Analysis of Risk Factors for a Low Immune Response to Messenger RNA COVID-19 Vaccine in Kidney Transplant Recipients and Differences Between Second and Third Dose.

BACKGROUND: The efficacy of the response to SARS-CoV-2 vaccination in kidney transplant recipients is low. The aim of our study was to evaluate the risk factors correlated with the low antibody response and whether there was an improvement between the second and the third dose. METHODS: A prospective study was conducted on 176 kidney transplant recipients who received the second and the third dose of the anti-SARS-CoV-2 mRNA Comirnaty vaccine. We evaluated the seroconversion process after administration of the second and the third dose and assessed a possible correlation with age, time between transplant and vaccination, and type of immunosuppressive therapy. RESULTS: A total of 98 of the 176 patients (55.7%) responded positively after the inoculation of the second dose and according to the multivariable logistic regression analysis the lack of seroconversion was independently associated with patient age ≥60 (P = .025; odds ratio [OR], 2.094), time since transplant of 1 to 3 months (P = .032; OR, 2.118), and triple therapy (P = .044; OR, 2.327). After the vaccine third dose, the seroconversion increased to 62.5%, and it was negatively influenced by calcineurin inhibitor use (12/21, 57.1% vs 71/78, 91.0%, P = .0006) and triple therapy (13/21, 61.9% vs 72/78, 92.3%, P = .0014). The median of antispike antibody response significantly increased from 18.5 IU/mL after the second dose to 316.9 IU after the third dose (P < .0001). CONCLUSIONS: We demonstrated a correlation between older age and shorter distance from the transplant and triple immunosuppressive therapy with the lack of seroconversion. We noticed a significant improvement in antibody response by a third dose of messenger RNA vaccine.

Debris-Filled Duodenal Diverticulum and Lemmel's Syndrome.

We report a case of a 73-year-old woman affected by Lemmel's syndrome, a rare type of obstructive jaundice caused by a periampullary duodenal diverticulum. The patient was admitted to the Emergency Department for pneumonia associated with mild epigastric pain and vomiting. While hospitalized for antibiotic treatment, the appearance of jaundice led us to discover a periampullary duodenal diverticulum by endoscopy and CT scan. The jaundice was successfully managed endoscopically with removal of food debris from the diverticulum.

Embolization of the renal artery before graft nephrectomy: a comparing study to evaluate the possible benefits.

The graft nephrectomy is burdened by immunological and surgical complications. The main surgical complications of graft nephrectomy are hemorrhage, infections, vascular injury and death. The mortality is high, with percentages varying between 1.3 and 38%. Therefore, graft nephrectomy should be recommended only in selected cases. We conducted a retrospective study, comparing the data of 26 patients undergoing an allograft nephrectomy (2009-2013), without embolization of the renal artery (NO EMBO group) with the data of 40 patients undergoing an allograft nephrectomy (2014-2019), with embolization of the renal artery (EMBO group). We included only graft nephrectomies performed at least 6 months after transplantation. The patients included in the study were consecutive because until 2013 we did not perform the embolization of the renal graft artery. Afterwards, from 2014, instead, we routinely carry out embolization to all patients to be subjected to graft nephrectomy. We, therefore, wanted to analyze whether this surgical approach compared to the previous technique can lead to an improvement in morbidity and mortality, reducing the risk of bleeding and operating times. The examination of our data highlights that embolization of renal artery reduces the operating times of the explant, in addition the group subjected to embolization had less changes in hemoglobinemia and less blood loss.

Canal wall down mastoidectomy with obliteration versus canal wall up mastoidectomy in primary cholesteatoma surgery.

