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Mannelli M.,University of Florence | Mannelli M.,Instituto Toscano Tumori | Colagrande S.,University of Florence | Valeri A.,Chirurgia Generale | Parenti G.,Endocrine Unit
Seminars in Oncology | Year: 2010

In the last decades discoveries of adrenal masses incidentally during the course of diagnostic procedures for unrelated disorders (incidentalomas) have become progressively more frequent. The clinician in this position must answer two main questions: Is the mass benign or malignant?, and To what extent is the adrenal secretion altered? To come to a clinical decision, several diagnostic tools need to be engaged, starting with an accurate and correct radiological evaluation and a hormonal assessment of the adrenal function. When necessary, other diagnostic procedures such as functional imaging and fine-needle biopsy (FNB) can be considered in selected cases. Surgical removal is recommended for clinically relevant hypersecretory masses, as well as for masses suspected to be malignant. Most frequently, adrenal incidentalomas (AIs) are represented by benign cortical adenomas, a subset of which causes a mild hypercortisolism, known as subclinical Cushing's syndrome (SCS). The criteria to define this syndrome, as well as its treatment, are still debated and controversial. AIs that are not surgically removed should be re-examined in time to exclude a supervening increase in size or function. Follow-up criteria have not been established. Laparoscopic surgery is the recommended procedure to remove benign masses. The surgical procedure for adrenal malignancies is still debated. © 2010 Elsevier Inc. All rights reserved.


Imberti D.,Piacenza Hospital | Nicolini A.,Centro Emostasi e Trombosi | Cartelli C.,Chirurgia Generale II | De Paoli M.,Chirurgia Generale | And 3 more authors.
Obesity Surgery | Year: 2014

Background: The optimal dose of low molecular weight heparin (LMWH) to prevent venous thromboembolism (VTE) after bariatric surgery remains controversial. The aim of this multicentre, open-label, pilot study was to evaluate the efficacy and safety of two different doses of the LMWH parnaparin administered to patients undergoing bariatric surgery. Methods: Patients were randomised to receive 4,250 IU/day (group A) or 6,400 IU/day (group B) of parnaparin s.c. for 7-11 days. Bilateral colour Doppler ultrasound of the lower limb was performed before surgery and at the end of the treatment period. The primary efficacy outcome was a composite of asymptomatic and symptomatic deep vein thrombosis, symptomatic pulmonary embolism and death from any cause during treatment. The primary safety endpoint was major and clinically relevant non-major bleeding. Results: A total of 258 patients underwent randomization; 8 subjects were excluded following the safety analysis. One hundred thirty-one patients [106 females; mean age, 40.3 years (standard deviation (SD) ±9.6); mean body mass index (BMI), 44.6 kg/m2 (SD ±5.4)] were assigned to group A and 119 patients [93 females; mean age, 41.5 years (SD ±9.9); mean BMI, 44.2 kg/m2 (SD ±5.4)] were assigned to group B. The rate of the primary efficacy outcome was 1.5 % (two cases; 95 % confidence interval (CI), 0.2-6.0 %) in group A as compared with 0.8 % (one case; 95 % CI, 0.4-5.3 %) in group B (p = ns). The composite incidence of major bleeding and clinically relevant non-major bleeding was 6.1 % (eight cases; 95 % CI, 2.9-12.1 %) in group A and 5.0 % (six cases; 95 % CI, 2.1-11.1 %) in group B (p = ns). Conclusions: A parnaparin dose of 4,250 IU/day seems suitable for VTE prevention in patients undergoing bariatric surgery. © 2013 The Author(s).


