Efficacy of switching from infliximab to golimumab in patients with ulcerative colitis in deep remission.

BACKGROUND-AIM: Intravenously administered biologicals are associated with a huge pressure to Infusion Units and increased cost. We aimed to assess the impact of switching infliximab to golimumab in ulcerative colitis (UC) patients in deep remission. Patients and method: In a prospective, single-centre pilot study UC patients on infliximab mono-therapy for = 2 years, whowere in deep remission, consented to switch to golimumab and were followed for 1 year with clinical assessment, serum and faecal biomarkers, work productivity, satisfaction with treatment and quality of life parameters. Endoscopic remission was assessed by colonoscopy at 1 year. Patients fulfilling the same inclusion criteria, who did not consent to switch to golimumab and continued to receive infliximab mono-therapy, for the same period, served as controls. PATIENTS AND METHODS: In a prospective, single-centre pilot study UC patients on infliximab mono-therapy for ≥ 2 years, who were in deep remission, consented to switch to golimumab and were followed for 1 year with clinical assessment, serum and faecal biomarkers, work productivity, satisfaction with treatment and quality of life parameters. Endoscopic remission was assessed by colonoscopy at 1 year. Patients fulfilling the same inclusion criteria, who did not consent to switch to golimumab and continued to receive infliximab mono-therapy, for the same period, served as controls. RESULTS: Between October 2015 and October 2017, 20 patients were recruited; however one patient stopped therapy because of pregnancy. All 19 patients who were switched to golimumab were still in clinical, biomarker and endoscopic remission at 1 year and maintained excellent quality of life without any complications. In the control group, 18 of 19 patients were also in deep remission, since only one patient had a flare which was managed with IFX dose intensification. During a median 3 years extension treatment with golimumab only 2 patients experienced a flare of colitis. CONCLUSIONS: This pilot study indicates that switching from in-fliximab to golimumab in UC patients in deep remission does not compromise treatment effectiveness or the course of disease; golimumab offers a valid alternative to intravenous infliximab infusions during the COVID-19 pandemic.

Tentorial Incision vs. Retraction of the Tentorial Edge during the Subtemporal Approach: Anatomical Comparison in Cadaveric Dissections and Retrospective Clinical Case Series.

Objective The aim of this study was to compare tentorial incision (group A) versus retraction and tack up suture (group B) of the tentorial edge during the subtemporal approach for surgery in the high basilar region. Design 24 cadaveric dissections and 4 clinical cases of aneurysms of the high basilar region are presented. Assessment included visibility and operability afforded by either tentorial incision creating a dural flap (group A) or retraction of the tentorial edge and tethering with a suture (group B). Four patients, two with superior cerebellar artery aneurysms and two with proximal posterior cerebral artery aneurysms were treated with each approach. Results In the quantitative evaluations, we found no significant difference in the exposure of the posterior cerebral, superior cerebellar, and perforant arteries as well as surgical working area provided by either approach. However, tentorial incision allowed a significantly greater exposure of the basilar artery and the fourth cranial nerve (both p < 0.001). Concerning operability, tentorial incision provided no objective advantage for direct clipping of the high basilar region (groups A vs. B, p > 0.05). Subjectively, clipping of the high basilar segment was feasible using tentorial tethering only. Conclusion Retraction of the free edge of the tentorium downward by tethering with a suture is simple and fast method for exposure of aneurysms in the high basilar region when the pathology does not require a proximal control. In our data the rather more invasive and time consuming tentorial incision provided an additional objectified advantage only for placement of a proximal temporary clip.

The impact of timing of cranioplasty in patients with large cranial defects after decompressive hemicraniectomy.

BACKGROUND: It is unclear how soon after a decompressive hemicraniectomy that cranioplasty be safely performed in a patient in whom the ICP has been normalized. Early surgery has been associated with infection, intracerebral hematoma, and complications due to persistent or recurrent brain edema. Delayed cranioplasty of large cranial defects exposes the patient to different conditions known in the literature as the syndrome of the sinking skin flap. The purpose of this study was to investigate the hypothesis that timing of cranioplasty after decompressive hemicraniectomy influences outcome and complications. METHODS: We retrospectively examined outcome after cranioplasty performed at <7 weeks, 7-12 weeks, and >13 weeks after craniectomy in patients with large cranial defects after decompressive hemicraniectomy in our institution between 1997 and 2008. RESULTS: The time between craniectomy and cranioplasty ranged from 17 days to 4 months depending on several factors such as: the cause of decompression, infection before or after craniectomy, and skin flap concavity. The analysis of the registered postoperative complications revealed that there were no significant differences between the examined groups. The cranioplasty at <7 weeks, in the form of reimplantation of the own skull flap, led to a GOS improvement of 78 %, at 7-12 weeks 46 % and at >13 weeks 12 %, respectively. Pairwise comparisons showed that the difference between cranioplasty at <7 weeks versus 7-12 weeks or >13 weeks cranioplasty groups was statistically significant (p = 0.05 and p < 0.001, respectively). CONCLUSIONS: Our study suggests that many patients with large cranial defects after decompressive craniectomy can safely undergo cranioplasty in an early stage; direct answers to these questions of timing of cranioplasty are best addressed by prospective studies. Nevertheless, the present study provides a basis for decision-making in certain patients and for the design of future investigations.