OBJECTIVE: This study sought to compare disease recidivism rates between canal wall up mastoidectomy and a canal wall down with obliteration technique. METHODS: Patients undergoing primary cholesteatoma surgery at our institution over a five-year period (2013-2017) using the aforementioned techniques were eligible for inclusion in the study. Rates of discharge and disease recidivism were analysed using chi-square statistics. RESULTS: A total of 104 ears (98 patients) were included. The mean follow-up period was 30 months (range, 12-52 months). A canal wall down with mastoid obliteration technique was performed in 55 cases and a canal wall up approach was performed in 49 cases. Disease recidivism rates were 7.3 per cent and 16.3 per cent in the canal wall down with mastoid obliteration and canal wall up groups respectively (p = 0.02), whilst discharge rates were similar (7.3 per cent and 10.2 per cent respectively). CONCLUSION: Our direct comparative data suggest that canal wall down mastoidectomy with obliteration is superior to a canal wall up technique in primary cholesteatoma surgery, providing a lower recidivism rate combined with a low post-operative ear discharge rate.

Impact of cardiovascular/diabetic comorbidity on conversion rate during laparoscopic cholecystectomy for acute cholecystitis: a multi-center study on early versus very delayed approach.

BACKGROUND: The impact of diabetes and cardiovascular comorbidity on laparoscopic cholecystectomy has been long debated, evaluating them as risk factors for conversion to an open procedure especially in patients with acute cholecystitis: an "early" procedure, as suggested by 2013 Tokyo guidelines, has been compared to a "very delayed" one in patients under anticoagulant/antiplatelet therapy or treated for diabetes and referred by medical wards to surgery after the acute period. METHODS: We selected 240 patients operated for acute cholecystitis by laparoscopy over the last 4 years at St. Orsola University Hospital-Bologna and Umberto I University Hospital-Rome, comparing 98 diabetic/cardiovascular patients versus 142 subjects as control group: the selection was based on operative timing, "early" (73 patients treated within 3 days) and "very delayed" (167 patients operated after 6 weeks). RESULTS: In the "early" subgroup there was no difference comparing diabetic/cardiovascular patients (31 pts) versus control group (42 pts) while in the "very delayed" subgroup among diabetic/cardiovascular patients (67 pts) there was significantly male predominance, ASA III/IV prevalence and less positive imaging findings versus control group (100 pts). In both subgroups, the conversion rate was significantly higher for diabetic/cardiovascular patients ("early"=25.8% and "very delayed"=8.95%) compared to control groups ("early"=4.76% and "very delayed"=1%), showing a trend (p=0.058) towards an increased conversion rate in the early approach among diabetic/cardiovascular group. CONCLUSIONS: Our study showed a significantly increased conversion rate to an open cholecystectomy for diabetic/cardiovascular patients affected by cholecystitis, especially within 3 days by the acute episode.

The ERAS Protocol is at the forefront of the peri-operative pathway in colorectal surgery: monocentric clinical study.

INTRODUCTION: Colon cancer is one of the most common neoplastic diseases, with onset in old age; the benefits of the ERAS protocol were evaluated in the peri-operative treatment of patients affected by this neoplasm. METHODS: We studied 90 cases of colorectal neoplasia observed at the General Surgery UOC of the San Camillo de Lellis Hospital between September 2014 and April 2016, undergoing laparoscopic surgery and to which the ERAS protocol was applied; key points were the preoperative oral feeding, the epidural anesthesia, the reduced or failed hydro-electrolytic overload, the early mobilization and recovery of the feeding, the non-use of drainage. The most important parameers considered were the reduced duration of the operating hospital stay, the lower occurrence of early and distant complications. RESULTS: 85 surgical procedures were performed with laparoscopic technique (94.4%) and 5 with traditional open technique (5.6%). The conversion rate was 5.8% (5/85). 29 surgical procedures of right hemicolectomy (32.2%) and 26 of anterior resection of the rectum (28.9%) were performed; in another 29 patients (32.2%) an intervention with an open traditional technique was performed. A balanced anesthesia was performed in 41 patients (45.6%); epidural anesthesia in 32 cases (35.6%); the Tap Block in 17 subjects (18.9%). The average volume of liquid infusion was 1664cc ± 714; the average post-operative hospital stay of 4.3 ± 0.9 days. CONCLUSIONS: The ERAS protocol reduces the duration of the post-operative hospitalization, involves a lower incidence of precocious and remote complications, in particular if associated with a minimally invasive surgical method; it is easily applicable and reproducible in a hospital environment, with a marked reduction in healthcare management costs.