Frazzoni M.,Fisiopatologia Digestiva | Conigliaro R.,Gastroenterologia | Mirante V.G.,Fisiopatologia Digestiva | Melotti G.,Chirurgia Generale
Neurogastroenterology and Motility | Year: 2012

Background By analysis of symptom-reflux association, endoscopy-negative refractory heartburn can be related to acid/non-acid refluxes with impedance-pH monitoring. Unfortunately, patients frequently do not report symptoms during the test. We aimed to assess the contribution of quantitative analysis of impedance-pH parameters added to symptom-reflux association in evaluating patients with endoscopy-negative heartburn refractory to high-dose proton pump inhibitor therapy. Methods The symptom association probability (SAP), the symptom index (SI), the esophageal acid exposure time and the number of distal and proximal refluxes were assessed at on-therapy impedance-pH monitoring. Relationships with hiatal hernia and manometric findings were also evaluated. Key Results Eighty patients were prospectively studied. Refractory heartburn was more frequently related to reflux by a positive SAP/SI and/or abnormal impedance-pH parameters (52/80 cases) (65%) than by a positive SAP/SI only (38/80 cases) (47%) (P=0.038). In patients with refractory non-erosive reflux disease (NERD) defined by a positive SAP/SI and/or abnormal impedance-pH parameters, the prevalence of hiatal hernia was significantly higher (56%vs 21%, P=0.007) and the mean lower esophageal sphincter tone was significantly lower (18.7 vs 25.8mmHg, P=0.005) than in those (35%) with reflux-unrelated, i.e., functional heartburn (FH). On the contrary, no significant difference was observed subdividing patients according to a positive SAP/SI only. Conclusions & Inferences Quantitative analysis of impedance-pH parameters added to symptom-reflux association allows a subdivision of refractory-heartburn patients into refractory NERD and FH which is substantiated by pathophysiological findings and which restricts the diagnosis of FH to one third of cases. © 2011 Blackwell Publishing Ltd.


Frazzoni M.,Fisiopatologia Digestiva | Conigliaro R.,Gastroenterologia | Manta R.,Gastroenterologia | Melotti G.,Chirurgia Generale
Alimentary Pharmacology and Therapeutics | Year: 2011

Aliment Pharmacol Ther 2011; 34: 67-75 Summary Background EsophyX is a novel transoral incisionless fundoplication device developed to mimic surgical fundoplication. EsophyX fundoplication improves acid reflux parameters in proton pump inhibitor (PPI)-responsive GERD patients but its efficacy in refractory GERD has been scarcely studied. Aim To assess reflux parameters before and after EsophyX or laparoscopic fundoplication and their relationship with symptoms in refractory GERD. Methods In an open-label study, we enrolled prospectively patients with heartburn/regurgitation persisting despite high-dose PPI therapy. Impedance-pH monitoring was performed on PPI therapy before intervention and off PPI therapy 3 months after intervention. Results Ten patients chose to undergo EsophyX (EndoGastric Solutions, Redmond, WA, USA) fundoplication while ten chose laparoscopic fundoplication, and the baseline characteristics were comparable. Distal and proximal refluxes were significantly reduced post-operatively in the surgical but not in the endoscopic group and the median values were significantly lower in the former than in the latter. The oesophageal acid exposure time was normal in 50% of cases after EsophyX and in 100% of cases after surgery (P = 0.033); the number of distal refluxes was normal in 20% and 90% of cases (P = 0.005) and the number of proximal refluxes was normal in 40% and 100% of cases (P = 0.011), respectively. A positive persisting symptom-reflux association was found post-operatively in 6/10 patients in the EsophyX group and in 0/10 patients in the surgical group (P = 0.011). Conclusions In patients with refractory GERD, EsophyX fundoplication is significantly less effective than laparoscopic fundoplication in improving reflux parameters and accordingly, in inducing symptom remission. © 2011 Blackwell Publishing Ltd.


