Position paper on transanal irrigation in chronic non-organic constipation.

The practice of recto-colonic water irrigation to treat constipation has been used since ancient times with different, uncontrolled, and variably performing methods which have been considered interchangeably all alike. The use of better-performing devices with a standardized methodology is relatively recent, and the term Trans Anal Irrigation (TAI) defines a methodology performed with devices able to control the timing, volume, and pressure of the water introduced into the rectum and colon utilizing a catheter or a cone through the anus. Such practice has been implemented with favorable responses in patients with refractory chronic constipation secondary to neurological diseases. However, since the role of Trans Anal Irrigation as a therapeutic aid in chronic functional constipation and functional evacuation disorders is not yet fully clarified and standardized, a group of clinical investigators with recognized expertise in these clinical conditions intends to clarify the elements that characterize a TAI procedure that can benefit patients with functional constipation and functional defecation disorders defined according to the lastly updated Rome Diagnostic Criteria. Finally, the paper deals with adherence and practical implementation of TAI.

Global audit on bowel perforations related to transanal irrigation.

PURPOSE: Transanal irrigation is increasingly used against chronic constipation and fecal incontinence in selected patients. The aims were to estimate the incidence of irrigation-related bowel perforation in patients using the Peristeen Anal Irrigation(®) system, and to explore patient- and procedure-related factors associated with perforation. METHODS: External independent expert audit on the complete set of global vigilance data related to Peristeen Anal Irrigation from 2005 to 2013. RESULTS: In total, 49 reports of bowel perforation had been recorded. Based on sales figures, this corresponds to an average risk of bowel perforation of 6 per million procedures. The latest two-year data indicate a risk of 2 per million procedures. In 29 out of 43 evaluable cases (67 %), perforation happened within the first 8 weeks since start of treatment. After 8 weeks, long-term use has an estimated risk of less than 2 per million procedures. Among patients with non-neurogenic bowel dysfunction, 11 out of 15 (73 %) had a history of pelvic organ surgery compared to 5 out of 26 (19 %) in neurogenic bowel dysfunction. In 11 of 46 (24 %) evaluable cases, burst of the rectal balloon was reported. CONCLUSION: Enema-induced perforation is a rare complication to transanal irrigation with Peristeen Anal Irrigation, which increases the benefit risk ratio in support of the further use of transanal irrigation. Increased risk is present during treatment initiation and in patients with prior pelvic organ surgery. Careful patient selection, patient evaluation and proper training of patients are critical to safe practice of this technique.

Effect of a new synbiotic supplement on symptoms, stool consistency, intestinal transit time and gut microbiota in patients with severe functional constipation: a pilot randomized double-blind, controlled trial.

BACKGROUND: Data on the benefits of synbiotics in functional constipation are conflicting. The aim of this study was to assess whether the administration of the synbiotic supplement Psyllogel Megafermenti(®) normalized stool consistency and decreased intestinal transit time (ITT) in patients with severe functional constipation, based on its ability to impact on the gut microbiota. METHODS: We conducted a pilot randomized, double-blind, controlled trial. After a 2-week run-in period, patients from a tertiary care setting with severe functional constipation fulfilling the Rome III Diagnostic Criteria in the past year were randomly assigned to receive by mouth 2 bags/day of Psyllogel Megafermenti(®) (Group A) or 2.8 g of maltodextrin twice daily (Group B) for 8 weeks. Primary endpoints were increase of bowel evacuations with normal stool consistency and volume, and ITT reduction. Secondary endpoints included symptom improvement according to the Rome III Diagnostic Criteria, reduction of the Agachan-Wexner score and changes in gut microbiota composition. RESULTS: Twenty-nine patients completed the study: 17 were allocated to Group A and 12 to Group B. A statistically significant increase in stools with normal consistency was observed only in Group A (p = 0.001), even when considering patients with normal stools ≤50 % of time at baseline. In Group A, a significant reduction in ITT was also found (p = 0.022). According to polymerase chain reaction-denaturing gradient gel electrophoresis profiling of stool samples, 50 % of the patients treated with synbiotics harbored all the probiotic species of the study product. CONCLUSIONS: An 8-week treatment with Psyllogel Megafermenti(®) improved the main clinical parameters of functional constipation in patients extremely homogeneous for disorder severity and underlying pathophysiology ( Eudract.ema.europa.eu , No. 2008-000913-30).

Consensus review of best practice of transanal irrigation in adults.