Early versus delayed approach in cholecystectomy after admission to an emergency department. A multicenter retrospective study.

BACKGROUND: Discussion regarding the timing of cholecystectomy for acute cholecystitis is still ongoing. This study evaluates the outcomes of patients who underwent surgery for acute cholecystitis after emergency admission at St. Orsola University Hospital of Bologna and Umberto I Hospital La Sapienza University of Rome. PATIENTS AND METHODS: . We performed a retrospective study on 464 patients who underwent cholecystectomy for acute cholecystitis. We divided patients in three groups based on the time elapsed between the onset of symptoms and surgery: within 72 hours (Group A), between 72 hours and 6 weeks (Group B) and after 6 weeks (Group C). We performed both univariate and multivariate statistical analysis on the data collected. RESULTS: The best results were in Group C, with significant differences with the others two groups: higher rates of laparoscopic technique (93% of cases), no mortality, better morbidity and shorter hospital stay. On the contrary, no significant differences were observed between Groups A and B: laparoscopic cholecystectomy 67% vs 66%, morbidity (Clavien-Dindo III-IV) 5% vs 5%, mortality 2% vs 1%, hospital stay 6,6 vs 5,6 days. Conversion rate was 11% in Group A, 18% in Group B and 4% in Group C. CONCLUSION: Our experience shows better results for cholecystectomies performed after 6 weeks from the onset of symptoms, while earlier cholecystectomies have worse outcomes regardless if they are performed before or after 72 hours from the onset of symptoms.

Laparoscopic cholecystectomy for acute cholecystitis: are intended operative approach, timing and outcome affected by BMI? A multicenter retrospective study.

BACKGROUND: Laparoscopy is the gold-standard for cholecystectomy after acute cholecystitis, but the issue is controversial in obese subjects. PATIENTS AND METHODS: We reviewed 464 patients operated for acute cholecystitis (59 open and 405 laparoscopic) over the last five years at St Orsola University Hospital-Bologna and Umberto I University Hospital-Rome, comparing retrospectively: 1) BMI < 30 (397 patients) and BMI =/> 30 (67 patients) and moreover 2) BMI < 25 (207 patients) and BMI =/> 25 (257 patients). RESULTS: In the first comparison, obese patients showed higher cardiovascular co-morbidity (61.1% vs 44.5%, p=0.01), worse symptoms (Murphy's sign positive in 92.5% vs 80.8%, p=0.02; fever >38.5°C in 88.0% vs 76.0 %, p=0.02) and significant radiologic imaging (95.5% vs 85.1%, p=0.01) of acute cholecystitis. Laparoscopy was used in 83.6% of obese patients vs 87.9% without any difference, and operative time or conversion rate were similar. According to Tokyo Guidelines 2013, the number of patients who underwent surgery within 3 days or after 6 weeks was similar without statistical difference between the two groups. Hospital stay, morbidity and mortality were similar. Complications were seen in 25.4% of obese patients vs 15.9% (p= 0.03), mainly represented by wound infections. The second comparison did show no difference between two groups BMI =/>25 and BMI < 25. CONCLUSIONS: Our retrospective multicenter study showed no difference related to intended operative approach, timing and outcome in higher BMI versus lower BMI patients operated for acute cholecystitis.

Decoding bipedal locomotion from the rat sensorimotor cortex.