Frazzoni M.,Fisiopatologia Digestiva | Conigliaro R.,Gastroenterologia | Melotti G.,Chirurgia Generale
Digestive Diseases and Sciences | Year: 2011

Background: Patients with typical reflux symptoms (heartburn/regurgitation) persisting despite proton pump inhibitor (PPI) therapy are not uncommon. Impedance-pH monitoring detects gastroesophageal reflux at all pH levels and may establish if ongoing symptoms on PPI therapy are associated with acid/nonacid reflux. Laparoscopic fundoplication is a therapeutic option in such patients but reflux parameters on PPI therapy and after intervention and their relationship with symptom persistence/remission have been scarcely studied. Aims: The aim of this study was to assess reflux parameters and their relationship with symptoms before and after laparoscopic fundoplication, on and off PPI therapy, respectively, in patients with PPI-unresponsive heartburn/regurgitation and with a positive symptom-reflux association and/or abnormal reflux parameters detected on PPI therapy. Methods: Impedance-pH monitoring was performed on high-dose PPI therapy and 3 months after laparoscopic fundoplication, off PPI therapy, in 40 patients with PPI-unresponsive heartburn/regurgitation. Symptoms were scored by a validated questionnaire. Results: Esophageal acid exposure time as well as the number of total and proximal reflux events and of acid and weakly acidic refluxes decreased significantly after surgery: normal values were found in 100, 77, 95, 92 and 65% of cases, respectively. Weakly alkaline refluxes increased significantly postoperatively but neither before nor after intervention were associated with symptoms. All patients reported total/subtotal remission of heartburn/regurgitation 3 months after surgery. Conclusions: Laparoscopic fundoplication improves acid and weakly acidic reflux parameters when compared with PPI therapy. This improvement justifies the very high post-surgical symptom remission rate that we observed. Prolonged follow-up is warranted but our findings strongly support the surgical option in PPI failures. © 2010 Springer Science+Business Media, LLC.


Frazzoni M.,Fisiopatologia Digestiva | Conigliaro R.,Gastroenterologia | Melotti G.,Chirurgia Generale
Alimentary Pharmacology and Therapeutics | Year: 2011

Background In patients with heartburn that persists despite proton pump inhibitor (PPI) therapy, reflux oesophagitis is found rarely, and its pathogenesis has been scarcely studied. Aim To assess reflux parameters by impedance-pH monitoring in PPI-resistant reflux oesophagitis. Methods Impedance-pH monitoring was performed on PPI therapy in patients with symptomatic reflux oesophagitis detected despite standard or high-dose PPI therapy of at least 8-week duration. Results Twenty patients, ten on once daily and ten on twice daily PPI regimens, were studied. The gastric acid exposure time (per cent time pH <4) ranged from 10% to 81% and was >30% in 70% of cases, but the oesophageal acid exposure time (per cent time pH <4) was abnormal in 20% of patients only. The number of acid, weakly acidic and weakly alkaline refluxes was abnormal in 25%, 100% and 15% of patients, respectively. Conclusions Weakly acidic refluxes were above the normal range in all cases, whereas acid reflux parameters and weakly alkaline refluxes were normal in the vast majority of cases. Gastric acid secretion, with consequent intra-gastric pepsins activation, persists despite ongoing PPI therapy and activated pepsins may well be present in weakly acidic refluxes. As activated pepsins maintain their proteolytic activity in a weakly acidic environment, they may be responsible for mucosal damage. We conclude that weakly acidic refluxes have a major role in the pathogenesis of PPI-resistant reflux oesophagitis. Therapeutic interventions in patients with PPI-resistant reflux oesophagitis should be tailored on the basis of impedance-pH-monitoring results. © 2010 Blackwell Publishing Ltd.


Frazzoni M.,Fisiopatologia Digestiva | Conigliaro R.,Endoscopia Digestiva | Colli G.,Chirurgia Generale | Melotti G.,Chirurgia Generale
Surgical Endoscopy and Other Interventional Techniques | Year: 2012

