal lesions.

BACKGROUND: For almost 30 years, transanal endoscopic microsurgery (TEM) has been the mainstay treatment for large rectal lesions. With the advent of endoscopic submucosal dissection (ESD), flexible endoscopy has aimed at en bloc R0 resection of superficial lesions of the digestive tract. This systematic review and meta-analysis compared the safety and effectiveness of ESD and full-thickness rectal wall excision by TEM in the treatment of large nonpedunculated rectal lesions preoperatively assessed as noninvasive. METHODS: A systematic review of the literature published between 1984 and 2010 was conducted (Registration no. CRD42012001882). Data were integrated with those from the original databases requested from the study authors when needed. Pooled estimates of the proportions of patients with en bloc R0 resection, complications, recurrence, and need for further treatment in the ESD and TEM series were compared using random-effects single-arm meta-analysis. RESULTS: This review included 11 ESD and 10 TEM series (2,077 patients). The en bloc resection rate was 87.8 % (95 % confidence interval [CI] 84.3-90.6) for the ESD patients versus 98.7 % (95 % CI 97.4-99.3 %) for the TEM patients (P < 0.001). The R0 resection rate was 74.6 % (95 % CI 70.4-78.4 %) for the ESD patients versus 88.5 % (95 % CI 85.9-90.6 %) for the TEM patients (P < 0.001). The postoperative complications rate was 8.0 % (95 %, CI 5.4-11.8 %) for the ESD patients versus 8.4 % (95 % CI 5.2-13.4 %) for the TEM patients (P = 0.874). The recurrence rate was 2.6 % (95 % CI 1.3-5.2 %) for the ESD patients versus 5.2 % (95 % CI 4.0-6.9 %) for the TEM patients (P < 0.001). Nevertheless, the rate for the overall need of further abdominal treatment, defined as any type of surgery performed through an abdominal access, including both complications and pathology indications, was 8.4 % (95 % CI 4.9-13.9 %) for the ESD patients versus 1.8 % (95 % CI 0.8-3.7 %) for the TEM patients (P < 0.001). CONCLUSIONS: The ESD procedure appears to be a safe technique, but TEM achieves a higher R0 resection rate when performed in full-thickness fashion, significantly reducing the need for further abdominal treatment.

Efficacy of the over-the-scope clip (OTSC) for treatment of colorectal postsurgical leaks and fistulas.

BACKGROUND: Colorectal postsurgical leaks and fistulas are severe complications that dramatically increase morbidity and mortality. The aim of this study was to evaluate the clinical impact of over-the-scope clip (OTSC) closure to seal the visceral wall in the management of acute and chronic colorectal postsurgical leaks and fistulas. METHODS: We reviewed our prospective series of acute and chronic colorectal postsurgical leaks and fistulas observed between April 2008 and September 2011 and treated by OTSC. Indications were all cases with an orifice <15 mm in maximum diameter with no extraluminal abscess and luminal stenosis. RESULTS: Endoscopic OTSC closure was performed in 14 consecutive patients (mean defect = 9.1 mm in diameter) by means of 10.5- or 12-mm clips, depending on the wall defect diameter. In eight cases, the indication was an acute leak and in six cases a chronic leak, mainly after anterior rectal resection; two cases were complicated by a rectovaginal fistula and in two other cases by a colocutaneous fistula. OTSC treatment was used to complete endoscopic vacuum-assisted closure of a large defect in three cases. The overall success rate was 86 % (12/14): 87 % (7/8) in acute and 83 % (5/6) in chronic cases. No OTSC-related complications occurred. Further surgery was required in one case. CONCLUSION: Endoscopic OTSC closure of colorectal postsurgical leaks and fistulas is a safe technique, with a high success rate in both acute and chronic cases, including rectovaginal and colocutaneous fistulas.