STUDY DESIGN: Review article. OBJECTIVES: To provide a consensus expert review of the treatment modality for transanal irrigation (TAI). METHODS: A consensus group of specialists from a range of nations and disciplines who have experience in prescribing and monitoring patients using TAI worked together assimilating both the emerging literature and rapidly accruing clinical expertise. Consensus was reached by a round table discussion process, with individual members leading the article write-up in the sections where they had particular expertise. RESULTS: Detailed trouble-shooting tips and an algorithm of care to assist professionals with patient selection, management and follow-up was developed. CONCLUSION: This expert review provides a practical adjunct to training for the emerging therapeutic area of TAI. Careful patient selection, directly supervised training and sustained follow-up are key to optimise outcomes with the technique. Adopting a tailored, stepped approach to care is important in the heterogeneous patient groups to whom TAI may be applied. SPONSORSHIP: The review was financially supported by Coloplast A/S.

Reliability of the international spinal cord injury bowel function basic and extended data sets.

STUDY DESIGN: This study was designed as an international validation study. OBJECTIVE: The objective of this study was to assess the inter-rater reliability of the International Spinal Cord Injury Bowel Function Basic and Extended Data Sets. SETTING: Three European spinal cord injury centers. METHODS: In total, 73 subjects with spinal cord injury and a history of bowel dysfunction, out of which 77% were men and median age of the subjects was 49 years (range 20-81), were studied. The inter-rater reliability was estimated by having two raters complete both data sets on the same subject. First and second tests were separated by 14 days. Cohen's kappa was computed as a measure of agreement between raters. RESULTS: Inter-rater reliability assessed by kappa statistics was very good (≥0.81) in 5 items, good (0.61-0.80) in 11 items, moderate (0.41-0.60) in 20 items, fair (0.21-0.40) in 11 and poor (<0.20) in 5 items. CONCLUSION: Most items within the International Spinal Cord Injury Bowel Function Data sets have acceptable inter-rater reliability and are useful tools for data collection in international clinical practice and research. However, minor adjustments are recommended.

Evaluation with 64-slice CT of the prevalence of coronary artery variants and congenital anomalies: a retrospective study of 3,236 patients.

PURPOSE: This study retrospectively evaluated the prevalence of anatomical coronary artery variants and congenital anomalies in 3,236 patients imaged with 64-slice computed tomography (CT). MATERIALS AND METHODS: Over a period of 4 years, 3,236 patients underwent CT coronary angiography performed with the standard protocol. We assessed coronary artery dominance, presence of the intermediate branch, presence and number of diagonal and marginal branches and coronary anomalies subdivided into anomalies of origin and course, intrinsic anomalies and termination anomalies. RESULTS: Coronary dominance was right-sided in 88.1% of patients; the intermediate branch was present in 21.3%, the number of diagonal and marginal branches was one to two in >90%, and the number of coronary anomalies was 224 (89 of origin and course, 129 intrinsic anomalies and six termination anomalies). CONCLUSIONS: Sixty-four-slice CT coronary angiography provides accurate three-dimensional evaluation of the coronary artery tree with correct visualisation of any coronary anomalies, a relatively common finding that had a prevalence of 5.7% in our study population.

Role of 64-slice cardiac computed tomography in the evaluation of patients with non-ST-elevation acute coronary syndrome.

PURPOSE: This study was done to evaluate the feasibility, sensitivity and specificity of 64-slice computed tomography (CT) in identifying haemodynamically significant (>50%) coronary artery stenoses in patients with suspected acute coronary syndrome (ACS) by correlating the CT findings with the clinical event and data provided by conventional coronary angiography (CCA). MATERIALS AND METHODS: Sixty-four patients (38 men and 26 women; mean age 65 years; range+/-10 years) presenting to our hospital's emergency department with a clinical suspicion of ACS were studied with 64-slice CT followed by CCA within 24 h of arrival. RESULTS: Two patients (3.1%) were excluded from the analysis due to artefacts. Per-patient analysis in the remaining 62 patients identified 24 cases (38.7%) of negative CT findings (no stenoses or stenoses <50%), 35 cases of positive CT findings (56.4%) with identification of the culprit lesion, two cases in which the culprit lesion was not identified and one patient with unconfirmed stenosis. Sensitivity and specificity were 94.6% and 96%, respectively. Per-vessel analysis (186 vessels) revealed 17 non-evaluable vessels (9.1%) due to motion artefacts, 61 vessels (32.8%) with stenosis >50%, seven overestimated vessels (3.7%) due to extensive calcifications, three vessels (1.6%) with underestimated stenosis and 98 vessels (52.6%) without stenosis. Sensitivity and specificity were 95.3% and 93.3%, respectively. CONCLUSIONS: In this type of emergency, coronary CT angiography could lead to considerably lower healthcare costs by identifying patients without coronary disease and allowing immediate discharge without any need for further diagnostic procedures.