[Cranioplasty after supratentorial decompressive craniectomy: when is the optimal timing]. / Kranioplastik nach supratentorieller dekompressiver Kraniektomie : Wann ist der Zeitpunkt optimal?

BACKGROUND: The purpose of this study was to evaluate the outcome and complication rates of different cranioplastic procedures. PATIENTS AND METHODS: This study retrospectively reviewed 242 consecutive patients who underwent cranioplasty. The indications for craniectomy, the timing and materials employed for the cranial repair procedures were analysed in all patients as well as their early and long-term results. The immediate patient's outcome after cranioplasty was assessed by reviewing medical records and the late outcome was evaluated with a telephone questionnaire. The patients were divided into three groups depending on the timing of cranioplasty [ultra early group (until 6 weeks), early group (7-12 weeks) and delayed group (after 13 weeks following craniectomy)]. RESULTS: The ultra early cranioplasty in the form of reimplantation of the patient's own skull flap led to a rapid improvement of the patient's neurological function and late outcome. The analysis of the registered postoperative complications revealed that there were no significant differences between the groups examined. CONCLUSION: This study found that ultra early cranioplasty by reimplanting the patient's own previously removed and frozen skull bone was a safe and successful strategy.

Do we present abstracts on ethical, legal, cost-effectiveness and patient care issues at major gastroenterology congresses?

INTRODUCTION: In the era of the new millennium, a lot of preclinical and clinical research is published. However, ethico-legal, cost-effectiveness and patient care issues are not addressed equally. AIM: To investigate whether abstracts presented at major international gastroenterology congresses refer to issues relevant to doctor-patient relationship, cost-effectiveness and care. METHODS: We reviewed the abstracts on disk CD-ROMs of the United European Gastroenterology Week (UEGW) and the Digestive Disease Week (DDW), for the years 1998-2006. We used the following keywords: ethical/ethically, legal, consent, cost-effective/effectiveness, care, quality and tolerable/tolerability. RESULTS: Over the study period, 1,612/20,018 (8.05%) and 764/45,628 (1.67%) abstracts including the above keywords were presented at UEGW and DDW congresses (p = 0.013), respectively. Statistically significant more abstracts containing separately any of the key words (apart from 'legal') were presented at the UEGW than at the DDW congress. There was a significant trend of increased referring to these key words over the study period for UEGW (p < 0.041) but not for DDW congresses (p = 0.70). CONCLUSION: The abstracts presented at the UEGW refer to ethico-legal, cost-effectiveness and patient care issues more frequently than those presented at the DDW. There is a trend of increased referring to these subjects at the UEGW but not at the DDW.

Combined minimal invasive techniques in deep supratentorial intracerebral haematomas.

Minimal invasive techniques (MIT) like microscopy, stereotaxy, endoscopy and neuronavigation facilitate and improve neurosurgical results and reduce the operative trauma. We report the combined employment of these techniques and the results obtained in our department during the last 7 years in 95 consecutive patients with supratentorial deep located intracerebral haematomas (ICHs). Thirty-six deteriorating patients with deep ICHs under 30 cm (3) volume associated to intraventricular bleeding, were treated early (first 24 hours after bleeding) with neuronavigation guided stereotactic lysis, using multiplanar targets (1 to 3). Microsurgical clot aspiration through an enlarged burr-hole was frequently combined with endoscope- or neuronavigation-assisted evacuation within the first 6 hours after bleeding for the rest of the deteriorating patients with ICHs larger than 30 cm (3). A 1.2 cm narrow surgical corridor assured the least injury to vital cortical areas, tracts and blood vessels. In 86 cases the clots were adequately removed (non-measurable rest) with a reduced morbid mortality (13.8 and 8.6 as well as 23.3 and 16.9 for stereotactic and microscopic MIT, respectively). In our experience, the use of combined MIT adapted to the surgical urgency of the individual patient reduces the operative trauma and improves the accuracy for the access to the clot allowing an adequate haematoma evacuation and a satisfactory outcome in most of the cases.

A prospective randomized controlled trial of intravenous ciprofloxacin as an adjunct to corticosteroids in acute, severe ulcerative colitis.

