A multicenter randomized phase 4 trial comparing sodium picosulphate plus magnesium citrate vs. polyethylene glycol plus ascorbic acid for bowel preparation before colonoscopy. The PRECOL trial.

Background: Adequate bowel preparation before colonoscopy is crucial. Unfortunately, 25% of colonoscopies have inadequate bowel cleansing. From a patient perspective, bowel preparation is the main obstacle to colonoscopy. Several low-volume bowel preparations have been formulated to provide more tolerable purgative solutions without loss of efficacy. Objectives: Investigate efficacy, safety, and tolerability of Sodium Picosulphate plus Magnesium Citrate (SPMC) vs. Polyethylene Glycol plus Ascorbic Acid (PEG-ASC) solutions in patients undergoing diagnostic colonoscopy. Materials and methods: In this phase 4, randomized, multicenter, two-arm trial, adult outpatients received either SPMC or PEG-ASC for bowel preparation before colonoscopy. The primary aims were quality of bowel cleansing (primary endpoint scored according to Boston Bowel Preparation Scale) and patient acceptance (measured with six visual analogue scales). The study was open for treatment assignment and blinded for primary endpoint assessment. This was done independently with videotaped colonoscopies reviewed by two endoscopists unaware of study arms. A sample size of 525 patients was calculated to recognize a difference of 10% in the proportion of successes between the arms with a two-sided alpha error of 0.05 and 90% statistical power. Results: Overall 550 subjects (279 assigned to PEG-ASC and 271 assigned to SPMC) represented the analysis population. There was no statistically significant difference in success rate according to BBPS: 94.4% with PEG-ASC and 95.7% with SPMC (P = 0.49). Acceptance and willing to repeat colonoscopy were significantly better for SPMC with all the scales. Compliance was less than full in 6.6 and 9.9% of cases with PEG-ASC and SPMC, respectively (P = 0.17). Nausea and meteorism were significantly more bothersome with PEG-ASC than SPMC. There were no serious adverse events in either group. Conclusion: SPMC and PEG-ASC are not different in terms of efficacy, but SPMC is better tolerated than PEG-ASC. SPMC could be an alternative to low-volume PEG based purgative solutions for bowel preparation. Clinical trial registration: [ClinicalTrials.gov], Identifier [NCT01649674 and EudraCT 2011-000587-10].

Perception of the COVID-19 Pandemic Among Patients With Inflammatory Bowel Disease in the Time of Telemedicine: Cross-Sectional Questionnaire Study.

BACKGROUND: After the COVID-19 outbreak, the Italian Government stopped most regular health care activity. As a result, patients with inflammatory bowel disease (IBD) had limited access to outpatient clinics and hospitals. OBJECTIVE: This study aimed to analyze the perception of the COVID-19 emergency among patients with IBD during the early weeks of the lockdown. METHODS: We invited adult patients with IBD from the University of Salerno (Campania, South Italy) and the University of Padua (Veneto, North Italy) by email to answer an ad hoc anonymous survey about COVID-19. We also collected data on demographic and disease characteristics. RESULTS: In total, 167 patients with IBD from Padua and 83 patients from Salerno answered the survey (age: mean 39.7 years, SD 13.9 years; female: n=116, 46.4%). We found that patients with IBD were particularly worried about the COVID-19 pandemic (enough: 77/250, 30.8%; much/very much: 140/250, 56.0%), as they felt more vulnerable to COVID-19 due to their condition (enough: 70/250, 28.0%; much/very much: 109/250, 43.6%). Patients with IBD from the red zone of Veneto were more worried than patients from Campania (P=.001), and men felt more susceptible to the virus than women (P=.05). Additionally, remote medicine was appreciated more by younger patients than older patients (P=.04). CONCLUSIONS: The results of our survey demonstrate that the lockdown had a significant impact on the psychological aspects of patients with IBD and suggest the need for increasing communication with patients with IBD (eg, through telemedicine) to ensure patients receive adequate health care, correct information, and proper psychological support.

Combined endo-laparoscopic approach in a patient with a duodenal foreign body and bowel obstruction.

We report the successful removal of an intraduodenal foreign body (f.b.) by endo-laparoscopic rendezvous, in a 67-year-old patient with mental disorders and duodenal occlusion by a large peach seed impacted in the duodenum. During a first endoscopic diagnostic evaluation it was possible to retract the peach seed into the stomach and have a confirmation of a stenosis of the second portion of the duodenum. Otherwise, the endoscopic procedure failed during removal out of the esophagus due to the large size of the f.b., and a second treatment in general anesthesia was planned. A 4 cm anterior gastrotomy was than performed by laparoscopy, and with a real endo-laparoscopic rendezvous, the peach seed out of the stomach was positioned, avoiding any intra-gastric surgical manouver and directly passing from Dormia basket into laparoscopic plastic retrieval bag. The gastrotomy was than closed with a single cartridge of a linear stapler and reinforced with an oversewn suture.

From trials to a real hospital setting: effectiveness of pegylated interferon-alpha-2b/ribavirin combination therapy for naïve chronic hepatitis C patients.

Registration trials regarding pegylated interferon treatment of hepatitis C have created great expectations for improved results, but there is little information on actual outcomes in everyday hospital practice. We aimed to define the effectiveness of this treatment in a hospital setting. Seventy-four naïve patients with hepatitis C treated with 12 kD-pegylated-interferon-alpha-2-b/ribavirin (PEG-IFN) were retrospectively analyzed in comparison with 54 patients treated with IFN-alpha-2-b/ribavirin (STANDARD IFN) and with results of three main registration trials. Overall sustained viral response rates were 46% in the STANDARD IFN group and 54% in PEG-IFN group, ranging from 48-61% in similar arms of the registration trials considered, although more of our patients presented comorbidity and high-grade fibrosis, and our dosages at outset of PEG-IFN were lower than optimal (mean 1.18 microg/kg BW). In our hospital setting, the effectiveness of PEG-IFN/ribavirin therapy appeared similar to that reported in large registration trials.

Worse clinical course of disease in Crohn's patients with previous appendectomy.

OBJECTIVES: The aim of the present study was to assess the effect of previous appendectomy in a series of Crohn's disease (CD) patients on the clinical characteristics and course of disease. METHODS: Demographic and clinical data were retrospectively analysed for 129 consecutive outpatients (68 men and 61 women, median age 38 years) with CD. For each patient, information concerning appendectomy, indication for surgery (acute/chronic) and the date of surgery were recorded. The date of the appendectomy in relation to the date of CD diagnosis was carefully assessed in order to evaluate the precise relationship between the two events. A total of 129 CD patients who had not undergone previous appendectomy served as controls. The severity of disease was assessed retrospectively by evaluating the need for systemic steroids, immunosuppressants and surgical treatment for CD, particularly resective procedures. RESULTS: Forty-one CD patients (31.8%) underwent appendectomy before the diagnosis of disease. Appendectomy before diagnosis showed a negative association with colonic disease localization and with articular manifestations. In addition, the 41 patients with previous appendectomy had a significantly greater risk of surgery, particularly resective. Multivariate analysis confirmed appendectomy performed before diagnosis as an independent risk factor for surgery; on the contrary, colonic site and inflammatory type of disease were independent factors protecting against surgery. Although current smokers were at an increased risk of surgical treatment, a smoking habit alone did not seem to be relevant at the multivariate analysis. CONCLUSION: The results of this study indicate a worse clinical course of CD in patients appendicectomized before diagnosis.