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Biomedical subjects

E Corazziari

Publications and source records attributed to E Corazziari.

At least 19 recordsLinked to original sources
PubMed2003

Clinical trial guidelines for pharmacological treatment of irritable bowel syndrome.

Appropriate guidelines for clinical trials in irritable bowel syndrome are needed because of the inadequacy of previously performed trials, the use of new and more adequate patient definition, new emerging pathophysiological models and the unique requirements related to the assessment of treatment outcome that, in the absence of a biological marker, can rely only on the evaluation of clinical manifestations. This consensus report highlights the following points. (a) A 4-week period is considered to be adequate to assess drug efficacy for the control of symptoms. (b) For the cyclic and non-life-threatening nature of the disease, a long-term study of 4-6 months or more of active treatment to establish efficacy is considered to be inappropriate in the large majority of patients. (c) In the initial assessment phase of drug efficacy, the withdrawal effect of treatment can be ascertained during a follow-up period prolonged for a sufficient time (4-8 weeks) after stopping treatment. Subsequent trials with proper withdrawal phase design and duration can then ascertain the drug post-treatment benefit. (d) Considering the intermittent clinical manifestations of irritable bowel syndrome, designing trials with on-demand or repeated cycles of treatment could be envisaged. However, the lack of a definition of what constitutes an exacerbation is a major obstacle to the design of such trials. In the absence of an established gold standard, appropriately justified novel trial designs are welcome. (e) Patients eligible for inclusion should comply with the Rome II diagnostic criteria for irritable bowel syndrome. (f) The main efficacy outcome of the treatment should be based on one primary end-point. (g) The primary efficacy end-point could combine, in a global assessment, the key symptoms (abdominal pain, abdominal discomfort, bowel alterations) of irritable bowel syndrome or rate any single symptom for drugs considered to target specific symptoms. (h) A 50% improvement in the primary efficacy end-point seems to be a reasonable definition of a responder.

Clinical Trials as Topic↗
PubMed2003

Prevalence of sexual and physical abuse and its relationship with symptom manifestations in patients with chronic organic and functional gastrointestinal disorders.

UNLABELLED: A history of physical and/or sexual abuse is a frequent occurrence in patients referred for chronic gastrointestinal disorders and it may predispose to the development of functional gastrointestinal disorders, and multiple medical complaints. This study was aimed to determine: (a) prevalence of abuse history in Italian patients with chronic gastrointestinal disturbances, and (b) relationship between abuse history and clinical manifestations. SUBJECTS AND METHODS: Consecutive gastrointestinal out-patients filled in a self-administered standardised questionnaire, made up of two separate sections: (1) a medical section enquiring on gastrointestinal and extra-gastrointestinal symptoms, and (2) a section on abuse enquiring on the presence and type of abuse suffered during their lifetime. Associations between number of symptoms and abuse history were evaluated using univariate and multivariate logistic models. RESULTS: Questionnaires were handed out to 260 patients; 13% of whom did not fill in the questionnaires. Functional gastrointestinal disorders were diagnosed in 72.5% of patients and organic gastrointestinal diseases in 27.5%. A total of 31% of patients with organic gastrointestinal diseases and 32% of those with functional gastrointestinal disorders referred to a history of sexual or physical abuse. Histories of physical plus sexual abuse, sexual abuse, childhood abuse and female gender, were statistically associated with an increased number of gastrointestinal and extra-gastrointestinal symptoms irrespective of functional or organic disorders, whereas there was no statistical association with physical abuse only. Furthermore, diagnosis of functional gastrointestinal disorders was associated with a significantly (p<0.001) greater number of gastrointestinal symptoms than the diagnosis of organic gastrointestinal diagnosis. A total of 10 patients met the diagnostic criteria of somatization disorder. Of these, eight reported a history of severe physical and sexual abuse that had occurred, in all but one, during childhood. CONCLUSIONS: A history of physical and/or sexual abuse has a high prevalence in Italian patients with chronic gastrointestinal disorders, irrespective of organic or functional diagnosis. Abuse history has no relevant role in the pathogenesis of either functional or organic chronic gastrointestinal disorders but it can affect their clinical expression irrespective of functional or organic diagnosis. Severe physical and sexual abuse and childhood abuse were found in patients who met diagnostic criteria for somatization disorder, suggesting a role of abuse history in this subset of patients.