BACKGROUND: The role of antibiotics in the treatment of ulcerative colitis is controversial. This study aims at assessing the therapeutic role of ciprofloxacin as an adjunct to corticosteroids in acute severe ulcerative colitis. METHODS: In this prospective, randomized, double-blind, placebo-controlled trial, 55 consecutive patients fulfilling the criteria of Truelove and Witts for severe ulcerative colitis were randomized on admission to the hospital to receive intravenously ciprofloxacin (400 mg b.i.d.) (n = 29) or placebo (n = 27). All patients received parenteral nutrition, intravenous hydrocortisone (100 mg q.i.d.) and hydrocortisone enemas (100 mg b.i.d.). Patients were assessed after 10 days of continuous treatment, or at any time a severe complication occurred. RESULTS: At study entry, there were no significant differences between treatment groups in any patient or disease-related parameter. Twenty-three of 29 patients (79.3%) treated with ciprofloxacin and 20 of 26 patients (77%) treated with placebo showed substantial improvement and were given oral steroids (P > 0.1). Six patients in each group did not improve (n = 10) or developed complications (n = 2). Nine of these 12 patients underwent emergency colectomy; three patients consented to receive intravenous cyclosporin but did not achieve remission of colitis and they underwent elective colectomy. There were no perioperative or late deaths. CONCLUSIONS: A short course of intravenous ciprofloxacin does not seem to augment the effect of corticosteroids for patients with acute, severe ulcerative colitis.

Primary melanoma of the oesophagus treated endoscopically. A case report.

Primary melanoma is a rare neoplasm of the oesophagus, with dismal outcome in most cases. We report a case of primary melanoma of the oesophagus treated endoscopically, as coexisting illness prohibited surgical resection of the tumour. A review of the literature is made.

A prospective randomized controlled trial of oral ciprofloxacin in acute ulcerative colitis.

OBJECTIVES: The aim of this prospective, randomized, controlled trial was to evaluate the role of ciprofloxacin as an adjunct to corticosteroids in acute ulcerative colitis. METHODS: Seventy consecutive patients with mild (n = 37) or moderately active (n = 33) ulcerative colitis were randomized to receive oral ciprofloxacin (250 mg b.i.d., n = 34) or placebo (n = 36) for 14 days. In addition, they were given oral prednisolone (initial dose 20 or 40 mg for mild and moderately active ulcerative colitis, respectively) and rectal betamethasone enemas (2 g at night) for 7-9 weeks. All patients were receiving olsalazine (0.5 g twice daily). At study entry, the groups were similar with respect to age, sex, extent, duration, and severity of disease, and previous treatments. Patients were assessed clinically, endoscopically, and histologically before, at the end of the trial (day 14), and on completion of steroid treatment, or at any time worsening of symptoms or a complication of ulcerative colitis occurred. RESULTS: At the end of the study, 24 patients (70.5%) in the ciprofloxacin group and 26 patients (72%) in the placebo group achieved remission (p > 0.1, Yates chi 2). Ten patients in each group necessitated higher doses of oral (n = 12) or intravenous (n = 8) steroids. Of the latter patients, two underwent emergency colectomy without perioperative deaths. Clostridium difficile toxin A was not detected in nonresponders to ciprofloxacin treatment. CONCLUSIONS: A short course of oral ciprofloxacin treatment does not seem to increase the proportion of patients with active ulcerative colitis going into remission.

The role of colonoscopy in the differential diagnosis of acute, severe hemorrhagic colitis.

BACKGROUND AND STUDY AIMS: This study assesses the diagnostic value of colonoscopy performed at an early stage of a first attack of acute, severe hemorrhagic colitis. PATIENTS AND METHODS: One hundred fourteen consecutive patients were prospectively studied. The colonoscopic diagnosis was compared with the final diagnosis of the colitis, which was based on clinical, microbiological, endoscopic, and histological criteria during the acute illness, but also on the results of a thirty-month follow-up of the patients aiming to confirm whether the colitis was relapsing or nonrelapsing in nature. RESULTS: The colonoscopic diagnosis was ulcerative colitis (UC) in 40, Crohn's disease in four, and infective colitis (IC) in 70 patients. The endoscopic diagnosis was finally confirmed in all 40 UC patients and in 68 of 70 (97.1%) IC patients. Two patients with an initial endoscopic and histological diagnosis of IC presented with typical attacks of UC 28 and 30 months later, respectively. Prominent endoscopic appearances in IC were mucosal edema, erythematous areas, hemorrhagic spots, bleeding, microaphthoid ulcers, and luminal exudate. Although rectal sparing was occasionally seen, endoscopic lesions were continuous and severe in the distal colon, but were patchily and unevenly distributed in other parts of the colon in IC. In UC, prominent colonoscopic findings were bleeding, mucosal friability, granularity, and ulceration; lesions were continuously distributed in the involved area. CONCLUSIONS: Colonoscopy is a useful procedure in the differential diagnosis of severe bloody diarrhea of unknown cause.