Cryptogenic stroke in hanging. A case report.

This paper reports the unique neuroimaging findings of a 37-year-old woman who attempted suicide by hanging. To our knowledge, this is the first reported case describing neuroimaging findings of unilateral lesions instead of the well-documented bilateral lesions after a hanging event. Computed tomography demonstrated a low density area in the right thalamus and no hemorrhage. 3.0 T Magnetic resonance revealed a hyperintense area on both T2-weighted and FLAIR images on the right thalamus. Diffusion weighted images demonstrated no area of diffusivity restriction. Another smaller lesion with the same signal characteristics was found in the left cerebellum. A second relevant point of this report is the observation that the most probable cause of the documented unilateral lesions was an ischemic-arterial event.

Molecular imaging and magnetic resonance imaging in early diagnosis of Alzheimer's disease. A literature review.

Alzheimer's disease (AD), a progressive neurodegenerative disorder, is the most common cause of dementia in the elderly. Magnetic resonance (MR) or computed tomography (CT) imaging is recommended for routine evaluation of dementias. The development of molecular imaging agents and the new techniques of MR for AD are critically important for early diagnosis, neuropathogenesis studies and assessing treatment efficacy in AD. Neuroimaging using nuclear medicine techniques such as SPECT, PET and MR spectroscopy has the potential to characterize the biomarkers for Alzheimer's disease. The present review summarizes the results of radionuclide imaging and MR imaging in AD.

Evaluation of an occupational therapy program for patients with spinal cord injury.

STUDY DESIGN: Clinical controlled trial. OBJECTIVES: To evaluate the effectiveness of an occupational therapy (OT) program combined with neuromotor rehabilitation, by assessing the degree of functional independence reached by patients with spinal cord injuries at first hospitalization. SETTINGS: Subjects selected from the Spinal Cord Unit of the Rehabilitation Institute of Montecatone (Imola, Italy). PARTICIPANTS: Thirty-six male patients below age 60, with complete paraplegia (ASIA-A) in thoracic-lumbar level, at first hospitalization. METHODS: Patients were divided into experimental and control groups. Subjects in the experimental group underwent neuromotor rehabilitation coupled with an OT program, whereas those in the control group followed neuromotor rehabilitation only. Increase in functional independence at discharge was evaluated by the Valutazione Funzionale Mielolesi (VFM) assessment scale. RESULTS: Patients in the experimental group showed a significant increase in the total VFM score, and in domains concerning transfers and wheelchair use. A significant improvement was observed in unmarried patients as compared to married ones. CONCLUSION: An OT service within a Spinal Cord Unit allows us to achieve a higher level of functional independence.

Study of the effectiveness of bronchial clearance in subjects with upper spinal cord injuries: examination of a rehabilitation programme involving mechanical insufflation and exsufflation.

STUDY DESIGN: Randomized controlled trial. OBJECTIVES: To establish whether the use of mechanical insufflation/exsufflation leads to a significant improve in tracheostomy subjects with upper spinal cord injuries (C1-C7), ASIA classification grade A and bronchial hyper secretion the following parameters: forced vital capacity (FVC), forced exspiratory volume on the first second (FEV1), FEV1/FVC, peak exspiratory flow (PEF), arterious pressure of O(2) (Pa O(2)), arterious pressure of CO(2) (Pa CO(2)), pH, saturation of O(2) (Sa O(2)). SETTING: Spinal Cord Unit, Montecatone Rehabilitation Institute, Imola, Italy. METHODS: The patients were split into two groups: the experimental group (EG) and the control group (CG). Each patient was given 10 treatments: the EG was given manual respiratory kinesitherapy associated with mechanical insufflation/exsufflation with inhale and exhale pressure between 15 cm H(2)O and 45 cm H(2)O, while the CG was only given manual kinesitherapy. The treatment sessions covered the necessary amount of time in order to achieve sufficient clearance. The study has been approved by the local ethic committee. The patients were informed before being enrolled in that study and gave their written consent. RESULTS: At the end of the treatment associated with the mechanical insufflation/exsufflation, the EG showed a significant increase in FVC, FEV1 and PEF, although it was not possible to compare the latter with the CG. The other parameters were also subject to variations, although not statistically significant. The CG did not show signs of any significant change. CONCLUSION: The use of mechanical insufflation/exsufflation in subjects with the aforementioned characteristics is shown to be an effective adjunct to manual respiratory kinesitherapy, since it makes it possible to achieve adequate bronco-pulmonary clearance, even removing thick, deep secretions and making it possible to insufflate any areas affected by atelectasis.