Adolescent↗
PubMed2003

Sphincter of Oddi dysfunction.

Biliary-like pain alone, or associated with a transient increase in liver or pancreatic enzyme, may be the clinical manifestations of sphincter of Oddi dysfunction. Since it is not always possible to dissociate functional conditions from subtle structural changes, the term sphincter of Oddi dysfunction is used to define motility abnormalities caused by 'sphincter of Oddi stenosis' and 'sphincter of Oddi dyskinesia'. Both sphincter of Oddi stenosis and sphincter of Oddi dyskinesia may account for obstruction to flow through the sphincter of Oddi and may thus induce retention of bile in the biliary tree and pancreatic juice in the pancreatic duct. Most of the clinical information concerning sphincter of Oddi dysfunction refers to post-cholecystectomy patients who have been arbitrarily classified according to clinical presentation, laboratory results and endoscopic retrograde cholangiopancreatography findings in: (a) biliary type I, (b) biliary type II, and (c) biliary type III. Prevalence of biliary-type of pain has been reported to vary from 1 to 1.5% in unselected postcholecystectomy people, to 14% in a selected group of patients complaining of postcholecystectomy symptoms. The frequency of sphincter of Oddi dysfunction, as shown by manometry, differs in the different clinical subgroups: 65-95% in biliary group I, mainly due to sphincter of Oddi stenosis; 50-63% in biliary type II, and 12-28% in biliary type III. In patients with idiopathic recurrent pancreatitis, sphincter of Oddi dysfunction varies from 39 to 90%. Diagnostic work-up of postcholecystectomy patients for suspected sphincter of Oddi dysfunction includes liver biochemistry and pancreatic enzymes, plus negative findings of structural abnormalities. Usually, this would include transabdominal ultrasound and endoscopic retrograde cholangiopancreatography. Depending on the available resources, endoscopic ultrasound and magnetic resonance cholangiography may precede endoscopic retrograde cholangiopancreatography in specific clinical conditions. Quantitative evaluation of bile transit from the hepatic hilum to the duodenum at choledochoscintigraphy appears valuable in the decision to undertake sphincter of Oddi manometry or to treat. Sphincterotomy is the standard treatment for sphincter of Oddi dysfunction. In biliary type I patients, the indication for endoscopic sphincterotomy is straightforward without the need of any additional investigation. Slow bile transit in biliary type II is an indication to undergo endoscopic sphincterotomy without sphincter of Oddi manometry. Slow bile transit in biliary type III patients is an indication to perform sphincter of Oddi manometry. Diagnostic work-up of patients with gallbladder in situ is part of the same diagnostic algorithm that has initially excluded the presence of a gallbladder dysfunction.

Constriction, Pathologic↗
PubMed2002

Outcome of endoscopic sphincterotomy in post cholecystectomy patients with sphincter of Oddi dysfunction as predicted by manometry and quantitative choledochoscintigraphy.