OBJECTIVE: Decoding forelimb movements from the firing activity of cortical neurons has been interfaced with robotic and prosthetic systems to replace lost upper limb functions in humans. Despite the potential of this approach to improve locomotion and facilitate gait rehabilitation, decoding lower limb movement from the motor cortex has received comparatively little attention. Here, we performed experiments to identify the type and amount of information that can be decoded from neuronal ensemble activity in the hindlimb area of the rat motor cortex during bipedal locomotor tasks. APPROACH: Rats were trained to stand, step on a treadmill, walk overground and climb staircases in a bipedal posture. To impose this gait, the rats were secured in a robotic interface that provided support against the direction of gravity and in the mediolateral direction, but behaved transparently in the forward direction. After completion of training, rats were chronically implanted with a micro-wire array spanning the left hindlimb motor cortex to record single and multi-unit activity, and bipolar electrodes into 10 muscles of the right hindlimb to monitor electromyographic signals. Whole-body kinematics, muscle activity, and neural signals were simultaneously recorded during execution of the trained tasks over multiple days of testing. Hindlimb kinematics, muscle activity, gait phases, and locomotor tasks were decoded using offline classification algorithms. MAIN RESULTS: We found that the stance and swing phases of gait and the locomotor tasks were detected with accuracies as robust as 90% in all rats. Decoded hindlimb kinematics and muscle activity exhibited a larger variability across rats and tasks. SIGNIFICANCE: Our study shows that the rodent motor cortex contains useful information for lower limb neuroprosthetic development. However, brain-machine interfaces estimating gait phases or locomotor behaviors, instead of continuous variables such as limb joint positions or speeds, are likely to provide more robust control strategies for the design of such neuroprostheses.

Metachronous elastofibromas.

Elastofibroma Dorsi (EFD) is a rare pseudo-tumor characterized by the overgrowth of elastic fibers mixed to adipose and connective tissues typically growing in the subscapular region. This can be bilateral but only rarely synchronous affecting different anatomical sites at the same time. Hereby we present a case of a 42-year-old male patient found with three different metachronous elastofibromas: bilateral EFD and a further third localization by the right elbow. The two EFs in the subscapular region were resected. After surgery pain reoccurred on the right side. This required the implantation of a spinal electro-stimulator. The elbow lesion was not excised as it was asymptomatic.

Prevention of complications during reoperative thyroid surgery.

BACKGROUND: Thyroidectomy performed by an experienced surgeon is associated with a low incidence of recurrent laryngeal nerve injury and permanent hypoparathyroidism. During reoperative thyroid surgery there is a higher technical risk because detection and preservation of the recurrent laryngeal nerves and parathyroid glands are more difficult than in the primary surgery. AIM: Our retrospective cohort study was to assess short- and long-term complications associated with reoperative thyroid surgery in order to suggest a technical approach to lower the morbidity rate. MATERIALS AND METHODS: From January 2005 to September 2013, 745 patients underwent surgery for thyroid disease. Before surgery all patients underwent clinical examination, laboratory blood tests, hormonal assays, neck ultrasound, chest radiography and indirect laryngoscopy. Patients were followed up at 1, 3, 6 months and then annually after operation with hormonal assays, blood tests and neck ultrasound. RESULTS: Eighty (10.7%) out of 745 patients (mean-age= 52.5 years; age-range 18-80) underwent reoperative surgery for recurrent thyroid disease. The primary treatments were enucleoresection (11.2%), thyroid lobectomy(56,3%), thyroid lobectomy with isthmectomy(10%) and subtotal thyroidectomy (22,5%). In the reoperative surgery group (Group Re) the transient RLN complications were 1.3% compared to 0.2% in the primary surgery group (Group P) (p= 0.51). The incidence of temporary hypocalcemia was 45% in the reoperative surgery group vs. 42.7% in the primary surgery group (p=0.72). CONCLUSIONS: Reoperative surgery should be reserved to experienced surgeons. However, even in this case, when surgical maneuvers reserved for primary surgery are applied, then this surgery is associated with a low complications rate.

Randomized controlled trial of percutaneous versus transcutaneous posterior tibial nerve stimulation in faecal incontinence.