Background Laparoscopic Nissen fundoplication (LNF) is a technically demanding surgical procedure designed to cure gastroesophageal reflux disease (GERD). It represents an alternative to life-long medical therapy and the only recommended treatment modality to overcome refractoriness to proton pump inhibitor (PPI) therapy. The recent development of robotic systems prompted evaluation of their use in antireflux surgery. Between 1997 and 2000, in a PPI-responsive series we found postoperative normalization of esophageal acid exposure time (EAET) in most but not all cases. Between 2007 and 2009, in a PPI-refractory series we found postoperative normalization of EAET in all cases. We decided to analyze retrospectively our prospectively collected data to evaluate whether differences other than the conventional or robot-assisted technique could justify postoperative differences in acid reflux parameters. Methods Baseline demographic, endoscopic, and manometric parameters were compared between the two series of patients, as well as postoperative manometric and acid reflux parameters. Results There were no significant differences in the baseline demographic, endoscopic, and manometric characteristics between the two groups of patients. The median lower esophageal sphincter tone increased significantly, and the median EAET decreased significantly after conventional as well as after robot-assisted LNF. The median postoperative EAET was significantly lower in the robot-assisted (0.2%) than in the conventional LNF group (1%; P = 0.001). Abnormal EAET values were found in 6 of 44 (14%) and in 0 of 44 cases after conventional and robot-assisted LNF, respectively (P = 0.026). Conclusions Robot-assisted LNF provided a significant gain in postoperative acid reflux parameters compared with the conventional technique. In a challenging clinical setting, such as PPI-refractoriness, inwhich the efficacy of endoscopic or pharmacological treatment modalities is only moderate, even a small therapeutic gain can be clinically relevant. In centers where robot-assisted LNF is available, it should be preferred to conventional LNF in PPI-refractory GERD. © 2011 Springer Science+Business Media, LLC.


Frazzoni M.,Fisiopatologia Digestiva | Manta R.,Endoscopia Digestiva | Mirante V.G.,Endoscopia Digestiva | Conigliaro R.,Endoscopia Digestiva | And 2 more authors.
Neurogastroenterology and Motility | Year: 2013

Background: Impedance-pH monitoring allows assessment of retrograde and antegrade intra-esophageal movement of fluids and gas. Reflux is followed by volume clearance and chemical clearance, elicited by secondary and swallow-induced peristalsis, respectively. We aimed to assess whether chemical clearance is impaired in gastro-esophageal reflux disease (GERD). Methods: Blinded retrospective review of impedance-pH tracings from patients with erosive reflux disease (ERD) and non-erosive reflux disease (NERD), and from proton pump inhibitor (PPI)-refractory patients before and after laparoscopic fundoplication. The number of refluxes followed within 30 s by swallow-induced peristaltic waves was divided by the number of total refluxes to obtain a parameter representing chemical clearance namely the postreflux swallow-induced peristaltic wave (PSPW) index. Key Results: The PSPW index was significantly lower in 31 ERD (15%) and in 44 NERD (33%) off-PPI patients than in 30 controls (75%), as well as in 18 ERD (16%) and in 48 NERD (31%) on-PPI patients than in 26 on-PPI functional heartburn (FH) cases (67%) (P < 0.05 for all comparisons). In 29 PPI-refractory patients, the median PSPW index was unaltered by otherwise effective antireflux surgery (20% postoperatively, 21% preoperatively). The overall sensitivity, specificity, positive, and negative predictive values of the PSPW index in identifying GERD patients were 97%, 89%, 96%, and 93%. Conclusions & Inferences: Impairment of chemical clearance is a primary pathophysiological mechanism specific to GERD: it is unaffected by medical/surgical therapy, is not found in FH, and is more pronounced in ERD than in NERD. Using the PSPW index could improve the diagnostic efficacy of impedance-pH monitoring. © 2013 Blackwell Publishing Ltd.