BACKGROUND: Sphincter of Oddi dysfunction is diagnosed at manometry and, after cholecystectomy, non-invasively at quantitative choledochoscintigraphy. Patients may benefit from endoscopic sphincterotomy. AIMS: The aim of this study was to assess the usefulness of choledochoscintigraphy compared with manometry in predicting outcome of sphincterotomy in post cholecystectomy patients with sphincter of Oddi dysfunction. PATIENTS AND METHODS: Thirty patients with biliary-type pain complying with the Rome diagnostic criteria of sphincter of Oddi dysfunction and belonging to biliary group I and II were subjected to clinical evaluation, choledochoscintigraphic assessment of the hepatic hilum-duodenum transit time, endoscopic retrograde cholangiopancreatography, and perendoscopic manometry. Twenty two biliary group I and II patients with prolonged hepatic hilum-duodenum transit times were invited to undergo sphincterotomy. Fourteen patients underwent sphincterotomy; eight refused. Clinical and scintigraphic assessments were performed at follow up. RESULTS: Hepatic hilum-duodenum transit time was delayed in all patients with manometric evidence of sphincter of Oddi dysfunction, in all biliary group I patients and in 64% of biliary group II patients. At follow up, all patients who underwent sphincterotomy were symptom free and hepatic hilum-duodenum transit time had either normalised or significantly improved. A favourable post sphincterotomy outcome was predicted in 93% of cases at choledochoscintigraphy and in 57% at manometry. CONCLUSIONS: Quantitative choledochoscintigraphy is a useful and non-invasive test to diagnose sphincter of Oddi dysfunction as well as a reliable predictor of sphincterotomy outcome in post cholecystectomy biliary group I and II patients, irrespective of clinical classification and manometric findings.

Adult↗
PubMed2001

Small intestine contrast ultrasonography (SICUS) in the diagnosis of small intestine lesions.

After the ingestion of iso-osmolar polyethylene glycol solution, the small bowel can be visualized on ultrasonography. The aim of this study was to assess sensitivity and specificity of SICUS in diagnosis of small bowel lesions. A total of 53 consecutive patients with suspected intestinal pathology underwent a diagnostic workup, including a small bowel follow-through and SICUS performed by independent operators. The sonologist was unaware of the clinical data. Diagnostic sensitivity and specificity were assessed using radiologic findings. Diagnostic sensitivity of SICUS was 100%, with a specificity of 97%. The concordance index was 0.956 (p < 0.003, kappa statistics) and the conformity between SICUS and radiology was 1. The diagnostic accuracy of SICUS to detect small bowel lesions is comparable to that of small bowel follow-through. Results of this study support the use of noninvasive, widely available, inexpensive, and nondemanding SICUS as an initial investigation in patients with suspected small bowel disease.

Adolescent↗
PubMed2001

Neurologic disorders affecting the anorectum.

Neurologic disorders that affect the brain, spinal cord, or extrinsic innervation may present with similar symptoms and share common pathophysiology, such as rectal impaction, loss of an urge to defecate, inability to trigger a defecation sequence, obstructive defecation, or incontinence. If these symptoms are persistent or bothersome, they require treatment. The management of a patient with neurologic anorectal dysfunction depends on the underlying pathophysiologic mechanisms. Dietary advice, bowel training, pharmacotherapy, and rehabilitative treatment may be used alone or in combination.

Defecation↗
PubMed2001

Increased sphincter of Oddi basal pressure in patients affected by gall stone disease: a role for biliary stasis and colicky pain?

BACKGROUND AND AIMS: Even if the motor activity of the gall bladder and sphincter of Oddi (SO) are integrated, it is not known if the presence of stones in the gall bladder affects SO function. The aim of the study was to compare SO motor activity in patients with and without gall stones. PATIENTS AND METHODS: In a series of 155 patients consecutively submitted to endoscopic retrograde cholangiopancreatography and SO manometry for suspected biliary or pancreatic disease, 23 gall stone patients had recurrent episodes of biliary or pancreatic pain (colicky group); 52 patients had non-biliary/pancreatic-type abdominal pain/discomfort, and of these, 15 had gall stones (non-colicky group), 25 were free of stones (controls), and 12 had undergone cholecystectomy. RESULTS: SO basal pressure in gall stone patients in the colicky or non-colicky group was significantly higher than in controls (p<0.001). SO basal pressure recorded in postcholecystectomy patients did not differ from controls. SO phasic activity did not differ between the patient groups. SO dysfunction was detected in more than 40% of gall stone patients irrespective of associated biliary/pancreatic pain but in none of the control subjects (p<0.001). CONCLUSIONS: Gall stones are frequently associated with increased SO tone which may obstruct bile flow thus acting to facilitate gall bladder stasis, and may play a role as a cofactor in biliary/pancreatic pain.