BACKGROUND: Percutaneous, transcutaneous and sham transcutaneous posterior tibial nerve stimulation was compared in a prospective blinded randomized placebo-controlled trial. METHODS: Patients who had failed conservative treatment for faecal incontinence were randomized to one of three groups: group 1, percutaneous; group 2, transcutaneous; group 3, sham transcutaneous. Patients in groups 1 and 2 received 30-min sessions of posterior tibial nerve stimulation twice weekly for 6 weeks. In group 3, transcutaneous electrodes were placed in position but no stimulation was delivered. Symptoms were measured at baseline and after 6 weeks using a bowel habit diary and St Mark's continence score. Response to treatment was defined as a reduction of at least 50 per cent in weekly episodes of faecal incontinence compared with baseline. RESULTS: Thirty patients (28 women) were enrolled. Nine of 11 patients in group 1, five of 11 in group 2 and one of eight in group 3 had a reduction of at least 50 per cent in weekly episodes of faecal incontinence at the end of the 6-week study phase (P = 0·035). Patients undergoing percutaneous nerve stimulation had a greater reduction in the number of incontinence episodes and were able to defer defaecation for a longer interval than those undergoing transcutaneous and sham stimulation. These improvements were maintained over a 6-month follow-up period. CONCLUSION: Posterior tibial nerve stimulation has short-term benefits in treating faecal incontinence. Percutaneous therapy appears to have superior efficacy to stimulation applied by the transcutaneous route. REGISTRATION NUMBER: NCT00530933 (http://www.clinicaltrials.gov).

Gastrointestinal stromal tumors treatment in the Imatinib era. The role of fair indication.

AIM: Gastrointestinal stromal tumor (GIST) is the most common mesenchymal tumor of the gastrointestinal tract. Surgery remains the elective treatment. We retrospectively compared two group of patients, who underwent surgery for GIST before and after Imatinib advent in order to analyze the recurrence and survival rate. METHODS: Two patient groups who underwent surgery for GIST, from January 1997 to December 2002 (Pre-Imatinib group) and from January 2003 to December 2008 (Post-Imatinib group) were compared. Patients were evaluated on the base of gender, age, clinical manifestations, primary location and metastasis positivity, tumor size, mitotic index, immunoreactivity for CD117 and the outcome, including date of death. RESULTS: In the Pre-IM group only one patient died for prostate cancer, 12 months after operation, the other died because of GIST with a 24.6 months of median survival rate (range 15-51). In the remaining 12 patients the median follow up period was 55 months (range 6-152 months). In the Post-IM group the mean follow up was 50.7 months (range 26-74) and they are still being assessed for oncological as well as surgical treatment. CONCLUSION: Early diagnosis and radical resection remain the standard of cure for GISTs. To date, the use of Imatinib lead to its utilization as adjuvant and neo-adjuvant therapy in adults. Our experience suggests that there is a correlation between the mutational status of KIT and clinical outcome. These aspects should be explored for targeted therapy that can effectively combine biological therapy to surgery.

Current controversies in the management of Warthin tumour.

Warthin tumour is the second most common benign neoplasm of the parotid gland. It has a low rate of growth and exhibits malignant transformation in 0.3% of cases. Although its aggressiveness has not been a concern, surgical resection remains the most common treatment modality. This entails the risk of a general anaesthetic and those pertaining to the procedure itself, most notably permanent facial nerve damage. This has led some authors to use conservative management, albeit rarely. There are those who condemn such a policy despite the encouraging results reported thus far. To understand the rationale underpinning non-operative management, it is imperative that one has a comprehensive understanding of the pathogenesis, clinical presentation and diagnosis of Warthin tumour. The aim of this review therefore is to detail these elements and clarify the current controversies in managing this lesion.

[Open mesh technique versus laparoscopic transabdominal preperitoneal (TAPP) approach in inguinal hernia repair. Our experience]. / Tecnica open versus TAPP nel trattamento dell'ernia inguinale. Nostra esperienza.