Frazzoni M.,Fisiopatologia Digestiva | Piccoli M.,Chirurgia Generale | Conigliaro R.,Endoscopia Digestiva | Manta R.,Endoscopia Digestiva | And 2 more authors.
Surgical Endoscopy and Other Interventional Techniques | Year: 2013

Background: Some patients with typical (heartburn/regurgitation) symptoms of gastroesophageal reflux disease (GERD) are refractory to proton pump inhibitor (PPI) therapy. Impedance-pH monitoring can identify PPI-refractory patients who could benefit from laparoscopic fundoplication, but outcome data are scarce. We aimed to assess whether PPI-refractory GERD as diagnosed by impedance-pH monitoring can be cured by laparoscopic fundoplication. Methods: Forty-four consecutive GERD patients with heartburn/regurgitation refractory to high-dose PPI therapy entered a 3-year outcome assessment following robot-assisted laparoscopic fundoplication. Preoperative on-PPI impedance-pH diagnostic criteria consisted of positive symptom association probability (SAP)/symptom index (SI), and/or abnormal percentage esophageal acid exposure time (%EAET), and/or abnormal number of total refluxes. GERD cure was defined by 3-year postoperative off-PPI normal impedance-pH findings with persistent symptom remission. Results: Preoperatively, 24 of 38 (63 %) patients who completed the outcome assessment had a positive SAP/SI, 20 of 38 (53 %) for weakly acidic refluxes; 3 of 38 (8 %) patients had an abnormal %EAET, 11 of 38 (29 %) an abnormal number of total refluxes only. Postoperatively, heartburn/regurgitation recurred in 3 patients; abnormal impedance-pH findings were found in two of them, and they responded to PPI therapy. GERD cure was achieved in 34 of 38 (89 %) patients, 11 of 11 with an abnormal number of total refluxes as the only preoperative abnormal impedance-pH finding. Postoperatively, there was a significant decrease of the %EAET (1 vs. 0.1 %, P = 0.002) and of the number of total refluxes (68 vs. 8, P = 0.001), with the latter finding mainly due to a decrease in the number of weakly acidic refluxes. Conclusions: Normal reflux parameters and persistent symptom remission at 3-year follow-up can be achieved with laparoscopic fundoplication in the majority of patients with PPI-refractory GERD as diagnosed by impedance-pH monitoring. On-PPI impedance-pH diagnostic criteria should include SAP/SI positivity, an abnormal %EAET, and an abnormal number of total refluxes. Weakly acidic refluxes have a major role in the pathogenesis of PPI-refractory GERD. © 2013 Springer Science+Business Media New York.


Pucciarelli S.,University of Padua | Del Bianco P.,Servizio Sperimentazioni Cliniche e Biostatistica | Efficace F.,Data Center | Serpentini S.,University of Padua | And 5 more authors.
Annals of Surgery | Year: 2011

Objective: To prospectively describe patient-reported outcomes (PROs) after preoperative chemoradiotherapy (pCRT) for rectal cancer. Background: Little evidence is available on PROs after pCRT for rectal cancer. PATIENTS AND Methods: Patients with rectal cancer, candidates to receive pCRT, were enrolled in a multicenter prospective observational trial. Health-related quality of life was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and its colorectal cancer module (QLQ-CR38), and fecal incontinence and bowel function were evaluated using the fecal incontinence score questionnaire and a set of ad hoc questions. Questionnaires were filled out before CRT (t0), 2 to 3 weeks after completion of CRT (t1), and at 6 (t2) and 12 months (t3) after surgery. Primary analysis of selected scales included: global quality of life, physical functioning, social functioning, fatigue, body image, future prospective, and gender-related sexual problems. Results: Of 149 eligible patients, questionnaires were completed in 100%, 95%, 88% and 77% of cases at t0, t1, t2, and t3, respectively. At t3, 78% of patients reported stool fractionation and 72% sensation of incomplete defecation. Only 14% of patients had optimal continence. Physical/social functioning, fatigue, and body image showed a decrease just after pCRT and returned to baseline levels at 1 year after treatment. Global quality of life was stable over time. Male sexual problems were greatly impaired throughout the study period (P < 0.001) with major clinically meaningful changes between baseline and 1 year after treatment. Background: These findings add to the body of evidence available regarding pCRT and help clinicians to make more informed treatment decisions. © 2010 Lippincott Williams & Wilkins.

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