Adolescent↗
PubMed2000

Anorectal function in multiple system atrophy and Parkinson's disease.

This study was designed to investigate anorectal function in Parkinson's disease and multiple system atrophy (MSA). After a standardized interview, 17 patients with Parkinson's disease (PD) and 16 patients with multiple system atrophy (MSA) underwent anorectal manometry with a continuously perfused multi-lumen catheter, located to record pressures from the anal canal, and a balloon for rectal distension. Data were analyzed by observers blind to the neurologic diagnosis. Disease duration was shorter in the MSA than in the PD group (6+/-4 versus 10+/-5 yrs, p<0.05). Most patients reported a bowel frequency of less than three evacuations per week and some patients had fecal incontinence. Most manometric recordings disclosed an abnormal pattern during straining (a paradoxic contraction or lack of inhibition) in 13 patients with MSA and 11 patients with PD. Mean anal pressures and rectal sensitivity threshold were not significantly higher in the MSA group, whereas the inhibitory anal reflex and rectal compliance thresholds were within the normal range in both groups. Manometric patterns did not differentiate patients with MSA from patients with PD. Most patients in both groups showed an abnormal straining pattern, decreased anal tone, or both dysfunctions. In conclusion, our findings suggest that although bowel and anorectal dysfunctions do not differentiate MSA from PD, both abnormalities occur earlier and develop faster in MSA than in PD.

Aged↗
PubMed2000

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.

Adolescent↗
PubMed2000

Small intestine contrast ultrasonography.

The entire small bowel can be visualized on ultrasonography after ingestion of nonabsorbable, isosmotic polyethylene glycol electrolyte balanced oral solution, termed small intestine contrast ultrasonography. The aims of this study were to assess whether the ingestion of different volumes of sonographic contrast solution may differently affect (1) small bowel distention and thus its sonographic appearance and (2) the time to visualize the entire small intestine. An additional aim was to identify the minimal amount of contrast solution necessary to visualize the entire small bowel. An ultrasonographic examination of the abdomen was performed twice in six healthy subjects after the ingestion of the isosmotic polyethylene glycol solution. During the first investigation each subject was asked to drink increasing amounts of sonographic contrast solution until the jejunum was visualized at ultrasonography. During the second investigation each subject was asked to drink increasing amounts of sonographic contrast solution, not to exceed a total volume of 260 ml. At the first examination the entire small bowel was visualized 39.3 +/- 17 min after ingestion of 647 +/- 105 ml of contrast solution. At the second examination the entire small bowel was visualized 43.5 +/- 13.5 min (not significant with respect to the first study) after the ingestion of 239 +/- 32 ml of contrast solution (P < 0.01 versus the first study). The mean luminal diameter and wall thickness at three intestinal levels did not differ in the two studies and were not statistically related to the amount of ingested sonographic contrast solution. Loose stools were the only side effect and were reported after the ingestion of more than 600 ml. Ultrasonography offers reproducible information on the morphology of the contrast agent-filled small bowel after ingestion of a wide range of volumes (175 to 820 ml) of isosmotic polyethylene glycol electrolyte balanced solution. On average, the entire small intestine could be visualized on ultrasonography by about 45 min after the ingestion of 600 ml or less of contrast solution without any side effects.

Adult↗
PubMed1999

Biliary tract imaging.

In addition to the detection of gallstones, common bile duct stones, and narrowed and dilated bile ducts, recent advancements in imaging techniques now make it possible to diagnose microlithiasis, pathology of normal-size ducts, and dysfunction of the gallbladder and the sphincter of Oddi (SO). More and more frequently, noninvasive imaging techniques obviate the risk of invasive investigation. These techniques can also take the place of unsuccessful or contraindicated direct cholangiography, and they play an essential role in treatment planning and diagnosis of postoperative complications. Transabdominal ultrasonography (TUS) remains fundamental for initial assessment of the biliary tract. Technical developments make magnetic resonance cholangiopancreatography the most promising diagnostic technique of the biliary tract. Endoscopic ultrasonography (EUS) is most helpful for detection of microlithiasis and evaluation of the ampullary region, the periductal structures, and the regional lymph nodes in neoplastic diseases. Cholescintigraphy is most valuable to assess bile dynamics in the diagnosis of gallbladder and SO dysfunction and in postoperative bile leakage.