Intestinal microflora and oral bacteriotherapy in irritable bowel syndrome.

On the basis of many clinical and experimental observations, it would appear feasible to hold that the characteristics of the luminal milieu, the relationship, the balance between luminal prokaryotic cells and mucosal eukaryotic cells and the consequent immunological and humoral local and systemic responses take part in the pathophysiology of several diseases and, consequently bacteriotherapy can play a relevant role in the treatment and prevention of irritable bowel syndrome and more in general, of the intestinal functional disorders. The irritable bowel syndrome is characterised by sudden and unforeseeable changes in the two main symptoms, constipation and diarrhoea, even within a few days. The amount and composition of proximal colon microflora, increasing with regard to the above-mentioned factors, and the time in which this development occurs, are, in our opinion, elements taking part, together with colon dysmotility and alterations of visceral perception, in the onset of the variability in stool frequency, typical of these patients. The present open noncontrolled trial is the first observation showing a clinical improvement related to changes in the composition of the faecal bacterial flora and in faecal biochemistry and, remarkably, in the colonic motility pattern, all of which induced by administration of probiotics, in patients with functional diarrhoea.

Effects of probiotic administration upon the composition and enzymatic activity of human fecal microbiota in patients with irritable bowel syndrome or functional diarrhea.

In a clinical trial, 10 patients suffering from irritable bowel syndrome or functional diarrhea were administered the probiotic preparation VSL-3. Preliminary results indicated that administration of VSL-3 improved the clinical picture and changed the composition and biochemistry of fecal microbiota. Titer variations of intestinal bacterial groups were evaluated by culture and PCR techniques. A significant increase in lactobacilli, bifidobacteria and Streptococcus thermophilus was observed as a consequence of probiotic treatment, while enterococci, coliforms, Bacteroides and Clostridium perfringens did not change significantly. The strains Bifidobacterium infantis Y1 and Bifidobacterium breve Y8, included in VSL-3, were specifically detected in feces of patients treated with the probiotic by using strain-specific PCR primers. In addition, fecal beta-galactosidase increased and urease activities decreased as a result of changes in the intestinal microbiota induced by VSL-3 administration.

Immune-endocrine status and coeliac disease in children with Down's syndrome: relationships with zinc and cognitive efficiency.

Immune defects, thyroid abnormalities, plasma zinc levels, and the presence of gastrointestinal disease were investigated in 43 children with Down's syndrome (DS). Peripheral T lymphocytes with the phenotype of helper cells or cluster of differentiation 4 (CD4) were decreased. Circulating activated T cells (CD3/HLA-DR-positive cells) and large granular lymphocytes (CD16/CD56 positive cells) were increased. Plasma levels of interleukin-6 were higher in DS children than in controls. Serum levels of thyroid-stimulating hormone were increased in DS. Coeliac disease was over-represented in the group of DS children and many of these children also showed increased serum levels of immunoglobulin-G (IgG) specific for gliadin antigen. The increment of serum interleukin-6 was age-related and correlated with anti-gliadin IgG levels in DS. Plasma zinc levels were lower in DS children with coeliac disease and in those with anti-gliadin IgG than in DS without detectable anti-gliadin IgG. Dietary antigens may represent a continuous stimulus for the immune system in this syndrome and interfere with normal immune responses. Altered intestinal absorption of nutrients may in turn affect endocrine functions, brain development, and cognitive performances.

Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial.

BACKGROUND & AIMS: Pouchitis is the major long-term complication after ileal pouch-anal anastomosis for ulcerative colitis. Most patients have relapsing disease, and no maintenance treatment study has been performed. We evaluated the efficacy of a probiotic preparation (VSL#3) containing 5 x 10(11) per gram of viable lyophilized bacteria of 4 strains of lactobacilli, 3 strains of bifidobacteria, and 1 strain of Streptococcus salivarius subsp. thermophilus compared with placebo in maintenance of remission of chronic pouchitis. METHODS: Forty patients in clinical and endoscopic remission were randomized to receive either VSL#3, 6 g/day, or an identical placebo for 9 months. Patients were assessed clinically every month and endoscopically and histologically every 2 months or in the case of a relapse. Fecal samples were collected for stool culture before and after antibiotic treatment and each month during maintenance treatment. RESULTS: Three patients (15%) in the VSL#3 group had relapses within the 9-month follow-up period, compared with 20 (100%) in the placebo group (P < 0.001). Fecal concentration of lactobacilli, bifidobacteria, and S. thermophilus increased significantly from baseline levels only in the VSL#3-treated group (P < 0.01). CONCLUSIONS: These results suggest that oral administration of this new probiotic preparation is effective in preventing flare-ups of chronic pouchitis.