BACKGROUND: In the last ten years the introduction of various open mesh and laparoscopic techniques has increased the interest in inguinal hernia surgery. Anyway controversy persists about the most effective inguinal hernia repair. The aim of this study was to compare the results of open mesh technique and laparoscopic transabdominal preperitoneal (TAPP) repair for inguinal hernia. PATIENTS AND METHODS: We considered 584 patients, 532 man and 52 woman, between 19 and 86 years: 332 (56.8%) had open mesh repair and 252 (43.2%) laparoscopic TAPP repair of groin hernia. Operative time, complications, recurrences and time to normal activities were recorded in both groups (range follow-up 1-10 years). RESULTS: The median operative time was 71 min for open group and 92 min for TAPP group. No intraoperative complications were observed. Postoperative complication rate was 4,5% in patients open group and 3% in TAPP group. The recurrence rate was less than 1% in both groups (0,6% for open repair and 0,4% for laparoscopic repair). Significant difference was observed in the median time to return to normal activities: 9,8 days in TAPP group versus 13,4 days in open approach. CONCLUSIONS: Our experience confirmed the safety and effectiveness of laparoscopic transabdominal preperitoneal (TAPP) approach to inguinal hernia repair as excellent alternative to conventional surgery. The reduction of operative time, complications and recurrences is correlated to the surgeon's experience and learning curve.

[Reoperative thyroid surgery: personal experience and review of the literature]. / Reinterventi in chirurgia tiroidea: contributo casistico e revisione della letteratura.

The goal of this study was to evaluate the complication rate of reoperative thyroid surgery and to find out the way to minimize the morbidity associated with it. We reviewed our experience in 622 patients, who underwent thyroid operation from January 2000 to September 2007. Among these ones, 76 were the patients who underwent reoperative thyroid surgery. Prior surgery in the 76 reoperations was: nucleo-resection in 9 pts (12.9%), lobectomy in 43 pts (55.5%), lobectomy+isthmectomy in 7 pts (9.3%), subtotal thyroidectomy in 17 pts (22.2%). Histologic examination revealed: benign lesions in 67 pts (88.15%), papillary cancer in 4 pts (5.26%), follicular cancer in 2 pts (2.63%), follicular adenoma in 1 pt (1.32%) and Hashimoto thyroiditis in 2 pts (2.63%). Complications included: section of recurrent laryngeal nerve, that was reconstructed in the same operation, and bilateral palsy of the recurrent laryngeal nerve so that was necessary to make a tracheotomy. One of the patient at the first thyroid surgery had monolateral palsy of the recurrent laryngeal nerve with dyspnoea and dysphonia. Temporary hypoparathyroidism (Ca<8 mg/dl) occurred in 47.3% of the patients, who underwent reoperative thyroid surgery and in 45.2% of the patients, who underwent prior thyroid surgery. Conclusions. This study documents that reoperative thyroid surgery can be performed with little morbidity to the patient if precise operative rules are respected.

[Adenocarcinoma of the appendix. A case report and review of the literature]. / L'adenocarcinoma dell'appendice ileo-ciecale: presentazione di un caso clinico e revisione della letteratura.

Primary adenocarcinoma of the appendix is a rare malignancy that constitutes less than 0.5% of all gastrointestinal neoplasms. Usually the diagnosis is made only after histological examination of surgically removed inflamed appendix. Alternatively represent an unexpected finding, confirmed by frozen section, during surgery performed for acute appendicitis or other non appendiceal pathologies. Natural history is strongly influenced by anatomic peculiarities of the appendix that predispose to early spread and perforation. Frequently is associated with synchronous and metachronous colorectal or extraintestinal cancers. The correct management is the right hemicolectomy as a primary procedure in the case of preoperatively or intraoperatively diagnosis or as secondary procedure, after two-three weeks from appendectomy, when the microscopic examination of specimen reveals the presence of adenocarcinoma. Right hemicolectomy is the best treatment for all histologic types (colonic, mucinous, adenocarcinoid), in presence of perforation and even in Dukes A tumors. A careful intraoperative search for synchronous lesions and a life-long program of surveillance for the detection of early stage metachronous carcinomas are recommended. The Authors report a case of primary adenocarcinoma of the appendix occurred in a 78 year-old female patient, diagnosed incidentally during surgery performed for ileus from suspected cecal neoplasm.