Biliary Tract Diseases↗
PubMed1999

Contrast ultrasonography of the normal small bowel.

In basal conditions, the small bowel loops cannot be properly visualized by means of real-time ultrasound (US). Aims of this study were: 1. to assess whether an isosmolar solution containing a nondigestable, nonabsorbable and nonfermentable hydrophilic macro molecule, such as polyethylene glycol (PEG), can be profitably used as a contrast agent to visualize the entire small intestine with US (small intestine contrast ultrasonography, SICUS); and 2. to define the normal US values of wall thickness and luminal diameter of the jejunum, ileum and terminal ileum. Real-time ultrasonography was performed in 10 healthy volunteers with 4-and 5-MHz linear-array transducers in basal fasting conditions and after ingestion of an isosmolar PEG solution. In basal fasting conditions, only a few segments of jejunum and/or ileum could be visualized in some of the investigated subjects. After ingestion of the contrast solution, the entire small bowel could be visualized in any single subject. A contrast sonography of the entire small bowel could be satisfactorily performed with 200 mL-820 mL of contrast solution in a time period that did not exceed 65 min. Luminal diameter at the level of the jejunum (19 +/- 2.3 mm) and proximal ileum (18 +/- 1.8 mm) was significantly greater (p < 0.01) than at the level of distal ileum (16.4 +/- 2.8 mm). Wall thickness was greater at the level of the terminal ileum (2 +/- 0.4 mm) than of the jejunum (1.6 +/- 0.5 mm) but the difference did not reach statistical significance. Details such as valvulae conniventes and multilayered structure of the wall could be recognized. In conclusion, after the ingestion of an isosmolar PEG electrolyte balanced solution, it is possible to visualize with ultrasonography the entire small intestine and to measure wall thickness and luminal diameter of the jejunum, the ileum and the terminal ileum. Such a noninvasive, inexpensive method can be used to investigate the morphological aspects of the small bowel.

Adult↗
PubMed1999

Functional disorders of the biliary tract and pancreas.

The term "dysfunction" defines the motor disorders of the gall bladder and the sphincter of Oddi (SO) without note of the potential etiologic factors for the difficulty to differentiate purely functional alterations from subtle structural changes. Dysfunction of the gall bladder and/or SO produces similar patterns of biliopancreatic pain and SO dysfunction may occur in the presence of the gall bladder. The symptom-based diagnostic criteria of gall bladder and SO dysfunction are episodes of severe steady pain located in the epigastrium and right upper abdominal quadrant which last at least 30 minutes. Gall bladder and SO dysfunctions can cause significant clinical symptoms but do not explain many instances of biliopancreatic type of pain. The syndrome of functional abdominal pain should be differentiated from gall bladder and SO dysfunction. In the diagnostic workup, invasive investigations should be performed only in the presence of compelling clinical evidence and after non-invasive testing has yielded negative findings. Gall bladder dysfunction is suspected when laboratory, ultrasonographic, and microscopic bile examination have excluded the presence of gallstones and other structural abnormalities. The finding of decreased gall bladder emptying at cholecystokinin-cholescintigraphy is the only objective characteristic of gall bladder dysfunction. Symptomatic manifestation of SO dysfunction may be accompanied by features of biliary obstruction (biliary-type SO dysfunction) or significant elevation of pancreatic enzymes and pancreatitis (pancreatic-type SO dysfunction). Biliary-type SO dysfunction occurs more frequently in postcholecystectomy patients who are categorized into three types. Types I and II, but not type III, have biochemical and cholangiographic features of biliary obstruction. Pancreatic-type SO dysfunction is less well classified into types. When non-invasive investigations and endoscopic retrograde cholangiopanreatography show no structural abnormality, manometry of both biliary and pancreatic sphincter may be considered.

Biliary Tract Diseases↗