Long term efficacy, safety, and tolerabilitity of low daily doses of isosmotic polyethylene glycol electrolyte balanced solution (PMF-100) in the treatment of functional chronic constipation.

AIMS: To assess the long term therapeutic effectiveness, safety, and tolerability of low daily doses of isosmotic PEG electrolyte solutions (PMF-100) administered for a six month period for the treatment of functional constipation, in a double blind, placebo controlled, parallel group study. METHODS: After an initial four week run in period with PMF-100 (250 ml twice daily; PEG 14.6 g twice daily), 70 patients suffering from chronic constipation (58 females, aged 42 (15) years) with normalised bowel frequency (>3 bowel movements (bm)/week) were randomly allocated to receive either PMF-100 or placebo, contained in sachets (one sachet in 250 ml of water twice daily) for 20 weeks. Patients were assessed at four week intervals, and reported frequency and modality of evacuation, laxative use, and relevant symptoms on a diary card. At weeks 1, 12, and 24, a physical examination and laboratory tests were performed. RESULTS: Complete remission of constipation was reported by a significantly (p<0.01) higher number of patients treated with PMF-100 compared with placebo at each four week visit. At the end of the study, 77% of the PMF-100 group and 20% of the placebo group were asymptomatic. Compared with placebo, patients treated with PMF-100 reported hard/pellety stools and straining at defecation less frequently, a significantly higher bowel frequency (week 12: 7. 4 (3.1) v 4.3 (2.5) bm/week, 95% CI 1.64, 4.42; week 24: 7.4 (3.2) v 5.4 (2.1) bm/week, 95% CI 0.13,3.93), reduced consumption of laxative/four weeks (week 12: 0.7 (2.7) v 2.2 (3.3), 95% CI -2.29, 0. 03; week 24: 0.2 (0.8) v 1.4 (2), 95% CI -2.07, -0.023), reduced mean number of sachets used (week 12: 33 (13) v 43 (12), 95% CI -17. 24, 4.56; week 24: 33 (13) v 44 (12), 95% CI -19.68, -2.24), and reduced number of drop outs for therapy failure (16 v 3; p<0.005). Adverse events, physical findings, laboratory values, palatability, and overall tolerance of the solutions did not differ between groups. CONCLUSIONS: Administration of small daily doses of isosmotic PEG electrolyte balanced solutions was effective over a six month period for the treatment of functional constipation. A mean daily dose of approximately 300 ml of PEG solution (PEG 17.52 g) appeared to be safe, well tolerated, and devoid of significant side effects.

Polyethylene glycol solution in subgroups of chronic constipation patients: experience in obstructed defaecation.

Low doses of polyethylene glycol solutions were administered in patients with long-standing constipation and in a subgroup with severe symptoms of obstructed defaecation and in whom anorectal surgery was considered. During treatment all patients with constipation improved and nineteen of the twenty-one patients with dyschezia became asymptomatic. Only two patients were submitted to surgery.

Illness behavior, affective disturbance and intestinal transit time in idiopathic constipation.

Patients with constipation differ not only from healthy subjects but can also be categorized into two groups: slow transit constipation (STC) and normal transit constipation (NTC) using measures of total intestinal transit time (TITT). We investigated the role of illness behavior and affective state in 45 NTC and 29 STC patients as compared with 20 healthy subjects. All subjects completed the Illness Behavior Questionnaire (IBQ), the Symptom Questionnaire (SQ), and the CES-D to assess illness behavior, psychological distress, and depression. The constipated patients reported more psychological distress than healthy subjects. Within the constipated group, the NTC subjects had significantly higher scores on the IBQ dimensions of hypochondriasis and disease affirmation. Our results suggest that even among constipated patients psychological distress is prominent and that measures of illness behavior help to discriminate among different pathophysiological groups.

Acute pancreatitis after azathioprine treatment for ulcerative colitis.

Inflammatory bowel disease, in addition to intestinal involvement, may be complicated also by other extra-intestinal manifestations. Moreover, drugs commonly employed in the treatment of ulcerative colitis and Crohn's disease may induce iatrogenic pancreatitis. Acute pancreatitis is described in two ulcerative colitis patients following azathioprine treatment.