[Parathyroid carcinoma: clinical case and review of the literature]. / Carcinoma paratiroideo: caso clinico e revisione della letteratura.

INTRODUCTION: Parathyroid carcinoma is a rare endocrine neoplasm, difficult to define clinically and histopathologically. CASE REPORT: The case concerns of a 20 years old male with situs viscerum inversus (with dextrocardia), and symptoms: asthenia, oliguresis, nausea, emesis, myalgia, lower limb paresthesia and very high levels of calcium and PTH. Laboratory findings (PTH 580 pg/ml; Ca 12.40 mg/dl; P 1.9 mg/dl), echography, TC, and parathyroid scintigraphy, associated with clinical data, have suggested hypothesis of parathyroid carcinoma confirmed by histological examination and immunochemistry. Surgery was efficacious with normalization of Calcium and PTH levels, and disappearance of symptoms. After two years no signs of local recurrence were present, but imaging show pulmonary micronodulations of uncertain pathological meaning. DISCUSSION AND CONCLUSION: No clinical or bio-humoral data allows a preoperative diagnosis of parathyroid carcinoma. Only with definitive pathology and immunohistochemistry it is possible to differentiate an adenoma from a carcinoma. Surgery is the only effective therapy and therefore should be always performed. This neoplasm usually relapses, locally first and later with distant metastases. For this reason after surgery the patients should always undergo a strict follow-up programme including evaluation of PTH and calcemia.

Quadruple therapy with lactoferrin for Helicobacter pylori eradication: a randomised, multicentre study.

BACKGROUND: Helicobacter pylori eradication rate with standard triple therapies is decreasing. Recently, lactoferrin administration has been shown to significantly increase the cure rate of 7-day rabeprazole, clarithromycin and tinidazole triple therapy. We assessed whether lactoferrin also increases the eradication rate of 7-day esomeprazole, clarithromycin and amoxycillin triple therapy as first-line treatment. METHODS: Overall, 133 consecutive patients with non-ulcer dyspepsia and H. pylori infection were randomised to receive either a standard 7-day triple therapy with esomeprazole 20mg b.i.d., clarithromycin 500 mg b.i.d. and amoxycillin 1g b.i.d. (68 patients) or a quadruple therapy comprising of the same regimen plus lactoferrin 200mg b.i.d. (65 patients). H. pylori at entry was assessed by endoscopy, while bacterial eradication was checked by (13)C urea breath test 4-6 weeks after treatment. RESULTS: H. pylori eradication following standard triple therapy was achieved in 53/68 (77.9%; 95% CI = 68-88) and in 53/66 (80.3%; 95% CI = 71-89) patients at ITT and PP analyses, respectively. Following the quadruple regimen, the infection was cured in 50/65 (76.9%; 95% CI = 67-87) and 50/64 (78.1%; 95% CI = 68-88) patients at ITT and PP analyses, respectively. No statistically significant difference emerged between the two therapeutic regimens, both at ITT (p = 0.9) and PP analyses (p = 0.9). Side effects were complained by seven (10.3%) patients and six (9.2%) patients following the triple and quadruple regimens, respectively (p = 0.9), with only one patient in the quadruple group interrupting the treatment due to side effects. CONCLUSIONS: Quadruple therapy with lactoferrin did not significantly increase the H. pylori cure rate of standard 7-day clarithromycin-amoxycillin based triple therapy in non-ulcer dyspepsia patients.